• Acebilustat is the first novel anti-inflammatory molecule evidencing the potential to reduce frequency of pulmonary exacerbations and prolong time to first exacerbation in CF patients 
• Celtaxsys, with continued support from the CF Foundation, has commenced preparations for designing and executing the acebilustat Phase 3 clinical program

ATLANTA – Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily anti-inflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), irrespective of the causative genotype. In the 200 patient, double-blind, placebo controlled study, acebilustat demonstrated clinically meaningful improvements in pulmonary exacerbations, both reducing the frequency of pulmonary exacerbations (PEx) and increasing time to next exacerbation over 48 weeks of therapy. Full results from the trial will be presented this fall at the North American Cystic Fibrosis Foundation annual meeting.

“The trial data provide credible evidence to advance the development of this novel anti-inflammatory molecule,” said Steven M. Rowe, M.D. MSPH, professor of medicine and director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama at Birmingham. “Patients in key prospectively-identified sub-groups, including those with mild obstruction at baseline or taking CFTR modulator therapy, derived the most benefit in pulmonary exacerbations. That benefit, when used in combination with a CFTR modulator, is an important consideration given the likelihood of an increase in the number of CF patients who are eligible to be treated with new CFTR modulators over the coming years.  This supports the unmet need to address lung inflammation adequately for the optimal treatment of patients with cystic fibrosis.”

On a per protocol assessment, acebilustat-treated patients exhibited an 19% reduction in PEx and a 22% reduced risk in progressing to first PEx versus placebo. Additionally, over 40% of patients treated with acebilustat completed the study without experiencing a PEx, an increase of 32% as compared with patients treated with placebo.  The benefits of acebilustat on pulmonary exacerbations were apparent as early as four months after start of treatment and persisted throughout the 48 weeks of the study. No difference in lung function, as measured by the primary endpoint of FEV1 percent predicted (FEV1pp), was observed in acebilustat-treated patients compared to placebo-treated patients over 48 weeks of treatment.  Additionally, FEV1pp response did not correlate with PEx rates.

Patients with less severe impairment of lung function (FEV1pp >75) achieved the largest benefit from acebilustat treatment, achieving a 34% reduction in PEx rate, a 43% reduction in risk of experiencing their first exacerbation and a 96% increased likelihood of being exacerbation free after 48 weeks of treatment. Furthermore, patients concomitantly treated with CFTR modulator therapy exhibited a clinically meaningful 20% reduction in PEx, a 29% increased time to first exacerbation and a 47% higher likelihood of no exacerbations compared to patients treated with CFTR modulators and placebo.

Acebilustat was well tolerated with no increased risk of infection, a key attribute for any anti-inflammatory development candidate to treat CF patients who have an increased risk of infection. The majority of adverse events were mild or moderate in severity with the most common adverse events regardless of treatment group, were infective pulmonary exacerbation, cough, nasopharyngitis, nasal congestion, headache, sputum increased, hemoptysis and fatigue. There was a low discontinuation rate from adverse events among patients treated with acebilustat, in line with patients treated with placebo.

Stuart Elborn, M.D., professor of respiratory medicine at Imperial College, director of the Adult CF Centre, Royal Brompton Hospital London and professor of respiratory medicine at Queen’s University Belfast, said, “I am encouraged by the data from this trial showing that acebilustat-treated patients had reduced frequency of pulmonary exacerbations, particularly as we recruited patients who had exacerbations in the year prior to study entry and therefore at high risk of new exacerbations. It was also interesting to see that a higher proportion of acebilustat-treated patients remained exacerbation free during the study compared to placebo. These data suggest that anti-inflammatory therapy effectiveness may be better assessed using clinical events such as pulmonary exacerbations. Pulmonary exacerbations, which are a clinical marker of unbridled lung inflammation, are significant events leading to acute decompensation and chronic decline of lung function and are strongly related to reduced survival.  Given this, acebilustat has the potential to help protect patients from the progressive and irreversible damage that is associated with CF.”

Sanjeev Ahuja, M.D., chief medical officer of Celtaxsys, said, “Acebilustat is notably the first novel anti-inflammatory molecule to prospectively demonstrate benefits in both reducing the frequency of pulmonary exacerbations and prolonging time to first exacerbation, when added to a CF patient’s existing treatment regimen in a clinical trial.  We would like to thank all the patients who participated in this trial and their families who supported them. We are grateful to the study investigators and coordinators and our advisors who helped us design and execute the program. We also appreciate the scientific insights and financial support of the CF Foundation that were essential in enabling us to conduct this important study.”

About acebilustat: Acebilustat is a once-daily oral drug candidate progressing to Phase 3 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including cystic fibrosis (CF). More specifically, an overactive immune response driven by neutrophils results in excessive inflammation in the CF lung. This leads to irreversible damage resulting in excessive morbidity and mortality in CF patients. Acebilustat is designed to modulate the neutrophil driven immune response bringing the inflammation to homeostasis, preventing overactive inflammation from occurring, and thus could be potentially helpful in CF patients. By contrast, pro-resolving agents theoretically tone down inflammation once it is overactive and already contributing to lung damage in patients. Furthermore, unlike immunosuppressive treatments, such as corticosteroids, acebilustat has not demonstrated any evidence of immunosuppression in preclinical studies or in clinical trials in humans, including healthy volunteers and CF patients. Acebilustat is the most advanced therapy in development in the CF anti-inflammatory pipeline.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection and inflammation of the lungs. Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity. Excessive production of a neutrophil byproduct, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient. Excessive production of neutrophil elastase can also lead to reduced bacterial clearance. Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF, leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority.  Learn more about CF.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

Media Contact: Angela Walsh
awalsh@celtaxsys.com
470-206-0153 ext. 124

(Reuters) – Privately held Celtaxsys Inc said on Thursday a mid-stage trial testing its experimental cystic fibrosis treatment was successful in reducing a key symptom of the genetic lung disease, but did not improve lung function.

There are few treatment options for the 70,000 cystic fibrosis patients worldwide, who rarely live beyond 40 and possess a defective gene that leads to the build-up of thick mucus which clogs the lungs and other organs, often triggering inflammation.

