Iterion Therapeutics, an oncology-focused biopharmaceutical company developing small molecule inhibitors of Transducin beta-like protein 1 (TBL1), a downstream target in the Wnt/beta-catenin signaling pathway, announced today it is actively enrolling a Phase 1b/2a clinical trial of its lead molecule, tegavivint, in patients with advanced hepatocellular carcinoma (HCC) that have failed at least one line of systemic therapy.

Activation of the Wnt/beta-catenin pathway is a hallmark of several forms of cancer, including HCC, in which approximately half of patients have tumors with Wnt-activating mutations. Unfortunately, key members of this pathway (including beta-catenin) have either been resistant to conventional drug development or plagued with off-target toxicities. Extensive pre-clinical study results across multiple tumor types suggest that TBL1 is a downstream target that is necessary for Wnt/beta-catenin-activated oncogenesis. TBL1 binds nuclear beta-catenin thus stabilizing the transcription complex necessary to turn on cancer-causing genes. Tegavivint’s direct binding to TBL1 displaces beta-catenin and disrupts this complex, allowing the degradation of free nuclear beta-catenin and preventing downstream oncogenic gene transcription.

“By targeting TBL1, tegavivint promotes potent inhibition of nuclear beta-catenin oncogenic activity without inducing toxicities observed for other drugs that are upstream in the Wnt-pathway” stated Rahul Aras, Ph.D., President & CEO for Iterion Therapeutics. “HCC is a devastating cancer with a high prevalence of Wnt-activated tumors, and we are committed to developing tegavivint for this patient population that otherwise has very few therapeutic options”.

HCC is the sixth most commonly diagnosed cancer and the third leading cause of cancer death globally. In 2023, the National Cancer Institute (NCI) estimated 41,210 new HCC cases diagnosed in the US, with 29,380 deaths. The overall prognosis is poor, with a 5-year survival rate of 21.6%. Wnt-activation plays multiple roles in the pathogenesis of HCC by initiating tumorigenesis, promoting metastasis, and enhancing an immunosuppressive tumor microenvironment. Patients with elevated nuclear beta-catenin and TBL1 demonstrate particularly poor outcomes. Despite this, there are no FDA-approved therapies targeting this pathway.

“There is a desperate need for novel targeted therapies to address the large unmet clinical need in HCC” expressed Casey Cunningham, M.D., Chief Medical Officer for Iterion Therapeutics. “Tegavivint has demonstrated excellent tolerability and has the potential to address a large portion of this population by directly inhibiting beta-catenin’s oncogenic activity”.

The ongoing clinical trial will enroll approximately 35 patients in dose escalation and optimization cohorts of patients with unresectable locally advanced or metastatic HCC that have failed at least one line of systemic treatment. The study will evaluate safety and clinical efficacy in addition to pharmacokinetic and pharmacodynamic markers to determine a Recommended Phase 2 Dose (RP2D) in HCC. Tegavivint has demonstrated safety, clinical and pharmacodynamic activity in a Phase 1 clinical study of patients with desmoid tumors.

For more information about this Phase 1b/2a clinical trial of tegavivint in patients with advanced HCC, please visit www.ClinicalTrials.gov using the identifier NCT05797805.

About Iterion Therapeutics

Iterion Therapeutics is a clinical-stage biotechnology company developing novel cancer therapeutics. The company’s lead product, tegavivint, is a potent and selective small molecule that binds to Transducin beta-like protein 1 (TBL1), a newly characterized target in the Wnt/beta-catenin pathway. TBL1 binds to nuclear beta-catenin, forming an active transcription complex that prevents nuclear degradation of beta-catenin and activates genes necessary for the Wnt/beta-catenin oncogenic activity. Tegavivint binds to TBL1 and disrupts the interaction between beta-catenin and TBL1, thus promoting the degradation of nuclear beta-catenin and preventing the transcription of Wnt/beta-catenin targeted oncogenes. Iterion is currently advancing multiple clinical programs investigating tegavivint in cancer indications where nuclear beta-catenin overexpression is a known factor. These include Iterion-sponsored programs in hepatocellular carcinoma (HCC), as well as investigator-sponsored programs in non-small cell lung cancer (NSCLC), diffuse large B-cell lymphomas (DLBCL), and pediatric solid tumors. Iterion is the recipient of combined a $18.9 million in Product Development Awards from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information on Iterion, please visit  www.iteriontherapeutics.com.

SOURCE Iterion Therapeutics

Financing included participation from new and existing investors

Pro forma cash and cash equivalents expected to fund current operating plan into 2027

enGene Holdings Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced that it has agreed to sell 20 million of its common shares at a price per share of $10.00, representing a 31% premium over the closing price on February 13, 2024. The financing is expected to close on February 16, 2024, subject to customary closing conditions. enGene anticipates the gross proceeds from the private placement to be $200 million, before deducting any offering-related expenses.

The financing included participation from new and existing investors, including Adage Capital Partners, LP, Blue Owl Healthcare Opportunities, Boxer Capital, Commodore Capital, Cormorant Asset Management, Deep Track Capital, an affiliate of Deerfield Management Company, Foresite Capital, Janus Henderson Investors, Logos Capital, Lumira Ventures, Marshall Wace, Perceptive Advisors, Soleus Capital, Surveyor Capital (a Citadel company), Venrock Healthcare Capital Partners, and a large investment management firm.

enGene intends to use the proceeds from this financing to fund the continued development of EG-70, the Company’s genetic medicine therapeutic candidate being evaluated in an ongoing pivotal study for BCG-unresponsive NMIBC, evaluation of expanded EG-70 development opportunities, potential new R&D programs and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash and cash equivalents are expected to be sufficient to fund the current operating plan into 2027.

Leerink Partners, Guggenheim Securities and Wells Fargo Securities are acting as placement agents on the offering.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. enGene has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the common shares issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About enGene

enGene is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company.

Forward-Looking Statements

Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s expectations, hopes, beliefs, intentions, goals, strategies, forecasts and projections. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: the timing and expectation of the closing of the private placement; the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; and the period over which enGene estimates the proceeds from the private placement, combined with its existing cash and cash equivalents, will be sufficient to fund its current operating plan.

Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company’s ability to recruit and retain qualified scientific and management personnel; establish clinical trial sites and enroll patients in its clinical trials; execute on the Company’s clinical development plans and ability to secure regulatory approval on anticipated timelines; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2023 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

SOURCE enGene

TPN-101 is the first PSP treatment to reduce NfL and IL-6 levels, key biomarkers of neurodegeneration and neuroinflammation in PSP

Participants treated with TPN-101 for the entire 48-week study in PSP showed a stabilization of their clinical symptoms as measured by the PSPRS

In the Phase 2 study of C9orf72-related ALS/FTD, TPN-101 showed effects on key biomarkers of neurodegeneration, neuroinflammation and microglial activation, including NfL, Tau, UCHL1, YKL-40 and osteopontin

TPN-101 also showed a clinical effect on Vital Capacity, an objective respiratory measure that correlates with mortality in patients with ALS

Transposon plans to advance TPN-101 to a Phase 3 registration study for PSP and is expanding the development of TPN-101 into Alzheimer’s disease

Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases including Alzheimer’s disease, today announced final results from its Phase 2 study of TPN-101 for the treatment of progressive supranuclear palsy (PSP). The company also announced interim results from its Phase 2 study of TPN-101 in patients with amyotrophic lateral sclerosis (ALS) and/or frontotemporal dementia (FTD) related to hexanucleotide repeat expansion in the C9orf72 gene (C9orf72-related ALS/FTD). Transposon will present final results from its Phase 2 study in PSP in a poster presentation at the hybrid AD/PD^™ 2024: 18^th International Conference on Alzheimer’s and Parkinson’s Diseases. The meeting will take place online and in Lisbon, Portugal, from March 5-9, 2024.

Final Phase 2 PSP Study Results

Final 48-week results from the Phase 2 study in PSP confirm and extend the 24-week interim results that showed TPN-101 is the first treatment for PSP to reduce levels of neurofilament light chain (NfL), a key biomarker of neurodegeneration in tauopathies such as PSP and Alzheimer’s disease. Participants treated with placebo from weeks 1 to 24 and then switched to 400 mg TPN-101 at week 24 experienced a reduction of NfL in the cerebrospinal fluid (CSF) from weeks 24 to 48 that was similar to that observed in the group of participants receiving the 400 mg dose from weeks 1 to 24. Participants treated with 400 mg TPN-101 for the entire 48-week treatment period showed no increase of NfL levels in the CSF from weeks 1 to 48. In contrast, NfL levels in the CSF are reported to increase by 9-18% annually in natural history studies of PSP.

The 48-week results also showed further dose-related reductions in interleukin 6 (IL-6) cytokine levels, as well as reductions in levels of osteopontin. IL-6 is a biomarker of neuroinflammation that is elevated in PSP and correlates with disease progression and severity. Osteopontin levels correlate with cognitive deficit in Alzheimer’s disease patients and lowering of osteopontin may predict cognitive improvement.

Participants treated with TPN-101 for the entire 48-week trial duration showed a stabilization of their clinical symptoms as measured by the PSP Rating Scale (PSPRS) between weeks 24 and 48. In contrast, participants who had been on placebo from weeks 1 to 24 continued to show a worsening of the PSPRS between weeks 24 and 48, suggesting a delay of clinical benefit onset of at least 24 weeks after start of drug treatment, and lagging behind the early effects on biomarkers seen in weeks 1 to 24.

“There are no effective treatments for PSP, a uniformly fatal disease that is similarly prevalent to ALS,” said Adam Boxer, M.D., Ph.D., Endowed Professor in Memory and Aging in the Department of Neurology at the University of California, San Francisco and principal investigator in the Phase 2 study of TPN-101 for PSP. “The effects of TPN-101 on CSF NfL concentrations, as well as other exploratory CSF biomarkers, have not previously been observed in any PSP trial and support further investigation of clinical treatment effects in a larger study.”

Interim Phase 2 C9orf72-Related ALS/FTD Study Results

Results from the pre-defined interim analysis of the Phase 2 study in C9orf72-related ALS/FTD demonstrated the impact of TPN-101 treatment on key biomarkers of neurodegeneration, neuroinflammation, and microglial activation including NfL, tau, UCHL1, YKL-40, and osteopontin from baseline to 24 weeks. The data also showed a clinical effect on Vital Capacity, an objective respiratory measure that correlates with mortality in patients with ALS. Notably, C9orf72-related ALS/FTD is a TDP-43 protein pathology associated with nuclear displacement of TDP-43 in the central nervous system. TDP-43 pathology also occurs in about 50% of patients with Alzheimer’s disease.

“Transposon’s founding mission was to establish human proof-of-concept that dysregulation of retrotransposable elements in neurodegenerative diseases such as PSP, ALS and Alzheimer’s disease can be addressed with a new class of LINE-1 reverse transcriptase inhibitors,” stated Eckard Weber, M.D., Founder and Chief Innovation Officer of Transposon. “The results obtained with TPN-101 in both PSP and ALS/FTD show for the first time that neurodegenerative diseases that involve LINE-1 dysregulation are treatable with a specific inhibitor of this important novel target. We look forward to advancing the development of TPN-101 into registration studies to address this devastating and rapidly growing disease category.”

“Given the large unmet needs in PSP and ALS, these promising results highlight the therapeutic potential of TPN-101 for both disorders,” added Murali Doraiswamy, MBBS, FRCP, Professor of Psychiatry and Geriatrics at Duke University and chair of Transposon’s clinical advisory board. “These data also provide key validation of targeting LINE-1 to treat other tauopathies such as Alzheimer’s disease.”

“Based on the groundbreaking study results shown by TPN-101 in both PSP and ALS/FTD, we plan to rapidly advance TPN-101 into a Phase 3 registration study for the treatment of PSP, and potentially ALS/FTD as well, pending final confirmatory study results,” said Dennis Podlesak, Chairman and Chief Executive Officer of Transposon. “Importantly, the totality of the results across both studies also provides compelling scientific rationale for targeting LINE-1 to treat Alzheimer’s disease. Based on these findings, we are expanding our development efforts into Alzheimer’s disease with the goal of bringing a novel drug treatment to patients that remain in dire need of an effective new therapeutic option.”

About AD/PD 2024

The hybrid AD/PD 2024: 18^th International Conference on Alzheimer’s and Parkinson’s Diseases will take place online and in Lisbon, Portugal, from March 5-9, 2024. Transposon will present final results from its Phase 2 study in PSP in a poster presentation (abstract #433) at AD/PD 2024 entitled: “A Phase 2a Study of TPN-101, a Nucleoside Reverse Transcriptase Inhibitor, in Patients with Progressive Supranuclear Palsy.” For more information, please visit the AD/PD 2024 website.

About the Phase 2 Study in PSP

The Phase 2 study in PSP is a multi-center, randomized, double-blind, placebo-controlled, parallel-group, 4-arm study with an open-label treatment phase in patients with PSP. Participants (n=42) were randomized to receive daily doses of 100 mg, 200 mg or 400 mg of TPN-101, or placebo. The study includes a 6-week screening period, a 24-week double-blind treatment period, a 24-week open label treatment period, and a follow-up visit 4 weeks post-treatment. All phases of the study, including the 24-week open label treatment period, have been completed. Further information on the study can be accessed at ClinicalTrials.gov.

About the Phase 2 Study in C9orf72-related ALS/FTD

The Phase 2 study in C9orf72-related ALS/FTD is multi-center, randomized, double-blind, placebo-controlled parallel-group, 2-arm study with an open-label treatment phase in patients with C9orf72-related ALS and/or FTD. Participants (n=42) were randomized to receive daily doses of 400 mg of TPN-101 or placebo. Similar to the Phase 2 study in PSP, this study includes a 6-week screening period, a 24-week double-blind treatment period, a 24-week open-label treatment period, and a follow-up visit 4 weeks post-treatment. The predefined interim analysis was performed after all patients completed the 24-week double-blind portion of the study. The open-label extension of the study is ongoing, with subjects and investigators blinded to the original treatment assignment. Further information on the study can be accessed at ClinicalTrials.gov.

About TPN-101

TPN-101 specifically inhibits the LINE-1 reverse transcriptase that promotes LINE-1 replication. LINE-1 elements are a class of retrotransposable elements that in humans are uniquely capable of replicating and moving to new locations within the genome. When this process becomes dysregulated, LINE-1 reverse transcriptase drives overproduction of LINE-1 DNA, triggering innate immune responses that contribute to neurodegenerative, autoimmune and aging-related disease pathology.

About PSP

PSP is a rare and fatal tauopathy with no approved treatment options. PSP mainly affects people in their mid- to late-60s and is characterized by early postural instability and falls, vertical gaze palsy, akinesia, rigidity, pseudobulbar palsy, and frontal dysfunction with cognitive and behavioral changes. The mean survival for individuals with PSP is 6 to 7 years.

About ALS and FTD

ALS is a neurodegenerative disease characterized by progressive muscle weakness, loss of ability to speak, eat, move or breathe. FTD is a progressive frontal / temporal cortex disease associated with behavior and personality changes, emotional problems, and difficulty walking, communicating or working. With onset commonly in middle age or earlier, patients with ALS have a mean survival of only 3 years. Patients with FTD have a mean survival of 9 years. 

About Transposon

Transposon Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a platform of novel therapies for the treatment of neurodegenerative and aging-related diseases, including Alzheimer’s disease. The company’s lead clinical compound, TPN-101, is first-in-class to address LINE-1 reverse transcriptase for treating neurodegenerative and autoimmune diseases. The company also has a discovery platform supporting a deep pipeline of novel therapies to address additional indications. Dr. Doraiswamy chairs the company’s clinical advisory board and has received compensation/stock options for his role.

