MANNHEIM, Germany – April 26, 2019 — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments to address functional mitral regurgitation (FMR) in patients with heart failure (HF), presented new data confirming significant reduction in regurgitant volume directly after implantation of the Carillon® Mitral Contour System® at the German Society of Cardiology annual congress, DGK 2019. The Carillon® System is a right-heart transcatheter mitral valve repair (TMVr) device designed to treat the primary cause of FMR in patients with MR grades 2+, 3+ and 4+.

Prof. Dr. Andreas Hagendorff, Head of Laboratory of Echocardiography of the Department of Cardiology-Angiology at the University of Leipzig and renowned echo-cardiologist led the study. “Functional mitral regurgitation is associated with increased morbidity and mortality in patients with heart failure. For patients ineligible to receive surgical treatment, interventional techniques represent a new therapy option.” Prof. Hagendorff continued, “The findings we presented confirmed the acute hemodynamic effects of the Carillon® device on mitral valve morphology and demonstrated an acute reduction in a regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation.”

“The significant acute MR benefit demonstrated in our study, achieved by a device that cinches the mitral apparatus via the coronary sinus without compromising the valve or future treatment options, makes the Carillon® System a front-line treatment option for FMR patients,” added Dr. Stephan Stoebe, co-author and presenter at DGK.

Presentations highlighting the Carillon® System this week during DGK 2019 include:

25 April 2019: New Devices and Therapies for Mitral Valve Insufficiency
Treatment of functional mitral regurgitation by the Carillon® Mitral Contour Device – an echocardiographic analysis of acute effects. S. Stöbe, K. Kreyer, U. Laufs, A. Hagendorff

26 April 2019: Functional MI in Heart Failure: Interventional Differential Therapie
Background on the Carillon® Mitral Contour System® & REDUCE FMR. H. Sievert
Carillon® Mitral Contour System® Live Case. M. Haude
Atrium-Triggered Annulus-Extension. M. Reinthaler
Combo-Cases – MitraClip & Carillon, Carillon® & MitraClip R. S. von Bardeleben
(select presentations from DGK 2019 can be found at DGK 2019 Presentations)

“We are pleased with the results from the University of Leipzig study validating the immediate impact of the Carillon® System on mitral regurgitation for a large percentage of FMR patients,” said Greg Casciaro, President and CEO of Cardiac Dimensions. “This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR – a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart.”

About the Carillon® Mitral Contour System
The Carillon® System offers a simple right-heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and improve the function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.^1,2 The Carillon® System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and reverse left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy ^3,4,5.

The Carillon® System has CE Mark (0344) approval and has been implanted in over 950 patients in Europe, Australia, Turkey, and the Middle East. The Carillon® System is not approved for sale in the United States.

About Cardiac Dimensions, Inc.
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company is funded by Aperture Venture Partners, Arboretum Ventures, Difference Capital, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia, and Germany.

Media Contact
Rick Wypych
rwypych@cardiacdimensions.com
(425) 605-5910

1. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
2. Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
3. Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3: e000411.
4. Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
5. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.

Related Article: Cardiac Dimensions Announces Positive Late-Breaking Results for Blinded Clinical Trial of Minimally Invasive Heart Failure Treatment

Funding supports Phase 3 development of STS101 for the acute treatment of migraine, including pivotal Phase 3 efficacy trial with planned initiation in Q3 2019

SOUTH SAN FRANCISCO, Calif., April 24, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma” or “the Company”), a clinical-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced a $62 million Series B preferred stock financing led by Wellington Management Company, with participation by existing investors RA Capital Management, TPG Biotech, and Shin Nippon Biomedical Laboratories, and new investors, Osage University Partners, CAM Capital, Surveyor, Eventide Asset Management, Cormorant, Lumira Ventures, and SBI Investment. 

Financing proceeds will support Phase 3 development of STS101. In consultation with the FDA, Satsuma has established key elements of its Phase 3 development program, including the design of the Phase 3 efficacy study, to support a New Drug Application (NDA) for STS101 for the acute treatment of migraine. Satsuma plans to initiate its randomized, double-blind, placebo-controlled Phase 3 clinical trial of STS101 in the third quarter of 2019. 

John Kollins, President and Chief Executive Officer of Satsuma, commented, “As we advance STS101 into Phase 3 development, we are privileged to have strong support from top-tier healthcare investors who share our vision of creating a best-in-class DHE therapeutic product with differentiated and demonstrated clinical benefits that address the unmet needs of many people with migraine.” 

About Satsuma Pharmaceuticals

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing STS101 as an important and differentiated therapeutic option for the acute treatment of migraine.  STS101 is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug, dihydroergotamine (DHE), with a pharmacokinetic profile optimized to provide consistent and robust clinical efficacy.  In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, self-administered, and non-injectable DHE product.  The Company believes STS101 will be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy.  STS101 has undergone extensive pre-clinical optimization and recently completed a Phase 1 clinical trial. 

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. 

CORPORATE CONTACTS:      

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

John Kollins, President and Chief Executive Officer
Satsuma Pharmaceuticals, Inc.
john@satsumarx.com

Related Article: Satsuma Pharmaceuticals Provides Corporate Update and Prepares to Advance Lead Product Candidate, STS101, Into Phase 3 Efficacy Trial for Acute Migraine

LISLE, Ill., April 24, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that the company received ISO 13485:2016 certification from British Standards Institution (BSI) for its Quality Management System (QMS). Endotronix’s adherence to internationally recognized standards for the medical device industry demonstrates its commitment to the highest level of product quality. They have developed a comprehensive heart failure solution, the Cordella™ Heart Failure System (Cordella System), which consists of a remote patient management platform and the implantable Cordella™ Pulmonary Artery Pressure Sensor (Cordella Sensor).

“We are focused on executing several key business, regulatory, and clinical milestones this year that ultimately drive the success of the company. The recent ISO certification ensures we are fully aligned with global regulatory requirements to provide a best-in-class product quality experience to our customers,” commented Harry Rowland, CEO of Endotronix. “Similarly, we continue to make excellent progress with our comprehensive clinical program, which will show the real-world benefits of the Cordella System and create U.S. and E.U. market access for the Cordella Sensor.”

The Cordella System is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The system can be seamlessly integrated with a next generation pulmonary artery (PA) pressure sensor, the Cordella Sensor, to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery activities.

The Cordella System is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella Sensor is an investigational device and is not available for commercial use in any geography.

About Endotronix

Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from chronic heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data platform and at-home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure.

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting, LLC
+1 (847) 951-7430

Related Article: Endotronix Raises $45 Million in Series D Financing for  the Treatment of Heart Failure

• Investigator-initiated trial to evaluate AVID200’s safety, anti-fibrotic activity, and ability to restore hematopoiesis in patients with myelofibrosis
• AVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal drivers of fibrosis in myelofibrosis and other fibrotic diseases
• AVID200 spares TGF-beta 2, the isoform that promotes hematopoiesis and normal cardiac function

Austin, TX and Montreal, QC (Apr. 24, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, announced today that the first patient has been dosed in a Phase 1b trial assessing AVID200, a novel TGF-beta 1 & 3 inhibitor, in patients with myelofibrosis (MF). This multicenter trial is sponsored by the Icahn School of Medicine at Mount Sinai and the Myeloproliferative Neoplasm Research Consortium (MPN-RC), with the support of a peer-reviewed NIH grant.

AVID200’s novel dual mode of action in MF centers around its anti-fibrotic effects and ability to restore hematopoiesis, as demonstrated in MF patient cells and in vivo models of the disease (Varricchio et al., 2018). Notably, treatment of cells from MF patients with AVID200 promoted proliferation of normal hematopoietic progenitors while decreasing the proportion of MF malignant progenitor cells.

“This clinical trial will evaluate the ability of AVID200 to achieve the disease-modifying outcomes of reversing bone marrow fibrosis and restoring normal hematopoiesis. Preclinical data demonstrate that selective neutralization of TGF-beta 1 & 3 by AVID200 results in both of these critical outcomes. We believe that AVID200 has the potential to become the first disease-modifying treatment for MF,” commented Dr. Ronald Hoffman, founder of the MPN-RC and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai.

The single-arm, dose-escalation Phase 1b trial (AVID200-02; NCT03895112) plans to enroll up to 24 patients with primary MF, post-essential thrombocythemia MF, or post-polycythemia vera MF with > grade 2 bone marrow fibrosis. Outcome measures include safety, response, clinical and hematological improvement, as well as assessment of the degree of bone marrow fibrosis.

About AVID200 and the AVID200-02 Trial

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3, the two principal pro-fibrotic TGF-beta isoforms. These TGF-beta isoforms are central regulators in the pathogenesis and progression of fibrotic diseases, including MF (Chagraoui et al., 2002). AVID200 was rationally designed to be minimally active against TGF-beta 2, which is a promoter of hematopoiesis and normal cardiac function. This optimal selectivity positions AVID200 to be an effective and well-tolerated therapeutic for MF and other fibrotic diseases.

AVID200-02 (NCT03895112) is an investigator-initiated, open-label, multicenter, Phase 1b trial to evaluate the safety and anti-fibrotic activity of AVID200, as well as its ability to restore normal hematopoiesis in patients with MF.

About the Myleoproliferative Neoplasm Research Consortium (MPN-RC)

The MPN-RC was founded in 2006 and is the only independent, multicenter, international consortium of scientists and clinicians dedicated to developing novel therapeutic strategies for MF and other myeloproliferative neoplasms (MPN). The MPN-RC is funded by the NIH to conduct clinical trials based on the most promising preclinical MPN research. The goal of the consortium is to adapt quickly in response to scientific advances and a changing clinical landscape, in order to develop effective therapeutics for MPN patients.

About Myelofibrosis (MF)

MF is a rare, life-threatening blood cancer characterized by progressive bone marrow fibrosis, which causes ineffective hematopoiesis. Approximately 30,000 people in the US alone are affected by this disease. Currently, there are no approved therapies targeting the underlying bone marrow fibrosis available to MF patients.

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

Related Article: 

Forbius Announces a Clinical Trial Collaboration with the Myeloproliferative Neoplasm Research Consortium to Evaluate AVID200

A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits

SAN CARLOS, Calif., April 23, 2019 /PRNewswire/ — BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced today that the U.S. Food and Drug Administration (FDA) has approved the TransPyloric Shuttle^® (TPS^®) Device , a non-surgical weight loss solution for adult individuals suffering from obesity with a body mass index (BMI) of 30 to 40 kg/m². The device is approved for up to 12 months of treatment, during which time patients undergo lifestyle modification counseling to help develop and maintain healthier habits.

The TPS® device is delivered and retrieved endoscopically and relies on its mechanical structure to maintain its shape to keep it in the stomach as opposed to traditional inflatable intragastric balloons. The constructed TPS® is the size of a small peach (~5.6 cm in diameter), 85-90% smaller than the fluid-filled balloons. Once in stomach, it is designed to slow the passage of food so patients feel full sooner and stay full longer. The 12-month treatment duration is twice as long as intragastric balloons currently approved in the U.S. The longer treatment duration potentially allows patients the opportunity to achieve more durable lifestyle changes and health benefits.

“Those of us who participated in the pivotal trial have the firsthand experience with the TPS® device and were pleased with its patient outcomes. In addition to the clinically meaningful weight loss seen in the study group who received the device, we also observed cardio-metabolic improvements in that cohort. We are excited to see that the device is approved by the FDA and look forward to using it in our clinical practice.” said Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study.

Obesity is one of the biggest drivers of the healthcare costs in the U.S., currently estimated as much as $210 billion annually. Effectively treating this condition will have a substantial impact on controlling ever-increasing healthcare costs.

“The vast majority of patients with obesity are left untreated today. Endoscopically delivered intragastric devices can help close the obesity treatment gap and offer alternative options for qualified patients who are not eligible, or unwilling, to undergo metabolic and bariatric surgery. The TPS device design addresses some of the limitations with the first-generation intragastric devices and offers longer treatment duration which is clinically attractive.” commented Dr. Wayne English, Associate Professor of Surgery, Clinical Trial Research Director at Vanderbilt University Weight Loss Center, and a principal investigator for the ENDObesity II study.   

 “FDA approval is a significant milestone for the company.” said Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova Inc. “The TPS® device is unique in its treatment efficacy and duration.  Further validation of potential comorbidity benefits, like cardiometabolic improvement observed in the pivotal study, during the post-market phase may translate to important advantages in achieving healthcare coverage for the TPS® device in the future. We look forward to bringing this new technology to patients and physicians.”

The approval of the TPS® is based on data from its pivotal trial (ENDObesity^® II study), a randomized, double-blind, and sham-controlled study that enrolled 302 patients from nine investigational centers across the United States. Patients treated with the TPS® device on average lost 3.4x more weight when compared to the sham-control group (9.5% for the TPS® group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS® lost 5% or more of their body weight, exceeding the study endpoint target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS® lost 10% or more weight (vs. 14% in sham-treated controls). A weight loss of 5% or more is considered clinically meaningful for achieving important health benefits. Improvements in blood pressure and other cardiometabolic risk factors as well as quality of life were also observed with TPS® treatment. The most common adverse events among people treated with the TPS® device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delayed gastric emptying.

About Obesity

Obesity is defined as a Body Mass Index (BMI) >30 kg/m². Individuals with obesity are at increased risk of developing over 70 comorbid conditions including hypertension, hyperlipidemia, and type 2 diabetes. Obesity is a worldwide epidemic that has placed a major burden on healthcare systems globally.  There are currently over 75 million adults in the United States with a BMI between 30-40 kg/m² and over 600 million adults worldwide who are candidates for a safe and effective non-surgical therapy.

About the TransPyloric Shuttle^®(TPS^®)

TPS^® is a novel device that is designed to be inserted and removed trans-orally using standard endoscopic techniques. It is mechanically constructed using solid silicone components and is not subject to inflation or deflation risks. The TPS/TPS® Delivery Device is indicated for weight reduction in adult patients with obesity with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behavior modification program.  The device is intended to reside in the stomach for 12 months.  The TransPyloric Shuttle®’s primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss.

About BAROnova, Inc.

BAROnova is a private medical device company that has developed a first-in-class non-surgical solution for obesity. BAROnova is headquartered in San Carlos, CA.

BAROnova, Inc., Contact:
Public Relations
+1-650-638-9796
inquiry@baronova.com

Related Article: BAROnova’s TransPyloric Shuttle^® (TPS^®) Device Presents Positive Trial Data at the 2018 Obesity Week Conference

• This trial evaluates the efficacy of AVID100 in TNBC patients with EGFR-overexpression
• 20% of TNBC patients highly overexpress EGFR; there is no approved targeted therapy
• AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development, targeting both wild-type and mutant forms of EGFR

Austin, TX, and Montreal, QC (Apr. 22, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced today that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-selective anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC).