The company is considering private financing, a public offering and possible financial support from the Cystic Fibrosis Foundation ahead of a late-stage study set for the second half of 2019, Chief Executive Officer Greg Duncan told Reuters.

The drug, acebilustat, reduced pulmonary exacerbations, or an acute worsening of symptoms, by 34 percent in patients with a mild form of the disease, which represent an estimated three-quarters of the total affected population, Celtaxsys said.

However, after 48 weeks, patients on the anti-inflammation treatment did not show a difference in lung function versus those on placebo.

A regulatory approval is contingent on proving the treatment’s effectiveness in either reducing pulmonary exacerbations or improving lung function and the next trial is likely to focus on the former, the Atlanta-based biotech company said.

The Cystic Fibrosis Foundation contributed $8 million to Celtaxsys’ mid-stage study, which tested two doses of the once-a-day oral medicine in 200 patients.

Currently, Vertex Pharmaceuticals Inc is considered the leader in developing treatments for cystic fibrosis and has three approved drugs on the market.

____________________

Reporting by Tamara Mathias in Bengaluru; Editing by Bernard Orr

This article was originally published by Reuters here.

VICTORIA, British Columbia– Aurinia Pharmaceuticals Inc. today announced that it will release its second quarter 2018 financial results on Thursday, August 9, 2018, after the market closes. Aurinia’s management will host a conference call to discuss the company’s second quarter 2018 financial results and provide a general business update.

The conference call and webcast is scheduled for August 9, 2018 at 4:30pm EDT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under “News/Events” through the “Investors” section of the Aurinia corporate website. A replay of the webcast will be available on Aurinia’s website.

About Aurinia

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN, FSGS and DES. The company is headquartered in Victoria, BC and focuses its development efforts globally.

Aurinia Pharmaceuticals
Investor Contact:
Celia Economides
VP, Corporate & Public Affairs
IR@auriniapharma.com
or
Media:
Christopher Hippolyte, 212-364-0458
Christopher.hippolyte@inventivhealth.com

Related Article: Aurinia Named Company of the Year by LifeSciences BC

SAN CARLOS, Calif., /PRNewswire/ — BAROnova, Inc., announced today that it has submitted a Pre-Market Approval (PMA) application for the TransPyloric Shuttle device intended for the treatment of obesity to the Food and Drug Administration (FDA).

Obesity is a worldwide epidemic with over 40% of adult Americans suffering from obesity and its attendant co-morbidities.  The investigational TransPyloric Shuttle device is a novel, non-surgical, weight-loss solution intended for patients with a BMI between 30-40 kg/m².   Based upon best-in-class pivotal trial outcomes, the company has filed a PMA submission with the FDA.

The TPS is trans-orally placed in the stomach during a standard endoscopic procedure and is intended to reside in the stomach for 12 months after which it is endoscopically removed.  The TransPyloric Shuttle’s primary mechanism of action is delaying gastric emptying which is a known mechanism of weight loss.  If approved by the FDA, the TPS will be the first and only intragastric implant with a 12-month duration of action available in the United States.

The PMA submission includes clinical data from its pivotal trial, the ENDObesity II study.  The ENDObesity II study was a randomized, double-blinded, sham-controlled study which enrolled 302 patients from 9 sites across the United States. Primary outcomes were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of subjects in the treatment group who achieved 5% TBL or more after 12 months. The trial successfully met its endpoints in a highly statistically significant fashion.  Results from the ENDObesity II Study are expected to be presented at the Obesity Week conference during November 11th-15th.

Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study said, “Obesity is on the rise in the United States and the world.  Patients and physicians are searching for effective solutions for this condition and its accompanying co-morbidities.  Based on the results I have seen with this device, I believe it will find a very meaningful role in clinical practice if approved by the FDA”.

David Thrower, Chief Executive Officer of BAROnova, added, “The PMA submission represents a major milestone for the company. We are pleased by the outcome of the ENDObesity II study and believe we have demonstrated best-in-class results for the TPS device. If approved, we will bring a new medical device option to physicians who treat patients with obesity and to patients who are motivated to lose significant weight and improve their health.”

About Obesity

The obesity epidemic has placed a major burden on healthcare systems globally.  Obesity is defined as a Body Mass Index (BMI) >30 and is strongly associated with multiple comorbidities including hypertension, hyperlipidemia, and type 2 diabetes. There are currently over 75 million adults in the United States with a BMI between 30-40 and over 600Madults worldwide who are strong candidates for a safe, efficacious, non-surgical therapy.

About the TransPyloric Shuttle

BAROnova’s novel weight-loss investigational device, the TransPyloric Shuttle, is inserted and removed trans-orally using standard endoscopic techniques. If approved, the TransPyloric shuttle will be the first intra-gastric device utilizing delayed gastric emptying as the primary mechanism of action and the first intra-gastric device with a twelve-month dwell time in the stomach in the United States.

About BAROnova, Inc. 

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

BAROnova, Inc., Contact:

David Thrower, CEO

+1-650-638-9796 x33

dthrower@baronova.com

SOURCE BAROnova, Inc.

MONTRÉAL and BOSTON, /CNW/ – enGene Inc., a biotechnology company developing novel non-viral vector gene therapies to provide oral delivery of a wide range of protein drugs, including the Gene Pill™ , today announced the appointment of Jason D. Hanson as President, Chief Executive Officer and Director.  Mr. Hanson will succeed enGene co-founder Anthony Cheung, Ph.D., who will assume the role of Chief Technology Officer at the company.

SOUTH SAN FRANCISCO, California, /PRNewswire/ — Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, has raised $15 million in Series C-1 financing led by Hillhouse Capital Management. Sirona Capital, along with existing investors Canaan Partners, Sofinnova Ventures, Brace Pharma Capital, Osage University Partners and Lumira Capital also participated in the round. In conjunction with the financing, Hillhouse will appoint a representative to Antiva’s board of directors.