Contact:
Rick Orr 
Transposon Therapeutics, Inc.
(858) 535-4821
rorr@transposonrx.com

SOURCE Transposon Therapeutics

A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes

Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 Diabetes (T2D), announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) to initiate a clinical study of the ReCET System for the treatment of T2D in adult patients, inadequately controlled by non-insulin, glucose lowering medications.

The ReCET Clinical Study is a multicenter, prospective, randomized, double blinded, sham controlled study assessing the safety and effectiveness of the ReCET™ System. The pivotal study will enroll up to 350 patients at clinical sites in the United States and Australia. 

“Endogenex is excited to achieve this important clinical milestone,” said Stacey Pugh, Endogenex CEO. “This is a critical next step in advancing the ReCET Procedure as a treatment that addresses the underlying causes of T2D that are not targeted by current diabetes medications.”

“Many people living with T2D struggle to remain in control of their blood sugar levels, even while using modern glucose lowering medications. This presents a significant challenge for patients and their care providers,” stated Richard Pratley, MD, Medical Director of the Advent Health Diabetes Institute in Orlando, Florida and Co-Principal Investigator for the ReCET Study. “Preliminary results of the ReCET Procedure have been very encouraging, so we look forward to participating in this study and expanding the understanding of how it may fulfill a significant need in the care of this patient population.”

“The role of the duodenum in metabolic function and signaling is well-established,” stated Dr. Barham Abu Dayyeh, MD, MPH, the Director of Advanced and Metabolic Endoscopy at Mayo Clinic in Rochester, Minnesota, and Co-Principal Investigator for the ReCET Study. “Regenerating duodenal tissue through the ReCET Procedure has the potential to target underlying pathophysiologic factors associated with Type 2 Diabetes. The evaluation of this procedure within the ReCET Study may pave the way for a novel treatment approach to this disease.”

The ReCET Clinical Study will be enrolling patients at up to 30 sites in the United States and up to 10 sites in Australia.

The ReCET™ Procedure:
ReCET is a novel, endoscopic, outpatient procedure that targets the underlying cellular pathology of the duodenum that may contribute to the development and progression of Type 2 Diabetes.

Through the application of highly controlled, non-thermal pulsed electric fields, the ReCET System is designed to initiate the body’s natural regenerative process to restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels.

The ReCET System has been evaluated as part of feasibility clinical studies including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. The clinical studies assessed safety and efficacy in adults with Type 2 Diabetes whose blood glucose levels were inadequately controlled, despite the use of insulin and non-insulin medications. Publication of preliminary study outcomes has been presented at clinical conferences globally.

The ReCET System has received Breakthrough Device Designation from the FDA for treatment of Type 2 Diabetes in adult patients inadequately controlled by glucose lowering medications.

About Endogenex:
Endogenex is a privately held, clinical stage company headquartered in Minneapolis, MN. Endogenex was founded, in partnership with Mayo Clinic, to develop therapies to improve outcomes for people living with Type 2 Diabetes. Endogenex’s focus is centered on the principle that effective treatment for Type 2 Diabetes can extend beyond pharmaceutical options, correct metabolic function, and help people regain control of their blood glucose levels.

For more information, please visit our website at www.endogenex.com or www.twitter.com/endogenex

Media Inquiries:
Brent Collins
bcollins@endogenex.com
+1(612)-227-6949

SOURCE Endogenex

• Funds will be used to support the advancement of COUR’s Myasthenia Gravis (MG) and Type 1 Diabetes (T1D) product candidates into Phase 2a clinical trials
• Participating investors include Roche Venture Fund, Pfizer, Bristol Myers Squibb, Angelini Ventures, and JDRF T1D Fund

CHICAGO, Jan. 30, 2024 (GLOBE NEWSWIRE) — COUR Pharmaceuticals, a clinical-stage biotechnology company focused on the development of first-in-class, disease modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases, today announced the closing of a Series A investment round, securing approximately $105 million in financing. The investment was co-led by Lumira Ventures and Alpha Wave Ventures, with participation from Roche Venture Fund, Pfizer (as part of the Pfizer Breakthrough Growth Initiative), Bristol Myers Squibb, Angelini Ventures, and the JDRF T1D Fund. In connection with the financing, Benjamin “Beni” Rovinski, Ph.D., Managing Director of Lumira Ventures, and Simon Greenwood, Senior Investment Director of Roche Venture Fund, will join the COUR Board of Directors.

The proceeds will enable COUR to advance multiple, wholly owned product candidates that leverage the company’s immune tolerance platform, including Phase 2a proof-of-concept clinical studies in Myasthenia Gravis and Type 1 Diabetes, and other pipeline opportunities. These product candidates, in addition to existing Phase 2 partnered programs with Takeda Pharmaceuticals in Celiac Disease and Ironwood Pharmaceuticals in Primary Biliary Cholangitis, continue to strengthen COUR’s position as the leader in antigen-specific immune tolerance.

“The impressive syndicate of thought-leading investors and prominent strategic investors is a testament to COUR’s platform technology and our paradigm-changing potential for patients impacted by a variety of autoimmune diseases,” said John J. Puisis, founder and chief executive officer of COUR. “We are excited to have this support as we advance our pipeline and revolutionize antigen-specific immune tolerance while avoiding immune system suppression in our mission to potentially bring to market life changing therapies for patients.”

Benjamin “Beni” Rovinski, Ph.D., managing director of Lumira Ventures added, “There is an urgent need for innovative strategies aimed at restoring self-tolerance safely and more effectively in autoimmune disorders. We believe COUR’s proprietary and strongly differentiated platform is a versatile and first-in-class approach to meet this critical medical need. We are dedicated to collaborating with COUR and its partners to help advance these potentially cutting-edge treatments for immune-related diseases.”

About COUR Pharmaceuticals: COUR Pharmaceuticals is a clinical-stage biotechnology company developing therapies to treat patients with autoimmune and inflammatory diseases. COUR’s first-in-class therapies are based on our proprietary antigen-specific immune tolerance platform and are designed to reprogram the immune system to address the underlying root cause of immune-mediated diseases. Data from multiple clinical and preclinical programs have demonstrated the ability of COUR’s product candidates to induce antigen-specific immune tolerance and have the potential to treat a wide range of autoimmune and inflammatory diseases.

COUR is developing product candidates in Myasthenia Gravis and Type 1 Diabetes in addition to having partnered products in Celiac Disease (with Takeda Pharmaceuticals), and Primary Biliary Cholangitis (with Ironwood Pharmaceuticals).

For more information, please visit www.courpharma.com

About Lumira Ventures: Founded in 2007, Lumira Ventures is a multi-stage life sciences investment firm with offices in Toronto, Montréal, Vancouver, and Boston. We partner with mission-driven entrepreneurs building companies that harness rapidly evolving advancements in medicine to develop transformative products for patients while delivering strong financial returns for our investors and meaningful economic value and impact for society.

For more information, visit www.lumiraventures.com

About Alpha Wave Global: Alpha Wave is a global investment company with offices in New York, Miami, London, Abu Dhabi, Tel Aviv, Bangalore, Jakarta, and Sydney. Its flagship global venture and growth fund, Alpha Wave Ventures, aims to invest in best-in-class venture and growth-stage companies and endeavors to be helpful long-term partners to the founders and management teams. Alpha Wave manages a variety of investment partnerships that cover several asset classes, themes, and geographies.

For more information, please visit www.alphawaveglobal.com

Contacts

For Investor Relations:

Brian Bock, Chief Financial Officer

bbock@courpharma.com

For Media:

Jason Braco, Ph.D.

jbraco@lifescicomms.com

Phase 2 FLAVOR clinical trial currently enrolling 150 patients to assess the safety and effectiveness of CYR-064 in treating patients with chronic smell loss following recovery from a viral infection (post-viral hyposmia)

No FDA-approved drug therapy available for this increasingly prevalent and serious chronic sensory condition

Cyrano Therapeutics, Inc., a regenerative medicine company pioneering the development of treatments for smell loss, announced today that it has secured a $9.0 million Series B financing to advance the development of CYR-064 as a potential first-ever treatment for post-viral smell loss (hyposmia). Co-lead investors participating in the financing include the Florida Opportunity Fund managed by DeepWork Capital and existing investors Lumira Ventures and Remiges Ventures.

Cyrano intends to use the proceeds from its Series B financing to advance FLAVOR, its Phase 2, double-blind, randomized clinical trial of CYR-064, an intranasal theophylline spray therapy to treat patients who have lost their sense of smell following recovery from a viral infection. The FLAVOR Phase 2 trial will be conducted at up to 15 sites in the US and the Series B financing is to fund the trial through data readout.

“This Series B financing enables us to advance what we believe to be a first-of-its-kind treatment for patients suffering from long-term smell loss due to a viral infection,” said Rick Geoffrion, President and CEO of Cyrano Therapeutics, Inc. “Smell loss correlates to functional loss of taste, which can both diminish quality of life and present significant health and safety risks, thus underscoring the urgency in advancing this important therapeutic. We also plan to conduct exploratory research for patients with Parkinson’s disease, 95 percent of whom often experience loss of smell and flavor as the first symptom of the disease.”

Jackson Streeter, MD, Venture Partner at DeepWork Capital, stated: “Cyrano Therapeutics represents an important investment for DeepWork and the Florida Opportunity Fund as we seek to identify and cultivate emerging biotechnology companies in Florida that combine executive and scientific expertise with therapeutic opportunities that offer the potential to address significant, unmet medical needs. We look forward to supporting the entire Cyrano team as the company advances CYR-064 through the FLAVOR Phase 2 trial.”

The number of patients experiencing long-term smell and flavor loss has increased 10-fold in the wake of the COVID-19 pandemic to more than 40 million patients in the US and Europe. Thirty percent of those suffering from smell loss will experience a hazardous event such as food poisoning or the inability to detect hazardous fumes. There is currently no FDA-approved drug therapy to treat smell loss from any cause.

About Hyposmia
Hyposmia, including post-viral hyposmia, is an increasingly prevalent and serious chronic sensory condition for which there is no approved drug therapy and limited treatment options. Hyposmia causes significant impairment in quality of life for many sufferers. Moreover, in older individuals, hyposmia is associated with an increased risk of cognitive impairment and mortality. Prior to the COVID-19 pandemic, an estimated 8 million individuals in the US and Europe suffered from long-term post-viral hyposmia. The COVID-19 pandemic has resulted in dramatically increased prevalence, with an estimated 40 million individuals in the US and Europe currently suffering from long-term post-viral hyposmia.

About Cyrano Therapeutics
Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and taste. To learn more, please visit cyranotherapeutics.com.

About the FLAVOR Trial
The Phase 2 FLAVOR trial is a 150 subject randomized, double-blinded, placebo-controlled, multi-dose, multi-site clinical trial of CYR-064 for the treatment of post-viral hyposmia. For more information, please visit ClinicalTrials.gov

About DeepWork Capital
DeepWork Capital invests professionally managed committed venture capital in growth-oriented, early-stage companies in the technology and life science sectors. We partner with visionary entrepreneurs building disruptive companies. DeepWork works closely with other investment groups and takes a hands-on approach with its portfolio companies. For additional information, please see www.deepworkcapital.com

Media Contacts:
Tiberend Strategic Advisors, Inc.

Dave Schemelia
dschemelia@tiberend.com
+1 609-468-9325

Eric Reiss
ereiss@tiberend.com
+1 802-249-1136

SOURCE Cyrano Therapeutics

HistoSonics, (www.histosonics.com), the manufacturer of the non-invasive Edison® Histotripsy System, announced today a patient from the University of Rochester Medical Center has received the world’s first targeted liver tumor treatments utilizing the Edison System following its recent FDA De Novo clearance. In the same week Cleveland Clinic treated their initial patients suffering from liver tumors utilizing histotripsy. HistoSonics’ image guided sonic beam therapy system uses proprietary technology and advanced imaging to deliver non-invasive, personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue at sub-cellular levels.

On December 18^th, Roberto Hernandez-Alejandro MD, Chief of the Division of Transplantation, Koji Tomiyama, MD, PhD Associate Professor of Surgery & Transplant, and team were first to use Edison to perform a histotripsy liver treatment on a patient suffering from recurrent liver tumors originating in the colon. “There is an enormous potential applicability of histotripsy in patients with liver tumors. By destroying targeted liver tumors, histotripsy opens the opportunities for patients to be downstaged and bridged for surgical resections and transplantation,” said Dr. Hernandez-Alejandro. He added, “One of the most interesting findings in our early experience is the preservation of the vessels and blood flow, which is unique and may open a new era in liver therapies.”

C.H. David Kwon, MD, PhD, Director of Minimally Invasive Liver Surgery at Cleveland Clinic, and his team performed their initial procedure on a patient with primary colorectal disease with metastasis to the liver that has continued to progress despite getting chemotherapy. “In our early experience, we have found that patients have the potential to benefit from histotripsy because it is less invasive than other treatment options and our patients reported a lack of pain following the procedure,” said Dr. Kwon. The Cleveland Clinic team led by Dr. Kwon, Federico Aucejo, MD, and Jaekeun Kim MD has treated three patients with liver tumors of multiple different diseases.

“Our purpose has always been to make a meaningful change in the lives of patients,” said Joe Herman MD, Medical Director. Herman added, “Working with the University of Rochester Medical Center and Cleveland Clinic as the first to offer non-invasive histotripsy to treat their patients’ liver tumors as part of standard clinical practice supports our ongoing mission.” HistoSonics is in the process of training key staff and launching over a dozen of its first partners programs around the United States. 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 resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

For more information on the University of Rochester Medical Center Histotripsy and Liver Surgery Team: University of Rochester Medical Center Liver Surgery and Transplant

For more information on the Cleveland Clinic Liver Surgery Team: Cleveland Clinic Liver Surgery and Transplant

The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease or condition. Use of Edison System in kidney applications is limited by federal law to investigational use.

About HistoSonics

HistoSonics is a privately held medical device company developing non-invasive platforms and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

Contacts

For Media Inquiries
Media contact:
Josh King
Vice President of Global Market Access
Email : Joshua.king@histosonics.com
Phone : +1 608.332.8124

AmacaThera, a leader in the development of novel injectable, localized therapeutics based upon its AmacaGel delivery platform, announced the closing of a CAD$4.0 million financing round, with a new lead investor, supported by existing investors; BDC Capital’s Women in Technology Venture Fund, Inveready, Lumira Ventures, StandUp Ventures, and MaRS IAF. The proceeds will be used to accelerate the clinical development of the lead clinical candidate, AMT-143, and also to advance multiple pipeline programs targeting the local, injectable, sustained release market.

Despite the continuing opioid epidemic, which results in ~80,000 deaths annually in the US alone, the treatment of pain continues to be frequently managed through opioid-based medications. This includes in post-surgical settings, where it can be a gateway to addiction and the abuse of prescription pain medicines and illicit narcotics. Leveraging the AmacaGel platform, AmacaThera is developing AMT-143 with the objective of it being a best-in-class, non-opioid, therapeutic able to provide an extended period of post-surgical pain relief and reduce with the aim of eliminating the need for opioids in the postsurgical recovery period. Pre-clinical studies have shown superior release kinetics to the current standard of care, resulting in rapid onset pain relief followed by long-acting pain control for up to 3 days, thereby providing relief over the most severe pain window following surgery. The Phase Ib clinical trial is scheduled to commence in early 2024.

The Company’s unique, injectable, hydrogel AmacaGel platform is effective for the delivery of a wide range of therapeutics, from small molecules to antibodies to lipid nanoparticles to stem cells, as demonstrated in over 40 peer-reviewed publications. With the demonstrated safety in humans, the funding will also be used to expand the application of the platform and to develop additional products for the pipeline.

Lead investor Paul Austin said, “AmacaThera is developing a product that fulfills both societal and medical needs for a large market.”

Lumira Ventures, Lu Han, agreed, “AmacaThera continues to build an innovative portfolio of therapeutics that have the potential to establish a new standard of care across a variety of indications.”