Approximately 20% of TNBC patients have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing TNBC (IHC 2+/3+). This is the third cohort that has been launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting ADC engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity in skin or other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

A recommended Phase 2 dose (RP2D) of 220 mg/m² (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment-related adverse events in the Phase 1 trial at the RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is on the development of agents that target the transforming growth factor-beta (TGF-beta) and the epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

Related Article: Forbius’ AVID100 Reports Positive Phase 1 Data at AACR

SEATTLE, April 16, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it has raised $35.5 million in Series B funding, led by River Cities Capital Funds with participation from new investors HealthQuest Capital, Aperture Venture Partners, Aphelion Capital, Lumira Ventures, and Rex Health Ventures. Existing equity investors, SV Health Investors, Health Enterprise Partners, and Ascension Ventures also joined the round. The funds will be used to further accelerate growth of its innovative P-wave focused cardiac monitoring platform through expansion of BardyDx’s sales force and monitoring services, and to support advanced development programs, including augmented intelligence and visualization technologies.

“The caliber of our new investors in addition to our exceptional existing syndicate of financiers underscores the exciting opportunity before us,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of BardyDx. “With these funds, we will grow our business by refining and expanding our primary goal of revealing to patients, and their physicians, the full complexity and meaning of their cardiac rhythm.” 

BardyDx’s Carnation Ambulatory Monitor (“CAM™”) is the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. The genesis of the CAM is a result of Dr. Bardy’s frustrations with the fundamental flaws rooted in the development and evolution of cardiac monitoring.

“For nearly 60 years, standard ECG engineering practices have over-processed the heart’s electrical message to make machines’ ‘lives’ easier at the expense of losing details in the ECG,” added Dr. Bardy. “In essence, such legacy engineering doesn’t listen to what the heart is trying to tell us but rather tells the heart what we are willing to hear. At BardyDx, our pioneering technology focuses on revealing the cardiac rhythm message fully, and in so doing, allows for precise and meaningful patient management predicated on cardiac truth.” 

BardyDx’s footprint within the cardiac monitoring industry continues to expand with growing recognition of the innovative P-wave centric technology. The company was recently selected winner of the Impact Pediatric Health Competition at SXSW, Children’s National Health System Pediatric Medical Device Innovation Competition, and 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation. “Our Series B capital will continue to fuel the technological innovation that Dr. Bardy has always insisted on and for which BardyDx has come to be known,” said Mark Handfelt, BardyDx’s Chief Operating Officer.

BardyDx also announced that Rik Vandevenne, Managing Director of River Cities Capital Funds, and Garheng Kong, Managing Director of HealthQuest Capital, will join the company’s board of directors.

“It’s not every day you have the opportunity to partner with such a groundbreaking serial entrepreneur and innovator as Dr. Gust Bardy and the team at BardyDx,” said Vandevenne. “The company has a clear focus on putting the patient first and they have developed a clinically-superior ECG platform that is revolutionizing heart monitoring. We are excited for the opportunity to help further drive growth for the company while positively impacting the lives of thousands of people every week.”

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac patch and other monitors to the industry. The company’s CAM patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children weighing more than 10kg (22lbs) through its lifestyle-enabling design. Designed to be worn comfortably and discreetly, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis. For more information, please visit www.bardydx.com.

About River Cities Capital Funds:

River Cities is a growth equity firm investing in high-potential healthcare and information technology companies. A consistent, cohesive team has honed its strategy over six funds with compelling performance. River Cities seeks to be a business partner first and a capital provider second, investing significant human capital to leverage its domain expertise and a network of thought leaders assembled over the last 25 years. With $750 million of capital raised and a consistent track record of success, River Cities has established itself as a preferred source of growth capital. The firm, located in Cincinnati, OH and Raleigh, NC, is actively seeking new investments for its Fund VI. For more information, please visit www.rccf.com.

MEDIA CONTACT:

Jonathan Wu
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

SOURCE: Bardy Diagnostics Inc.

VICTORIA, British Columbia–(BUSINESS WIRE) — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late clinical-stage biopharmaceutical company focused on the global immunology market, today announced the appointment of Mr. Peter Greenleaf as Chief Executive Officer and as a Director on the Aurinia Board. The Company also announced the elevation of George M. Milne, Jr., Ph.D. to Chairman of the Board of Directors. Dr. Richard M. Glickman, who previously announced his plans to retire on November 6, 2018, will step down from his role as Chairman and CEO concurrent with Mr. Greenleaf’s appointment on April 29, 2019, and will remain an advisor to the Company for a period of 12 months.

With more than twenty years of experience leading pharmaceutical and biotech firms, Mr. Greenleaf most recently served as the CEO of Cerecor, a leading U.S. pediatric orphan and rare disease pharmaceutical company. Prior to that, Mr. Greenleaf was the Chairman and CEO of Sucampo Pharmaceuticals which he led through the successful sale to Mallinckrodt Pharmaceuticals, PLC for $1.2B. Previously, Mr. Greenleaf served as the CEO and Board member of Histogenics, a regenerative medicine company. Prior to that he was the President of MedImmune, Inc, the global biologics arm of AstraZeneca, and President of MedImmune Ventures, a wholly owned venture capital fund within the AstraZeneca Group, where he led investment in emerging biopharmaceutical, medical device, and diagnostic companies.

“It is a pleasure to welcome Peter as the next Chief Executive Officer of Aurinia. As a seasoned leader in the pharmaceutical industry, Peter’s extensive knowledge of clinical and overall operations, along with business development and commercialization expertise, are ideally aligned with the next stages of growth for voclosporin and Aurinia,” stated Dr. George Milne, incoming Chairman of the Board of Aurinia Pharmaceuticals.

“The Aurinia team has made extraordinary progress with voclosporin, which I believe to be a truly transformative drug for the potential treatment of proteinuric kidney diseases, such as lupus nephritis (“LN”), as well as a unique opportunity for the treatment of dry eye syndrome (“DES”),” commented Mr. Greenleaf. “To that end, I am very excited to lead the Company at this pivotal time and through several critical datapoints over the next year including Phase 3 trial results by the end of 2019, followed by the planned regulatory submission and preparations for the potential commercialization of voclosporin during 2020.”

Dr. Milne further commented, “I am also humbled to be assuming the Chairman role from Dr. Glickman. On behalf of the entire board and organization, I would like to thank Dr. Glickman for all of his efforts and contributions that have brought Aurinia to where it is today. As we wish him all the best on his retirement, we are also gratified to have his insight as an advisor for the next year.”

Dr. Glickman stated, “Consistent with the succession planning set into motion last November, I am confident that Peter is the correct individual to lead Aurinia through the next set of value inflection points including the upcoming AURORA Phase 3 results, preparing for the potential launch of voclosporin, and expansion of the VOS dry eye syndrome program.”

About Mr. Peter Greenleaf

Peter Greenleaf previously served as CEO of Cerecor, Inc., since March 2018. Prior to that he served as Chairman and CEO of Sucampo Pharmaceuticals, Inc. from March 2014 to February 2018, when Sucampo was sold to Mallinckrodt PLC. Previously, Mr. Greenleaf served as CEO of Histogenics Corporation from June 2013 to March 2014, as President of MedImmune, Inc., and MedImmune Ventures from 2010 to June 2013, and Senior Vice President, Commercial Operations of MedImmune from 2006 to 2010. Mr. Greenleaf also held senior commercial roles at Centocor Biotech, Inc. (now Janssen Biotechnology, Johnson & Johnson), from 1998 to 2006, and at Boehringer Mannheim G.m.b.H. (now Roche Holdings) from 1996 to 1998. Mr. Greenleaf is a member of the Board of Directors of Cerecor since May 2017, is the Chairman of the Board of Bio-delivery Sciences since May 2018, EyeGate Pharmaceuticals since August 2018, and Antares Pharma since December 2018. Mr. Greenleaf chairs the Maryland Venture Fund Authority, and previously served on the boards of BIO, PhARMA, the Tech Council of Maryland and the University of Maryland Baltimore Foundation, Inc. Mr. Greenleaf earned an MBA degree from St. Joseph’s University and a BS degree from Western Connecticut State University.

About George M. Milne, Jr., Ph.D.

Dr. Milne was appointed to the Aurinia Board of Directors in May 2017 and serves as Chair of the Company’s Governance & Nomination Committee. Dr. Milne has over 30 years of experience in pharmaceutical research and product development. He joined Pfizer in 1970 and held a variety of positions conducting both chemistry and pharmacology research. Dr. Milne became director of the department of immunology and infectious diseases at Pfizer in 1981, was its executive director from 1984 to 1985, and was vice president of research and development from 1985 to 1988. He was appointed senior vice president in 1988. In 1993 he was appointed President of Pfizer Central Research and a senior vice president of Pfizer with global responsibility for human and veterinary medicine research and development. Dr. Milne has served on multiple corporate boards including Mettler-Toledo, Inc., MedImmune, Athersys, Biostorage Technologies, Aspreva, and Conor Medsystems. Dr. Milne received his B.Sc. in Chemistry from Yale University and his Ph.D. in Organic Chemistry from MIT.

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing voclosporin, an investigational drug, for the potential treatment of LN, Focal Segmental Glomerulosclerosis (“FSGS”), and DES. The Company is headquartered in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowanceis expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: voclosporin being a transformative drug for the potential treatment of proteinuric kidney diseases, such as lupus nephritis, as well as a unique opportunity for the treatment of dry eye syndrome; results from the Company’s Phase 3 trial in lupus nephritis by the end of 2019; timing for regulatory approval and commercialization of voclosporin for use in lupus nephritis; patent protection for voclosporin being extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 and until April 2028 with an anticipated pediatric extension; and intellectual property protection for voclosporin being extended to December 2037 in respect of a patent anticipated to be issued in connection with a new Notice of Allowance. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the costs and expenses associated with Aurinia’s clinical trials; Aurinia receiving approval from regulators to proceed with commercialization; Aurinia being able to complete its clinical trials in a timely fashion; Aurinia being able to extend its patents on terms acceptable to Aurinia; and the validity of our patents. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our AURORA clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN business may not be as estimated; and regulatory authorities not granting approval for use of voclosporin in a commercial manner, or not granting patents or extensions for patents at all or as Aurinia currently anticipates. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website.

We seek Safe Harbor.

Investor Contact:

Glenn Schulman, PharmD, MPH
Corporate Communications
gschulman@auriniapharma.com

Media Contact:

Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com

Related Article: Aurinia Announces Voclosporin Ophthalmic Solution Demonstrates Statistically Superior Efficacy vs. Restasis® in Phase 2 Head-to-Head Study for the Treatment of Dry Eye Syndrome

QUEBEC CITY, April 11, 2019 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the second quarter of 2019.

HIGHLIGHTS

• Consolidated revenues totaled $7.9M in the second quarter of 2019 compared with $5.4M in the corresponding period in 2018, an increase of $2.5M or 46%;
• Fractional Flow Reserve (“FFR”) revenues of $4.9M for the second quarter 2019 compared with $3.3M for the same period last year, an increase of 48%;
• Appointment of Alan Milinazzo as Executive Chairman of the Board of Directors;
• $8M credit agreement with CIBC Innovation Banking;
• Opsens’ dPR welcome in the interventional cardiology community in Japan, EMEA and Canada.

GROWTH STRATEGY

Opsens’ revenues reached a record level, a result of the growth of its medical business lines. FFR revenues increased by 48% year over year. “These results reflect cardiologists’ acceptance of the OptoWire’s distinctive features and the optimization of our sales approach deployed in the past year,” said Louis Laflamme, President and Chief Executive Officer of Opsens. “We are also pleased to report that our dPR, designed to assess intracoronary pressure without the injection of drug-stimulating medication, is gaining traction in the market,” he added.

“We continue to focus on improvements processes in sales, production and on driving innovation to capitalize on the growing physiology measurement market in cardiology,” concluded Mr. Laflamme.

Opsens’ product sales reached $7.2M in the three-month period ended February 28, 2019 compared with $5.3M in the same period the previous year. This increase is mainly explained by an increase in FFR revenues compared with the same quarter the year before. In addition, the Company recorded non-recurring license revenue of $0.7M ($0.1M for the same quarter last year) for consolidated total revenues of $7.9M ($5.4M for last year) for the quarter.

Gross margin increased to $4.6M for the quarter ended February 28, 2019 from $2.8M in the same period last year. Non-recurring licensing revenues accounted for $0.6M of this increase.

Net loss totaled $0.4M for the three-month period ended February 28, 2019, compared with a net loss of $1.3M for the same period last year.

As of February 28, 2019, the Company had a cash position of $10.3M ($10.9M as of August 31, 2018).

About Opsens Inc.

Opsens Inc. focuses mainly on the measure of FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 60,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

For Additional Inquiries contact:

Louis Laflamme, CPA, CA
Chief Executive Officer
418-781-0333

Robin Villeneuve, CPA, CA
Chief Financial Officer
418-781-0333

SOURCE: Opsens Inc. 

Related Articles:

Opsens – 50,000 Patients Diagnosed with OptoWire
Opsens Inc. Opens the Market

Breakthrough medical platform offers vision of personalized tumor treatments with its novel sonic beam therapy

ANN ARBOR, MICHIGAN // Apr. 8, 2019 – HistoSonics, developer of a non-invasive robotics platform and novel beam therapy, announced today that it has closed a $54 million Series C financing. The round was led by Varian Medical Systems, Inc., the global leader in radiation therapy and oncology solutions, and included healthcare investors Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Lumira Ventures, Venture Investors, the State of Wisconsin Investment Board, as well as participation from existing investors. The financing also included robotics pioneer Fred Moll, M.D., founder of Intuitive Surgical and Chairman and CEO of Auris Health. HistoSonics plans to use the proceeds of the financing to complete key regulatory and commercial milestones and expand development of its breakthrough platform.

“We believe that the HistoSonics platform offers a unique solution and significant promise to treat patients with a number of different diseases across global markets and care settings,” commented Greg Sorensen, Vice President of Strategy and Business Development at Varian and new HistoSonics Board of Directors member. Also joining the company’s Board as part of the financing are Gerry Brunk, Managing Director of Lumira Ventures, and an appointee from JJDC.

HistoSonics’ non-invasive platform, Robotically Assisted Sonic Therapy (RAST)™, combines advanced robotics and imaging with proprietary sensing technology to deliver personalized treatments with unparalleled precision and control, and uses the science of histotripsy and focused sound energy to generate pressures strong enough to liquify and completely destroy targeted tissues at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients, including the ability of the treatment site to recover and heal quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

“We are very excited to be adding this group of experienced investment partners who share in our vision and mission,” said President and CEO Mike Blue. “RAST™ will offer transformative change for both patients and physicians and will help overcome many of the major limitations and side effects of today’s cancer therapies. It has also shown great promise to work synergistically with other therapies and platforms, such as drug and immunotherapy, a big focus of our preclinical work, as well as with other surgical robotic platforms. We are confident that RAST™ will provide an entirely new experience for patients and physicians, as well as a more cost-effective alternative that better aligns with value-based healthcare initiatives, and we are thrilled to have such a strong syndicate joining us on this journey.”

The new financing follows a year of impressive progress at HistoSonics. The company achieved significant development milestones and generated compelling early clinical evidence, as well as continued to add deep domain experience and industry leadership to its team. HistoSonics was also recognized as one of the most promising start-ups with a top 10 ranking in The Observer’s “Top 20 Flyover Tech”.

“Venture Investors has been an investor in HistoSonics from the start,” added Jim Adox, Chairman of the Board “and it is incredibly exciting to see the progress we have made over the past several years. The vision of the company from the very beginning has been to develop a true platform that will revolutionize how patients are treated across a broad spectrum of diseases, including some of the most significant cancers, and it is very gratifying to now see the tremendous advancement of the system as it nears market launch.”