Antiva is currently assessing the safety and efficacy of its lead compound, ABI-1968, in two Phase 1b clinical studies. One study involves intravaginal delivery of topical ABI-1968 to women with high grade cervical intraepithelial neoplasia (CIN 2,3). CIN is a precancerous condition caused by HPV in which abnormal cell growth occurs on the surface of the cervix. The second study is assessing the use of topical ABI-1968 in high grade anal intraepithelial neoplasia (AIN 2,3). There are currently no FDA-approved drugs for either of these indications.

“We are seeing encouraging results in our ongoing clinical trials,” said Gail Maderis, president and CEO of Antiva. “This funding will support additional clinical studies in both indications over the next year, positioning us for strong Phase 2 studies in the second half of 2019.  We welcome Hillhouse to our board and look forward to benefiting from their expertise and relationships in the Chinese pharmaceutical industry. China is a strategic market for Antiva, given the high incidence and death rate from cervical cancer in China.”

HPV is an oncogenic virus responsible for 5% of all cancers worldwide and for almost all cases of cervical cancer. Globally, over 250,000 women die of cervical cancer each year; in some countries, cervical cancer is the number one cancer in women in both incidence and death. The World Health Organization (WHO) has designated screening and treatment of precancerous lesions to prevent cervical cancer a “Best Buy” intervention, prompting many countries to implement national screening and treatment programs.  ABI-1968 has the potential to fit the WHO’s “Screen and Treat” strategy:  a self-administered product capable of treating all stages of CIN and effective against all strains of HPV.

Hillhouse’s healthcare team expressed, “We are eager to leverage our global experience to assist Antiva in developing a topical therapy that has the potential to help millions of men and women across the world.  We believe in Antiva’s mission and are excited to partner with a talented team.”

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.

About Hillhouse Capital 

Founded in 2005, Hillhouse Capital is a firm of investment professionals and operating executives who are focused on building and investing in high quality business franchises that achieve sustainable growth. Independent proprietary research and industry expertise, in conjunction with world-class operating and management capabilities, are key to its investment approach. Hillhouse Capital partners with exceptional entrepreneurs and management teams to create value, often with a focus on Asia. Hillhouse Capital invests in the healthcare, consumer, TMT, advanced manufacturing, financial and business services sectors in companies across all equity stages. Hillhouse Capital and its group members manage more than US$50 billion in assets on behalf of institutional clients such as university endowments, foundations, sovereign wealth funds, and family offices.

Contact:
Gail Maderis
Antiva Biosciences, Inc.
650-822-1401

William Nevius
Canaan Partners
202-577-7929
wnevius@canaan.com

SOURCE Antiva Biosciences

RESEARCH TRIANGLE PARK, N.C., July 09, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced appointments for two newly created executive leadership roles to support the company’s continued growth. John Demaree joins the company as Chief Commercial Officer and Stillman Hanson has been named General Counsel.

“We are excited to welcome John and Stillman to G1, and look forward to their contributions as we build out our commercial capabilities and expand our business development, legal and regulatory efforts,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “John’s experience building a world-class commercial oncology organization will be invaluable as our three clinical-stage programs move toward key clinical and regulatory milestones. Moreover, Stillman’s extensive life sciences corporate legal experience will be critical as the company continues to grow and evolve from research and development to commercialization.”

Mr. Demaree has more than 20 years of oncology experience, building commercial capabilities and leading multiple successful product launches. Prior to joining G1, Mr. Demaree served as Vice President, Oncology Marketing at Astellas Pharma, where he was responsible for establishing and leading the oncology marketing function, including the successful launch of Xtandi^® (enzalutamide). Mr. Demaree oversaw commercial strategy and execution for two approved products and three compounds in development, as well as market access and reimbursement strategy, product lifecycle management and external commercial collaborations. Previously, Mr. Demaree led oncology business development and alliance management at Abbott. He has also held marketing leadership positions at Novartis and Eli Lilly.

Mr. Hanson recently served as Associate General Counsel and Vice President at IQVIA, where he led the Quintiles legal team in the $20 billion merger of Quintiles and IMS Health to create QuintilesIMS (now IQVIA). In prior positions at Quintiles, he negotiated strategic contracts, represented Quintiles in its initial public offering and was responsible for its public company securities reporting. Before joining Quintiles in 2010, Mr. Hanson practiced corporate law, including merger and acquisitions, commercial contracting, securities reporting and corporate governance.

About G1 Therapeutics, Inc. 
G1 Therapeutics, Inc. (G1) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for the treatment of cancer. Two of the company’s pipeline assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a short-acting IV CDK4/6 inhibitor designed to preserve hematopoietic stem cell and immune system function (myelopreservation) during chemotherapy. G1T38 is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1’s ability to recruit and enroll patients in its studies; competition in the industry in which G1 operates; and market conditions. Except as required by law, G1 assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein

The Enterprisers: Life Science Leadership In Action

External Link

IN 2016, AN ESTIMATED 564,000 CANADIANS SUFFERED FROM DEMENTIA. By 2031, says the Alzheimer’s Society of Canada, that figure will rise to 937,000. In the US it is estimated that the Alzheimer’s burden will triple from 5.3 million people today to 16 million by 2050. Worldwide, nearly 44 million people have or are living with an Alzheimer’s related disease. In 2016, the cost to Canada’s health care system, and to those who live with dementia, was estimated at $10.4 billion. By 2031, that total will likely reach $16.6 billion. In 2014, the direct costs of caring for people living with the disease was estimated to total well over $210 billion in the US.

Clearly, the need to act, to improve treatment and to pursue the eventual prevention of Alzheimer’s disease, is great. Fortunately, while the need is great, so is the response. In the US alone, approximately $991 million was spent on Alzheimer’s disease and dementia-related research in 2016. The Alzheimer’s disease therapeutics and diagnostics market alone reached more $6.7 billion. Among those leading the way is KalGene Pharmaceuticals, a privately held Canadian company working in partnership with leading clinician-scientists and academic institutions. One of the key reasons KalGene believes it is on the road to success, says its president and chief scientific officer, is because the road it has chosen to take accounts for the multiple failures of the past: It must attack the true pathological target, efficiently deliver the drug to the brain and select the patient group by utilizing novel AI technology which can best benefit from the drug treatment.