“We are excited to welcome our new lead investor to our board, as they share our enthusiasm for AmacaThera’s vision and potential for long-term success”, said Dr. Michael Cooke, CEO and Co-Founder, “This investment will enable us to expand and accelerate our efforts in developing new long-acting injectable products”.

“This financing provides further evidence of the importance of therapeutic delivery in the life science innovation cycle”, said Dr. Molly Shoichet, CSO, Co-Founder, and University Professor at the University of Toronto. “The commitment of our existing investors reflects their recognition of the platform opportunity and the potential product portfolio.”

About AmacaThera

AmacaThera Inc., a resident company of Johnson & Johnson Innovation, JLABS @ Toronto is a clinical-stage company transforming therapeutics to make a difference in patient health. AmacaGel, our unique, injectable hydrogel platform, provides localized sustained drug delivery for improved patient outcomes across multiple therapeutic areas, including post-surgical pain management, cancer and other hard-to-reach, unmet medical needs.

For more information, please visit www.amacathera.ca.

SOURCE AmacaThera Inc.

For further information: Michael Foorer, mike_foorer@amacathera.ca

CAD$191 million gross proceeds from the transaction to support the advancement of the clinical program and pipeline expansion

Pivotal clinical trial for lead program EG-70 targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) currently enrolling patients

Lumira Ventures portfolio company enGene Holdings Inc., (“enGene” or the “Company”), a clinical-stage biotechnology company developing genetic medicines, has completed a business combination with a special purpose acquisition company and a concurrent oversubscribed private investment in public equity (PIPE) financing. As a result of this combination, enGene has become a publicly traded company whose shares are now listed on the Nasdaq market under the symbol “ENGN.” Gross proceeds from this transaction totaled approximately CAD$191 million.

With operations in Montréal and Boston, enGene is currently enrolling patients in a pivotal trial of its lead program EG-70 (detalimogene voraplasmid) in patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ.  EG-70 was developed using the company’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables a carrier to penetrate mucosal tissue and deliver a wide range of sizes and types of cargo, including DNA and various forms of RNA, by turning mucosal cells into therapeutic production “factories” that generate proteins and RNAs for a desired local effect.

“We are extremely proud of the progress enGene has made since our foundational investment in the company in 2015 via our Merck Lumira Biosciences Fund,” stated Peter van der Velden, Managing General Partner of Lumira Ventures. “That fund focused on identifying and building transformative biotechnology companies in Quebec, and enGene is certainly fulfilling that promise. Our commitment to the company runs deep and we are pleased to have provided the continuity of capital that is so critical for success in our sector, via investments in enGene from multiple Lumira-managed funds, including most recently via Lumira Ventures Fund IV’s participation in the PIPE transaction.”

“Lumira Ventures financial support and strategic guidance have been critical to enGene’s ability to develop our therapeutic platform, build a world-class team, and complete this important transaction,” said Jason Hanson, Chief Executive Officer of enGene. “We now look forward to advancing our shared mission to expand genetic medicine into the mainstream of clinical practice and address the high disease burden faced by patients in our areas of focus.”

Gerry Brunk, Managing Director of Lumira Ventures and enGene board member, added: “We extend our appreciation to the entire enGene management team and board in achieving this important milestone, as well as to our longtime enGene co-investors, Fonds de solidarité FTQ and Forbion. We also note the support of this transaction by other Lumira limited partners Northleaf Capital Partners, Investissement Québec, and other new investors including BVF Partners, Omega Funds, Cowen Healthcare Investments, and Vivo Capital.”

Based on data from Pitchbook and the CVCA, we believe enGene’s entry onto the Nasdaq exchange represents the first Canadian biotechnology company to debut in the public markets since 2020. We also believe that the company’s oversubscribed PIPE is the largest equity financing for a private or public Canadian biotechnology company in 2023.

For complete details on this transaction, please visit this link.

About Lumira Ventures

Founded in 2007, Lumira Ventures is a multi-stage life sciences investment firm with offices in Toronto, Montréal, Vancouver, and Boston. We partner with mission-driven entrepreneurs building companies that harness rapidly evolving advancements in medicine to develop transformative products for patients while delivering strong financial returns for our investors and meaningful economic value and impact for society. For more information, visit www.lumiraventures.com

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is EG-70 for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG) – a disease with a high clinical burden. EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit www.enGene.com.      

Forward-Looking Statements

Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”).  enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s expectations, hopes, beliefs, intentions, goals or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative versions of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: enGene’s expected future business plans and expansion of gene therapy into clinical practice; the potential benefits of the DDX platform and the future results and timing of Phase 1 and Phase 2 studies; the expected use of net proceeds of the Business Combination and the associated private funding; the effectiveness and use cases of enGene’s EG-70 Program; the expected timeline for the interim Phase 2 results from the EG-70 program. Readers are cautioned that forward-looking statements are not guarantees of future performance and that actual results or developments may differ materially from those expressed or implied in the forward-looking statements.

All forward-looking statements, including, without limitation, our examination of historical operating trends, are based upon our current expectations and various assumptions. Certain assumptions made in preparing the forward-looking statements include the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration for clinical trials and acquire technologies complimentary to, or necessary for, its programs; the Company is able to enroll a cohort of patients in the Phase 2 LEGEND trial to assess EG-70’s efficacy and safety in the BCG-naïve patient population to evaluate its ultimate potential as a monotherapy in first line patients and expanding EG-70’s opportunity; the Company is able to file a Biologics License Application in 2025 with the FDA for approval to market EG-70 in the United States as a monotherapy to treat BCG-unresponsive NMIBC; EG-70’s product profile can be integrated seamlessly into community urology clinics where the vast majority of NMIBC patients are treated; the Company is able to retain commercial rights to EG-70 in the United States and commercialize EG-70 independently, while selectively partnering outside of the United States; the Company is able to execute the “pipeline-in-a-product” development strategy for EG-70; and the Company is able to utilize the dually derived chitosan gene delivery platform to develop effective, new agents for the delivery of genetic medicines to mucosal tissues.

All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. These risks and uncertainties include: the expected benefits of the Business Combination;  enGene’s financial performance following the Business Combination, including financial projections and business metrics and any underlying assumptions thereunder; the ability to maintain the listing of enGene securities on Nasdaq following the Business Combination; enGene’s success in recruiting and retaining, or changes required in, officers, key personnel or directors following the completion of the Business Combination;  enGene’s plans and ability to execute product development, manufacturing process development, preclinical and clinical development efforts successfully and on anticipated timelines; enGene’s ability to design, initiate and successfully complete clinical trials and other studies for its product candidates and its plans and expectations regarding its ongoing or planned clinical trials;  enGene’s plans and ability to obtain and maintain marketing approval from the U.S. Food and Drug Administration and other regulatory authorities, including the European Medicines Agency, for its product candidates; enGene’s plans and ability to commercialize its product candidates, if approved by applicable regulatory authorities; the degree of market acceptance of enGene’s product candidates, if approved, and the availability of third-party coverage and reimbursement; the ability of enGene’s external contract manufacturers to support the manufacturing, release testing, stability analysis, clinical labeling and packaging of enGene’s products; enGene’s future financial performance and the sufficiency of  enGene’s cash and cash equivalents to fund its operations; the outcome of any known and unknown litigation and regulatory proceedings; enGene’s ability to implement and maintain effective internal controls; or other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and U.S. Securities and Exchange Commission on EDGAR.

Any forward-looking statement speaks only as of the date on which it was made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaim any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made.

Specific Biologics Inc. (“Specific”), a venture-backed, early-stage genome editing company, is pleased to announce it has appointed Steven Kanner, PhD, as an Independent Director. Dr. Kanner joins Brent Stead, PhD, MBA, as well as seasoned company builders Daniel Hétu, MD, MBA of Lumira Ventures, Nikhil Thatte, B.Eng of Lumira Ventures and Frédéric Lemaître Auger, MSc, PhD, MBA of adMare BioInnovations. The appointment coincides with renewed investment from Lumira Ventures and adMare BioInnovations to advance the preclinical development of therapeutics based on Specific’s proprietary Dualase® platform gene editors.

“We are thrilled to have the renewed commitment from Lumira and adMare and to welcome Dr. Kanner to the Board of Directors,” said Dr. Stead, CEO of Specific Biologics Inc. “He brings decades of experience in executive leadership roles in genome editing and rare disease companies from preclinical research to commercially launched products. He will be an immense asset to Specific as we advance our gene editing technology toward the clinic and, most importantly, bring potentially life-changing therapeutics to patients with serious genetic diseases.”

“This is an exciting time to be joining Specific Biologics as the potential for gene editing technologies to transform the lives of patients is starting to be realized in the clinic,” said Dr. Kanner. “Specific’s differentiated Dualase gene editor has promise to modify a number of disease-causing mutations in vivo that are not easily targeted with today’s gene editors, and I look forward to helping the team implement Dualase’s potential.”

Dr. Kanner serves as Chief Scientific Officer at Caribou Biosciences where he is leading preclinical discovery, technical operations, and translational development of genome-edited cell therapies.  He has held research leadership positions at prominent life sciences organizations, including Bristol-Myers Squibb, Astex Pharmaceuticals, Agensys/Astellas Pharma, and Arrowhead Pharmaceuticals. Prior to joining Caribou Biosciences, Dr. Kanner served as Vice President of Discovery Biology at Arrowhead Pharmaceuticals, where he helped lead the discovery and development of novel RNAi-based therapeutic candidates for oncology and genetic diseases. At Bristol-Myers Squibb, he facilitated a discovery program ultimately leading to the development and launch of Sprycel® (dasatinib), a treatment for chronic myeloid leukemia. Dr. Kanner graduated from the University of California, Berkeley with a B.A. in genetics and earned his Ph.D. in immunology and microbiology from the University of Miami’s Miller School of Medicine. Dr. Kanner completed his postdoctoral fellowship in oncology at the University of Virginia’s Department of Microbiology, Immunology, and Cancer Biology.

Dualase’s unique two-site mechanism of action enables efficient and precise disruption and repair in therapeutic areas that are not easily addressed with existing gene editors. Specific has demonstrated the benefit of this two-site mechanism in externally validated studies in disease-relevant models at a broad and diverse set of genetic mutations where Dualase uniquely addresses the mutation or has a differentiated advantage. The additional investment from Lumira Ventures and adMare BioInnovations will be used to advance preclinical testing of Dualase gene editors in liver, ocular and CNS disorders. In addition, Specific will continue the development of Dualase gene editors for Cystic Fibrosis with preclinical studies supported by the Cystic Fibrosis Foundation.

“Our additional investment in Specific demonstrates our belief that Dualase gene editors have a unique advantage at many targets for therapeutic gene editing,” noted Dr. Daniel Hetu, Managing Director at Lumira Ventures. “The efficiency and precision of Dualase edits in disease-relevant cell models generated by third-party researchers support this thesis.”

“adMare is excited to continue to partner with Specific and provide them with the necessary financial, commercial, and scientific resources to advance their preclinical data packages in various therapeutic areas with significant unmet medical needs,” shared Dr. Frédéric Lemaître Auger, Vice President of Investments at adMare BioInnovations. “We look forward to working together to select the most promising clinical applications of the Dualase technology.”

About Specific Biologics Inc.

Specific Biologics Inc. (“Specific”) is a venture-backed early-stage biotechnology company on a mission to develop novel gene editing technologies to treat diseases through efficient and precise gene editing. Our differentiated two-site Dualase® platform gene editors cut DNA in a way that optimally exploits the cell’s naturally occurring DNA repair pathways. This enables two gene editing outcomes, precise DNA deletions to disrupt genes or increased repair to correct genes to target new therapeutic areas for gene editing. Specific also develops lipid nanoparticles to deliver the gene editor to target cells and is developing a pipeline of Dualase®-based therapeutics in areas of high unmet medical need. To learn more, visit www.specificbiologics.com.

About Lumira Ventures

Lumira Ventures is a North American healthcare venture capital firm with decades of experience of investing in and helping to build transformative biomedical companies.  We are a multi-stage investor that partners with mission-driven entrepreneurs and like-minded investors to build innovative healthcare companies.  These companies are harnessing rapidly evolving innovations in genomics, cell therapy, gene therapy, bioengineering, robotics and artificial intelligence to develop high impact, often transformative products for patients while generating exceptional returns for their investors and meaningful economic value to society. To date, Lumira’s companies have brought dozens of biomedical innovations to the market, impacting the lives of patients worldwide. Lumira Ventures manages its activities from offices in Toronto, Montréal, Vancouver and Boston.  For more information, please visit www.lumiraventures.com

About adMare BioInnovations

With a strong track record of globally-competitive scientific discovery, Canadian life sciences are primed to lead the world. To make this a reality, adMare BioInnovations uses its scientific and commercial expertise, specialized R&D infrastructure, and seed capital to build strong life sciences companies, develop robust ecosystems, and foster industry-ready talent. It re-invests its returns into the Canadian industry to ensure its long-term sustainability. adMare currently has 29 portfolio companies that have attracted $2.3 billion of risk capital, have a combined value of $4 billion, and have created over 1,000 jobs in Canada. For more information, please go to www.admarebio.com.

SOURCE Specific Biologics Inc.

Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has secured a commitment of up to C$23 million from the Government of Canada for a pivotal Phase 3 clinical study of the company’s first-in-class therapeutic candidate.

Edesa’s experimental drug, called EB05 (paridiprubart), represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body’s own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are agnostic to the causal agent and can be stockpiled preemptively for seasonal outbreaks and unexpected emergencies and threats.

“This project has the potential to increase survival rates, reduce ICU costs and improve outcomes for critically ill patients,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “With this validation and the continued support from the federal government, we believe we are in a position to accelerate research, expand our reach to more hospitals and move another significant step closer to commercialization.”

Edesa’s current project builds on the success of a government-supported Phase 2 clinical study completed during the pandemic which demonstrated that paridiprubart reduced mortality by 84% among critically ill patients with a severe form of respiratory disease called Acute Respiratory Distress Syndrome (ARDS). A parallel in vitro study at the University of Toronto also demonstrated recently that paridiprubart inhibits inflammation from influenza and other pathogens.

“We are proud of our track record of delivering successful results on time and on budget for our government-supported projects,” said Dr. Nijhawan. “The development of breakthrough medicines – especially in the critical care fields – is key to building a strong biopharma sector, creating jobs and most importantly improving patient outcomes at home and abroad. We are honored to be a part of these efforts.”

The Honorable Francois-Philippe Champagne, Minister of Innovation, Science and Industry said that the Strategic Innovation Fund (SIF) funding announced today is part of the government’s plan to grow a strong and competitive life sciences sector, and ensure the nation’s readiness for future pandemics or other health emergencies.

“This project is a prime example of Canada’s determination to the development of the next generation of medicine, while creating good jobs and securing long-term economic growth,” said Minister Champagne.

Edesa intends to use the SIF funding toward study expenses, including hospital and physician expenditures, as well as scale-up of commercial drug product should the development program be successful. Funding is provided under the federal government’s Strategic Innovation Fund (SIF) following a competitive review process.

Additional information regarding the funding are outlined in the company’s Current Report on Form 8-K, which Edesa expects to file with the U.S. Securities and Exchange Commission and on the SEDAR+ system in Canada.

About ARDS

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to the pandemic, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About EB05 (Paridiprubart)

Paridiprubart is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic (HDT) candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated both by viruses, like SARS-CoV2, SARS-CoV1 and Influenza, as well as in the pathogenesis of chronic autoimmune diseases.