About HistoSonics

HistoSonics is a venture-backed medical device company developing a non-invasive robotic platform and novel beam therapy, Robotically Assisted Sonic Therapy (RAST)™ . RAST™ uses the science of histotripsy and the pressure created by focused sound energy to liquify and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company’s new platform deliverers personalized, tissue specific treatments with unparalleled precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities. Histotripsy was developed at the University of Michigan and exclusively licensed to HistoSonics. The company is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, Michigan and Minneapolis, MN.

For Media Inquiries contact:

Josh King, Vice President of Marketing
Email: joshua.king@histosonics.com
Phone: 608-332-8124

Video Transcript:

Related Article: MAKO Surgical acquired for $1.65 billion by Stryker Corp.

“The MAKO Robot is an essential tool that helps us in surgery when we do a joint replacement like total hips and total knees and partial total knees. For us in this area, we’re the first ones to provide this robotic arm technology to assist surgeons in making their cuts, and their alignments, perfect in every joint, and so what makes it distinct, is that no one else can offer this in the region. Robotics is really important as an assistant tool to the surgeon. The robot doesn’t replace the surgeon, but what it does is provide extra guidance and extra assistance to make sure that every single cut and every alignment is perfect every single time. The MAKO Robot is a really important step in the way we do total joint surgery.”

“Geinsinger has a long history of being at the forefront of technology and innovation. The MAKO Robot is just another small step in that direction. Our founder Abigail Geinsinger said ‘Make it the best’ and there’s no question in my mind that having this as an assistive technology makes our total joint care the best.”

“The ideal candidate would be anybody considering a total joint replacement of their hip or knee today. Because the MAKO robotic procedure is less innovative and allows us to make more accurate cuts, we believe it can lead to faster recovery and better outcomes.”

Michael Suk, MD, Chair of the Geisinger Musculoskeletal Institute and the Department of Orthopaedic Surgery

SOURCE: Geisinger

• AVID100 is the only clinical-stage anti-EGFR ADC that targets both wild-type and mutant forms of EGFR with limited off-tumor toxicity due to novel mechanism of action
• Phase 1 confirmed that AVID100 was well-tolerated and established a recommended phase 2 dose (RP2D) of 220 mg/m² (~6 mg/kg) q3w, one of the highest amongst ADCs in development and predicted to be in therapeutic range
• Phase 2 trials ongoing in EGFR-overexpressing (IHC 3+) squamous cell carcinoma of the head and neck (SCCHN) and squamous non-small cell lung cancer (sqNSCLC)

Austin, TX, and Montreal, QC (Mar. 29, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, announces today that it will report the results from its Phase 1 dose-finding trial with novel, tumor selective, anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) AVID100 at the AACR Annual Meeting 2019. An additional AACR poster presentation will feature preclinical data confirming AVID100’s novel mechanism of action, which potently targets tumor cells while sparing EGFR-expressing non-tumor cells.

Presentation Details:

CT056 / 13 – A Phase Ia/IIa trial of AVID100, an anti-EGFR antibody-drug conjugate

Poster presentation: April 1, 8:00 AM – 12:00 PM EST, Section 17
Author: N. Lakhani
(Abstract available here)

• AVID100 was well-tolerated in a Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin (any EGFR status)
  • Most common treatment-related adverse events (TRAEs, in > 25% patients) were rash (66.7%; grade 1 or 2), nausea (41.7%; grade 1 or 2), and fatigue (29.2%; grade 1 or 2)
  • Recommended Phase 2 dose (RP2D) of 220 mg/m² (~6 mg/kg) confirmed, one of the highest RP2Ds reported for maytansinoid payload ADCs (Deslandes, 2014)
• Phase 2 (AVID100-01; NCT03094169) enrollment ongoing to evaluate AVID100 efficacy, safety, and tolerability in patients with EGFR-overexpressing (IHC 3+) SCCHN and sqNSCLC

218 / 9 – AVID100 is an anti-EGFR ADC that promotes DM1-meditated cytotoxicity on cancer cells but not on normal cells

Poster presentation: March 31, 1:00 PM – 5:00 PM EST, Section 9
Author: M. Thwaites
(Abstract available here)

• AVID100 is highly potent and selectively cytotoxic against EGFR-expressing cancer cells, while sparing normal EGFR-positive keratinocytes
• Protection of EGFR-expressing normal cells is shown to be a function of AVID100’s antibody moiety, which inhibits EGFR signaling and proliferation in normal cells

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) that was engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity, including in EGFR-overexpressing tumor models that are resistant to marketed EGFR inhibitors. AVID100 is the only anti-EGFR ADC in clinical development that targets both wild-type and mutant forms of EGFR.

In a successfully completed Phase 1 study, AVID100 reported a recommended Phase 2 dose (RP2D) of 220 mg/m² (~6mg/kg), which is expected to be in the therapeutically active range based on preclinical efficacy studies. Treatment was generally well-tolerated, with the majority of treatment-related adverse events in the Phase 1 trial at RP2D being grade 1 or 2 in severity.

AVID100-01 (NCT03094169) is an open label, multi-center, dose-escalation study to evaluate the safety and efficacy of AVID100 in patients with confirmed EGFR-overexpressing tumors.

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents that target the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

March 27, 2019 — Medexus Pharmaceuticals Inc (CVE:MDP) (FRA:P731) CEO Ken d’Entremont provides an overview of the company and highlights its recent financial reporting. The company is the results of the recent amalgamation of three specialty pharmaceutical companies: Pediapharm Inc, Medexus Inc, and Medac Pharma. As d’Entremont explains, the combined entity provides Medexus Pharmaceuticals with a footprint in both Canada and the United States, while expanding its therapeutic expertise to include pediatrics, autoimmune diseases, oncology, and rheumatology. The merger was undertaken to allow the company to rapidly scale. Further, Medexus Pharmaceuticals can now drive revenue while opex stays flat, benefiting from the organic growth of a larger product portfolio. Medexus Pharmaceuticals announced Q3 Fiscal 2019 revenues of $14.4 million, a 512 percent increase year-over-year.

About Medexus Pharmaceuticals Inc.

Medexus Pharmaceuticals Inc. is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork.  Medexus is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products are Rasuvo and Metoject, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall, an innovative allergy medication with a unique mode of action.

For more information, please contact:

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexusinc.com  

Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-762-2626 ext. 202
E-mail: roland.boivin@medexusinc.com

Investor Relations (U.S.):

Crescendo Communications, LLC
Tel: +1-212-671-1020
Email: MDP@crescendo-ir.com

Investor Relations (Canada):

Frank Candido
Direct Financial Strategies and Communication Inc.
Tel: 514-969-5530
E-mail: frank.candido@medexusinc.com

VICTORIA, British Columbia (BUSINESS WIRE) — In recognition of World Kidney Day and National Kidney Month, Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP), a late clinical-stage biopharmaceutical company with research ongoing in two kidney diseases, Lupus Nephritis (LN) and Focal Segmental Glomerulosclerosis (FSGS), today announced a host of activities, including an initiative with The National Kidney Foundation (NKF), designed to raise awareness for kidney disease. To find out more and to get involved in National Kidney Month, Aurinia invites all to:

• Explore important resources and activities from NKF and ALL IN, Aurinia’s educational program and support community for people living with LN, on The ALL IN Program website. Aurinia is working with the NKF to go #ALLINorange throughout the month of March. ALL IN community members will receive #ALLINorange buttons to wear to show support for kidney disease, as well as receive access to helpful information. Learn more.
• Visit our National Kidney Month calendar on Aurinia’s corporate website to get information about kidney disease and a quick overview of the important kidney awareness activities happening in March.
• Re-share, like or comment on the useful resources and surprising facts about kidney disease that we are posting from our handle @AuriniaPharma on Twitter and Facebook

“National Kidney Month is so important because it is imperative that kidney health becomes a part of everyday conversations,” said Joseph Vassalotti, MD, Chief Medical Officer with the National Kidney Foundation. “Kidney diseases such as lupus nephritis and FSGS can be devastating for people living with those diseases as well as their friends, family and loved ones. For these reasons, we are excited to work with Aurinia to both spread awareness and provide helpful resources.”

“Both LN and FSGS are serious and often debilitating diseases for which there are currently no FDA or EMA approved therapies,” said Neil Solomons, M.D. Chief Medical Officer at Aurinia. “Additionally, LN and FSGS can lead to an end-stage renal disease requiring dialysis or a kidney transplant. In extreme cases, these diseases can even lead to death. Aurinia is committed to raising awareness around these kidney diseases and to developing innovative products to potentially help,” he added.

Learn more about The ALL IN program and LN.

About Aurinia Pharmaceuticals

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The company is currently developing an investigational drug, for the treatment of Lupus Nephritis (LN), Focal Segmental Glomerulosclerosis (FSGS) and Dry Eye Syndrome. The company is headquartered in Victoria, British Columbia and focuses its development efforts globally.

About Kidney Disease

In the United States, 30 million adults are estimated to have chronic kidney disease and most aren’t aware of it. 1 in 3 American adults is at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity, and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end-stage renal disease (kidney failure).¹

About National Kidney Foundation

The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S.

Forward-Looking Statements

Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include, but are not limited to statements or information with respect to the projected worth of the lupus nephritis (LN) market, that voclosporin is potentially a best-in-class calcineurin-inhibitor (CNI) with robust intellectual property protection and exclusivity and the likelihood of data exclusivity in major markets, the expectation that voclosporin will be the only CNI with a label for LN, the expected progress of the AURORA study; the anticipated commercial potential of voclosporin for the treatment of LN and FSGS.

When used in these marketing materials, the words “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements or information.

We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN program; that another company will not create a substantial competitive product for Aurinia’s LN business without violating Aurinia’s intellectual property rights; and the size of the LN market. Even though the management of Aurinia believes that the assumptions made and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the market for the LN business may not be as estimated; and competitors may arise with similar products.

Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website.

¹ https://www.kidney.org/news/newsroom/factsheets/KidneyDiseaseBasics

For Aurinia Pharmaceuticals Investor Inquiries:

Glenn Schulman, PharmD, MPH
Corporate Communications
gschulman@auriniapharma.com

For Media Inquiries contact:

Christopher Hippolyte, VP, Corporate Practice Counsel
Syneos Health Communications
(212) 364-0458
Christopher.Hippolyte@syneoshealth.com

Related Article: Aurinia Completes Enrollment of AURORA, its Phase 3 Clinical Trial for the Treatment of Lupus Nephritis (LN)

• 1st Spine PMA approved by the FDA in more than 3 years
• 15-month PMA approval process vs. 30-month average for Ortho/Spine in the last 10 years

WASHINGTON (PRNewswire) — On March 7, 2019, MCRA, LLC announced its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the Orthofix M6-C^™ artificial cervical disc for the treatment of single level cervical disc degeneration. A next-generation artificial cervical disc, the M6-C disc developed by Spinal Kinetics LLC is the only artificial cervical disc designed to mimic the anatomic structure of a natural disc. To date, MCRA has assisted companies with 11 successful PMAs, including seven in the spine.

Spinal Kinetics, which was acquired by Orthofix Medical Inc. in 2018, initially retained MCRA, LLC in 2008 during the early stages of developing the clinical study strategy for the M6-C artificial cervical disc. The FDA approved the PMA for the M6-C disc on February 6, 2019, resulting in a 15-month review time between PMA submission and FDA approval. Additionally, the PMA approval for the M6-C artificial cervical disc is the first original PMA approval for a spinal device since 2015.

Tom Afzal, Founder and CEO of Spinal Kinetics and current General Manager of Motion Preservation at Orthofix, said, “We brought MCRA in early in our U.S. clinical trial process to evaluate our strategy and, thereafter, work with the team to support the PMA submission and ongoing FDA interactions. They provided tremendous support in analysis and presentation of data, input on responses, communications with the FDA, and overall messaging of safety and effectiveness of the M6-C artificial cervical disc. Their interactions with the FDA provided a high level of confidence for us and led to a timely PMA approval. They were an excellent partner and our collaboration with them couldn’t have gone better.”

Kevin B. McGowan, Director of Regulatory Affairs at MCRA, LLC added, “We are extremely pleased to have worked with Spinal Kinetics in clinical study strategy and ultimately through the FDA’s rigorous PMA review process to enable the company to provide U.S. patients with another treatment option for cervical disc replacement. The MCRA regulatory team remains committed to helping companies bring new medical products to the U.S. market through our scientific and clinical knowledge coupled with our proven experience with the FDA approval process.”

About MCRA, LLC

Founded in 2004, MCRA, LLC is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 500 clients globally. MCRA has a demonstrated history of driving success in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

For Additional Information Contact:

David W. Lown
General Manager, MCRA, LLC
Phone: (212) 583-0250 ext. 2111
Email: dlown@mcra.com

Related Article: Orthofix Announces Agreement to Acquire Spinal Kinetics

SUMMIT, N.J. (PRNewswire) — Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a Rapid Epileptic Seizure Termination (REST) therapy for people who experience a predictable pattern of  epileptic seizures, today announced it will present clinical data from the open-label portion of the randomized Phase 2b StATES Study (Staccato Alprazolam Terminates Epileptic Seizures) at the 2019 American Academy of Neurology Annual Meeting, which will be held May 4–10, 2019, in Philadelphia.

The poster is entitled, “A Two-Part, Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Patients with Epilepsy with a Predictable Seizure Pattern: Results from the Initial Open-Label Feasibility Part.”

“The Open-Label data are encouraging and we are very pleased to have the opportunity to showcase research that could lay the groundwork for an ultra-rapid option for acute seizure rescue treatment,” said Dr. Jaqueline French, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health, in the Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. “Many patients with epilepsy live with the fear that a seizure may occur at any moment, highlighting the need for a rescue medication that could give patients the confidence that a seizure could be rapidly aborted.”

Presentation details are as follows: 

Presenter:                                          Jacqueline French, M.D.

Session Date and Time:                  May 5, 11:30 a.m. to 6:30 p.m. EDT

Poster Presentation Number:     5-023

The StATES study will enroll patients from more than 45 trial sites in the U.S., Australia, Canada, and Jamaica. Approximately one hundred fifteen subjects will be enrolled in the double-blind, placebo-controlled portion of the trial which commenced on January 2019.

About Engage Therapeutics, Inc.

Engage Therapeutics, Inc. is developing Staccato alprazolam, for the immediate cessation of active and acute epileptic seizures. The investigational product is in the Rapid Epileptic Seizure Termination (REST) category of products. It is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting FDA-approved delivery system with FDA-approved alprazolam. Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The product has now proceeded into a Phase 2b randomized study known as the StATES study. Engage Therapeutics is based in Summit, N.J.

For Additional Information Contact:

Greg Mayes, Chief Executive Officer, (215) 696-9659; gmayes@engagetherapeutics.com

Related Article: Epilepsia Publishes Phase 2a Data for Staccato Alprazolam

IRVINE, Calif., — Edwards Lifesciences Corporation EW, -0.99% the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced two strategic transactions involving companies with structural heart disease technologies.