“It’s true, we have taken a novel approach to slowing down the progression of Alzheimer’s disease,” says Dr. T. Nathan Yoganathan. “A major obstacle to treating neurodegenerative diseases like Alzheimer’s is delivering therapeutics past the blood-brain barrier. Using technology licensed from the National Research Council of Canada, we’re overcoming that obstacle. As a result, our development candidate is able to pass through the blood-brain barrier, rapidly inducing brain and CSF-amyloid-beta clearance. Studies to date have indicated dramatic plaque removal.”

“The treatment we developed at the NRC and licensed to Kalgene is one of the first in the field to effectively deliver Alzheimer’s medicine to the target site inside the brain, using our revolutionary blood-brain barrier carriers, says Dr. Balu Chakravarthy, Team Leader, Central Nervous System Pharmacology at the NRC’s Human Health Therapeutics Research Centre.

KalGene’s work – and its success – has not gone unnoticed. Late last year, the firm received significant financial support from a syndicated investment led by Lumira Capital. Also participating in the transaction were Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices. François Gilbert, CEO of Anges Québec and Anges Québec Capital, explained the decision to support KalGene this way: “We were impressed by the quality of the science behind KalGene and their approach to Alzheimer’s treatments. We know that important challenges lie ahead in this race to tackle Alzheimer’s disease, but we are confident that the KalGene team has what it takes to succeed.”

If Dr. Yoganathan shares that optimism – and he does – he says it’s largely because of KalGene’s ability to attract and work with key partners, including the National Research Council of Canada and McGill University, where a number of the lead clinicians and researchers are located. “The scientists there deserve a lot of credit for what we’ve accomplished,” he says. “No doubt, their contributions have helped us move forward with confidence. The Douglas Hospital is at the forefront of AD clinical research. We will be employing brain imaging and are developing an innovative AI-based approach for patient monitoring which will allow us to progress rapidly, once the therapeutic enters the clinic.”

Dr. John Gillard, KalGene VP, Product Development, is a seasoned researcher and drug developer, he expresses his enthusiasm for the project as a “remarkable example of a collaborative venture, combining the best of Canadian drug design ingenuity with world-leading clinical insight to create a molecule with a real promise, and which I am proud to move forward.” The drug product is being bio-manufactured in Canada using a process developed by the team at the National Research Council Human Health Division in Montreal.

And forward is definitely the direction KalGene is heading. Dr. Yoganathan expects the company to hold the first clinical trial of its Alzheimer’s therapeutic candidate at McGill University in 2019. The company has worked closely with the McGill Centre for Aging over the past 2 years to characterise the molecule in a battery of tests resembling the proposed clinical study. Dr. Pedro Rosa Neto is the Assoc. Director at the Centre for Aging, who will also oversee the clinical trial. He says “We have had contributions from Canada’s leading Brain Research Foundations, Weston Brain Foundation, Ontario Brain Institute (OBI), Brain Canada and CQDM so we understand the workings of this molecule so well now. We have seen success in all the studies to date and we are now actively recruiting patients with the best chance of demonstrating a clinical effect”, He says the safety studies are expected to last about three months, the initial efficacy study a little less than a year.

In the meanwhile, KalGene will continue to pursue the development path it has chosen, confident that its approach towards Alzheimer’s Disease modification is the right one. Not only are we confident that we are headed in the direction, we’re carrying out our studies with the right partners … With the commitment of talented scientists, drug developers and clinicians; and the financial support from our investors, foundations, public agencies and granting sources we’ve created a dynamic biotechnology collaborative program well suited to develop a breakthrough therapy for this terrible disease.

____________________

This article was originally published in the Spring 2018 edition of the BIOTECanada Magazine. You can find a copy of the article here: KalGene.BIOTEC

As life expectancies around the globe continue to go up, the accompanying steady rise in senior populations has given way to a newly intensified global focus on dementia in recent years. Dr. Marga­ret Chan, director-general of the World Health Organization, underscored the ur­gency of current and future needs in her 2015 address to the first WHO Ministe­rial Conference on Global Action Against Dementia, warning of the “tidal wave of dementia coming our way”. Adding, “I can think of no other disease where innovation, including breakthrough dis­coveries, is so badly needed.”

A year earlier, public research agencies in the UK had pledged more than £200 million to the cause and last November Bill Gates personally invested $50 million in the Dementia Discovery Fund express­ing on his blog, “Of all the disorders that plague us later in life, one stands out as a particularly big threat to society: Alzheimer’s.”

A big part of that threat is the associ­ated costs of caring for afflicted patients. Until we discover a way to prevent the disease, the health system costs to care for and support patients bear the brunt of the impact. In 2017, the US spent $259 billion on hospital, hospice and long-term care for dementia patients. This is ex­pected to increase to $1 trillion by 2050.

An estimated 46 million people world­wide suffer from dementia. According to the Alzheimer’s Society of Canada some 564,000 Canadians suffered from demen­tia in 2016 and by 2031 that number will nearly double to 937,000. The associated costs to the health care system for treat­ment, care and support is estimated at $10.4 billion and will grow to $16.6 billion by 2031.

Clearly the need to improve treatment and to pursue the eventual prevention of Alzheimer’s disease is immense—both from an economic and social perspective. Industry response has been to step up research efforts to accelerate the develop­ment process. In the US, National Institute of Health funding has increased in the past five years from $503 million per year to $1.391 billion per year.

While Canada’s public research agencies are working to increase current research funding levels of just under $50 million, the private sector is stepping up to bridge the gaps and support promising new tech­nologies with the potential to change the way we treat the disease.

One such company is KalGene Phar­maceuticals, a privately held company working in partnership with leading clinician-scientists and academic institu­tions. The company has taken the road-less-travelled approach to its clinical program, looking to slow down disease progression by developing a treatment that can penetrate the blood-brain bar­rier. This breakthrough puts KalGene on the road to success according to president and chief scientific officer Dr. T. Nathan Yoganathan.