About Phase 3 Clinical Study

Edesa’s Phase 3 study of EB05 (paridiprubart) is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in critical-care patients. The current protocol calls for treatment of ARDS subjects hospitalized with SARS-CoV2 infections who are on invasive mechanical ventilation, both with and without additional organ support. The primary endpoint is the mortality rate at 28 days. In addition to SARS-CoV2 induced ARDS, Edesa is currently exploring various approaches to evaluate EB05 in a general ARDS population.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company’s most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis (scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs such as the lungs, heart and kidneys. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

Edesa 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. 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: 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, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as Covid-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contact

Gary Koppenjan
Edesa Biotech, Inc.
(289) 800-9600
investors@edesabiotech.com

SOURCE: Edesa Biotech

There is currently no FDA-approved therapy for this increasingly prevalent and serious chronic sensory condition.

Cyrano Therapeutics, Inc., a regenerative medicine company pioneering the development of treatments for smell loss, announced today that it has commenced enrollment in the Phase 2 FLAVOR trial, a randomized, double-blinded, placebo-controlled, multi-dose clinical trial of CYR-064, its novel, soft-mist nasal-spray product candidate, for the treatment of post-viral hyposmia. Post-viral hyposmia is an increasingly prevalent and serious chronic sensory condition for which there is currently no approved drug therapy.

“Hyposmia, along with the associated alterations in taste results in a significant reduction in quality of life, as this common and serious condition manifests as a loss of two of the five basic human senses,” stated Mas Takashima, MD FACS, Professor and Chairman of the Department of Otolaryngology – Head and Neck Surgery at Houston Methodist Hospital and the principal investigator for the FLAVOR trial. “CYR-064 has the potential to become the first pharmaceutical product to restore the senses of smell and taste in patients with post-viral hyposmia and thereby address a major unmet clinical need.”

Cyrano expects to enroll approximately 150 subjects in the FLAVOR trial, which is designed to assess the local nasal safety, tolerability, and effectiveness of CYR-064 as compared to placebo in the treatment of post-viral hyposmia over a six-month period. The FLAVOR trial is a multi-institutional prospective study being conducted at fifteen clinical sites in the United States. 

“We are excited to announce a significant milestone in our commitment to advancing medical science and improving the lives of those affected by post-viral smell loss,” said Rick Geoffrion, President and CEO of Cyrano Therapeutics, Inc. “With the enrollment of the first patients in our Phase 2 trial of CYR-064, we take a giant step forward in addressing a pressing health concern. In a world where post-viral smell loss continues to affect an ever-growing number of individuals, we’re dedicated to pioneering solutions that make a difference.”

About Hyposmia

Hyposmia, including post-viral hyposmia, is an increasingly prevalent and serious chronic sensory condition for which there is no approved drug therapy [and limited treatment options]. Hyposmia causes significant impairment in quality of life for many sufferers. Moreover, in older individuals, hyposmia is associated with an increased risk of cognitive impairment and mortality. Prior to the COVID-19 pandemic, an estimated 8 million individuals in the U.S. and Europe suffered from long-term post-viral hyposmia. The COVID-19 pandemic has resulted in dramatically increased prevalence, with an estimated 40 million individuals in the U.S. and Europe currently suffering from long-term post-viral hyposmia. 

About Cyrano Therapeutics

Cyrano Therapeutics, Inc. is a private, venture-backed, clinical-stage regenerative medicine company. Since our inception, we have been working diligently to develop therapies for people struggling with the loss of smell and taste. For more information, please visit cyranotherapeutics.com.

SOURCE Cyrano Therapeutics

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The prospective, dual-arm trial aims to expand access to New York Heart Association (NYHA) class II HF patients and support efficient and scalable remote patient management with a clinician-directed, patient self-management strategy.

“The evidence in favor of PA pressure-guided therapy for NYHA class III HF patients has been consistently validated over the last 15 years. However, questions remain as to the therapy benefit in NYHA class II patients and how to best scale effective remote HF management,” stated Lynne W. Stevenson M.D., Heart Failure Specialist at Vanderbilt University Medical Center in Nashville, TN, and Global Principal Investigator (PI) of the PROACTIVE-HF 2 clinical trial. “The randomized arm of PROACTIVE-HF 2 will be the first study to compare PA pressure-guided therapy to a telehealth control arm. The single-arm cohort evaluates the power of engaged patients and subsequent impact on outcomes. Together these studies help us better understand the impact of pulmonary hypertension on right ventricular function over time and provide guidance on how to scale this important therapy with patient engagement.”

The PROACTIVE-HF 2 prospective, open-label randomized controlled clinical trial will enroll up to 1,500 patients in the U.S. and Europe. The dual arm study design was presented over the weekend at HFSA and the first patient is expected to be enrolled later this year. The randomized arm will assess the safety and efficacy of PA pressure-guided therapy using Cordella in NYHA class II patients at risk for congestion. In both cohorts, patients and clinicians will have access to daily trended telehealth data (i.e. blood pressure, heart rate, and weight) and the treatment cohort will also have access to daily PA pressure data. The study will evaluate safety and efficacy, using a compositive first HF event or death rate, for up to 24 months. The single-arm study will assess the impact of clinician-directed patient self-management at home in NYHA class III HF patients who are at risk for poor outcomes using a 12-month endpoint for safety and incidence of HF hospitalization or death.  Both arms will collect data on secondary endpoints including changes in right ventricular function in relation to PA pressure, and patient engagement.

Additionally, the Company presented 12-month sub-study data from its initial pivotal PROACTIVE-HF trial at the HFSA conference, demonstrating a low HF hospitalization rate of 0.34 at 12 months in NYHA class III HF patients.

In December 2021, the prospective, multi-center pivotal PROACTIVE-HF trial was redesigned from a randomized controlled trial, with patients and providers in a control arm blinded to PA pressure values, to a single-arm study where both groups had access to patient data. The data for 63 former control arm patients was evaluated before and during the 12-month period following the unblinding, demonstrating significant improvements in mean PA pressure (mPAP) and outcomes, as well as strong patient interest in having access to PA pressure data.

• In the unblinded period, average seated mPAP for patients above target (>20 mmHg) decreased significantly (28.1 mmHg vs. 23.6 mmHg, p=0.03)
• 12-month unblinded HF hospitalization rate was significantly lower than the 12 months prior to implant (0.3 ±0.9 vs. 3±0.9, p<0.0001)
• 78% of patients made lifestyle changes based on their mPAP trends
• 86% of patients rated a positive impact of PA pressure management on their health

This data dovetails the announcement that the PROACTIVE-HF study has completed its primary endpoint follow-up period and the data is being prepared for pre-market approval (PMA) submission to the FDA by the end of the year and data presentation in the first half of next year.

“We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data. The team is driving towards PMA submission before the end of this year and looks forward to sharing the results from the full study cohort in 2024,” commented Harry Rowland, CEO and co-founder of Endotronix. “We remain confident in the benefits Cordella brings to patients and clinicians to improve heart failure outcomes and remain on track for a mid-2024 launch.”

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography. CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation. The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

MEDIA CONTACT:

Carla Benigni

SPRIG Consulting, LLC

+1 (847) 951-7430

carla@sprigconsulting.com

Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, and OpSens, Inc. (TSX:OPS) (OTCQX:OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that they have entered into a definitive agreement under which Haemonetics will acquire all outstanding shares of OpSens for CAD $2.90 per share in an all-cash transaction representing a fully diluted equity value of approximately USD $253 million at current exchange rate.

OpSens offers commercially and clinically validated optical technology for use primarily in interventional cardiology. OpSens’ core products include the SavvyWire^®, the world’s first and only sensor-guided 3-in-1 guidewire for TAVR procedures, that acts as pacing and pressure monitoring wire advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients, and the OptoWire®, a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (FFR) and diastolic pressure ratio (dPR) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease. OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications. 

Stewart Strong, President, Global Hospital at Haemonetics, said, “With the acquisition of OpSens, we expand our leadership in interventional cardiology and strengthen our foundation for additional growth and diversification. By leveraging OpSens’ proprietary optical sensor technology, our global commercial infrastructure, and our relationships with the top US hospitals performing TAVR and PCI procedures, we have a powerful opportunity to improve standards of care for more physicians and patients worldwide. We are excited to welcome OpSens’ talented team and look forward to advancing our shared commitment to maximizing patient benefits and value for our customers.”

This transaction creates compelling financial and strategic benefits for Haemonetics:

• Expands Hospital business unit portfolio with innovative fiber optic sensor technology in the attractive interventional cardiology market. OpSens’ portfolio utilized in TAVR and PCI procedures offers strong competitive advantages with a total addressable market of approximately $1 billion. OpSens technology is also being used across a range of medical and industrial applications, representing additional avenues for growth and diversification.
• Leverages Haemonetics’ commercial and geographic breadth to accelerate adoption. OpSens’ product portfolio has already demonstrated commercial success and is well-positioned for long-term growth. Haemonetics’ commercial success with its VASCADE^® Vascular Closure portfolio, combined with extensive existing commercial and clinical infrastructure, will accelerate customer access to OpSens’ products with the potential to make SavvyWire the leading guidewire for TAVR procedures in the U.S. Additionally, Haemonetics’ presence in high-growth international markets will enable further penetration of OpSens products in these regions.
  
• Augments long-term growth with additional product and market expansion opportunities. Haemonetics plans to build on the OpSens acquisition to further expand its Hospital business through internal and external R&D, clinical, and other business development efforts. Over the past several quarters, Haemonetics has made additional strategic investments, which would further complement OpSens’ portfolio and strengthen Haemonetics’ leadership in interventional cardiology, including in VivaSure Medical^®, the company that developed PerQSeal^®, an innovative percutaneous large-bore vessel closure technology.
  
• Delivers immediate and longer-term financial benefits. The transaction is expected to be immediately accretive to Haemonetics’ revenue growth. On a GAAP basis, Haemonetics expects this transaction to be slightly dilutive to earnings per diluted share in fiscal year 2024 due to transaction and integration costs and accretive thereafter. Haemonetics expects this transaction to be immediately accretive to adjusted earnings per diluted share.

Transaction Details and Financing: The transaction will be affected by way of an arrangement under the Business Corporations Act (Québec). Completion of the acquisition is subject to the approval of OpSens shareholders, receipt of court and regulatory approval, as well as certain other closing conditions customary for transactions of this nature. The transaction is expected to close by the end of January 2024.

Haemonetics plans to finance this acquisition through a combination of cash and a revolving credit facility. Following this acquisition, Haemonetics’ net debt to EBITDA ratio, per the terms set forth in the Company’s existing Credit Agreement, is expected to be approximately 2.1x.

Advisors: Goldman Sachs & Co. LLC served as financial advisor for Haemonetics and DLA Piper as legal advisor. Piper Sandler LLC served as OpSens’ financial advisor, while Norton Rose Fulbright served as its legal advisor.

Supplemental Information: Haemonetics posted supplemental slides with additional information about this transaction to Haemonetics’ investor relations website. These slides can also be accessed by following this link: https://haemonetics.gcs-web.com/static-files/7e0041fd-89d4-4f20-bbd0-947c00118c05 

About Haemonetics

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains 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. Forward-looking statements do not relate strictly to historical or current facts and may be identified by the use of words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “forecasts,” “foresees,” “potential” and other words of similar meaning in conjunction with statements regarding, among other things, (i) plans and objectives of management for the operation of Haemonetics, (ii) statements regarding the timing of completion of the acquisition and the consummation of the acquisition, (iii) the anticipated financing of the transaction and the Company’s net debt to EBITDA ratio following completion of the acquisition, (iv) the anticipated benefits to Haemonetics arising from the completion of the acquisition, (v) the impact of the acquisition on Haemonetics’ business strategy and future business and operational performance, and (vi) the assumptions underlying or relating to any such statement. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics’ current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.

Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the failure to realize the anticipated benefits of the acquisition or the acquisition, its announcement or pendency having an unanticipated impact, Haemonetics’ ability to predict accurately the demand for products and products under development by it or OpSens and to develop strategies to successfully address relevant markets, the impact of competitive products and pricing, technical innovations that could render products marketed or under development by Haemonetics or OpSens obsolete, risks related to the use and protection of intellectual property, the risk that the transaction may not be completed in a timely manner or at all (whether due to the failure of OpSens to obtain shareholder approval, the failure to obtain approval of the Québec Superior Court or otherwise), and the risk that using debt to finance, in part, the acquisition will increase Haemonetics’ indebtedness. These and other factors are identified and described in more detail in Haemonetics’ filings with the U.S. Securities and Exchange Commission (“SEC”). Haemonetics does not undertake to update these forward-looking statements.

Non-GAAP Financial Measures

This press release contains financial measures that are considered “non-GAAP” financial measures under applicable SEC rules and regulations. Management uses non-GAAP measures to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results. Performance targets for management are also based on certain non-GAAP financial measures. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, the Company’s reported financial results prepared in accordance with U.S. GAAP. In this release, supplemental non-GAAP measures have been provided to assist investors in evaluating the expected impact of the Company’s acquisition of OpSens and provide a baseline for analyzing trends in the Company’s underlying businesses. We strongly encourage investors to review the Company’s financial statements and publicly-filed reports in their entirety and not rely on any single financial measure.

When used in this release, adjusted earnings per diluted share excludes restructuring costs, restructuring related costs, digital transformation costs, amortization of acquired intangible assets, asset impairments, accelerated device depreciation and related costs, costs related to compliance with the European Union Medical Device Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”), integration and transaction costs, certain tax settlements and unusual or infrequent and material litigation-related charges, and the tax impact of these items. Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures to similarly titled measures used by other companies.

The Company does not attempt to provide reconciliations of forward-looking adjusted earnings per diluted share guidance to the comparable GAAP measures because the combined impact and timing of recognition of certain potential charges or gains, such as restructuring costs and impairment charges, is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the Company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of the Company’s financial performance.

Additional Information Regarding the Transaction

In connection with the proposed transaction, OpSens will file with the Canadian Securities Administrators in each of the provinces of Canada (the “CSA”) and mail or otherwise make available to its shareholders a management information circular (the “Proxy Circular”) regarding the proposed transaction. BEFORE MAKING ANY VOTING DECISION, OPSENS’ SHAREHOLDERS ARE URGED TO READ THE PROXY CIRCULAR IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED WITH THE CSA IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Proxy Statement and other documents that OpSens files with the CSA (when available) from the CSA’s website at www.sedarplus.ca and from OpSens’ website at www.opsens.com.

Investor Contacts:

SOURCE Haemonetics Corporation

HistoSonics^®, (www.histosonics.com), the manufacturer of the Edison^® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. Marketing authorization makes Edison the first and only histotripsy platform available in the Unites States.

As recently presented at the annual CIRSE Congress in Copenhagen, a technical success rate of 95.5% was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors. Also, only 3 procedure related CTCAE Grade 3 or higher adverse events through 30 days post-histotripsy were observed across all 44 subjects treated, representing a complication rate of 6.8% with each event being common to focal liver therapies and not specific to histotripsy.

“This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible – integrating the many complexities of histotripsy into a completely non-invasive clinical platform,” commented Mike Blue, President, and CEO of HistoSonics. The Company noted it has expanded its commercial and operational capacity over the previous year in preparation for commercial activities. Blue added, “We have been thoughtfully adding professionals with deep domain experience in operations, market development and education and are prepared to begin scheduling physician training immediately. This is a fantastic day for patients who will benefit from the novel advantages of histotripsy, and I commend the FDA for working so expeditiously with us throughout the review process.”

The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue, including tumors, at sub-cellular levels. HistoSonics’ Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control. The company believes that the novel mechanism of action of their proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

“As a surgeon, it’s rewarding to be able to offer a procedure where we can precisely destroy liver tumors without using a scalpel or needles, hopefully enabling the patient’s quick recovery while avoiding certain complications like surgical site infections or radiation illness common with other modalities,” commented Joe Amaral MD, VP Medical Affairs for HistoSonics. “Based on the data and patient experiences in our studies we are confident histotripsy will have a meaningful impact for patients suffering from unresectable liver disease, including liver tumors, and we look forward to the role histotripsy will play in treatment strategies going forward,” added Amaral.