Edwards has invested $35 million in an exclusive right to acquire Corvia Medical, Inc., the developer of the world’s first transcatheter device designed to treat heart failure with preserved or mid-range ejection fraction. The company’s InterAtrial Shunt Device is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure.  The therapy has received CE Mark in Europe and is being studied as part of a Food and Drug Administration pivotal clinical trial. 

Separately, Edwards has also acquired certain assets of Mitralign, Inc., including intellectual property and associated clinical and regulatory experience.  Mitralign is a developer of an investigational transcatheter annuloplasty system designed to treat functional mitral and tricuspid regurgitation. 

Additional terms of these transactions remain confidential. Today’s announcement is not expected to impact Edwards’ 2019 financial guidance.

About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements regarding financial guidance, expected product benefits, transaction expectations, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unexpected delays or changes in clinical trials, regulatory approvals and product introductions, unanticipated outcomes of longer-term clinical experience with the new products, or unanticipated manufacturing, legal, quality or regulatory delays or issues. These factors are detailed in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2018. These filings, along with important safety information about our products, may be found at edwards.com. Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries

Related Article: Corvia Medical Announces Enrollment Of First Patients In Pivotal Trial Of The IASD® System II For The Treatment Of Heart Failure

LOS ANGELES, March 8, 2019 /CNW/ — Stellar Biotechnologies, Inc. (Nasdaq: SBOT), a leading manufacturer of a key protein utilized in immunotherapy and immuno-oncology development pipelines, has executed a share exchange agreement with privately-held Edesa Biotech Inc., a Canadian company, and Edesa’s shareholders to create a company focused on the development of innovative therapeutics for dermatological and gastrointestinal indications with clear unmet medical needs.

Under the terms of the share exchange agreement, Edesa shareholders have agreed to exchange their shares of Edesa for newly-issued common shares of Stellar. At the closing, Edesa will become a wholly-owned subsidiary of Stellar. Following the closing, current Stellar shareholders are expected to own approximately 10%, and the current shareholders of Edesa are expected to own approximately 90%, of the combined company on a fully-diluted basis, subject to a 2% upward or downward adjustment based upon the amount of Stellar’s working capital balance immediately prior to the closing. Following the closing, Stellar will change its name to “Edesa Biotech Inc.”

“We believe this proposed business combination provides new growth opportunities for Stellar shareholders. We have been impressed with Edesa’s management team and are looking forward to implementing a new vision for the combined company,” said Frank R. Oakes, Stellar President and Chief Executive Officer.

“This agreement marks another milestone for Edesa and our mission to efficiently develop novel, safe and effective treatments for conditions where patients have limited treatment options available,” said Par Nijhawan, MD, Chief Executive Officer of Edesa. “We believe we are at a significant inflection point in our company’s history and look forward to offering shareholders additional value creation opportunities as we reach milestones in our clinical programs.”

The proposed transaction, which will result in a change in control, is expected to close during the second quarter of 2019, subject to customary closing conditions, including Stellar shareholder approval for the issuance of Stellar common shares to acquire Edesa. Following closing, Stellar intends to develop a plan for the disposition of Stellar’s operations, which is expected to include the wind down or spin-off of Stellar’s legacy business. Following a diligent review of strategic alternatives, Stellar’s Board of Directors has determined that the share exchange agreement is fair and in the best interests of Stellar and Stellar’s shareholders. For further information about the proposed transaction, investors should refer to Stellar’s SEC filings.

H.C. Wainwright & Co. acted as transaction advisor and Greenburg Traurig LLP (USA) and McMillan LLP (Canada) acted as legal advisors to Stellar. Fasken Martineau DuMoulin LLP (Canada) and Stubbs Alderton & Markiles, LLP (USA) acted as legal advisors to Edesa.

About Stellar Biotechnologies 
Based north of Los Angeles at the Port of Hueneme, Stellar Biotechnologies, Inc. (Nasdaq: SBOT) is the leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an immune-stimulating protein utilized as a carrier molecule in therapeutic vaccine pipelines (targeting cancers, immune disorders, Alzheimer’s and inflammatory diseases) and for assessing immune system function. KLH can also be used in immunotoxicology studies for monitoring the immunomodulatory effects of drug candidates. Stellar KLH is a trademark of Stellar Biotechnologies.

About Edesa Biotech Inc. 
Edesa Biotech Inc. is a clinical-stage company focused on efficiently developing innovative treatments that address significant unmet medical needs. The company’s leading product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule for the treatment of allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. Edesa is based in Toronto, Canada.

Stellar Forward-Looking Statements 
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the expectations related to the transaction, including the timing of the transaction, resulting ownership of the combined company, and the plans relating to the resulting business. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include, but may not be limited to: the possibility that Stellar may be unable to obtain shareholder approval required for the proposed transaction, the expected timing and likelihood of completion of the proposed transaction, the possibility that Stellar’s working capital decreases prior to the transaction, and therefore, the Stellar shareholders are subject to decreased ownership in the combined company, the inability to successfully integrate the businesses or the risk that such integration may be more difficult, time-consuming or costly than expected, the occurrence of any event, change or other circumstances that could give rise to the termination of the share exchange agreement, the inability of the parties to meet expectations regarding the accounting and tax treatments of the proposed transaction, the potential for the proposed transaction to involve unexpected costs, the risk that the parties may not be able to satisfy the conditions to the proposed transaction in a timely manner or at all, risks related to disruption of management time from ongoing business operations due to the proposed transaction, the risk that the expected benefits of the proposed combination are not realized, the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Stellar’s common stock, the ability to maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation, as well as general economic and business conditions, technology changes, competition, changes in strategy or development plans, availability of funds and resources, anticipated requirements for operating capital, governmental regulations and the ability or failure to comply with governmental regulations, changes in trade policy and international law and other factors referenced in Stellar’s filings with securities regulators. Risks and uncertainties related to Edesa that may cause actual results to differ materially from those expressed or implied in any forward-looking statements include, but are not limited to: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property and the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond Stellar’s, Edesa’s or the combined company’s ability to control or predict.

Other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on November 30, 2018 for the year ended September 30, 2018 and any Quarterly Reports on Form 10-Q filed thereafter, and in other filings that Stellar makes and will make with the SEC in connection with the proposed transactions, including the proxy statement described below under “Important Information and Where to Find It,” as well as its filings with the British Columbia Securities Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise.

Important Information and Where to Find It

Stellar and Edesa and certain of their directors and executive officers may become participants in solicitation of proxies from Stellar shareholders in connection with the proposed transaction. Additional Information regarding persons who may, under the rules of the SEC, be deemed to be participants in the solicitation of the Stellar shareholders in connection with the proposed transaction, and who have interests, whether as security holders, directors or employees of Stellar or Edesa or otherwise, which may be different from those of Stellar shareholders generally, will be provided in the proxy statement and other materials to be filed with the SEC.

Each member of Stellar’s board of directors and Stellar’s executive officers, and Edesa’s board of directors and Edesa’s executive officers may be deemed “participants” in the solicitation of proxies from the Stellar shareholders in connection with the proposed transaction.

Information regarding the special interests of these directors and executive officers in the transaction will be included in the proxy statement referred to above. Additional information regarding Stellar’s directors’ and executive officers’ respective interests in Stellar by security holdings or otherwise is set forth in Stellar’s Annual Report on Form 10-K for the year ended September 30, 2018, as filed with the SEC on November 30, 2018.

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. A definitive proxy statement and a proxy card will be filed with the SEC and will be mailed to Stellar’s shareholders seeking any required shareholder approvals in connection with the proposed transaction. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT STELLAR MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Shareholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Stellar with the SEC in connection with the proposed transaction at the SEC’s website (http://www.sec.gov), at Stellar’s website or by writing to the Corporate Secretary at Stellar Biotechnologies, Inc., 332 E. Scott Street, Port Hueneme, California 93041.

Investor Relations

Gary Koppenjan, Stellar Biotechnologies, Inc. (805) 488-2800, ir@stellarbiotech.com

Michael Brooks, Edesa Biotech Inc. (905) 475-1234, investors@edesabiotech.com

• This trial will evaluate the efficacy of AVID100 in SCCHN patients with EGFR IHC 3+ tumors
• AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development
• 20% of SCCHN patients highly overexpress EGFR; no therapy is approved for these patients

Austin, TX, and Montreal, QC (Mar. 7, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of fibrosis and cancer, announced today that the first patient has been dosed in a Phase 2a squamous cell carcinoma of the head and neck (SCCHN) clinical trial.

The majority of SCCHN patients have tumors that overexpress epidermal growth factor receptor (EGFR) and approximately 20% have tumors that highly overexpress EGFR (more than 50% of cells with EGFR 3+ staining by a validated immunohistochemistry assay). No therapy is approved for the treatment of EGFR-overexpressing SCCHN.

The multicenter SCCHN trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with EGFR IHC 3+ tumors and follows the previously announced Phase 2a trial of AVID100 in patients with advanced squamous non-small cell lung cancer.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the only broadly active anti-EGFR ADC in clinical development.

A recommended Phase 2 dose (RP2D) of 220 mg/m² (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 is an open label, multicenter, dose-escalation study to evaluate the safety and efficacy of AVID100 in patients with confirmed EGFR-overexpressing tumors.

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is on the development of agents that target the transforming growth factor-beta (TGF-beta) as well as the epidermal growth factor receptor (EGFR) pathways.

Quebec City, Quebec, March 4, 2019 – Opsens Inc. (“Opsens”) (TSX:OPS) (OTCQX:OPSSF) is pleased to announce the appointment of Mr. Alan Milinazzo as Executive Chairman of the Board of Directors.

“We are delighted to see Alan, a renowned leader in the medical device industry, join us. Alan has had extensive success in building high-performance commercial teams in interventional cardiology. Alan’s extensive experience as an executive of leading global businesses and his expertise in driving adoption of new technologies for interventional cardiology, spine, and surgical products will be a precious asset for Opsens,” said Denis M. Sirois who is transitioning his Chairmanship role to Mr. Milinazzo.  Sirois continues, “Opsens will greatly benefit from Alan’s broad board experience and his outstanding track record of two decades of executive management in the healthcare industry”.

“We have ambitious goals and our growth is just beginning. We are fortunate to have Alan join our board and benefit from his deep knowledge of the North American and international interventional cardiology market, as we expand global marketing of our optical-based FFR and dPR products to assess intracoronary pressure and designed to provide the lowest drift in the industry,” said Louis Laflamme, President and CEO of Opsens.

“I am excited to be joining the Opsens board of directors at such a dynamic phase of the company’s growth and evolution. The company is well positioned to drive adoption of its state-of-the-art physiology and optical based technologies and to continue to bring important innovation to the minimally invasive markets,” said Mr. Milinazzo. “I am looking forward to working with the Board and Management to accelerate and optimize the market opportunities for our technologies and in doing so, to unlock significant value for our shareholders,” he added.

Alan Milinazzo is a Partner at Heidrick & Struggles’ in Boston and a member of the Global Healthcare and Life Sciences Practice specializing in the Medical Device sector. Prior to joining Heidrick & Struggles, Alan was Chief Executive Officer of InspireMD, a pioneer in embolic prevention systems (EPS) for coronary and vascular applications. He previously served as President and Chief Executive Officer of Orthofix International N.V., a $600 million publicly traded global orthopedic and Spine Company, as well as general manager of Medtronic, Inc.’s coronary and peripheral vascular businesses where he was instrumental in the development and commercialization of several key products, including the company’s first coronary drug-coated stent platform, Endeavor. Mr. Milinazzo also spent 12 years with Boston Scientific in multiple global sales and marketing leadership roles during a period of unprecedented top line growth in the cardiology franchise.

Alan currently serves as a director of Flexion Therapeutics (Nasdaq: FLXN), CasMed (Nasdaq: CASM) and the Musculoskeletal Transplant Foundation. Prior directorships included LDR Spine (Nasdaq LDRH acquired by Zimmer-Biomet) Medpace (acquired by PE sponsor Cinven), HET Systems (acquired by Covidien) and LumenR (acquired by Boston Scientific).  He earned a bachelor’s degree, cum laude, from Boston College and interned at the White House, the US House of Representatives and the John F. Kennedy Library.

Denis M. Sirois remains on the BOD

“Opsens warmly thanks Denis M. Sirois for his contribution as he held the helm of the board for the past four years. We are grateful for his innovative ideas and strategic thinking that has allowed Opsens to make great strides,” added Louis Laflamme. “Denis will remain on the Board to continue building the Company,” Laflamme concluded.

About Opsens Inc.

Opsens focuses mainly on the measure of FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a 2nd-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 50,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

 Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

 Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accept responsibility for the adequacy or accuracy of this release.

-30-

For further information, please contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

Related Article: Opsens – 50,000 patients diagnosed with the OptoWire

• This trial will evaluate the safety and anti-fibrotic effects of AVID200 in diffuse cutaneous systemic sclerosis patients
• AVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3
• TGF-beta 1 & 3 are the principal drivers of fibrosis in systemic sclerosis and other indications, supporting broad utility of AVID200

Austin, TX, and Montreal, QC (Mar. 4, 2019) – Forbius, a clinical-stage company that develops biologics for the treatment of fibrosis and cancer, announced today that the first patient has been dosed in a diffuse cutaneous systemic sclerosis (SSc) Phase 1b trial with AVID200, a rationally designed and highly potent inhibitor of TGF-beta 1 & 3.

“The basic defect in SSc and most other fibrotic diseases is increased TGF-beta signaling. Selective TGF-beta inhibition by AVID200 could rapidly reverse fibrosis, and I am keen to investigate the potential of AVID200 to transform the treatment of SSc,” commented Coordinating Principal Investigator Robert Lafyatis, M.D., Professor of Medicine, Medsger Professor and Director of the Scleroderma Center at the University of Pittsburgh Medical Center.

TGF-beta signaling is central to SSc pathogenesis (Lafyatis, 2014), and TGF-beta isoforms 1 & 3, but not 2, correlate positively with disease severity (O’Connor et al., 2018). AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus simultaneously neutralizing the principal pro-fibrotic TGF-beta isoforms and providing optimal efficacy.

“For decades, safe and potent neutralization of TGF-beta has been the holy grail for the treatment of fibrotic diseases. To achieve this, our team of pioneers in the TGF-beta field identified the two principal disease-driving TGF-beta isoforms and designed selective inhibitors that simultaneously neutralize these isoforms, while sparing the isoform that is critical for safety,” commented Mr. Ilia Tikhomirov, CEO of Forbius. “AVID200 has the potential to transform the treatment of many diseases and is the first of several new generation TGF-beta inhibitors being developed by Forbius.”

About Diffuse Cutaneous Systemic Sclerosis and the AVID200-01 Trial

SSc is a rare, severe, and progressively debilitating fibrotic disease that predominately affects women in mid-life. The 10-year survival rate of SSc patients is approximately 55%. No therapeutic is currently approved for the treatment of SSc, which affects an estimated 50,000 people in the U.S. alone.

AVID200-01 (NCT03831438) is a Phase 1 open-label, dose-escalation study to evaluate safety, pharmacokinetics, pharmacodynamics, and anti-fibrotic activity of AVID200 in patients with documented SSc.

About AVID200: TGF-beta 1 & 3 Inhibitor

AVID200 is a rationally designed, highly potent TGF-beta 1 & 3 inhibitor undergoing Phase 1 clinical testing in fibrosis and solid tumors. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and is a positive regulator of hematopoiesis. AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy, while circumventing cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings.