“A major obstacle to treating neurode­generative diseases like Alzheimer’s is de­livering therapeutics past the blood-brain barrier,” says Dr. Yoganathan. “Using technology licensed from the National Re­search Council of Canada, we’re overcom­ing that obstacle. As a result, our develop­ment candidate is able to pass through the blood-brain barrier, rapidly inducing CSF-amyloid-beta clearance. Studies to date have indicated dramatic plaque removal.”

KalGene has worked closely with the McGill center for Ageing over the past 2 years to characterise the therapeutic molecule in a battery of test resembling the proposed clinical study. They have received contributions from Weston Brain Foundation, Ontario Brain Institute, Brain Canada and CQDM for this study.

KalGene’s preclinical success has not gone unnoticed. Late last year, the firm received significant financial support from a syndicated investment led by Lumira Capital. Also participating in the transaction were Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices.

“We know so much more now about this terrible disease than we did just a few years back,” says Jacki Jenuth, partner at Lumira Capital. “Kalgene will benefit tremendously from these new insights es­pecially as it relates to patient recruitment with their partners at McGill.”

For François Gilbert, CEO of Anges Qué­bec and Anges Québec Capital, KalGene’s novel approach was key to their decision. “We were impressed by the quality of the science behind KalGene and their approach to Alzheimer’s treatments,” he says. “We know that important challenges lie ahead in this race to tackle Alzheimer’s disease, but we are confident that the Kal­Gene team has what it takes to succeed.”

Dr. Yoganathan shares that optimism largely because of KalGene’s ability to attract and work with key partners, in­cluding the National Research Council of Canada and McGill University, where a number of the lead clinicians and re­searchers are located. “The scientists there deserve a lot of credit for what we’ve accomplished,” he says. “No doubt, their contributions have allowed us to move forward.”

Accel-Rx sees the work that KalGene is doing as exemplary of the potential of Canada’s health sciences environment to nurture and grow a vibrant sector. “When our ecosystem aligns—scientific exper­tise, industry-led strategy, private capi­tal—it provides a catalyst for companies like KalGene to drive hard to deliver on tremendous promise,” says Natalie Dak­ers, president & CEO, Accel-Rx. “When promising therapies are commercialized, ultimately it’s the patient who wins.”

“We are extremely confident with our approach—and that we are carrying out our work in the right place,” says Dr. Yoganathan. “The national ecosystem in which we conduct our research, with its government support, with the par­ticipation of talented scientists from other institutions, with the financial support of private and public foundations, is an ecosystem ideal for the breakthroughs we need to confront and eventually over­whelm this terrible disease.”

The company expects to conduct the first clinical trial of its Alzheimer’s thera­peutic candidate at McGill University in 2019. Safety studies are expected to last about three months and the efficacy studies a little less than a year.

Public-Private Partnerships Prove Promising

As researchers continue to grapple with the Alzheimer’s puzzle, countries around the world are increasingly looking towards public-private partnerships as the most effective strategy to stave off a health tsunami that will surpass cancer and heart disease as the population ages. Recalling the model to battle polio in the mid-20th century, nations are combining the funding strength of the public sector, research breakthroughs of academia and the developmental/commercial acumen of the biopharmaceutical industry to accelerate the path to treatment and care.

Anthony Boone is a writer and commu­nications professional with experience in the health sciences and clean tech sectors.

____________________

This article was originally published in the Summer 2018 edition of the Biotechnology Focus Magazine. You can find a copy of the article here: KaIGene.BIOFOCUS

LISLE, Ill., June 28, 2018 /PRNewswire/ — Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced they have joined the American Heart Association’s Center for Health Technology & Innovation’s (CHTI) Innovators Network. The collaboration allows Endotronix to integrate the Association’s digital resources into the Cordella™ Heart Failure System to support guideline-based care. The system is currently in commercial use in the U.S.

In the US, nearly 6 million people suffer from heart failure and it is the leading cause of hospitalization in people over the age of 65¹. With high mortality rates, frequent hospital readmissions and annual treatment costs over $31B in the U.S., there is a need for better proactive management and coordination of care for patients with chronic heart failure^1,2.

The collaboration between Endotronix and the Association aims to shift the heart failure care paradigm and improve at-home care management by coupling Endotronix’s Cordella System with the Association’s patient education materials and content.

Endotronix joins the Association’s Center for Health Technology & Innovation Innovators Network with a comprehensive heart failure management system, designed to streamline clinical workflow. The Cordella System allows physicians to effectively scale HF management with the Association’s comprehensive CarePlans and education materials to improve patient outcomes. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient clinical data and insights to the clinician, which enable guideline-directed medical therapy. For suitable patients, the system seamlessly integrates pulmonary artery (PA) pressure data with a proprietary wireless, an implantable sensor that is currently in late-stage clinical development. Clinical studies have demonstrated that PA pressure-guided management can reduce HF-related hospitalizations by 37% and provide a mortality benefit^3,4.

“This collaboration with the American Heart Association is essential as we strive to extend high-quality care into the home to improve the standard of care for chronic heart failure patients,” said Harry Rowland, Chief Executive Officer and co-Founder of Endotronix. “As we begin commercialization, it is exciting to see the impact this integration is having on strengthening the communication between heart failure patients and their clinicians, enhancing coordinated care that improves outcomes and ultimately allowing patients to enjoy life again.”

The Cordella System is currently in commercial use in the U.S. The targeted launch is expected to accelerate in anticipation of the U.S. Pivotal Study for the Cordella Pulmonary Artery Pressure Sensor, which is planned for the near future. Endotronix’s goal to advance the treatment of heart failure took a leap forward this January when they announced their successful First-in-Human (FIH) implantation of the Cordella PA Pressure Sensor and initiation of the SIRONA FIH clinical trial.

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

1 Mozzafarian D, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016
2 Heidenreich PA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933–44.
3 Abraham WT et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized control study. Lancet. 2011 Feb 19;377(9766):658-66.
4 Abraham WT et al. Pulmonary artery pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Abstract 902-04, ACC2015, San Diego.