The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/.

Contacts

Media contact:
Josh King
Vice President of Marketing
Email: Joshua.king@histosonics.com
Phone: 608.332.8124

Sept. 28, 2023 — Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka’s pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK2¹⁰ (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board.

The funding follows the seed round investment of USD $5 million led by CEO John Mumm, Series A financing of USD $20 million announced in November 2021, co-led by Leaps by Bayer and ECHO Investment Capital, and a USD $21.5 million Series B1 co-led by Lumira and Leaps by Bayer in 2022. The previous financings have enabled Deka to advance a pipeline of multiple Diakines^TM, conduct critical IND enabling experiments, manufacture drug substance/drug product with Cytovance Biologics, start the first Phase I clinical trial, as well as to expand into a new facility.

About Deka Biosciences
Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, and testing. Deka has developed disease specific Diakines™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient’s immune response to different Diakines™, Deka hopes to maximize the impact of its Diakines™ by building specific targeted therapies for everyone.

SOURCE Deka Biosciences

enGene, Inc., a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for the delivery of therapeutics to mucosal tissues and other organs, today announced the appointment of Richard Bryce, MBChB, MRCGP, MFPM as its Chief Medical Officer, effective September 19, 2023. Dr. Bryce will oversee the clin­i­cal develop­ment of EG-70, enGene’s lead product candidate for non-muscle invasive bladder cancer (NMIBC), as well as the devel­op­ment strat­e­gy for enGene’s ther­a­peu­tic pipeline of tissue-targeted non-viral gene therapies.

“We are thrilled to have Dr. Bryce join enGene during a pivotal period in our growth as we advance our Phase 1/2 registrational LEGEND study for EG-70 in NMIBC,” said Jason Hanson, CEO of enGene. “We believe that the potential efficacy and ease of administration of EG-70 could transform how NMIBC is managed, and Dr. Bryce’s extensive track record advancing oncology therapeutics through late-stage trials and approval makes him well positioned to lead this program, while also leveraging our Dually Derivatized Oligochitosan (DDX)® platform to expand our pipeline.”

Before joining enGene, Dr. Bryce was most recently Chief Medical Officer at Rain Oncology, a late-stage company developing precision oncology therapeutics, where he built a clinical development team and oversaw multiple clinical studies, including a global Phase 3 registrational study in dedifferentiated liposarcoma. Prior to that, he was Chief Medical & Scientific Officer at Puma Biotechnology, where he led the development strategy for neratinib. His leadership of this program resulted in FDA, EMA and multiple other global approvals, a diverse clinical development program, and an active translational program with several hundred scientific and clinical publications during his tenure. Earlier in his career, Dr. Bryce was Senior Director of Clinical Science for Onyx Pharmaceuticals, where he oversaw the Phase 3 registrational studies for carfilzomib.

“I am excited to join the enGene team and share in its relentless focus on patient needs and dedication to the translation of innovative science into practical non-viral genetic medicines,” said Dr. Bryce. “I believe EG-70 has the potential to change the treatment paradigm for NMIBC patients and clinicians, and I look forward to advancing the pivotal LEGEND study and expanding our pipeline of non-viral genetic medicines.”

Dr. Bryce obtained his Bachelor of Medicine and Bachelor of Surgery (MBChB) Degrees from the University of Edinburgh and is certified in the EU in primary care/general practice and pharmaceutical medicine. He holds numerous postgraduate specialist clinical qualifications including those from the Royal College of Obstetricians & Gynaecologists (RCOG) and the Royal College of Physicians (RCP). He also served as a Surgeon Lieutenant Commander in the Royal Navy.

About enGene Inc.

enGene Inc. is a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for delivery of therapeutics to mucosal tissues and other organs, potentially creating new ways to address diseases with high unmet clinical needs. Our proprietary Dually Derivatized Oligochitosan (DDX)® platform is designed to enable a carrier to penetrate mucosal tissue and deliver a wide range of sizes and types of cargo, including DNA and various forms of RNA, by turning mucosal cells into therapeutic production “factories” that generate proteins and RNAs for a desired local effect. This platform will enable localized treatment specifically to the target site without the immunogenicity and systemic effects typical of viral vector-based genetic medicines, potentially expanding gene therapy to multiple clinical settings.

About enGene’s EG-70 Program

enGene’s lead product candidate, EG-70, is a non-viral immunotherapy comprised of three gene cargos delivered via our proprietary DDX platform; it is being evaluated as a monotherapy in a registrational study to treat NMIBC patients with carcinoma-in-situ (Cis) who are unresponsive to treatment with Bacillus Calmette-Guérin (BCG). It is also being studied as a monotherapy to treat NMIBC patients with Cis who are naïve to BCG. EG-70 is applied by intravesical administration and encodes two RIG-I agonists intended to stimulate the innate immune system and IL-12 to stimulate the adaptive immune system. With cargoes selected to stimulate both arms of the immune system, EG-70 is designed to generate a strong local immune reaction in proximity to tumors, enabling the immune system to reduce or clear the tumor and develop memory to resist recurrence without significant systemic toxicities.

About the LEGEND study

The LEGEND study, both first-in-human and first-in-class, is a Phase 1/2 open-label, monotherapy, multi-center, dose-escalation trial evaluating the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov. For additional information about the LEGEND study, please visit TheLegendStudy.com.

Note regarding forward-looking statements

This press release contains certain “forward-looking statements” that reflect enGene’s beliefs and assumptions based on currently available data and information. These forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this press release may include, for example, statements regarding: enGene’s research and development programs, regulatory and business strategy, future development plans, and management; enGene’s ability to advance product candidates and the timing or likelihood of regulatory filings and approvals. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on enGene’s current beliefs, expectations, and assumptions that, by definition, involve risks and uncertainties that are difficult to predict and are subject to factors outside of management’s control, and that could cause actual results to differ substantially from statements made including but not limited to: risks associated with the success of preclinical studies, clinical trials, research and development programs, as well as regulatory approval processes. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. enGene has no approved drugs available for sale marketing at this time and may never have an approved drug. You are cautioned not to rely on enGene’s forward-looking statements, which are only made as of the date hereof. enGene is under no obligation to update these statements.

Additional Information and Where to Find It

The information provided herein may be relevant to the proposed business combination between enGene and Forbion European Acquisition Corp. (“FEAC”) (Nasdaq: FRBN), In connection with the business combination agreement and the proposed transaction, enGene Holdings Inc. (“Newco”), which will be the surviving public company of the business combination, has filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus, and this communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Newco or FEAC has filed or may file with the SEC in connection with the proposed business combination. After the registration statement on Form S-4 has been declared effective, the definitive proxy statement/prospectus will be mailed to shareholders of FEAC as of a record date to be established for voting on the proposed business combination and the other proposals regarding the proposed business combination set forth in the proxy statement/prospectus. Before making any voting or investment decision, investors and shareholders of FEAC are urged to carefully read the entire proxy statement/prospectus, when available, as well as any amendments or supplements thereto, because they will contain important information about the proposed business combination. FEAC investors and shareholders will also be able to obtain copies of the preliminary and definitive proxy statements/prospectuses, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to: Forbion European Acquisition Corp., Gooimeer 2-35, 1411 DC Naarden, The Netherlands, Attention: Cyril Lesser.

Participants in the Solicitation

FEAC, enGene, Newco and their respective directors, managers, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from FEAC’s shareholders with respect to the proposed business combination under the rules of the SEC. FEAC’s investors and security holders may obtain more detailed information regarding the names and interests in the proposed business combination of FEAC’s directors and officers, without charge, in FEAC’s filings with the SEC, including the preliminary proxy statement/prospectus and the amendments thereto, the definitive proxy statement/prospectus, and other documents filed with the SEC. Such information with respect to enGene’s and Newco’s directors and executive officers will also be included in the proxy statement/prospectus.

No Offer or Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and will not constitute an offer to sell or exchange, or a solicitation of an offer to buy or exchange, any securities (including securities of enGene, FEAC, Newco or the combined company), nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

SOURCE enGene

AmacaThera Co-Founder, Chief Scientific Officer and University Professor Molly Shoichet is the new Scientific Director of PRiME Next-Generation Precision Medicine, a University of Toronto (U of T) Strategic Initiative based at the Leslie Dan Faculty of Pharmacy. As an accelerator for precision medicine, PRiME brings together multi-disciplinary research talent and innovators to tackle unmet needs in drug discovery, diagnostics, and disease biology.

“It is such an exciting time in precision medicine,” says Shoichet, who is the Michael E Charles Professor of Chemical Engineering at U of T. “We know that a one size fits all approach doesn’t work well in medicine. We can now take advantage of advances in omics – genomics, metabolomics, proteomics – AI, and engineered materials to design therapeutics more precisely for individual needs. From a research and translation perspective, it’s crucial that we address not just the complexity of disease but how we can diagnose and do a better job delivering these new treatments to patients.”

Since launching in 2019, PRiME has grown to include more than 90 faculty from 16 departments across U of T’s three campuses, with more than 200 graduate trainees connected to the initiative. Under the leadership of Shoichet, PRiME will focus on expanding translation of research advances through collaboration with U of T’s partner hospitals and industry colleagues, growing PRiME into a hub  to enable researchers to develop new solutions for key clinical challenges.

“U of T is a powerhouse in biomedical research that is recognized throughout the world,” says Shoichet. “This is strengthened not only by researchers in fields like pharmacy and engineering, but by being part of a broad ecosystem that is uniquely poised to accelerate new solutions for unmet needs in human disease. PRiME brings the diversity of ideas into solutions-focused, multidisciplinary research that will help us move the needle.”

For example, PRiME principal investigators Professors Stéphane Angers and Molly Shoichet are collaborating with SickKids Senior Scientist Dr. Peter Dirks to tackle glioblastoma – the deadliest primary tumour for which there are no therapies. Working with commercialization partner TIAP and industry partner Amgen, PRiME scientists are identifying new therapeutic targets for glioblastoma by combining their expertise in gene editing and specifically-designed hydrogels. Shoichet is known internationally for innovative research in drug delivery, drug discovery and hydrogels. Materials and techniques invented by Shoichet and her team aim to both promote tissue repair in the brain and spinal cord and discover new drugs in cancer. An Officer of the Order of Canada and Fellow of the Royal Society (UK), Shoichet was awarded Canada’s most prestigious award for science and engineering in 2020 – the Gerhard Herzberg Canada Gold Medal for Science.

As the new Scientific Director of PRiME, with a cross-appointment at the Leslie Dan Faculty of Pharmacy, Shoichet is excited to bring her passion for research and translation to the initiative.

“The Toronto biotech ecosystem is thriving,” says Carolyn Cummins, Associate Professor in the department of pharmaceutical sciences at the Leslie Dan Faculty of Pharmacy and the Associate Scientific Director of PRiME. “I am excited to work closely with Professor Shoichet to deliver the potential of PRiME at this pivotal time.”

In the coming months, PRiME will launch many new programs and events for PIs and trainees to build inter-disciplinary and translational collaborations. This includes the new PRiME Inter-Disciplinary Catalyst Program and Fellowships in fall 2023, with partners from across the Toronto drug discovery community.

Montreal, Quebec – August 15, 2023 – Thryv Therapeutics Inc., a clinical stage biotechnology company developing therapies for rare diseases including Congenital Long QT Syndrome (LQTS), atrial fibrillation, and resistant cancers, announced today FDA clearance of its Investigational New Drug application (IND) for THRV-1257.  THRV-1257 is being investigated for the treatment of advanced Anaplastic Thyroid Cancer (ATC), including those patients with the common BRAF mutation V600E.  The first in human study will determine the optimal dosing of THRV-1257 in patients with solid tumors, followed by treatment in combination with approved cancer therapies.   

At the same time, the company announces acceptance of a late breaking poster that will be presented at the upcoming American Thyroid Association (ATA) annual meeting in Washington DC, on September 30th, 2023, from 10:00 a.m. to 1:00 p.m. The presentation will highlight in vitro and in vivo preclinical results of SGK1 inhibition in models of ATC.

“Preclinical evaluation of our SGK1 inhibitors uncovered novel biology and synergy with existing cancer treatments to extend their activity and reverse resistance.  These studies have revealed a significant opportunity to intervene in several oncology treatment paradigms with an SGK1 inhibitor” Eric Campeau, Vice President, Translational Research.

According to the ATA, approximately 64,000 people in the United States are diagnosed with thyroid cancer each year. ATC makes up approximately 2% of these cases.  Although ATC is rare compared to other thyroid cancers, it is one of the fastest growing and most aggressive of all cancers. Rapid evaluation and diagnosis are critical for ATC patients, as the disease manifests as a rapidly growing neck mass that impairs speech, swallowing and breathing. Activation of Serine and Glucocorticoid Kinase 1 (SGK1) was determined to be a critical component of ATC cell proliferation, including in tumor cell lines with mutated BRAF. Inhibition of SGK1 was unique in its capacity to suppress ATC cell proliferation compared to other inhibitors tested. Thryv Therapeutics is collaborating with expert scientists and oncologists in ATC to evaluate its SGK1 inhibitors as a potential treatment option to improve the outcome of people with this devastating disease.

“We are excited to advance our portfolio of potent SGK1 inhibitors into the treatment of aggressive, treatment resistant cancers.  SGK1 has been implicated in a number of treatment-resistance oncology pathways and our work has demonstrated the potential to delay resistance and restore activity of approved therapies and ultimately improve progression free and overall survival outcomes,” Debra Odink, President, and Chief Development Officer.

About Thryv Therapeutics Inc.

Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.) is a privately owned company based in Montreal, Quebec, Canada.  Thryv Therapeutics is pioneering a precision medicine approach to treat genetic and drug-induced Long QT Syndromes, atrial fibrillation, and resistant cancers with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase. For more information, please visit www.thryvtrx.com.

Media Inquiries

daphne@thryvtrx.com +1 (514) 973 0915

TORONTO, June 13, 2023 — DAMONA Pharmaceuticals, a preclinical biopharmaceutical company focused on the discovery and development of first-in-class small molecules for the treatment and prevention of cognitive symptoms associated with brain disorders and aging, today announced the appointment of John Reilly as the company’s Chief Executive Officer and member of the Board of Directors.

Prior to joining DAMONA, Mr. Reilly co-founded and served as President and CEO of Apic Bio, a gene therapy company developing first-in-class treatments for rare neurological and liver diseases. At Apic, he secured multiple funding rounds, oversaw development programs, and orchestrated a global licensing agreement with uniQure for the company’s lead program to treat superoxide dismutase 1 (SOD1), a rare, genetic form of ALS. Previously, Mr. Reilly held a number of senior management positions at various biopharmaceutical companies, including Vice President of Business Development at Tetragenetics, which was acquired by Abcellera (Nasdaq: ABCL). Prior to Tetragenetics, he co-founded and served as CEO of Gendyne Therapeutics. Mr. Reilly holds a B.A. from Hamilton College and M.S. and M.B.A. degrees from Cornell University.

“I am very excited to join DAMONA as CEO and look forward to working with the board, management, and scientific team to continue the company’s impressive progress as we advance the preclinical pipeline and lead program for the treatment of cognitive symptoms associated with depression and diseases of aging into a Phase 1 clinical study,” said John Reilly, CEO of DAMONA Pharmaceuticals.

About DAMONA Pharmaceuticals
DAMONA is a privately held preclinical biopharmaceutical company developing small molecule therapeutics that transform the treatment of cognitive deficits and restore normal brain functions for underserved and understudied mental health conditions and for aging populations. DAMONA was founded by Etienne Sibille, Ph.D., and the Centre for Addiction and Mental Health (CAMH). In 2022, DAMONA closed a seed financing round co-led by Lumira Ventures and the Noetic Fund. For more information, please visit: www.damonapharma.com.