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of fibrosis and cancer. Our current focus is the development of agents that target the transforming growth factor-beta (TGF-beta) as well as the epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

• Allowed claims cover an individualized flat-dosed pharmacodynamic treatment protocol utilized in the AURA-LV study and the ongoing AURORA study in lupus nephritis
• Claims have the potential to protect voclosporin’s method of use and dosing protocol for LN until December 2037

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/ TSX:AUP) (the “Company” or “Aurinia”), a clinical-stage biopharmaceutical company focused on the global immunology market, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for U.S. patent application 15/835,219, entitled “PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS”. The allowed claims broadly cover the novel voclosporin dosing protocol adhered to and required in both the previously reported Phase II AURA-LV study and the ongoing Phase III confirmatory AURORA study. Notably, the allowed claims cover a method of modifying the dose of voclosporin in patients with lupus nephritis (LN) based on patient-specific pharmacodynamic parameters.

This Notice of Allowance concludes a substantive examination of the patent application at the USPTO, and after administrative processes are completed and fees are paid, is expected to result in the issuance of a U.S. patent with a term extending to December 2037. Issuance of the patent will expand the scope of intellectual property protection for voclosporin, which already includes robust manufacturing, formulation, synthesis and composition of matter patents.

The Company has also filed for protection of this subject matter under the Patent Cooperation Treaty (PCT) and has the option of applying for similar protection in the member countries thereof. This may lead to the granting of corresponding claims in the treaty countries which include all the major global pharmaceutical markets. “These method of use claims allowed in the U.S. broadly cover the personalized voclosporin dosing protocol utilized across our LN program, which includes specific dose modification requirements that we anticipate being incorporated into any potential future label for voclosporin in LN,” said Michael R. Martin, Chief Operating Officer of Aurinia.

“This Notice of Allowance is a significant milestone for Aurinia as it enhances our current intellectual property portfolio and provides potential exclusivity for Aurinia’s protocol for the treatment of proteinuric kidney diseases, including LN, until late 2037. Importantly, these claims provide validation of some unique and differentiating features of voclosporin compared to the legacy CNIs.” stated Richard M. Glickman, Chairman and CEO of Aurinia. “Establishing a robust exclusivity platform is a critical part of our strategy as we work towards regulatory approvals in the United States and internationally.”

About Aurinia

Aurinia Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the potential treatment of lupus nephritis (LN), focal segmental glomerulosclerosis (FSGS), and dry eye syndrome (DES). The company is headquartered in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin’s composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Voclosporin’s unique dosing protocol used in both the AURA-LV and the AURORA studies for LN has also been granted a Notice of Allowance from the USPTO, these allowed claims have the potential to provide additional coverage for voclosporin until late 2037.

About Lupus Nephritis (LN)

LN in an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. Unlike SLE, LN has straightforward disease outcomes (measuring proteinuria) where an early response correlates with long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (“eGFR”), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (“ESRD”), thus making LN a serious and potentially life-threatening condition.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to the USPTO granting a new patent for the Company’s protocol with LN; the new patent having a patent term extending to 2037; Aurinia’s new patent claims being listed in the FDA’s Orange book; filings with the PCT leading to the granting of corresponding claims in treaty countries; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; the patent life for Aurinia’s patents; and the potential to extend that patent life on the occurrence of certain events. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: that another company will not create a substantial competitive product without violating Aurinia’s intellectual property rights; that the FDA will grant Aurinia approval for use of voclosporin with LN; that voclosporin in LN would qualify for publication in the FDA’s Orange Book; that the USPTO will issue a new patent once applicable steps have been followed and fees paid in respect of the Notice of Allowance; and Aurinia being able to extend its patents on terms acceptable to Aurinia. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our AURORA clinical trial; the FDA may not approve voclosporin for use with LN or for any other purpose; Aurinia not being able to extend or protect its patent portfolio for voclosporin or VOS; and competitors may arise with similar or more competitive products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

Aurinia Pharmaceuticals Investor Contact:

Michael R. Martin
Chief Operating Officer/Intellectual Property
mmartin@auriniapharma.com

or

Celia Economides
Vice President, Corporate & Public Affairs
ceconomides@auriniapharma.com

Media Contact:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com

• MPN-RC sponsored, NIH-supported Phase 1/2 trial in myelofibrosis to commence imminently
• TGF-beta is a central driver of bone marrow fibrosis in myelofibrosis
• AVID200 selectively inhibits TGF-beta 1 & 3, the principal fibrotic TGF-beta isoforms, while sparing TGF-beta 2, a positive regulator of hematopoiesis

Austin, TX and Montreal, QC (Feb. 14, 2019) – Forbius, a clinical-stage company that develops biologics for the treatment of cancer and fibrosis, announced today a collaboration agreement with the Icahn School of Medicine at Mount Sinai and the Myeloproliferative Neoplasm Research Consortium (MPN-RC). This collaboration launches an investigator-initiated trial (IIT) evaluating AVID200, a highly potent and isoform-selective TGF-beta inhibitor, as a potential treatment for myelofibrosis (MF). The Phase 1/2 clinical trial will be sponsored by the MPN-RC with NIH grant support and is expected to start during Q1 2019.

“We have demonstrated that blocking TGF-beta signaling reverses bone marrow fibrosis and restores hematopoiesis in preclinical models. We believe that selective TGF-beta inhibition by AVID200 could address the underlying cause of bone marrow failure and become the first disease-modifying therapy in MF. Our consortium is eager to commence evaluation of AVID200 in the upcoming clinical study,” commented Dr. Ronald Hoffman, founder of the MPN-RC and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai.

Forbius is evaluating the immuno-oncology and anti-fibrotic effects of AVID200 in Phase 1 trials, including solid tumors and systemic sclerosis. Additionally, Forbius is expanding the AVID200 clinical development program by supporting IITs through the provision of drug, scientific input, and collaboration on the conduct of translational studies. Additional details pertaining to the prospective IIT in MF will be disclosed in due course.

About the Myeloproliferative Neoplasm Research Consortium (MPN-RC)

The MPN-RC was founded in 2006 and is the only independent, multi-center, international consortium of scientists and clinicians that is dedicated to developing novel therapeutic strategies for MF and other myeloproliferative neoplasms (MPN). The MPN-RC is funded by the NIH to conduct clinical trials based on the most promising preclinical MPN research. The goal of the consortium is to adapt quickly in response to scientific advances and a changing clinical landscape, in order to develop effective therapeutics for MPN patients.

About AVID200

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3, the two principal pro-fibrotic TGF-beta isoforms. These TGF-beta isoforms are central regulators in the pathogenesis and progression of fibrotic diseases, including MF (Chagraoui et al., 2002). AVID200 was rationally designed to be minimally active against TGF-beta 2, which is a promoter of hematopoiesis and normal cardiac function. This optimal selectivity positions AVID200 to be an effective and well-tolerated therapeutic in MF and other fibrotic diseases.

About Myelofibrosis (MF)

MF is a rare, life-threatening blood cancer characterized by progressive bone marrow fibrosis, which causes ineffective hematopoiesis. Approximately 30,000 people in the US alone are affected by this disease. Currently, there are no approved therapies targeting the underlying bone marrow fibrosis available to MF patients.

About Forbius

Forbius is a clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Media Relations

Claudia Resch, info@forbius.com

Related Article: Forbius Announces the First Patient Dosed in a Phase 1 Oncology Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor

• VOS showed statistical superiority to Restasis® on FDA-accepted objective signs of DES
• 42.9% of VOS subjects vs 18.4% of Restasis® subjects (p=.0055) demonstrated ≥ 10mm improvement in STT at Week 4
• Primary endpoint of drop discomfort at 1-minute on Day 1 showed no statistical difference between VOS and Restasis®, as both exhibited low drop discomfort scores
• Aurinia to advance VOS for the treatment of DES

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive results for its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution (VOS 0.2%) versus Restasis®(cyclosporine ophthalmic emulsion 0.05%) for the treatment of dry eye syndrome (DES). Both drugs were shown to be well-tolerated and there was no statistical difference between VOS and Restasis® for the primary endpoint as both drugs exhibited low drop discomfort scores.

On the key pre-specified secondary endpoints of Schirmer Tear Test/STT (an objective measure of tear production), and Fluorescein Corneal Staining/FCS (an objective measure of structural damage to the cornea), which are FDA-accepted efficacy endpoints, VOS showed rapid and statistically significant improvements over Restasis® at Week 4 (STT: p=.0051; FCS: p=.0003).

This 100-patient, double-masked, head-to-head study was designed to evaluate the efficacy, safety and tolerability of VOS versus Restasis® in subjects with DES. Both arms of the study received either VOS or Restasis® (1:1) administered twice daily, in both eyes, for 28 days. Key pre-specified secondary endpoints, which are FDA-accepted endpoints, include STT, FCS, and assessments of dry eye symptoms.

*worst eye

Both treatment arms also demonstrated substantial and statistically significant improvements on the Symptom Assessment in Dry Eye (SANDE) score from baseline to Week 4.

No serious adverse events were reported in the study, and there were no unexpected safety signals.

“Improvements in STT and FCS are considered by regulators to be two of the most clinically meaningful measures of efficacy in this disease. The rapid onset and overall efficacy (as measured by the STT and FCS) demonstrated by VOS in this head-to-head study conducted against Restasis® is astounding and could be a game changer in the treatment landscape for dry eye,” said Joseph Tauber, M.D., Principal Investigator and head of the renowned Tauber Eye Institute in Kansas City, MO.

Neil Solomons, M.D., Aurinia’s Chief Medical Officer said, “We are extraordinarily excited with the superior efficacy shown by VOS when compared to Restasis®, which is the current market leader for the treatment of DES in the US. The efficacy endpoints exceeded our expectations and provide further validation of the potential of VOS to provide a highly differentiated and efficacious treatment option for the more than 16 million patients living with this all-too-common disease.”

“Based on these positive data, we plan to aggressively advance VOS for the treatment of DES, which we believe can create considerable value for both patients and our shareholders,” said Richard M. Glickman, Chairman and CEO of Aurinia. “Our pursuit of further development of VOS provides the company with an enhanced pipeline that further capitalizes on the differentiating features of voclosporin and positions us for substantial growth.”

Aurinia will present the results of the clinical trial during a conference call and webcast presentation to be held at 8:00am ET Tuesday, January 22, 2019. A link to the live webcast and slides will be available on the Investors section of the Company’s website.

About Aurinia
Aurinia Pharmaceuticals Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the potential treatment of lupus nephritis (LN), focal segmental glomerulosclerosis (FSGS), and dry eye syndrome (DES). The company is headquartered in Victoria, British Columbia and focuses its development efforts globally.

About VOS
VOS (voclosporin ophthalmic solution) is an aqueous, preservative free nanomicellar solution containing 0.2% voclosporin intended for use in the treatment of DES. Studies have been completed in rabbit and dog models, and a single Phase I has also been completed in healthy volunteers and patients with DES. VOS has IP protection until 2031.

About Dry Eye Syndrome (DES)
Dry eye syndrome (DES) is a chronic disease and is characterized by irritation and inflammation that occurs when the eye’s tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye’s surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. While there are FDA approved therapies available for the treatment of DES, there is opportunity for potential improvement in the efficacy in addition to other measures such as onset of action, tolerability and dosing.

About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension.

About Restasis®
RESTASIS® and RESTASIS MULTIDOSE™ Ophthalmic Emulsion help increase your eyes’ natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye. RESTASIS® and RESTASIS MULTIDOSE™ did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs.

Forward-Looking Statements
Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Voclosporin Ophthalmic Solution (VOS) and the data as it relates to the phase 2 study: voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity, the development of VOS creating considerable value for patients and Aurinia’s shareholders; Aurinia being positioned for substantial growth; there being opportunities for improvement of efficacy, onset of action, tolerability and closing in DES; VOS being a game changer in the treatment landscape for dry eye; efficacy findings of VOS; the patent life for Aurinia’s patents; and the potential to extend that patent life on the occurrence of certain events. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: that another company will not create a substantial competitive product for Aurinia’s LN or DES business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend its patents on terms acceptable to Aurinia; and the size of the LN or DES market. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our AURORA, FSGS or DES clinical trials; difficulties we may experience in completing the development and commercialization of voclosporin or VOS; the market for the LN or DES business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or protect its patent portfolio for voclosporin or VOS; and competitors may arise with similar or more competitive products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website.

Aurinia Pharmaceuticals
Investors:
Celia Economides
VP, Corporate & Public Affairs
ceconomides@auriniapharma.com
or
Media:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com

Related Article: Aurinia Initiates Phase 2 Clinical Trial for Voclosporin Ophthalmic Solution for the Treatment of Dry Eye Syndrome

VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”). In accordance with Zymeworks’ 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0 million for Lilly’s submission of an IND application for an immuno-oncology bispecific antibody enabled by Zymeworks’ proprietary Azymetric™ platform.

“We believe that Lilly’s submission of a second IND on an Azymetric™ bispecific drug candidate within a six-month period is further evidence that Zymeworks’ platform technologies are enabling our global pharmaceutical partners to accelerate drug development into the clinic. As one of our first collaborators, Lilly’s successes demonstrate the ease of use, productivity and promise of our proprietary platforms, especially for advancing therapeutic programs into the clinical setting.”

– Ali Tehrani, Ph.D., President & CEO of Zymeworks. 

Under its two licensing and collaboration agreements with Lilly, Zymeworks has granted Lilly worldwide licenses to research, develop, and commercialize multiple bispecific therapeutics directed towards Lilly’s targets. To date, Zymeworks has received multiple equity investments, an upfront licensing payment and multiple research and development milestone payments under these agreements. Zymeworks is also eligible to receive further development and commercial milestone payments and tiered royalties on global product sales.

About the Azymetric™ Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. This unique technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. An Investigational New Drug (IND) application was recently accepted by the Food and Drug Administration (FDA) for its second product candidate, ZW49, a novel bispecific antibody-drug conjugate (ADC). Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to Zymeworks receipt of future milestone payments and royalties from Lilly or any of its other partners, the speed and success of drug discovery and development, the likelihood of Zymeworks’ partners advancing drug candidates to clinical trials and other information that is not historical information. When used herein, words and phrases such as “will,” “eligible to,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its fiscal quarter ended September 30, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Related Article: Zymeworks Reports IND-Submission Milestone Achieved in Lilly Corporation

Medical Device Industry Expert to Spearhead European Sales of the Carillon Mitral Contour System

KIRKLAND, Wash.–(BUSINESS WIRE)–Cardiac Dimensions^®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Carmelo Mastrandrea as the company’s Vice President of Sales.

“Cardiac Dimensions has an opportunity to make an enormous impact by offering physicians a safe, effective, and easy-to-use option to treat patients earlier in their disease diagnosis when treatment can have the biggest impact on disease progression and quality of life.”

Mastrandrea is an accomplished medical device veteran, having held diverse leadership positions in sales and management over the past 20 years. Prior to joining Cardiac Dimensions, Mastrandrea most recently served as Vice President of Sales for REVA Medical, a leader in bioresorbable polymer technologies for vascular applications. Previously, Mastrandrea held global sales management positions at Biosensors International, Biotronik, Guidant, and Avintos.