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting LLC
(847) 951-7430
Carla@sprigconsulting.com

Related Article: Endotronix Receives ISO 13485:2016 Certification

RESEARCH TRIANGLE PARK, N.C., June 08, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced that Cynthia Schwalm and Willie Deese have been appointed to its board of directors, effective June 7, 2018.

“We are pleased to welcome Cynthia and Willie as new independent directors to our board. Cynthia’s expertise in commercialization and Willie’s experience in operations broadens the board’s knowledge base and will enhance our efforts to develop and commercialize novel therapeutics that may benefit people living with cancer,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

Ms. Schwalm most recently served as President and Chief Executive Officer of Ipsen North America. Prior to joining Ipsen, she held several senior commercial leadership positions at Eisai Pharmaceuticals, Amgen and Johnson & Johnson.

Mr. Deese previously served as President of the Merck Manufacturing Division and a member of the Merck Executive Committee before retiring in 2016. Prior to his roles at Merck, Mr. Deese held operational leadership roles at GlaxoSmithKline, SmithKline Beecham and Kaiser Permanente.

Ms. Schwalm and Mr. Deese will fill board seats previously held by Christy Schaffer, Ph.D. and Tyrell Rivers, Ph.D., who have stepped down from the board following the expiration of their respective terms in June of this year.

“Christy and Tyrell provided invaluable counsel as we matured from a small, venture-backed startup with promising preclinical research to a publicly traded company that is now advancing multiple clinical-stage programs,” said Dr. Velleca. “We thank them for their contributions to our growth.”

About G1 Therapeutics
G1 Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for the treatment of cancer. Two of the company’s pipeline assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a short-acting IV CDK4/6 inhibitor designed to preserve hematopoietic stem cell and immune system function (myelopreservation) during chemotherapy. G1T38 is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics’ ability to recruit and enroll patients in its studies; competition in the industry in which G1 Therapeutics operates; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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

Vancouver, Canada, Tokyo, Japan and Basking Ridge, NJ (May 14, 2018)– Zymeworks Inc. (NYSE/TSX: ZYME), aclinical-stage biopharmaceutical company developing multifunctional therapeutics, and Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced today that they entered into a new license agreement, building upon their 2016 cross-licensing and collaboration agreement.

“With a successful track record and our first bispecific antibody incorporating the Azymetric and EFECT technology having achieved a key research milestone in 2017, we look forward to adding two more bispecific compounds to our pipeline,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “We are exceptionally impressed with the robust impact that Zymeworks’ technology brings to antibody development.”

Under the terms of the second agreement, Daiichi Sankyo will acquire licenses to Zymeworks’ Azymetric™ and EFECT™ technology platforms to develop two additional bispecific antibody therapeutics. In exchange, Zymeworks will receive an upfront technology access fee of US$18 million and may receive up to US$466.7 million in potential clinical, regulatory and commercial milestone payments. In addition, Zymeworks will receive up to double-digit tiered royalties on global product sales.

“Expanding our relationship with a leading global pharmaceutical partner like Daiichi Sankyo is extremely satisfying as it underscores the power, versatility, and attractiveness of our technology platforms,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Having already used our platforms to discover one bispecific antibody, Daiichi Sankyo now has increased access to our technology to create additional therapeutic candidates. We are pleased to be working with a healthcare pioneer with a proven track record of over 100 years of innovation leading to major breakthroughs in patient care.”

Zymeworks and Daiichi Sankyo began working together in September 2016 through an agreement to develop one bispecific antibody therapeutic for which Zymeworks is eligible to receive preclinical, clinical, and commercial milestones payments, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales.

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

About the EFECT™ Platform
The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks’ second product candidate, ZW49, capitalizes on the unique design and antibody framework of ZW25 and is a bispecific antibody-drug conjugate, or ADC, armed with its proprietary ZymeLink™cytotoxic payload. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.

Cautionary Note Regarding Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to Zymeworks’ technology, potential future milestones and royalties and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “potential”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions, Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three months ended March 31, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts:

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Daiichi Sankyo
Jennifer Brennan
Daiichi Sankyo, Inc.
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)
jbrennan2@dsi.com

Topline Data Expected H2-2019

Peachtree BioResearch Solutions to Execute Multi-Center Trial

SUMMIT, N.J., May 03, 2018 (GLOBE NEWSWIRE) — Engage Therapeutics, Inc., today announced dosing of the first patient in its multi-center, double-blind, randomized Phase 2b StATES (Seizures) trial to investigate the safety and efficacy of Staccato alprazolam in subjects with epilepsy that have a predictable seizure pattern.

The StATES trial (NCT03478982) will enroll 108 patients across 40 U.S.-based clinical sites. The primary endpoint is the cessation of seizure activity. Seizure episode severity, as well as the incidence of adverse events, will also be evaluated. Topline data is expected in the second half of 2019. Staccato alprazolam, a single use, investigational epileptic seizure rescue therapy, combines the Staccato delivery technology, which is currently used in a U.S. Food and Drug Administration (FDA)-approved product, with alprazolam, an FDA-approved benzodiazepine. Together, this combination is novel for an epilepsy application in a patient population in need of innovative rescue options.

Greg Mayes, president, CEO and founder of Engage Therapeutics, said, “For individuals with epilepsy that have a predictable seizure pattern, currently available rescue treatments can only address the prevention of seizure activity once the first seizure ends, but Staccato alprazolam has the potential to be the first and only product that can abort an active seizure. We are excited by the enthusiastic response that this study has received from the epilepsy community and how quickly we have been able to advance this promising candidate to this point in development.”

Kristy Nichols, president and co-founder of Peachtree Bioresearch Solutions, a growing clinical research organization in the U.S., added, “Engage is the type of client we seek – an emerging CNS focused company with a novel therapy that addresses a significant unmet medical need. We are confident that our deep clinical trial management experience for CNS disorders and our demonstrated passion for partnership will result in a mutually successful outcome.”