Contact:
Mary Moynihan
M2Friend Biocommunications
+1 (802) 951-9600
mary@m2friend.com

SOURCE DAMONA Pharmaceuticals

Cadence Neuroscience announced that it has secured $26 million in Series B financing. The round was led by Angelini Lumira Biosciences Fund (co-managed by Lumira Ventures and Angelini Ventures) and included other new investors F-Prime Capital, LivaNova USA, Angelini Ventures, Spectrum Financial Services, and Mayo Clinic, as well as the company’s Series A lead investor JAZZ Venture Partners. Gerry Brunk of Lumira Ventures and Kevin Chu of F-Prime Capital have joined the company’s board of directors.

Cadence is a clinical-stage company developing a novel neuromodulation therapy for treating pediatric and adult patients with focal drug resistant epilepsy based on research by a Mayo Clinic Neurology and Neurosurgery team, led by Gregory Worrell M.D., Ph.D., lead investigator and Mayo Clinic epileptologist. The therapy utilizes chronic subthreshold cortical stimulation to modulate EEG biomarkers associated with epilepsy to reduce or eliminate seizures. The company will use the Series B funds to complete pivotal clinical studies and pursue FDA clearance.

“The Cadence team has extensive domain expertise in developing active neural implants and conducting human clinical studies in the field,” said Kent Leyde, Cadence’s co-founder and Chief Executive Officer. “During the last three years, we have been closely collaborating with Mayo Clinic in the design, manufacture, and engineering tests of our therapy system. These efforts are nearing completion and will enable us to begin clinical testing.”

“As an active investor in both medical devices and pharmaceutical therapies for epilepsy, we believe Cadence is well-positioned to drive important advances in the field of neuromodulation, with the potential to revolutionize the treatment of drug refractory epilepsy, a disease which affects millions of people across the world,” said Gerry Brunk, Managing Director at Lumira Ventures. “We believe Cadence’s platform solution has the potential to become an important standard of care in drug-resistant epilepsy as well as other difficult-to-treat brain disorders,” said Paolo Di Giorgio, CEO of Angelini Ventures. 

“We think the precise, patient-specific stimulation method being developed by Cadence is unique and exciting,” said Kevin Chu, healthcare team Principal at F-Prime Capital. “We are thrilled to join the team on its important mission to bring life-changing therapies to this debilitating and difficult-to-treat disease.”

About Cadence Neuroscience
Cadence Neuroscience is a medical device company developing new therapies for the treatment of epilepsy and other neurological disorders. The company’s core technology was developed at Mayo Clinic and is under clinical evaluation. Founded in 2017 and headquartered in Redmond, Washington, Cadence is led by seasoned executives with extensive backgrounds in neural implant product development and clinical studies.

About Angelini Lumira Biosciences Fund
Lumira Ventures and Angelini Ventures partnered to create the Angelini Lumira Biosciences Fund in 2021 to invest in early-stage companies in North America developing innovative therapies for disorders of the central nervous system. Founded in 2007, Lumira Ventures is a multi-sector healthcare venture capital firm with offices in Toronto, Boston, Montreal and Vancouver. Angelini Ventures is the corporate venture capital arm of Angelini Industries, an Italian multi-sector group that operates in 21 countries in the health, industrial technology and consumer goods sectors, with 5,800 employees and revenues of €2 billion. With €300M in investment capital, Angelini Ventures creates and invests in companies developing innovative solutions in the fields of biotechnology, life sciences and digital healthcare.

Related Links
https://www.cadenceneuro.com/  
https://www.lumiraventures.com/ 
https://fprimecapital.com/
https://www.jazzvp.com/ 
https://www.livanova.com/ 
https://www.angeliniventures.com/ 
https://businessdevelopment.mayoclinic.org/ 

Mayo Clinic and Dr. Worrell have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Media Contact:
Kent Leyde
425-298-3184
359168@email4pr.com 

The study met secondary study endpoints and long-term sensor use was associated with significant improvements in patient quality-of-life metrics and low event rates for heart failure hospitalization and death.

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive 12-month data from the SIRONA 2 clinical trial that demonstrated long-term use of the Cordella Pulmonary Artery (PA) Sensor was associated with significant improvements in patient quality-of-life metrics and low HF hospitalization and death (HFH/D) event rates for New York Heart Failure (NYHA) class III patients. The results expand on the previously published positive 90-day primary endpoint data on device safety and pressure accuracy for the Cordella PA Sensor. The 12-month results were presented on May 20th at the European Society of Cardiology’s annual conference, Heart Failure 2023, by Professor Birgit Aßmus, a heart failure cardiologist at the University of Giessen in Giessen, Germany.

“Adding to a robust foundation of clinical evidence supporting the use of Cordella, the 12-month SIRONA 2 data further validates the benefit of PA pressure-guided therapy to improve patient outcomes for NYHA class III patients,” stated Prof.  Aßmus. “Cordella’s comprehensive approach consists of PA pressure data plus non-invasive data, including blood pressure, weight, and heart rate, which enables my team to efficiently titrate key HF medications remotely and help patients feel better. By actively monitoring the trended health data, we can bring down the PA pressures to avoid acute HF hospitalizations which delivers meaningful benefits to our overall health system and to patient lives.”

The Cordella solution is the first and only patient management platform to provide both critical PA pressure data with an implanted sensor, and noninvasive vitals for comprehensive clinical management delivered in the patient’s home. The easy-to-use devices securely transmit a patient’s daily health status for trended insights that support optimal dosing of guideline-directed medical therapy (GDMT) across all types of heart failure. The patient-friendly system engages the patient and allows them to view their trended health data which has been shown in clinical evaluation to support healthy lifestyle choices. The streamlined workflow enhances current clinical practice, providing a scalable solution that enables new treatment standards to reduce and prevent HF congestion.

SIRONA 2 is an open-label, single-arm trial of 70 European patients that met its primary endpoints for safety and accuracy with the previously reported 90-day results. The 12-month results extended both the strong safety profile, with no PA sensor failures and no additional device/system-related complications (DSRC=1.3%), as well as accurate PA pressure measurement, with good agreement with the gold standard fluid-filled reference catheter (Swan Ganz). The recent results also met secondary endpoints for validated patient quality-of-life metrics and demonstrated low event rates for HF Hospitalization / Death (HFH/D) as indicated below.

12-Month SIRONA 2 Key Findings

• Significant improvement in patient quality-of-life metrics, including NYHA classification over 12 months (p<0.0001) and 6-minute walk test distance at both 3 months (p=0.005) and 12 months (p=0.02)
• Low event rates for HF Hospitalization/Death and only 5 deaths (7.1%) at 12 months
  • Cumulative hazard rate for HFH (0.27) and HFH/D (0.33)
• 78.6% reduction in HFH rate in the year following implant compared to the year prior
• Consistently high patient compliance with daily submissions of heath data – 95% at 12 months

“We are thrilled with the significant improvement in patient quality of life and low event rates demonstrated in the 12-month SIRONA 2 data, which sets the stage for upcoming PROACTIVE-HF trial results in early next year,” commented Harry Rowland, CEO of Endotronix. “Together, this clinical evidence will serve as the foundation for our upcoming commercial launch and enable clinicians to improve patients’ lives for the better.”

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor which directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice, and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella Sensor is under clinical investigation and is not available for commercial use in any geography. The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

SOURCE Endotronix, Inc.

Proceeds to Support Key Efficacy Studies for ABI-2280 including Phase 2 Trial in High-Grade Cervical Intraepithelial Neoplasia (CIN 2,3) and Exploratory Study as Treatment for High-Risk HPV Infections

Antiva Biosciences, Inc. biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, today announced the closing of a $53 million Series E equity financing. The financing was supported by a syndicate of premier life science investors led by MPM-BioImpact Capital, and joined by the company’s existing investors including Canaan Partners, Sofinnova Investments, Adjuvant Capital, GV and Lumira Ventures, among others. In conjunction with the financing, president and chief executive officer Gail Maderis is transitioning to chairman of the company’s board of directors and is being succeeded as CEO by Kristine Ball. Additionally, Ms. Ball, along with Florencia Segal, M.D., and Brian Goodman, Ph.D., both of MPM-BioImpact Capital, will join the Antiva board.

Proceeds from the financing, which will fund the company into late 2025, will support the advancement of the company’s lead development candidate, ABI-2280, into key efficacy studies following completion of its ongoing Phase 1 trials. Planned studies include a Phase 2 clinical trial in high-grade cervical intraepithelial neoplasia (CIN 2,3) and an exploratory study as a potential treatment for high-risk HPV infection, specifically in subtypes that can lead to cancer. ABI-2280 has potent antiviral activity across all serotypes of HPV and works by both directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to formulate a vaginal tablet of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing impact potential for patients.

The treatment of high-risk HPV infections with ABI-2280 holds the potential to address a significant global health challenge. HPV infections account for nearly all cases of cervical cancer around the world and an accessible and effective treatment holds the promise to dramatically reduce these cancers. Currently, there are no treatments available to resolve HPV infections and prevent their development into cancer. This remains a crucial unmet medical need with more than 5.5 million women in United States alone affected by high-risk HPV infections each year despite ready access to vaccines.

“We believe that Antiva has the opportunity to make a transformative impact on global health across several large, unmet therapeutic indications with its ABI-2280 program and are thrilled to be able to lead this round of financing. The company has advanced the development of ABI-2280 to patients with CIN 2,3 and is now poised to expand clinical development into high-risk HPV infection. ABI-2280 can make the World Health Organization’s screen-and-treat approach to HPV infection a reality,” said Dr. Segal.

Dr. Goodman added, “With MPM-BioImpact’s growing focus on the field of virology, Antiva represents the type of impactful investment that we are looking to make in this space. We look forward to supporting Kristine in her new role as CEO and seeing the continued progress that is made under her leadership.”

Ms. Ball joins Antiva with more than 20 years of executive experience in the life sciences industry across companies of all stages ranging from discovery to clinical to commercial. She has significant transactional expertise, having participated in multiple initial public offerings, corporate M&A deals, partnerships and financings. Ms. Ball most recently served as chief executive officer of Soteria Biotherapeutics, a venture backed immuno-oncology company and previously held leadership positions at Menlo Therapeutics, Relypsa, Inc., and KAI Pharmaceuticals, and served on the board of Forty Seven, Inc., until its acquisition by Gilead.  Ms. Ball currently sits on the board of Atreca, Inc., a publicly traded, clinical-stage oncology company.

“I am deeply grateful for this opportunity to join Antiva at such an exciting time in the company’s maturation. ABI-2280 has tremendous potential to play a significant role in advancing both global health and women’s health, bringing about a long-needed breakthrough in HPV infections and HPV-related cancers in both men and women,” stated Ms. Ball. “I am eager to carry forward the significant momentum that has been generated by the Antiva team and look forward to the important upcoming clinical development milestones that will move us closer to this goal. I am also excited to be able to work closely with Gail in her new role as board chair, leaning on the experience and knowledge she has gained during her time as president and CEO.”   

“I take great pride in turning the CEO role over to Kristine with the company in such a strong position following this transformative financing. She is a talented and experienced life science executive who is perfectly suited to lead Antiva as it expands clinical development of ABI-2280,” said Ms. Maderis. “I look forward to remaining intimately connected to the company in the role of board chair and offer a special thanks to Steve James, who has provided Antiva with great leadership and guidance as board chair and will remain an executive advisor to the company.”

About HPV-Related Diseases and Cervical Cancer

Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years.  When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers.

The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need.

Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 604,000 women were diagnosed with cervical cancer worldwide and approximately 342,000 women died from the disease in 2020.

About Antiva Biosciences
Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in South San Francisco, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company’s lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection.

For more information, please visit: www.antivabio.com.

Contact Information:

Kristine Ball
Antiva Biosciences, Inc.
650-822-1400
info@antivabio.com

Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com

PIC Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-mechanism, first-in-class allosteric small molecule therapies targeting eIF4E, is presenting pre-clinical data today on the company’s advancing eIF4E program for breast cancer in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, FL.

Advanced or metastatic breast cancers represent a large patient population with limited long-term solutions that address both the heterogenous nature of resistant tumors and the aggressiveness of their proliferation. The aim of our therapies is to drive strong mechanistic responses, in a majority of breast cancer tumor subtypes, that induce a rapid commitment to cell death. To accomplish this, our approach addresses a key fundamental mechanism in protein translation at the convergence of many oncogenic signaling pathways through which resistance arises.

eIF4E is a key component of protein translation that often becomes dysregulated in breast cancer, supporting cell survival and metastasis alongside therapeutic resistance. PIC compound regulation of eIF4E induces rapid commitment to apoptosis and selective proteomic shifts that are consistent with canonical eIF4E regulation including cell cycle impacts, e.g. effects on cyclin family members and CDKs, DNA repair regulation and metabolic proteins. PIC Compounds also potently impact multiple clinical drivers for ER+ and Triple Negative Breast Cancers, which are evidenced by mRNA signatures that include changes consistent with proteomic impacts to key transcription factors.

Previous communications revealed our eIF4E regulators potently cause cell death in primary breast cancer organoid models, but spared models derived from healthy tissue. Expanding our efforts in this domain, the impact on normal immune cells was evaluated by exposing PBMCs, CD4+ T cells, and bone marrow mononuclear cells to our compounds. Our eIF4E regulators did not impair survival of these cells up to a maximum tested dose of 25 micromolar. Primary CD4+ T cells were also found to be functional in the presence of eIF4E regulators up to 5 micromolar, which included assessments of CD3/CD28 stimulated cytokine production and proliferative responses, highlighting its remarkable differentiated impact on normal cells compared to tumor cells.

“We continue to uncover interesting and distinctive preclinical data sets that underscore the potential for unique therapeutic advantages of allosterically regulating eIF4E, as a promising strategy for patients with various subtypes of breast cancer,” said Kathy Bowdish, Ph.D., President and Chief Executive Officer of PIC Therapeutics.

Our findings suggest that allosteric regulation of eIF4E provides a unique and efficient way to address multiple resistance mechanisms while sparing normal immune cellular function. Our eIF4E regulators represent a potential beneficial therapeutic approach to address multiple resistant cancer patient populations and fulfill the promise of this elusive target.

Presentation details:
Title: eIF4E allosteric regulators cause rapid commitment to apoptosis in cancer cells while sparing immune cells
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date and Time: Monday April 17, 9:00 AM – 12:30 PM
Location: Section 17
Poster Board Number: 14
Abstract Number: 1624

About PIC Therapeutics, Inc.

PIC Therapeutics is a preclinical-stage biotechnology company pioneering the discovery and development of first-in mechanism, first-in-class small molecule medicines focused on fundamentally changing how we treat cancer by developing therapeutics that regulate protein translation in a context dependent manner. PIC Therapeutics targets a “master switch” of cancer signaling pathways, selectively impacting oncogene protein production by altering the Pre-Initiation Complex (PIC) that drives their mRNA translation. PIC Therapeutics’ selective approach regulates cancer cell proteomes, impacting multiple dysregulated oncogenic drivers leading to a powerful new generation of cancer-treating therapeutics. Our agents offer the opportunity to address both drug resistance and tumor heterogeneity, issues that plague many existing treatments. For more information visit www.pictherapeutics.com

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the clearance of investigational new drug (IND) applications for [²²⁵Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [¹¹¹In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies’ multi-asset collaboration agreement.

FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

“The IND filing for FPI-2068 is an important milestone for Fusion as we advance this novel TAT, created by combining our radiopharmaceutical expertise, actinium supply and manufacturing infrastructure with AstraZeneca’s bispecific antibody which preferentially binds to cancer cells that express both EGFR and cMET,” said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. “FPI-2068, which we believe will be the first TAT for two validated targets to enter the clinic, was designed to provide enhanced tumor specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets. We are excited about the innovative work with AstraZeneca as we advance this and other programs under our broad collaboration agreement.”