“Cardiac Dimensions is strongly positioned to be a leader in the mitral valve repair sector, with exceptional clinical data supporting the use of our minimally invasive heart failure treatment, our newly approved German DRG reimbursement in place, and growth expected in other European regions,” said Gregory D. Casciaro, Cardiac Dimension’s President and CEO. “We are thrilled to welcome Carmelo to the Cardiac Dimensions team at this important time for our company. His wealth of global sales leadership experience will be tremendously valuable to our team and the customers they serve.”

In October 2018, Cardiac Dimensions announced that InEK, the German Institute for the Hospital Remuneration System, has granted a permanent DRG (Diagnosis Related Group) code covering reimbursement for the company’s Carillon^® Mitral Contour System to treat patients with Functional Mitral Regurgitation (FMR) in Germany. The new reimbursement became effective on January 1, 2019.

“I am excited to join Cardiac Dimensions’ exceptional team to execute on the company’s vision of reshaping the course of heart failure,” said Mastrandrea. “Cardiac Dimensions has an opportunity to make an enormous impact by offering physicians a safe, effective, and easy-to-use option to treat patients earlier in their disease diagnosis, when treatment can have the biggest impact on disease progression and quality of life.”

The Carillon Mitral Contour System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. FMR occurs when the left ventricle of the heart is enlarged, dilating the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent the worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. The Carillon System is a minimally invasive approach that offers patients annular reduction while keeping adjunctive therapy options open.

To date, over 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, Italy, and The Netherlands. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for the CE Mark demonstrating safety and performance. The recently released REDUCE FMR data is expected to assist with expanding reimbursement and usage in additional geographies such as Poland, France, the United Kingdom, and Australia. Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

Cardiac Dimensions and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

Related Article: Cardiac Dimensions Announces $39 Million Series B Financing for Innovative Device to Treat Patients with Heart Failure

• AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitor
• Best-in-class efficacy and safety potential by selectively targeting principal oncogenic TGF-beta isoforms
• Reverses immunosuppression and renders tumors sensitive to checkpoint blockade in pre-clinical models

Jan. 7, 2019 – Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, announced today that the first patient was dosed in a Phase 1 clinical trial with AVID200. The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200 in patients with solid tumors.

“Our goal is to significantly expand the number of cancer patients who benefit from checkpoint blockade and other immunotherapies. AVID200 was designed to have the potency and isoform selectivity to effectively counteract the highly immunosuppressive effects of TGF-beta in the tumor microenvironment and reverse resistance to immunotherapy,” commented Dr. Maureen O’Connor-McCourt, CSO of Forbius.

AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity was also designed to circumvent cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action focuses on the reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune cell infiltration, and increased efficacy of immune checkpoint agents.

About Forbius

Forbius is a clinical-stage protein engineering company that designs, develops, and commercializes biotherapeutics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Our lead program targeting the TGF-beta pathway is AVID200. AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitor. This TGF-beta isoform selectivity was chosen in order to achieve an optimal therapeutic index. The AVID200 program has been cleared by the FDA for two Phase 1b clinical trials in fibrotic indications, as well as a Phase 1 clinical trial in solid tumors. Additional clinical trials in fibrotic indications are planned for 2019.

Forbius’ lead program targeting the EGFR pathway is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate. This program has completed a Phase 1 clinical trial and has commenced Phase 2a clinical trials in EGFR overexpressing solid tumors.

Media Relations

Claudia Resch, info@forbius.com

Veteran Life Sciences Executive Brings Proven Experience Developing CNS Therapeutics

MONTREAL and TORONTO, Jan. 4, 2019 /CNW/ – KalGene Pharmaceuticals Inc., a biotechnology company developing therapeutics to slow the progression of Alzheimer’s disease, today announced the appointment of James Callaway, Ph.D. as chief executive officer, effective immediately.

“This has been a very important transition year as we have confirmed our initial thesis with respect to validating the company’s lead KG207, which in pre-clinical studies was shown to successfully cross the blood brain barrier and safely reduce plaque load.  The company has successfully completed early toxicology studies and has carried out all the requisite steps to manufacture product,” said Dr. Jacki Jenuth, Chairperson of the Kalgene’s board of directors.  “We are very pleased to have executed on the next key step of our strategy in attracting an accomplished new CEO to the company as we leverage this foundation and address significant inbound interest for the company and its lead program.  Jim brings an ideal set of leadership skills and domain expertise to guide the team through the transition from a pre-clinical to a clinical stage company.”

“KG207 has shown exceptional potential in pre-clinical studies, and I am excited about the prospect of bringing such a promising compound into the clinic,” Dr. Callaway commented. “I look forward to working with the savvy and talented team at KalGene as we strive to make a difference in the lives of individuals affected by Alzheimer’s disease.”

Dr. Callaway has over three decades of biopharmaceutical development experience, primarily targeting CNS therapeutics, and has served most recently as CEO for two privately-held biotech companies.  As the CEO of ArmaGen, he brought its products from the laboratory to the clinic, helping the company emerge as the first to demonstrate the ability of engineered biologics to cross the blood-brain barrier.  In addition, Dr. Callaway led the Alzheimer’s immunotherapy program at Elan Pharmaceuticals, which became the first company to introduce disease-modifying biologics (e.g., AN1792, bapinuzumab, ACC001) into clinical studies.  Dr. Callaway has filed and defended numerous NDAs and INDs during his career, including shepherding the approval of MyoBloc^® and the production of Tysabri^®.  He previously served in senior development roles at Bayer Pharmaceuticals, SmithKline Beecham (GSK), and InGene (since acquired by Xoma Corporation).  He holds a Ph.D. in Biological Chemistry from UCLA, with a focus on peptide chemistry.

About KalGene Pharmaceuticals Inc.
KalGene Pharmaceuticals Inc. is a pre-clinical-stage company focussed on the development of precision medicine therapeutics to slow the progression of Alzheimer’s disease both safely and effectively.  The company’s lead therapeutic candidate, KG207, targets toxic amyloid beta oligomers, and has been shown in animal models of Alzheimer’s disease to cross the blood-brain barrier, significantly reducing the plaque burden and leading to improved cognition and neuronal connectivity.  The molecule is a bifunctional agent that is a synthesis of two novel innovations licensed from the National Research Council of Canada (NRC).

LISLE, Ill., Jan. 3, 2019 –  Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that industry veteran Jim Yearick has joined the executive leadership team as Senior Vice President of Sales and Marketing. Mr. Yearick will oversee Endotronix’s worldwide sales and marketing efforts for the Cordella™ Heart Failure System (Cordella System).

“Jim is a respected sales and marketing leader in heart failure with both early-stage and established company experience. He is commercially savvy, with a solid track record of building and developing high-performing teams,” commented Harry Rowland, CEO and co-founder of Endotronix. “His strong background across cardiology will be invaluable as we accelerate the Cordella System commercialization and initiate our landmark, PROACTIVE-HF pivotal study of the Cordella PA Sensor.”

Mr. Yearick joins Endotronix after leading market development and global expansion for HeartWare, an innovator of minimally invasive, miniaturized, left ventricular assist devices (LVADs) that provide mechanical circulatory support for patients with advanced heart failure. Following HeartWare’s acquisition by Medtronic in August 2016, Mr. Yearick helped lead the integration efforts for Medtronic’s newly formed Heart Failure Mechanical Circulatory Support (MCS) Division. Prior to his tenure at HeartWare/Medtronic, Mr. Yearick has held senior-level positions in sales and marketing in the medical device and consumer goods industries, including Global Vice President roles at CHF Solutions and Medtronic’s Cardiac Rhythm Management division.

“It is an exciting time at Endotronix. The Cordella System is on the cusp of transforming heart failure treatment with a proactive patient management solution that improves the experience for the implanting physician, managing clinician, and patient,” Yearick said. “We’re entering a pivotal phase for the company that will produce commercial success and clinical data that accelerates our market adoption. I look forward to working with the team and executing on our strategy.”

The Cordella System is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The platform consists of a comprehensive remote patient management system coupled with a seamlessly integrated, next-generation implantable pulmonary artery (PA) pressure sensor to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery activities.

The Cordella System, without the sensor, is available for commercial use in the U.S. and currently in centers across the U.S. In parallel, the company will initiate an investigation device exemption (IDE) study, PROACTIVE-HF, in early 2019 to demonstrate the safety and effectiveness of the Cordella PA Sensor.

About Endotronix
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. 

 Related Article: Endotronix Hires Seasoned Life Sciences Executive John Flavin as CFO

Trial evaluating safety and efficacy of Staccato Alprazolam in subjects with epilepsy and a predictable seizure pattern

Results from the open label portion of the study will be presented at a major medical meeting in 2019

NEW ORLEANS, Dec. 03, 2018 (GLOBE NEWSWIRE) — Engage Therapeutics today announced from the American Epilepsy Society’s Annual Meeting the successful completion of the open label portion of the StATES (Staccato Alprazolam Terminates Epileptic Seizures) study. Enrollment will now commence in the double blind, placebo-controlled portion of the study. Results from the open label portion of the study will be presented at a major medical meeting in the first half of 2019.

“We are very pleased to be moving one step closer in our research toward validating what could ultimately become an ultra-rapid option for acute seizure rescue treatment,” said Dr. Jaqueline French, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health, in the Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. French currently serves as the Epilepsy Foundation Chief Scientific Officer.  “Many patients with epilepsy live with the fear that a seizure may occur at any moment, highlighting the need for a rescue medication that could give patients the confidence that a seizure could be rapidly aborted.”

The StATES study is investigating the safety and efficacy of Staccato Alprazolam in subjects with epilepsy who have a predictable seizure pattern. The therapy combines the FDA-approved Staccato delivery technology with alprazolam, an FDA-approved benzodiazepine.

“We are grateful for the contributions of those who participated in the open label portion of the Phase 2b study and want to encourage people to visit www.epilepsyhealthstudy.com to determine whether they, or someone they know, may be a good candidate to join the double-blind placebo-controlled portion of the trial, and help us to more quickly make this therapy’s promise a reality,” said Greg Mayes, president, CEO and founder of Engage.

Engage Therapeutics has lined up 50 U.S.-based clinical trial sites for the StATES study, in addition to sites in Australia, Canada and Jamaica as part of an effort to increase accessibility for participants. One hundred subjects are needed for the double blind, placebo-controlled portion of the trial which should be completed in the second half of 2019. A map of U.S. site locations can be found online at www.engagetherapeutics.com/study-locations.

About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam, for the immediate cessation of active and acute epileptic seizures. The investigational product is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting delivery system already used in an FDA-approved product with FDA-approved alprazolam. Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The product has now proceeded into a Phase 2b study known as the StATES study. Engage Therapeutics is based in Summit, N.J. For additional information please see www.EngageTherapeutics.com.

International Group of Investors from Canada, the U.S. and China Support Former Senior Executives from Pharmasset and Idenix in New Venture

ATLANTA, Nov. 27, 2018 /PRNewswire/ — Antios Therapeutics, Inc. (“Antios”) today announced the completion of a US$25 million oversubscribed Series A financing led by Lumira Ventures and Domain Associates, two prominent life science venture capital firms.  Other investors participating in the financing include CAM Capital, Delos Capital, Quantum Vista Capital, Fonds de solidarité FTQ and Georgia Research Alliance Venture Fund.  The proceeds from this financing will be used to develop ATI-2173, Antios’ lead oral drug candidate for treating patients infected with Hepatitis B virus (HBV) and potentially Hepatitis D virus (HDV).

Antios is a biopharmaceutical company focused on the development of novel antiviral therapies for unmet medical needs.  The company’s lead program is aimed at developing a curative regimen for chronic HBV, a major unmet global health problem affecting over 250 million people worldwide, and a leading cause of chronic hepatitis, liver cirrhosis and liver cancer.  The company’s founders include former senior executives from Pharmasset (acquired by Gilead Sciences) and Idenix (acquired by Merck), with decades of experience in the successful discovery, development and commercialization of transformative therapies and technologies to treat and cure viral infections.

“The next frontier in virology is to cure Hepatitis B. At Antios, we are committed to this pursuit,” said co-founder and Chief Executive Officer, Abel De La Rosa, Ph.D. “The strong financial support from our investors along with their extensive experience in clinical development and success building innovative companies in the infectious disease field will enable us to accelerate the development of ATI-2173 as a potential backbone of therapy to cure HBV.”

“The unique mechanism of action combined with liver targeting and the potential for a one pill, once-a-day combination regimen makes ATI-2173 an exciting candidate for development to treat HBV,” added Douglas Mayers, M.D., co-founder and Chief Medical Officer.

“We believe ATI-2173 has demonstrated highly unique properties and could be part of a paradigm shift in the treatment of HBV,” said Beni Rovinski, Ph.D., Managing Director at Lumira Ventures.  “We are excited to work again with Dr. De La Rosa and the team at Antios to advance this promising therapy.”

Following the completion of the financing round, Dr. Beni Rovinski (Lumira Ventures), Nicole Vitullo (Domain Associates), Scott Morenstein (CAM Capital), Henry Chen (Delos Capital) and Dr. Abel De La Rosa, have joined Antios’ Board of Directors.

About Antios Therapeutics

Antios Therapeutics is a biopharmaceutical company devoted to developing innovative therapies for viral diseases. With an experienced and proven leadership team, the company is focused on the development of its lead oral drug candidate for a potentially curative treatment of HBV infections.

Exact Imaging’s Novel ExactVu™ Micro-Ultrasound System is Helping Urologists Worldwide Revolutionize Prostate Cancer Detection

TORONTO, Nov. 22, 2018 /PRNewswire/ – Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, proudly announces this it has been chosen as Life Science Ontario (LSO)’s 2019 Life Science Company of the Year.

“Exact Imaging is redefining the diagnosis of prostate cancer by driving significant benefits for patients, clinicians and the healthcare system globally”, says LSO President and CEO Dr. Jason Field. “They are an excellent example of how Ontario-based innovation, coupled with manufacturing and commercialization expertise is fostering world-class medical device companies. We are proud to have chosen Exact Imaging as our 2019 Life Science Company of the Year and look forward to watching their continued growth in the global marketplace”.

“We are honored to have been selected as LSO’s 2019 Life Science Company of the Year and I’m especially pleased for our 54-person team who have worked tirelessly to create and commercialize a technology that is changing lives and, through our customers, changing outcomes,” says Randy AuCoin, Exact Imaging’s President and CEO. “We are incredibly proud to be a Canadian-based company and are appreciative of the amazing ecosystem of medical device suppliers, partners and experts in Ontario who make up our extended family”.

The LSO awards will be presented to Exact Imaging during LSO’s Celebration of Success Awards Dinner at Toronto’s Liberty Grand, February 27, 2019.

About Life Sciences Ontario:

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the province’s vibrant and diverse life sciences sector. LSO collaborates with governments, academia, industry, and other life science organizations in Ontario and across Canada to promote and encourage commercial success throughout the sector. Membership in Life Sciences Ontario includes individuals, students, emerging companies, investors, service providers, and companies with marketed products. The organization provides a wide range of networking and educational events and operates a mentorship program that is helping to develop highly-skilled talent and build new business opportunities for the life sciences sector. LSO is an effective conduit for delivering policy options to governments and is dedicated to promoting Ontario’s life sciences sector internationally.