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

About Peachtree
Entering its 10^th year, Peachtree BioResearch Solutions, Inc. is a Clinical Research Organization that specializes in providing clinical development services for emerging to mid-sized biotechnology, pharmaceutical, and medical device companies. With a highly-experienced clinical development team, Peachtree offers Clinical Project Management, Clinical Monitoring, Medical Monitoring, Biometrics (data management and statistical analysis), Technical Report Writing, Quality Assurance, and Clinical Staff Resourcing. Starting with one client at inception, Peachtree has grown its portfolio to over 65 clients providing services ranging from niche projects to full support. For additional information, visit www.peachtreebrs.com.

Media Contact
Greg Mayes
Engage Therapeutics
gmayes@engagetherapeutics.com

John Durkee
Vice President, Marketing & Business Development
john.durkee@peachtreebrs.com

KIRKLAND, Wash.–(BUSINESS WIRE)– Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for patients with heart failure, today announced the company has closed a $39 million Series B financing. The round includes new investor, Australia-based Hostplus, venture debt from Oxford Finance LLC, as well as support from existing investors M. H. Carnegie & Co., Arboretum Ventures, Lumira Capital, LSP Health Economics Fund and Aperture Venture Partners.

The financing will be used to continue to build clinical evidence for Cardiac Dimensions’ Carillon^® Mitral Contour System^® for the treatment of functional mitral regurgitation (FMR) in patients with heart failure, including continuing The CARILLON Trial U.S. pivotal study and completing the follow-up and publication of the landmark randomized, double-blinded REDUCE FMR global study.

The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life.

“Our clinical data and commercial experience suggest that the Carillon System offers a viable treatment option that addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. This funding will provide the resources to complete and publish the landmark REDUCE FMR trial, continue to support enrollment in The CARILLON pivotal trial here in the U.S., and enhance our presence throughout world markets,” said Gregory D. Casciaro, president and CEO of Cardiac Dimensions. “We welcome our newest investors to the team and are grateful to our returning investors for their continued support.”

Functional mitral regurgitation affects approximately seven million people in the United States, and occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The primary therapy for patients with this disease is to treat them with medical management.

“Hundreds of thousands of people around the world, and an estimated 50,000 Australians, have heart failure and FMR, and could benefit from treatment with the Carillon System,” said David Elia, chief executive officer of Hostplus. “We are excited to work with Cardiac Dimensions to expand access to the Carillon System to patients in need, not only here in Australia, but across the globe.”

About Hostplus

Hostplus is the national superannuation fund for those that live and love Australian hospitality, tourism, recreation and sport. The Australian Hotels Association and United Voice jointly established the fund in 1987. Hostplus is one of the largest in the country with over one million members, 170,000 employers and $30 billion in funds under management.

About Oxford Finance LLC

Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated over $4 billion in loans, with lines of credit ranging from $5 million to $100 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in San Diego, California; Palo Alto, California; and the greater Boston and New York City areas.

About the Carillon Mitral Contour System

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

To date, more than 850 patients worldwide have been treated with the Carillon System. The Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, the Netherlands and Italy. Clinical data from three completed international studies of the Carillon System (AMADEUS, TITAN, and TITAN II) have demonstrated the performance of the device. In addition, the company is completing the follow up period of the landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR. The results of the REDUCE FMR Trial are expected before the end of 2018. Additionally, The CARILLON Trial, the company‘s U.S. pivotal study, is currently enrolling participants.

About Cardiac Dimensions

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

The Carillon Mitral Contour System is limited to investigational use in the U.S. Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

Contacts

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

Related Article: New Data Confirms Cardiac Dimensions’ Carillon^® System Provides Acute Hemodynamic Efficacy in Patients with Functional Mitral Regurgitation

Quebec City, Quebec, April 24, 2018 – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS)(OTCQX:OPSSF) applauds Japan’s Ministry of Health, Labor and Welfare (“MHLW”) on its new regulation requiring the evaluation of any coronary stenosis prior to its treatment, specifically mentioning Fractional Flow Reserve (“FFR”) as a preferred assessment method.

The MHLW recently revised medical fees and established a requirement that functional ischemia (blockage of arteries) be evaluated before treatment for stable coronary artery disease.

This new review regulation is consistent with the results of multiple studies, such as the FAME study, which demonstrate that, when a patient’s lesion is assessed with FFR prior to treatment selection, clinical outcome is improved significantly.

The MHLW regulation is expected to have a positive impact on FFR penetration in the Japanese market, which currently represents the largest user of Opsens’ FFR products. Opsens’ revenues may be positively impacted as soon as the fourth quarter of fiscal year 2018.

About Opsens Inc. (www.opsens.com or www.opsensmedical.com)

Opsens focuses mainly on the measure of FFR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire (OptoWire) that aims at improving the clinical outcome of patients with coronary artery disease. Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

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

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

-30-

For further information, please contact:

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

Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333

LISLE, IL – APRIL 12, 2017- Endotronix, Inc., a medical technology company providing device and digital health solutions for heart failure management, today announced the appointment of seasoned life sciences executive and entrepreneur John Flavin as Chief Financial Officer. He joins the team as the company prepares to scale business operations in preparation of clinical trials and commercialization of the Cordella™ Heart Failure  (HF) System.

The Cordella System is a comprehensive HF management solution that extends care into the home by collecting and securely transmitting daily patient health data and insights to the clinician to guide treatment. The easy-to-use system is designed to create more time for patient care and strengthen the patient-clinician relationship. For patients with challenging disease management, the system includes a wireless, implantable pulmonary artery (PA) pressure sensor that enables proactive HF management.  PA pressure-guided HF management has demonstrated a mortality benefit and a reduction in HF-related hospitalizations.

The company implanted it’s first PA pressure sensor in a patient suffering from heart failure in Belgium in late 2017 and the Cordella System without the sensor has been in clinical use for over a year in the U.S.

“John has a rich background in life science technology commercialization, both from doing it directly in a hands-on operating role as well as creating an environment in which it can flourish,” said Harry Rowland, CEO and Co-founder of Endotronix. “His expertise will be a great asset as we prepare to commercialize the Cordella System later this year.”