Fusion’s radiopharmaceuticals are a type of precision medicine whereby the cancer-targeted vector (e.g., the bispecific antibody) can be used to screen patients for expression of a tumor biomarker when combined with a corresponding imaging isotope (e.g., indium-111), and subsequently used for therapy when combined with the alpha-emitting radionuclide, actinium-225. Using imaging to identify patients who show uptake of the drug in tumors increases the likelihood of response to therapy. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening in order to better predict the cadence of patient enrollment. 

FPI-2068 will be the first program to enter clinical development under the Company’s previously announced collaboration agreement with AstraZeneca, which includes joint discovery, development and the option to co-commercialize novel TATs leveraging Fusion’s proprietary Fast-Clear™ linker technology platform with antibodies from AstraZeneca’s oncology portfolio, as well as exploration of potential combination strategies involving existing assets in their respective portfolios. Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.

About FPI-2068

[²²⁵Ac]-FPI-2068 (FPI-2068) is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are validated cancer targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. FPI-2068 will be evaluated in a Phase 1 study.

About Fusion

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, Inc. and BWXT Medical.

Forward-Looking Statements

This press release contains “forward-looking statements” for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding Fusion Pharmaceuticals Inc.’s (the “Company”) future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “expect,” “plans,” “anticipates,” “intends,” “will,” and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company’s potential drug candidates, including any expressed or implied statements regarding the successful development of its product candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance FPI-2068 in the clinic, through the regulatory process or to commercialization; management’s expectations could be affected by unexpected patient recruitment delays or regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials; the Company’s ability to obtain additional funding required to conduct its business activities; and changes in the Company’s business plan or objectives. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management’s expectations are described in greater detail under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the year ended December 31, 2022, as filed with the SEC and in any subsequent periodic or current report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company’s views, expectations or beliefs at any date subsequent to the date of this release. While Fusion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change.

Investors and others should note that Fusion communicates with its investors and the public using the Fusion website, www.fusionpharma.com, including, but not limited to, company disclosures, investor presentations, SEC filings, and press releases. The information that Fusion posts on this website could be deemed to be material information. As a result, Fusion encourages investors, media and others interested to review the information that Fusion posts there on a regular basis.

Contact:
Amanda Cray
Senior Director of Investor Relations & Corporate Communications
(617) 967-0207
cray@fusionpharma.com

SOURCE Fusion Pharmaceuticals

Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, today announced it has entered into a Research Collaboration and License agreement with Incyte to discover and develop targeted protein degraders for novel oncology targets.

“We are pleased to embark on this collaboration with Incyte to identify targeted protein degraders for novel oncology targets. Biotheryx and Incyte share a commitment to finding new, transformative treatment options for people living with cancer,” said Philippe Drouet, President and Chief Executive Officer of Biotheryx. “Our PRODEGY platform is designed to increase efficiency in degrader discovery and design, enabling the development of therapies for previously undruggable targets. We look forward to leveraging this differentiated approach in our collaboration with Incyte and in the continued advancement of our pipeline of first-in-class, next generation bifunctional degraders and molecular glues for the treatment of cancers and inflammatory disease.”

Under the terms of the agreement, Biotheryx will utilize its distinctive PRODEGY platform to identify and initially develop molecular glue degraders for multiple historically undruggable oncology targets. For the initial target, Biotheryx will receive a technology access fee of $7 million plus up to an additional $6 million in potential research and development funding from Incyte for costs associated with the collaboration. Biotheryx is also eligible to receive potential future regulatory and commercial milestones of up to $347 million plus tiered single-digit royalties on global net product sales for the initial target. Incyte will be solely responsible for further development and commercialization of any molecular glue degraders discovered by Biotheryx’s PRODEGY platform. Additionally, under the terms of the agreement, the collaboration can be expanded under the same financial terms. Further financial terms of the deal were not disclosed.

“As we work to transform the oncology treatment landscape, Incyte is harnessing breakthrough science that may offer patients with unmet needs new treatment options,” said Dashyant Dhanak, Ph.D., Executive Vice President and Chief Scientific Officer of Incyte. “The Biotheryx team has significant expertise in targeted protein degradation, one of the most promising modalities in oncology, and we look forward to collaborating to develop therapies that can help improve patient lives.”

About Biotheryx, Inc.

Biotheryx is a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders, including bifunctional degraders and molecular glues. Our initial focus is on deploying the differentiated potential of degraders towards validated targets in cancer and inflammatory disease. Members of our founding and scientific teams previously developed the first U.S. Food and Drug Administration (FDA) approved modulators of Cereblon, the most widely validated E3 ligase involved in protein degradation, and we have applied our expertise in Cereblon binding to build our proprietary PRODEGY platform. Our pipeline of bifunctional degraders includes the first-ever degraders of SOS1 for pan-KRAS mutant cancers, CDK4/6 for solid tumors and PDE4 for inflammatory diseases. Our pipeline of molecular glues includes BTX-1188, a rationally designed, dual-targeting molecular glue degrader of GSPT1 and IKZF1/3 for acute myeloid leukemia and solid tumors. For more information, please visit www.biotheryx.com and engage with us on LinkedIn.

SOURCE Biotheryx, Inc.

Deka Biosciences (“Deka”), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced today that the first subject has been dosed in a Phase 1 clinical trial of DK2¹⁰ (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK2¹⁰ (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

“We are beyond thrilled to begin the clinical trial of DK2¹⁰ (EGFR), marking our first program to enter clinical development,” said John Mumm, Ph.D., President and CEO of Deka. “Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first Diakine^TM, establishing a solid foundation for the expanded use of this treatment in cancer patients.”

DK2¹⁰ (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10. While IL-2 is known to be toxic, when coupled with IL-10, toxicity is not only reduced but its potency is increased, thereby creating a more tolerable and effective treatment for patients. It is the first of several experimental therapeutics in Deka’s platform of molecules which are being developed to treat both cancer and inflammatory diseases. These therapeutics, known as Diakines^TM, involve coupling two cytokines together onto a single chain variable fragment (scFv) targeting system to enhance their precision in targeting specific tissues. Furthermore, the scFv scaffold used in the Diakine^TM platform also improves efficacy, safety and manufacturability of each treatment.

About Deka Biosciences

Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, testing and clinical development. Deka has developed disease specific Diakines™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient’s immune response to different Diakines™, Deka hopes to maximize the impact of its Diakines™ by building specific targeted therapies for everyone.

SOURCE Deka Biosciences

OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced a significant milestone for the Company as the SavvyWire has been successfully used by physicians in 1,000 procedures. The SavvyWire is OpSens’ sensor-guided solution for transcatheter aortic valve replacement procedures, TAVR or TAVI, to treat aortic valve stenosis.

“The successful use of the SavvyWire in 1,000 patients marks an important milestone towards full-scale commercialization of our innovative device. The early commercialization phase is progressing steadily and the impressive number of procedures completed demonstrates the acceptance and relevance of the SavvyWire within the structural heart market” said Louis Laflamme, President and Chief Executive Officer of OpSens.

“We are gaining positive traction in the U.S. and Canada with our proprietary 3-in-1 solution for TAVR  procedures. Our sales team is operating at a high level as they educate cardiologists on the benefits of the SavvyWire to expand the number of accounts and drive adoption. Additionally, signing a GPO agreement last month with one of the largest group purchasing organizations in the United States and SavvyWire being featured in two live case broadcasts during the CRT conference is expected to drive continuous growth going forward,” Mr. Laflamme concluded.

The SavvyWire is the first and only Sensor-Guided solution for TAVR procedures to treat aortic valve stenosis. It uniquely provides a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly on cardiology. The Company 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 more than 200,000 patients in more than 30 countries. It is approved for sale in the United States, the European Union, the United Kingdom, Japan and Canada.

OpSens has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). This unique guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access.

OpSens’ SavvyWire is on trend with a minimalist approach to TAVR and advances the procedure, allowing patients to leave the hospital earlier, sometimes the same day.

The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027.

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

SOURCE OpSens Inc.

For further information: Louis Laflamme, CPA, President and Chief Executive Officer, 418.781.0333; John Hannigan, FCA, Chief Financial Officer, 418.781.0333

HistoSonics, (www.histosonics.com), the developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the first kidney patient has been treated using the Company’s histotripsy platform. The procedure was performed in Leeds, UK, by Professor Tze Min Wah, Senior Consultant Radiologist and Clinical Lead for Interventional Oncology Program at Leeds Teaching Hospitals NHS Trust, UK. This procedure marks the initial treatment in the HistoSonics sponsored “CAIN” Trial which is a Phase I prospective, multi-center study designed to evaluate the safety and technical success of the Company’s histotripsy system in targeting and destroying primary solid renal tumors, completely non-invasively and without the need for incisions or needles. The trial is named in honor of Charles Cain PhD, former Chair of Biomedical Engineering at the University of Michigan, co-inventor of histotripsy, and co-founder of HistoSonics, who passed away in March of 2020.

Professor Tze Min Wah commented, “I was delighted to lead the clinical team in carrying out this world’s first kidney tumor treatment using histotripsy and a real privilege to have the trust of the patient and their family in translating this innovative technology into our clinic. The CAIN Trial represents a significant milestone for treatment of solid renal tumors with histotripsy as a needle-less technology and is a paradigm shift from this point onwards.”

HistoSonics’ image guided sonic beam therapy system uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with precision and control. The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted tissue 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 resorb quickly. Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

HistoSonics histotripsy systems are not currently available for sale. Any use is limited to clinical investigations. The HistoSonics Edison™ System is pending FDA review for a destruction of liver tissue indication. The CAIN Trial is expected to support a future expansion of the indication to include the destruction of kidney tissue.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on the continued development of its Edison^™ Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced its PROACTIVE-HF pivotal study successfully completed enrollment. Designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor, the data will support the pre-market approval (PMA) application for market access in the U.S.

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella PA Sensor is an implantable pulmonary artery (PA) pressure sensor which directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella™ PA Pressure Sensor System is an investigational device and is not currently approved for clinical use in any geography.

CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation.

The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

Congruence Therapeutics, a biotechnology company working at the interface of computational and experimental drug discovery to design novel small molecules for diseases of protein misfolding, announced today the close of an extension to its Series A financing, bringing the total amount raised to over US$65 million. This extension was led by new investor BDC Capital’s Thrive Venture Fund, with participation from current investors Amplitude Ventures, Fonds de solidarité FTQ, OrbiMed, Investissement Quebec (IQ), SilverArc, and others.

“This financing provides further evidence of the emerging role that technology must play to drive innovation in biotechnology. We are proud to be pioneers in tech-enabled drug discovery with the support of high-quality investors who share our commitment to developing computational tools that will re-invent the way that drugs are discovered,” said Dr. Clarissa Desjardins, CEO of Congruence. “These additional proceeds will allow us to accelerate our pace, advancing our Revenir™ platform and our pipeline of first-in-class and best-in-class programs for devastating genetic, rare and neurological diseases toward the clinic.”

Michelle Scarborough, Managing Partner, Thrive Venture Fund at BDC Capital added, “With an incredible team led by Clarissa and a first-of-its-kind discovery platform, Congruence will quickly emerge as a leading biotechnology company who is well-positioned to disrupt traditional drug discovery and deliver real benefits to patients. We are proud to lead this investment round and look forward to supporting Congruence through its next phase of growth.”

In February 2022, Congruence announced the close of its Series A financing of US$50 million, led by Amplitude Ventures and Fonds de solidarité FTQ, with participation from Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management, and others. Congruence Therapeutics was founded in 2021 by Clarissa Desjardins, Ph.D., previously the founder and chief executive officer of Clementia Pharmaceuticals, a company developing therapies for rare pediatric bone diseases and sold to Ipsen in early 2019 for US$1.3 billion. Clementia’s lead product, Sohonos^™ (palovarotene), was recently approved in Canada and is under review at the FDA as the first treatment for Fibrodysplasia Ossificans Progressiva, a debilitating and progressive rare bone disorder. At Congruence, Dr. Desjardins has put into place a team of ‘drug hunters’ with experience in rare disease strategy and clinical development, computational chemistry, medicinal chemistry, and business development.

About Congruence Therapeutics

Congruence Therapeutics is a drug discovery company that is uniquely harnessing the power of innovative fields such as protein dynamics, biophysics, machine learning, AI, and computational chemistry to advance drug discovery. Our ground-breaking discovery engine, Revenir^TM, captures the biophysical features of functional proteins and their pathogenic counterparts in order to discover functional allosteric and cryptic pockets which can lead to small molecule hits at unprecedented speed. 

For more information, please visit www.congruencetx.com.

Company Contact
Tanya Borsuk
EVP of Corporate and Business Development
tborsuk@congruencetx.com

Media Contact
Amy Conrad
Juniper Point
amy@juniper-point.com 
858-366-3243

No serious adverse events related to drug product were reported
Patients demonstrated improvements in exercise capacity and reductions in episodes of chest pain
Cardiac imaging results provide mechanistic evidence supporting the therapeutic potential of XC001 in cardiovascular disease

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.  EXACT met both safety and efficacy objectives. There were no safety issues related to drug product or unexpected serious adverse events related to XC001 administration.  Six-month data from 28 patients in the Phase 2 portion of the study showed improvements in several key efficacy measures, including reduction in ischemic burden.

“We are excited to see EXACT completing its 6-month endpoint.  The trial met all of its safety and exploratory objectives, showing intriguing benefits in these needy patients across a variety of objective and subjective measures,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “The strong range of mechanistic evidence demonstrate that administration of XC001 is a scientifically-sound approach for achieving a biological effect that has the potential to improve patients’ quality of life.”

XC001 is a one-time gene therapy designed to reduce ischemic burden by creating new blood vessels in  the heart. In the Phase 2 portion of the EXACT trial, evidence of the drug’s mechanism of action was demonstrated by the reduction of ischemic burden measured by cardiac positron emission tomography (PET) imaging.  The reduction in ischemic burden was accompanied by an improvement in total exercise duration, an important measure of exercise capacity. Prior to treatment, almost all subjects had marked limitations on ordinary physical activity. Six months after treatment, nearly half of all subjects were able to conduct ordinary physical activity without causing angina. The data from the Phase 2 EXACT study are potentially meaningful for patients with refractory angina, which includes more than one million people in the United States, who have no treatment options.

“We are excited to share this positive topline data from the Phase 2 portion of the EXACT trial, reinforcing our confidence in XC001 as a novel therapeutic approach with the potential to address the significant unmet medical needs of people with refractory angina,” said Al Gianchetti, President and CEO of XyloCor. “We now look forward to pursuing key upcoming milestones in XC001’s continued development, including finalizing our pivotal trial design through our ongoing discussions with the FDA and other regulatory authorities.”

About XC001

XC001 is designed to promote new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients’ quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects.

About the EXACT Study

The recently completed Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial was a Phase 1/2 multicenter, open-label, single-arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, followed by an expansion phase of the trial in which additional subjects were enrolled at the highest tolerated dose (1 x 10¹¹ vp, the highest tested dose). The investigational gene therapy is administered directly to the heart muscle through a mini-thoracotomy by a cardiac surgeon.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain.

About XyloCor

XyloCor Therapeutics is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations:

Brian Davis, XyloCor Therapeutics

brian.davis@xylocor.com

610-541-2056

Media Contact:

Mike Beyer, Sam Brown Inc. Healthcare Communications

mikebeyer@sambrown.com

312-961-2502

Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CYR-064, paving the way for the company to initiate a randomized, placebo-controlled multi-dose Phase 2 clinical trial of its soft mist nasal spray therapy to treat patients who have lost their sense of smell following recovery from a viral infection.  There is currently no FDA-approved drug therapy to treat post-viral smell loss.