About Exact Imaging:

Exact Imaging is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas. For those cases where MRI might assist (i.e., prior negative biopsies), the FusionVu™ micro-US/MRI fusion application operates on the ExactVu™ micro-ultrasound platform and facilitates MRI fusion-based targeting. The ExactVu™ micro-ultrasound system including the FusionVu application have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).

Related Article: Exact Imaging Becomes UroGPO Imaging Partner By Providing Micro-Ultrasound Based Targeting Solution for Prostate Biopsies

Individuals Treated with TPS lost 3-fold More Weight Than Those in Sham-Controlled Placebo Arm

SAN CARLOS, Calif., Nov. 15, 2018 /PRNewswire/ — BAROnova, Inc., a clinical stage medical device company focused on the development of non-surgical solutions for the treatment of obesity, announced today the presentation of primary results of its pivotal trial, the ENDObesity II study, as a late-breaking clinical trial, at the scientific sessions of the 2018 Obesity Week conference.

The ENDObesity II study was a randomized, double-blinded, sham-controlled study that assessed the safety and effectiveness of the TransPyloric Shuttle Device for the treatment of obesity in patients with a body mass index of 30-40 kg/m². Primary endpoints were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of people in the treatment group who achieved 5% TBL or more after 12 months.

Individuals treated with the investigational TPS device on average lost three times (3x) more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS lost 5% or more of their body weight, exceeding the pre-specified performance target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS lost 10% or more weight (vs. 14% in sham-treated controls). A weight loss of 5% or more is considered clinically meaningful for achieving health benefit. People in the TPS group also demonstrated greater improvement in their blood pressure and other cardiometabolic risk factors as well as a significant improvement in their quality of life when compared to those in the control group.

“Obesity is a worldwide epidemic with up to 40% of adult Americans suffering from obesity and its associated co-morbidities. We need effective solutions that are safe and acceptable by physicians and by people who live with this chronic condition. The TransPyloric Shuttle represents the next generation of intragastric devices that was designed to address some of the undesirable side effects with the first-generation devices and offer longer treatment duration.  Based on the successful results from this study, this treatment will likely find a very meaningful role in clinical practice, if approved by the FDA,” said Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study who presented the results.

The ENDObesity II study enrolled 302 patients from nine investigational centers across the United States. In the trial, the most common adverse events among people treated with the TPS device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delay gastric emptying.

“We are pleased to see the magnitude of weight loss and significant clinical benefit demonstrated in the study.  Based on the positive pivotal study results, we have submitted the PMA application to the FDA,” said Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova Inc.. “We would like to thank all our clinical investigators and their staff for their contribution to the success of this trial. We look forward to bringing this new technology to patients and physicians if approved by the FDA.”

About Obesity
Obesity is defined as a Body Mass Index (BMI) >30 kg/m². Individuals with obesity are at increased risk of developing over 70 comorbid conditions including hypertension, hyperlipidemia, and type 2 diabetes. Obesity is a worldwide epidemic that has placed a major burden on healthcare systems globally.  There are currently over 75 million adults in the United States with a BMI between 30-40 kg/m² and over 600 million adults worldwide who are candidates for a safe and effective non-surgical therapy.

About the TransPyloric Shuttle
The TransPyloric Shuttle is a novel investigational device that is designed to be inserted and removed trans-orally using standard endoscopic techniques. It is mechanically constructed using solid silicone components and is not subject to inflation or deflation risks. The device is intended to reside in the stomach for 12 months.  The TransPyloric Shuttle’s primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss.  If approved by the FDA, the TPS will be the first and only intragastric device with a 12-month treatment duration available in the United States.

About BAROnova, Inc.
BAROnova is a Silicon Valley, venture-backed company that has developed a first-in-class non-surgical solution for obesity. BAROnova is headquartered in San Carlos, CA. For more information about the company, please visit www.BAROnova.com.

QUEBEC CITY, Nov. 1, 2018 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) has reached an important milestone with more than 50,000 patients assessed with the OptoWire™, a pressure guidewire used to measure Fractional Flow Reserve (“FFR”) to diagnose and treat cardio vascular disease.

The use of pressure guidewires to measure FFR for the evaluation of coronary blockages has grown over the years and is now considered the gold standard. Clinical data have shown a reduction in mortality in patients assessed using this technique.

As Societies of Cardiology are recommending expanding the use of pressure guidewires and physiology assessments, Opsens has scaled up manufacturing to respond to the growing demand for the OptoWire in its main markets, namely Japan, the United States, Europe and Canada, and to expand its reach to new geographies.

“This milestone is a testament to the quality of our product, of our team and of our vision to take on the challenge to bring a second-generation fiber optic technology pressure guidewire to the market,” said Louis Laflamme, President and CEO. “Our customers are delighted by the benefits brought on by the OptoWire and we are encouraged by their excellent feedback in terms of diagnostic accuracy as well as the time-saving and cost-effectiveness it can provide to the procedure.”

Opsens differentiates from the competition by the performance of the OptoWire in terms of vessel accessibility, as well as for the reliability and the accuracy of its second-generation fiber optic sensor.

Market adoption of the OptoWire has grown at a rapid pace and Opsens is now commercializing the OptoWire in more than 30 countries, with especially robust growth in the United States and Japan.

Laflamme concluded by sharing the unique passion that lives at Opsens: “Passing the 50,000 units sold, especially when more than half of these sales were completed in the last 12 months is a tremendous achievement. More than a number of units sold, our team gets pride in supporting physicians to provide accurate diagnostic and proper treatment to their patients.”

With Reimbursement in Place and Positive Late-Breaking Data, Company Expects Continued Growth in Germany

Kirkland, Wash. – October 18, 2018 – Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced that InEK, the German Institute for the Hospital Remuneration System, has granted a permanent DRG (Diagnosis Related Group) code covering reimbursement for the company’s Carillon Mitral Contour System to treat patients with functional mitral regurgitation (FMR) in Germany. The new reimbursement becomes effective January 1, 2019.

Previously, the Carillon System had been available in limited volumes under the Neue Untersuchungs- und Behandlungsmethoden (NUB) program. The DRG approval will allow every eligible patient in Germany to have access to the Carillon procedure.

“With this reimbursement in place and following the positive late-breaking clinical data from REDUCE FMR presented last month at TCT, we expect to see significant growth in Germany, the largest market in which the Carillon Mitral Contour System is currently available,” said Gregory D. Casciaro, President and CEO of Cardiac Dimensions. “We are pleased that this decision means many more people will now benefit from Carillon therapy.”

Data presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego last month showed that the REDUCE FMR clinical trial met its primary endpoint, demonstrating a statistically significant reduction in regurgitant volume at one year in patients who received the Carillon Mitral Contour System versus the control cohort, consisting of patients under guideline-directed medical therapy who underwent a sham procedure. The reduction represented a 22% reduction in regurgitation in the treatment group, compared to an overall increase of 8% in regurgitation in the control group (p=0.03). Study patients, the imaging core lab, and the clinical assessors were blinded as to the patients’ randomization group through the one-year follow-up period of the study.

“This positive decision is good news for patients in need of mitral valve repair due to FMR,” said Prof. Michael Haude, M.D., Director of the Department of Internal Medicine I, Cardiology, Lukas Krankenhaus Neuss, who has been treating patients with the Carillon System since the Amadeus study in 2007. “The Carillon System provides an important option for patients that is easy to use and that can be used to treat patients earlier in the progression of their disease to prevent worsening quality of life.”

The company announced last month that it had enrolled its first patient in the pivotal CARILLON Trial, a multi-center, double-blinded, randomized controlled trial expected to randomize 450 patients at up to 75 centers in North America and Europe.

Functional mitral regurgitation occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. The Carillon System is a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

To date, approximately 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, Italy and The Netherlands. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for the CE Mark demonstrating safety and performance. The recently released REDUCE FMR data is expected to assist with expanding reimbursement and usage in additional geographies such as Poland, France, United Kingdom and Australia.  Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.

The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.

Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

###

Media Contact:

Rick Wypych

rwypych@cardiacdimensions.com

(425) 605-5910

-Target enrollment has been exceeded and completed ahead of schedule

-Company anticipates primary data analysis in Q4 2019

In Randomized Blinded Study, the Carillon Mitral Contour System Catheter-Based Treatment Meets Endpoint for Reduction in Regurgitant Volume

September 19, 2018 06:45 AM Eastern Daylight Time

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced it has named Anthony (Tony) Polverino, Ph.D., Executive Vice President of Early Development and Chief Scientific Officer. In his new role, Dr. Polverino will be instrumental in setting and driving the Zymeworks R&D strategy. He will also manage the advancement of product candidates from discovery research through translational research/early development, thereby creating a seamless link with clinical development. In this newly created position, Dr. Polverino will report to Ali Tehrani, Ph.D., President & CEO of Zymeworks.

“Having had the opportunity to assess Zymeworks’ technologies and pipeline, I believe they are extremely well positioned to deliver novel treatments for a number of serious diseases, and I am delighted to be joining the company.” – Ali Tehrani, Ph.D., President & CEO, Zymeworks

“Tony joins us with an extensive and productive background in drug discovery and development,” said Dr. Tehrani. “His career includes a number of successes identifying and advancing programs from discovery through to clinical development and beyond. With expertise in biologics, antibodies, and small molecule therapeutics, as well as a broad background in immunotherapy and cancer biology, he is well suited to lead and contribute on many fronts as Zymeworks enters the next phase of its growth in building a diversified pipeline of first and best-in-class preclinical and clinical therapeutic programs.”

From 2016 until 2018, Dr. Polverino was at Kite Pharma, Inc., which was acquired by Gilead Sciences, Inc. in 2017. While at Kite he served as the interim Chief Scientific Officer and before that as Vice President of Research. During his tenure, Yescarta®, Kite’s lead chimeric antigen receptor (CAR)-T cell therapy, was approved for relapsed or refractory B cell lymphoma, and multiple programs were advanced to the clinic. Dr. Polverino also assembled an innovative chimeric antigen receptor discovery and development team. Prior to Kite, he was at Amgen Inc. from 1994 to 2014, serving in a number of research leadership roles of increasing responsibility. While at Amgen he managed and advanced numerous research programs utilizing multiple therapeutic modalities, including immunotherapy, oncolytic viruses, bispecific antibodies, antibody-drug conjugates, and small molecules. He also played a key role in the development of over 12 novel antigens for antibody therapeutics.

“Having had the opportunity to assess Zymeworks’ technologies and pipeline, I believe they are extremely well-positioned to deliver novel treatments for a number of serious diseases, and I am delighted to be joining the company,” said Dr. Polverino. “Zymeworks’ multiple platforms will provide abundant opportunities to apply my scientific curiosity and passion for creating new medicines for patients.”

Dr. Polverino earned his undergraduate degree in pharmacology from Adelaide University and his Ph.D. in biochemistry from Flinders University, both in Adelaide, Australia. Subsequently, he was a post-doctoral scientist at Cold Spring Harbor Laboratory located in Cold Spring Harbor, New York. Dr. Polverino has authored dozens of scientific publications and is a named inventor on multiple patents. He serves as a board member for BrainStorm Cell Therapeutics, a biotechnology company developing adult stem cell therapeutics for neurodegenerative diseases.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to future contributions by the new Chief Scientific Officer, Zymeworks’ technology and potential future growth, the success of Zymeworks’ drug discovery and development, Zymeworks’ ability to deliver novel treatments or develop new medicines, and other information that is not historical information. When used herein, words and phrases such as “will,” “believe,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D., 604-678-1388
ir@zymeworks.com
or
Media Inquiries:
Angela Bitting, 925-202-6211
a.bitting@comcast.net

Related Article: Zymeworks Adds Experienced Executives to Management Team to Support Expanding Clinical Development

KIRKLAND, Wash.- Cardiac Dimensions, Inc. a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the company has randomized its first patient in the CARILLON Pivotal Trial.

The CARILLON Trial is evaluating the Carillon^® Mitral Contour System^® for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines. The multi-center, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe. The trial has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status. The CARILLON Trial also includes a cross-over feature that allows patients originally randomized to the control group to receive the Carillon System after their one year follow-up visit.

“Current treatments to improve the quality of life for patients with FMR fall short and many heart failure patients are too frail for open-heart surgery,” said Samir Kapadia, M.D., interventional cardiologist and Cath Lab director at the Heart & Vascular Institute, Cleveland Clinic, and one of the principal investigators of the CARILLON Trial. “Transcatheter treatments have been shown to be safe and effective in the treatment of valve diseases, but there is no minimally invasive intervention yet approved in the U.S. for these patients. Today, most FMR patients are treated with medical therapy only for decreasing symptoms but this does not address the underlying anatomical problem leading to mitral regurgitation. The CARILLON Trial should provide us a better understanding of the benefits of the Carillon System as an option for heart failure patients with FMR.”

Functional mitral regurgitation occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.

Prof. Tomasz Siminiak, professor of cardiology at Poznan University of Medical Sciences in Poznań, Poland, randomized the first patient in the CARILLON Trial.

“We are very excited to participate in this landmark trial to study the Carillon System for patients with FMR,” said Prof. Siminiak. “These patients need access to less invasive treatment options, and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease, is very important to us.”

An estimated 26 million people suffer from heart failure worldwide¹ and, of those, approximately 70 percent have FMR. In the U.S., an estimated two million people are affected by symptomatic FMR associated with HF.^2,3 Overall, HF is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.⁴

“The initiation of the CARILLON Trial is the pinnacle of our clinical program, which includes positive data from three previous clinical trials, and is the final step on our path to bringing the Carillon System to patients in the United States,” said Gregory D. Casciaro, president and CEO of Cardiac Dimensions. “Our vision is to have a significant impact on the treatment of patients with FMR, offering physicians a safe and easy-to-use option that can treat a broader range of patients with the goal of slowing disease progression and preventing worsening quality of life.”

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

To date, approximately 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has its CE Mark and is available in certain European markets as well as other key geographies including Turkey. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for CE marking demonstrating safety and performance. In addition, the company will announce the results of its landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference September 23, 2018. Additionally, the CARILLON Trial, continues to enroll patients.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.

The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.

Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

¹ Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25. doi: 10.1002/ehf2.12005.

² Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11.

³ Patel JB, Borgeson DD, Barnes ME, el at. Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail. 2004;10(4):285-91.

⁴ Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.

Contacts

Cardiac Dimensions
Rick Wypych, 425-605-5910
rwypych@cardiacdimensions.com

G1 Therapeutics (Nasdaq: GTHX), a clinical-stage oncology company, today announced that it is expediting analyses of myelopreservation data from its randomized Phase 2 trial of trilaciclib in combination with chemotherapy and Tecentriq^® (atezolizumab) in first-line small cell lung cancer (SCLC). Myelopreservation results from the trial will be reported in the fourth quarter of 2018.

“We elected to make myelopreservation the primary outcome of the randomized trilaciclib/chemotherapy/Tecentriq trial based on the strength of the first-line small cell lung cancer myelopreservation results from our randomized Phase 2 trilaciclib/chemotherapy trial, which we reported in March,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, Research and Development. “This protocol amendment, which we have discussed with U.S. and European regulatory authorities, enables us to accelerate analyses of mature myelopreservation data collected from the trilaciclib/chemotherapy/Tecentriq trial. The trial will remain blinded to investigators and participants, with no impact on our timeline to report overall survival data.”