“Clearance of the IND for CYR-064 brings us one step closer to our goal of developing medicines with the potential to benefit post-viral hyposmia patients, especially those affected by COVID-19,” said Rick Geoffrion, Chief Executive Officer of Cyrano Therapeutics. “Our clinical team has been diligently preparing for this moment and is now laser focused on enrolling our first patient, which we expect will occur in the second quarter of 2023.”

“Loss of the sense of smell has a significant impact on quality of life and presents safety issues for all who are affected. As a practicing otolaryngologist-head and neck surgeon, the inability to offer any proven intervention for patients with this common condition is very frustrating,” said Ron Kuppersmith, MD, Chief Medical Advisor of Cyrano Therapeutics and Past-President of the American Academy of Otolaryngology – Head and Neck Surgery. “While the inability to administer any therapy that can help is a challenge for physicians, the situation is even more frustrating for patients suffering with the condition. The potential for CYR-064 to help patients with post-viral hyposmia will represent a major breakthrough for these patients and address a major unmet clinical need.”

The Phase 2 clinical trial is designed to assess the local safety, tolerability, and effectiveness of treating post-viral hyposmia. The study is expected to enroll patients at twenty clinical sites in the United States and will evaluate treatment over a six-month time period.

About Post-Viral Hyposmia

Post-viral smell loss is a growing global issue.  Prior to the COVID-19 pandemic, 8 million patients in the U.S. and EU suffered from long-term post-viral smell loss.  This has grown to more than 40 million patients since the beginning of the COVID-19 pandemic.  Approximately 15% of 2020-era COVID-19 patients and ~5% of 2021 and 2022-era COVID-19 patients suffer from long-term smell loss.  At current rates, >10,000 patients each day in the U.S .and >10,000 patients each day in the EU are contracting long-term smell loss.

About Cyrano Therapeutics

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company.  Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and flavor. To learn more, please visit cyranotherapeutics.com.

SOURCE Cyrano Therapeutics

Funds Expected to Support Enrollment in U.S. Pivotal EMPOWER Trial and European Commercial Expansion for Carillon Mitral Contour System®.

Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced it has closed a $35 million Series D financing round. The financing was co-led by existing investor Horizon 3 Healthcare and an undisclosed strategic investor, with all other existing investors participating, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.

“Having two high quality co-lead investors, including a new strategic investor, as well as the continued financial support of all existing investors, continues to validate Cardiac Dimensions’ solution for heart failure patients suffering from mitral regurgitation. This funding will enable us to continue providing Carillon therapy to a large population of patients in dire need of treatment,” said Cardiac Dimensions CEO Rick Wypych. “We anticipate accelerating enrollment in our EMPOWER pivotal trial where we can now bring Carillon’s benefits to earlier-stage patients with much lower grades of mitral regurgitation. With strong reimbursement in place in key European markets, we also look forward to expanding adoption in these markets and adding new geographies this year.”

“We have been impressed with Carillon’s ability to improve patients’ lives both in clinical studies and in real-world use, and with the company’s ability to leverage these results to grow adoption and commercial sales,” said Matt McNamara, Chief Investment Officer and Board Director for Horizon 3 Healthcare. “We are enthusiastic about the device’s potential to treat heart failure at a much earlier stage than other device therapies, which could make it a frontline treatment with the potential to change the course of the disease.”

In 2021, Carillon therapy was added to the European Society of Cardiology (ESC) Guidelines covering the Diagnosis and Treatment of Acute and Chronic Heart Failure for the treatment of secondary mitral regurgitation (SMR). The guidelines note that the therapy met its primary endpoint in the blinded, sham-controlled, randomized REDUCE FMR trial, has a shorter learning curve and fewer technical requirements than clipping, and does not preclude other heart failure-related procedures.

Data encompassing 101 patients across Germany from the CINCH European post-market registry were recently presented at the 2022 Transcatheter Therapies (TCT) conference. The data showed that an MR grade of 2+ or less was achieved for 96 percent of patients at 12 months and 100 percent of patients by five years. More than 69 percent of patients had a NYHA class of II+ or less at one year, which improved to 79 percent of patients at five years. Safety data showed no device-related significant adverse events out to one year. At two years, the mortality and heart failure hospitalization rates were also notably better than both standard medical management and published data from other commercial device therapies. Previously published survival data on the Carillon device out to six years show favorable survival when compared to medical management.

About the Carillon Mitral Contour System

Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.

To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial is currently enrolling patients in the U.S., as well as in select centers worldwide.

The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.

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, secondary mitral regurgitation 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 secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.

Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

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

Contacts

Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274

AmacaThera, a clinical-stage biotechnology company developing advanced injectable biomaterials for local, sustained delivery of oncology and pain therapeutics, has received grant funding from the Innovations for Vets QuickFire Challenge: Lung Cancer & Physical Trauma.

The program, launched by Johnson & Johnson Innovation- JLABS (JLABS) with the Johnson & Johnson Office of Military and Veterans Affairs, was created with the goal of advancing technologies that benefit veterans.

“We founded AmacaThera to revolutionize the range of treatment options available to patients using a range of therapeutic agents, such as small molecules, antibodies, proteins or peptides,” says Dr. Michael J. Cooke, CEO and co-founder of AmacaThera. “We’re honoured to be among the companies selected to participate in this program, and excited to form new collaborations.” Molly Shoichet, co-Founder and CSO, added, “Our unique, responsive hydrogel strategy enables us to achieve success in this innovative approach to lung cancer treatment.”

About AmacaThera
AmacaThera is a clinical-stage biotechnology company transforming therapeutics to make a difference in patient health. Our unique, injectable hydrogel platform provides localized, sustained drug delivery to improve patient outcomes across multiple therapeutic areas, including post‑surgical pain management, cancer and other hard‑to‑reach target areas. To learn more, visit amacathera.ca.

SOURCE AmacaThera Inc.

For further information: Media Contact: Mike J. Cooke, CEO and Co-Founder, AmacaThera Inc., mikejcooke@amacathera.ca

Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.

TORONTO, ON / ACCESSWIRE / December 20, 2022 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, has received Fast Track designation from the U.S. Food and Drug Administration for its monoclonal antibody candidate, EB05. Approval of the company’s application follows favorable Phase 2 results from an international Phase 2/3 study of EB05 in hospitalized Covid-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe form of respiratory failure characterized by widespread inflammatory injury to the lungs.

The Fast Track program provides Edesa with the opportunity for more frequent communication with the agency to discuss the development path for EB05 as a treatment for ARDS in critically ill Covid-19 patients. Investigational drugs that receive Fast Track designation are also eligible for rolling review of their marketing application as well as potential pathways for accelerated regulatory approval. To receive this designation, drug candidates must both treat a serious disease and have non-clinical or clinical data that demonstrate the potential to address an unmet medical need.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that FDA’s decision is a significant development milestone for the company. “Fast Track designation provides additional validation of EB05’s potential to address a significant unmet need in hospitalized patients with ARDS,” said Dr. Nijhawan. “The Fast Track designation will facilitate our interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program.”

Edesa recently reported that Phase 2 results offered statistically significant evidence of EB05’s ability to reduce death in the most critically ill hospitalized Covid-19 patients. Among the results, critically ill hospitalized Covid-19 patients given EB05 plus standard of care treatment had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days.

About EB05

EB05 is a monoclonal antibody designed to inhibit toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq:EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear unmet medical needs. The company’s two lead product candidates, EB05 and EB01, are in later stage clinical studies. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

ARDS Clinical Program

EB05, a novel monoclonal antibody targeting Toll-like Receptor 4 (TLR4) as a critical care therapy for Acute Respiratory Distress Syndrome (ARDS) – Phase 3: Enrolling

EB05 inhibits signaling through TLR4 – a key pattern recognition receptor involved in the activation of the innate immune system. Excessive TLR4 pathway activation can be pathological and has been linked to various inflammatory conditions, including viral-mediated acute lung injury.

Contact Dermatitis Clinical Program

EB01, a non-steroidal anti-inflammatory compound that inhibits secretory phospholipase 2 (sPLA2) as a treatment for the symptoms of chronic allergic contact dermatitis (ACD) – Phase 2b: Fully Enrolled.

EB01 exerts its anti-inflammatory activity through the inhibition of sPLA2 pro-inflammatory enzymes. The sPLA2 enzyme family plays a key role in initiating inflammation associated with numerous diseases. By targeting sPLA2 with enzyme inhibitors – at the inception of inflammation rather than after inflammation has occurred – Edesa believes that drugs based on this technology could provide a powerful anti-inflammatory therapeutic strategy for treating diverse inflammatory/allergic conditions. EB01 has demonstrated efficacy for the treatment of ACD in two previous clinical trials.

Edesa 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 company’s belief that EB05 could regulate the overactive and dysfunctional immune response associated with ARDS; the company’s belief in the broad potential life-saving impact of its EB05 monoclonal antibody candidate; the FDA’s Fast Track program’s ability to get new drugs to market earlier; the company’s ability or intention to have more frequent communication with FDA regarding the development path of EB05; the eligibility for EB05 to receive rolling review of a future potential marketing application or accelerated regulatory approval; the company’s belief that EB05 has the potential to address a significant unmet need in hospitalized patients with severe disease, and that Fast Track designation for EB05 will facilitate its interactions with the FDA and will also allow for faster review and approval upon successful completion of a Phase 3 development program; and the company’s timing and plans regarding its clinical studies in general. 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: 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, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

SOURCE: Edesa Biotech

Important Regulatory Milestone Provides Runway to Move DK2¹⁰ (EGFR) into the Clinical Phase

GERMANTOWN, Md., Dec. 27, 2022 /PRNewswire/ — Today, Deka Biosciences, Inc. (Deka), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 23, 2022. The IND application supports Deka’s DK2¹⁰ (EGFR), a promising new cancer treatment that combines normal interleukin-2 with a high affinity interleukin-10, that is designed to accumulate in tumors by binding to the epidermal growth factor receptor (EGFR).

“With no dual cytokine therapy currently approved for the treatment of cancer, this IND application brings us one step closer to fulfilling our mission – to bring cures to patients with cancer and inflammatory diseases,” said John Mumm, CEO & Co-Founder of Deka. “We are thrilled to advance DK2¹⁰ (EGFR) to the clinical phase and anticipate beginning our Phase 1 trial as soon as possible after the FDA’s acceptance of our IND.”

The IND filing comes nearly 18 months after the discovery of DK2¹⁰ (EGFR), and the company is projecting to dose its first patient in early 2023.

DK2¹⁰ (EGFR) is the first of many experimental therapeutics developed as part of Deka’s platform of molecules. Each Diakine^™ in Deka’s platform consists of two complementary cytokines coupled together via attachment to a single chain variable fragment that enables the cytokines to accumulate more specifically in targeted tissues. The combination of the two cytokines increases potency and reduces toxicity while the targeting system also improves the drug’s efficacy, safety, and manufacturability. Deka has also identified genetic markers that are related to the differentiated responses to each Diakine^™. These markers will be evaluated in early clinical trials with the hope of using them as potential diagnostic tools to match patients with the most effective Diakine^™ treatment in later stage trials.

About Deka Biosciences

Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, and testing. Deka has developed disease specific Diakines^™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient’s immune response to different Diakines^™, Deka hopes to maximize the impact of its Diakines^™ by building these targeted therapies for everyone.

SOURCE Deka Biosciences

Financings Planned to Support Rapid Expansion of Histotripsy Platform as Company Welcomes Silk Road Medical CEO, Erica Rogers, to its Board of Directors

HistoSonics, Inc. (www.histosonics.com), the developer of a non-invasive, novel sonic beam therapy, announced today that it has raised $85 million in a financing led by Johnson & Johnson Innovation – JJDC, Inc., with participation from existing investors including Venture Investors, Lumira Ventures, Yonjin Venture, and the State of Wisconsin Investment Board, among others. Concurrently, HistoSonics also secured a commitment for a $15 million expansion of the amount available under its existing debt facility with Signature Bank, which the company may access to accelerate strategic projects. Proceeds of the financings will be used to support HistoSonics anticipated commercial launch, additional clinical trials, and to expand application development of Edison™, the company’s novel histotripsy therapy platform, throughout the body.

Mike Blue, President and CEO of HistoSonics, commented, “These financings are an extraordinary vote of confidence in our team, as well as the novel platform and solution we have developed to transform experiences for patients and physicians who deal with the many challenges associated with significant disease, starting in the liver.”  The number of patients in the US who have primary liver tumors has increased 43% in the past 16 years and is expected to grow another 40% by 2030. HistoSonics recently submitted safety and efficacy data from its #HOPE4LIVER Clinical Trials to the US Food and Drug Administration (FDA) and expects market authorization in 2023.

HistoSonics also announced today the appointment of Erica Rogers, President and CEO of Silk Road Medical, Inc., to the company’s Board of Directors. Rogers brings decades of leadership experience in the medical technology sector and has a track record of delivering significant value creation for the companies she leads. Most recently, Rogers led Silk Road Medical from an early-stage start-up to explosive growth and a successful IPO in 2019. Silk Road Medical currently has a market cap of approximately $2.0 billion. “I have been following HistoSonics’ progress for years and believe that histotripsy offers a unique non-invasive solution capable of addressing a variety of significant unmet clinical needs. I look forward to being a part of the HistoSonics team, helping to ensure the Edison platform reaches its full potential to treat patients with significant disease across global markets and a broad number of care settings,” commented Rogers.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors at sub-cellular levels. The company is currently focused on the development of its Edison™ platform, combining advanced imaging with proprietary sensing technology to deliver personalized external beam treatments with unparalleled precision and control, and with the promise of reducing many of the side effects of conventional therapies. The Edison™ platform is not currently available for sale and is intended for use in the destruction of liver tissue. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com/

SOURCE HistoSonics, Inc.

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the appointment of Dmitri Bobilev, M.D., as chief medical officer.

“We are pleased to welcome Dmitri to Fusion’s leadership team at a time when Fusion has three Phase 1 novel targeted alpha therapy (TAT) programs and a multi-product development collaboration with AstraZeneca,” said Fusion Chief Executive Officer John Valliant, Ph.D. “Dmitri brings to our team his expertise as a seasoned drug developer and practicing medical and radiation oncologist with an impressive track record of success and clinical trial planning and execution. We look forward to his leadership in guiding our clinical development programs as we seek to bring our TATs to cancer patients in need.”

Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company’s acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development strategy for vidutolimod. Prior to Checkmate, Dr. Bobilev was vice president, head of clinical development at Vedanta Biosciences. He previously held clinical development leadership roles with Tesaro and Sanofi. Dr. Bobilev spent more than 10 years as a practicing medical and radiation oncologist.

Dr. Bobilev commented, “The next wave of radiopharmaceuticals based on alpha emitting isotopes are poised to make a significant impact on the landscape of cancer therapy. Fusion has established itself as a leader in targeted alpha therapies, combining internal R&D capabilities, with manufacturing and supply chain expertise to create a fully-integrated radiopharmaceutical company. I’m excited about the opportunity to guide the clinical strategy for a company with such a rich pipeline of innovative cancer therapies.”

Inducement Equity Award
Fusion’s Compensation Committee of the Board of Directors approved a grant of stock options to Dr. Bobilev to purchase 550,000 of Fusion’s common shares. Each option was granted as an inducement equity award outside Fusion’s 2020 Stock Option and Incentive Plan and was made as an inducement material to Dr. Bobilev’s acceptance of employment with Fusion. The options have an exercise price of $1.98 per share, which is equal to the closing price of Fusion’s common stock on November 7, 2022. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to Dr. Bobilev’s continued service with Fusion through the applicable vesting dates.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion’s first program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 study; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), which has received FDA investigational new drug (IND) clearance and will begin a Phase 1 study imminently. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF and Niowave, Inc.

For further information: Amanda Cray, Senior Director of Investor Relations & Corporate Communications, 617-967-0207, cray@fusionpharma.com

SOURCE Fusion Pharmaceuticals Inc.