This randomized, double-blind Phase 2 trial enrolled 107 patients to receive trilaciclib or placebo in combination with chemotherapy (carboplatin + etoposide) and Tecentriq as first-line treatment for SCLC. The trial is evaluating the myelopreservation potential of trilaciclib. Myelopreservation is the ability to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Anti-tumor efficacy measures including overall response rate, progression-free survival and overall survival are also being evaluated. Under the revised protocol, myelopreservation results are now the primary outcome and overall survival is being assessed as a secondary outcome. The trial completed enrollment in February 2018.

“Data from the trilaciclib/chemotherapy/Tecentriq trial have the potential to confirm the myelopreservation results observed in our randomized Phase 2 trial of trilaciclib in combination with chemotherapy. Both trials evaluated trilaciclib in first-line small cell lung cancer using the same chemotherapy backbone,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “By the end of the year we will have myelopreservation data from all four randomized Phase 2 trials of trilaciclib, including three in small cell lung cancer and one in triple negative breast cancer. In these trials, trilaciclib was used in first-, second- and third-line settings in combination with a variety of chemotherapy regimens. We plan to discuss the totality of the data, which includes approximately three hundred participants who received trilaciclib, with U.S. and European regulatory authorities in the first half of 2019.”

Webcast and Conference Call 
The G1 management team will host a webcast and conference call at 8:30 a.m. ET today to discuss the trilaciclib clinical development program. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3892548. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.

About Trilaciclib
Trilaciclib is a first-in-class myelopreservation therapy designed to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Trilaciclib is a short-acting intravenous CDK4/6 inhibitor administered prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials. In March 2018, G1 announced positive Phase 2 data showing myelopreservation benefits in newly diagnosed, treatment-naive small cell lung cancer (SCLC) patients (NCT02499770). Additional results from this trial will be reported at the European Society for Medical Oncology (ESMO) 2018 Congress being held October 19-23. The company plans to report data from three other randomized Phase 2 trials in 2018: a trial in combination with chemotherapy and Tecentriq^® in first-line SCLC, (NCT03041311), a trial in combination with chemotherapy in previously treated SCLC (NCT02514447), and a trial in combination with chemotherapy in triple-negative breast cancer (NCT02978716).

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; G1 Therapeutics’ development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Jeff Macdonald
Head of Investor and Public Relations
919-213-9835
jmacdonald@g1therapeutics.com

Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced the close of a Series D financing round totaling $45 million. The round was led by LSP, investing from its LSP Health Economics Fund 2, and included Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, SV Health Investors, Wanxiang Healthcare Investments, and an unnamed corporate strategic investor. Endotronix will expand the board of directors to include Fouad Azzam Ph.D., General Partner at LSP.

This financing supports the commercialization of the Cordella™ Heart Failure System (Cordella System) and clinical development of the Cordella™ Pulmonary Artery Sensor (Cordella Sensor) through CE Marking and FDA Premarket Approval (PMA). The product platform consists of a comprehensive remote patient management software solution coupled with a seamlessly integrated, next-generation implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.

“We are thrilled with the world-class leadership and support of LSP and our existing investor group as we launch into the next phase of our company,” commented Harry Rowland, CEO of Endotronix. “This financing accelerates our U.S. and E.U. launch of the Cordella System and supports our upcoming landmark randomized, controlled clinical study, PROACTIVE-HF, to demonstrate the safety and effectiveness of proactive heart failure management.”

The Cordella System is designed to address inefficiencies in heart failure management and promote guideline-based therapy so physicians can improve patient care and reduce re-hospitalizations with effective and scalable remote patient management. Over 26 million people worldwide suffer from heart failure and it is a leading cause of re-hospitalization for people over 65^1,2. With U.S. treatment costs reaching $31B per year, heart failure management remains a pressing unmet clinical need³.

“Endotronix is on the cusp of transforming heart failure management,” stated Fouad Azzam. “Their scalable Cordella System enables streamlined and timely flow of clinical-level information that can improve patient outcomes and supports sustainable care delivery revenue for healthcare providers. We’re excited to be part of the team to drive this transformation in the heart failure market.”

This announcement builds on the earlier news of successful first-in-human use of the Cordella Sensor in Europe and first commercial use of the Cordella System at select U.S. sites.

About the Cordella™ Heart Failure System

The Cordella™ Heart Failure System is a proactive heart failure management solution that brings patient management into the digital age and allows physicians to treat more patients with guideline-based therapy. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient data and insights to the heart failure clinician to guide therapy and optimal dosing. In the U.S. market, the system drives care delivery revenue using Medicare’s existing Chronic Care Management Services to support proactive, high-quality heart failure care. For suitable patients, the system seamlessly integrates pulmonary artery pressure data with a next-generation wireless, implantable sensor. Clinical studies have demonstrated that pulmonary artery pressure-guided management can reduce heart failure-related hospitalizations and reduce mortality.

About Endotronix

Endotronix, Inc., a digital health, medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. 

About LSP

LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, the LSP team has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1.7 billion ($2.0 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is Europe’s leading life sciences investor. The LSP Health Economics Fund 2 invests in innovative products that can increase the quality of health care, while reducing the cost of care.

Related Article: Endotronix Closes $32 Million in Financing to Address Heart Failure Management

G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that Garry Nicholson has been appointed to its board of directors, effective September 12, 2018.

“We are pleased to welcome Garry as an independent director to our board. He has a breadth of experience in oncology development and commercialization, including leading the global regulatory and launch strategy for the first CDK4/6 inhibitor approved in the U.S. and Europe. We look forward to his contributions as we advance our pipeline of innovative therapies to improve the lives of those affected by cancer,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

“I am excited to be joining the G1 board of directors as the company moves toward commercialization of its lead program. Trilaciclib is a first-in-class therapy that could benefit millions of people living with cancer,” added Mr. Nicholson.

Mr. Nicholson has more than 30 years of pharmaceutical and biotech oncology experience. He led the global oncology franchise at Pfizer in the role of President, Pfizer Oncology. His responsibilities included global commercialization and sales, clinical development and regulatory strategy, and business development. Mr. Nicholson also served on the board of directors of the Pfizer Foundation. Earlier in his career, he held various leadership positions in the oncology division of Eli Lilly and Company. Most recently, Mr. Nicholson served as President and Chief Executive Officer of XTuit Pharmaceuticals.

Mr. Nicholson currently serves on the board of directors of Five Prime Therapeutics, Inc., TESARO, Inc., and SQZ Biotechnologies.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, G1 Therapeutics’ ability to recruit and enroll patients in its studies; G1 Therapeutics’ initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; competition in the industry in which G1 Therapeutics operates; and market conditions, including future legislation that may increase the difficulty and cost for G1 Therapeutics to obtain marketing approval of and commercialize its product candidates. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
917-371-0940
jmacdonald@g1therapeutics.com

ExactVu™ micro-ultrasound platform – now with FusionVu – enables the highest real-time resolution for targeted prostate imaging and biopsy

Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced one-year follow-up data from the REDUCE LAP-HF I clinical study of its Interatrial Shunt Device (IASD^®). The IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. Data was presented in the late-breaking scientific session at the European Society of Cardiology meeting. Dr. Ted Feldman from Evanston Hospital in Illinois presented the results on behalf of the investigators and research staff.

REDUCE LAP- HF I is a prospective, double-blind, mechanistic study of 44 patients randomized to IASD or sham control. Primary study endpoints at 30 days included effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared to sham control, and procedural safety as assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE). The study met its primary endpoint.

The one-year results demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. Results further showed the IASD is safe, improved quality of life and is associated with favorable trends in heart failure hospitalization and reduction in New York Heart Association (NYHA) heart class. Results are published today in JAMA Cardiology.

“The REDUCE LAP-HF I clinical study is of tremendous interest to me because HFpEF is a clinical problem for which there is no effective therapy,” commented Ted Feldman, M.D., Evanston Hospital in Illinois and co-principal investigator. “We’ve now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up.”

Sanjiv Shah, M.D., Northwestern Memorial Hospital’s Center for Heart Failure at the Bluhm Cardiovascular Institute in Chicago, and co-principal investigator, commented “I am pleased with the results of the REDUCE LAP-HF trials so far. By leading and taking part in these studies, we hope to make a significant difference for patients who suffer from the devastating effects of this type of heart failure.”

“The data presented today by Dr. Feldman once again demonstrate the potential benefit of IASD therapy for the large underserved heart failure population,” said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “While this particular study was focused on demonstrating a mechanistic effect and by design, underpowered for other outcome measures, the clinical results are consistent with prior trials confirming the IASD provided symptom relief, improved quality of life, and reduced heart failure events. We now are focused on demonstrating, in the ongoing REDUCE LAP-HF II study, that these positive clinical outcomes are robust enough, in a larger patient population, to carry this new technology into clinical practice.”

REDUCE LAP-HF II is a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients. Recruitment is ongoing.

About the InterAtrial Shunt Device (IASD^®)

The Interatrial Shunt Device is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. For more information, please visit http://treatmyheartfailure.com/. The IASD is an investigational device and not available for commercial distribution in the United States

About Corvia Medical, Inc.

Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.

MEDIA CONTACT: 
Jennifer Fitzgerald
+1-484-678-5018
jen@sprigconsulting.com

SOURCE Corvia Medical, Inc.

Related Links

http://corviamedical.com

Forbius announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AVID200, an isoform-selective TGF-β inhibitor. This enables the company to begin a Phase 1 clinical study to evaluate AVID200 as a potential treatment for diffuse cutaneous systemic sclerosis (SSc), a life-threatening fibrotic disease.

SSc is a rare, severe, and progressively debilitating fibrotic disease, affecting predominately women in mid-life. The 10-year survival rate of SSc patients is approximately 55%. No therapeutic is currently approved for the treatment of SSc, which affects an estimated 50,000 people in the U.S. alone.

TGF-β is now widely accepted as being the primary driver of SSc pathogenesis (Lafyatis, R.Nat. Rev. Rheumatol. 10, 706–719 (2014)). Gene expression data demonstrate the increased expression of TGF-β regulated genes in SSc skin. Moreover, the extent of upregulation of expression of two of the three TGF-β isoforms (-β1 &-β3), which are the isoforms blocked by AVID200, correlates with the severity of SSc (O’Connoret al, JSRD, 2018, CO.22 Vol 3(1S):22-25)

“I am keen to investigate the potential of AVID200 to reverse this life-threatening condition. A substantial body of preclinical and clinical data demonstrate that the basic defect in SSc is diffusely increased TGF-β activity and that inhibition of TGF-β could reverse this disease. AVID200 appears to have the right profile to be the first disease modifying agent in SSc,” commented Coordinating Principal Investigator, Robert Lafyatis, M.D., Professor of Medicine, Medsger Professor and Director of the University of Pittsburgh Scleroderma Center at the University of Pittsburgh Medical Center.

The Phase 1 dose-escalation study will be conducted in multiple study centers throughout the United States. The trial will evaluate safety and pharmacokinetics, as well as pharmacodynamics and preliminary evidence of efficacy of AVID200 as a potential treatment of SSc.

About AVID200

The AVID200 program was recently featured in an oral presentation at the 5th Systemic Sclerosis World Congress and received an award from the World Scleroderma Foundation as “One of the Most Original Works Presented at the Congress”.

AVID200 is designed to be a highly potent and isoform-selective TGF-β inhibitor. AVID200 is unique since it selectively neutralizes TGF-β1 and -β3 with pM potency, while at the same time being minimally active against TGF-β2. Inhibiting the TGF-β1 and -β3 isoforms is advantageous since overexpression of these isoforms is closely associated with the progression of fibrosis and cancer. Conversely, blockage of TGF-β2 is undesirable because of the potential impact on normal cardiac function and dissemination of metastasis. AVID200 is therefore positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings. AVID200 is undergoing development for the treatment of fibrotic diseases and immune oncology.

About Forbius (Formation Biologics)

Forbius is a clinical stage company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. Forbius’ medicines are designed to radically transform patients’ lives. We use our strength in biological understanding and diverse protein engineering technologies to design superior inhibitors of validated pathways.We have particularly deep expertise in targeting the transforming growth factor-beta (TGF-β) and epidermal growth factor receptor (EGFR) pathways. For both of these pathways, there is a significant body of evidence validating their role as drivers of multiple life-threatening conditions, including cancer and fibrosis. However, in the case of the EGFR pathway, the majority of patients do not benefit from currently marketed EGFR inhibitors; in the case of the TGF-β pathway, no agent targeting this pathway has yet been approved. By using multiple complementary platform technologies, Forbius’ team overcame barriers that prevented the development of effective therapeutics targeting these pathways. For more information, please visit www.forbius.com.

Contacts

Forbius (Formation Biologics)
Ilia A. Tikhomirov
info@forbius.com

Forbius (Formation Biologics) announced today that it has been awarded a Product Development grant totaling $18.75 million from the Cancer Prevention and Research Institute of Texas (CPRIT). The grant will support operations and Phase 2a development of AVID100, a highly potent anti-EGFR antibody-drug conjugate, in three cancer indications with significant unmet medical need.

The new CPRIT grant award follows a successful completion of an AVID100 Phase 1 clinical trial. The CPRIT review for this grant included an in-depth evaluation of AVID100 preclinical, manufacturing, and clinical data by a panel of scientific, medical, commercialization, and financial experts. The evaluation also included rigorous regulatory, product development, and intellectual property due diligence. Acceptance of the award is subject to completion of contract negotiations.

This grant will support additional preclinical and translational research, manufacturing, personnel costs, and clinical development of AVID100 in patients with confirmed EGFR overexpression in three Phase 2a clinical trials: breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and non-small cell lung cancer (NSCLC). Currently, no therapy is approved for treatment of patients whose tumor overexpresses EGFR.

“AVID100 demonstrated a compelling profile in preclinical and Phase 1 clinical studies, and this significant CPRIT grant supports and accelerates development of this agent for several cancers with unmet medical needs. We are especially pleased to receive this award after the in-depth evaluation by CPRIT’s highly experienced panel of experts. We will commence dosing of patients with AVID100 in Phase 2a trials later this year,” commented Ilia A. Tikhomirov, CEO of Forbius.

About Forbius (Formation Biologics)

Forbius is a clinical stage company that designs and develops biotherapeutics for treatment of cancer and fibrotic diseases. Forbius’ medicines are designed to radically transform patients’ lives. We use our strength in biology and diverse protein engineering technologies to design superior inhibitors of validated biological pathways.

We have particularly deep expertise in targeting the transforming growth factor-beta (TGF-β) and epidermal growth factor receptor (EGFR) pathways. For both of these pathways, there is a significant body of evidence validating their role as drivers of multiple life-threatening conditions, including cancer and fibrosis. However, in the case of the EGFR pathway, the majority of patients do not benefit from currently marketed EGFR inhibitors; and in the case of the TGF-β pathway, no agent targeting this pathway has yet been approved. By using multiple complementary platform technologies, Forbius’ team overcame barriers that prevented the development of effective therapeutics targeting these pathways.  For more information, please visit www.forbius.com.

Contacts

Forbius (Formation Biologics)
Ilia A. Tikhomirov
info@forbius.com

August 16, 2018

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