Mr. Flavin most recently led the Polsky Center for Entrepreneurship and Innovation at the University of Chicago, where he founded the Polsky Exchange start-up incubator and helped raise over $135 million in philanthropic and corporate funding to support technology development, start-ups, and commercialization. Prior to that he held President and CFO roles at Advanced Life Sciences and MediChem Life Sciences where he oversaw corporate development and raised over $220 million in public and private capital, including two successful NASDAQ IPOs.

“I’ve spent much of my time at the University of Chicago fostering innovations that combine data science and healthcare, because I truly believe the combination will have the most direct impact on improving outcomes for complex health conditions,” Flavin said. “The Endotronix solution is an excellent example of this and I’m thrilled to be joining the team as they enter a new phase.”

Mr. Flavin is a board member at the Illinois Science and Technology Coalition, and he sits on Governor Bruce Rauner’s Illinois Innovation Council, Mayor Rahm Emanuel’s ChicagoNEXT technology council, and the City of Chicago’s Small Business Advisory Committee.

About Endotronix

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

Related Article: Endotronix Strengthens Management Team with Seasoned Medtech Executives

RESEARCH TRIANGLE PARK, N.C., March 12, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced the closing of an underwritten public offering of 3,910,000 shares of its common stock at a public offering price of $29.50, including 510,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. G1 Therapeutics received approximately $108.4 million in proceeds from the offering, net of underwriting discounts and commissions, but before estimated offering expenses.

J.P. Morgan Securities LLC and Cowen and Company, LLC served as joint book-running managers for the offering.  Needham & Company, LLC and Wedbush Securities Inc. acted as lead managers for the offering.  BTIG, LLC acted as co-manager for the offering.

A registration statement relating to the offering was filed with the Securities and Exchange Commission and was declared effective on March 7, 2018. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806.

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

About G1 Therapeutics
G1 Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer. G1’s two clinical assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of targets for anti-cancer therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as the backbone of multiple combination regimens. In addition, G1 is advancing G1T48, a potential first-/best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer. G1 is based in Research Triangle Park, NC.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics’ ability to recruit and enroll patients in its studies; competition in the industry in which G1 Therapeutics operates; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

• Statistically significant results highlight benefit of trilaciclib in several prospectively-defined parameters, including: Grade 4 neutropenia, G-CSF usage, and chemotherapy dose reductions and delays
• Clinically meaningful data favoring trilaciclib versus placebo, including: febrile neutropenia, Grade 3/4 anemia, and red blood cell transfusions
• Management to host webcast and conference call today at 8 a.m. EST

RESEARCH TRIANGLE PARK, N.C., March 05, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced positive topline data from its Phase 2a trial evaluating trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer (SCLC). Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function (myelopreservation) during chemotherapy.

“The data from this trial showed clear evidence that trilaciclib preserved bone marrow and immune system function from the damaging effects of chemotherapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “Moreover, the myelopreservation effects demonstrated by trilaciclib improved patient outcomes. Chemotherapy continues to be a cornerstone of cancer treatment, and trilaciclib has the potential to benefit many of these patients.”

Trial Design
This double-blind, placebo-controlled trial enrolled participants with a confirmed diagnosis of extensive-stage SCLC. The trial randomized 77 treatment-naïve participants in a 1:1 ratio, and 75 received trilaciclib or placebo administered intravenously prior to each dose of standard-of-care etoposide and carboplatin (EP) chemotherapy. Participants in both arms of the trial were able to receive standard supportive care as recommended by the trial investigator. Growth factors, including granulocyte colony-stimulating factor (G-CSF) and erythropoietin, and transfusion support were available to all participants. The statistical analysis plan prospectively defined several clinically-relevant hematologic endpoints.

Key Trial Findings
Data from this signal-generating Phase 2a trial demonstrated that trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Trilaciclib was well tolerated, with no Grade 3/4 trilaciclib-related treatment emergent adverse events (TEAEs) reported. Baseline demographics and disease characteristics were generally well balanced between the two arms. Key hematological results are shown in the table below.

1. etoposide and carboplatin
2. significance testing at two-sided alpha = 0.2 per prospectively defined analysis plan

The trilaciclib arm also showed favorable trends with reduced Grade 3 anemia, red blood cell transfusions, and Grade 3 thrombocytopenia versus placebo. There was no Grade 4 anemia or thrombocytopenia in either arm.

In addition to demonstrating myelopreservation benefits across multiple hematopoietic lineages, trilaciclib showed favorable trends versus placebo for overall response rate (ORR), duration of response (DOR), and progression free survival (PFS). The survival data are still immature.

• ORR by blinded independent central review (BICR): trilaciclib 66.7%, placebo 62.2% (p=0.6759)
• Median DOR (BICR): trilaciclib 5.7 months, placebo 4.3 months (p=0.1449)
• PFS (investigator, including clinical progression) median: trilaciclib 6.2 months, placebo 5.0 months (hazard ratio 0.6, p=0.06)

The company plans to share these data with U.S. and European regulatory authorities this year and discuss next steps for the development of trilaciclib. The company also plans to present results from this trial, including updated data from the Phase 1b portion, at a medical meeting later this year.

G1 is currently conducting two additional clinical trials of trilaciclib to assess myelopreservation in second- / third-line SCLC and first- / second- / third-line triple-negative breast cancer, with preliminary data from both trials expected in the fourth quarter of 2018. In addition to myelopreservation, trilaciclib’s effect on overall survival (OS) is being evaluated in a Phase 2a trial in first-line extensive stage SCLC as part of a combination regimen with Tecentriq® / carboplatin / etoposide. Enrollment of that trial was completed last month, two quarters ahead of schedule.

“The strength of this dataset provides us with a solid foundation to advance the development of trilaciclib and its ultimate commercialization,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “As shown by our non-exclusive collaboration with Genentech, there is significant interest in combining trilaciclib with checkpoint inhibitor / chemotherapy regimens. We believe that trilaciclib has the potential to become backbone therapy for multiple chemotherapeutic regimens across a variety of cancer types, delivering significant benefits to patients and creating a substantial long-term commercial opportunity.”

Webcast and Conference Call
The G1 management team will host a conference call and webcast at 8 a.m. EST today. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3098523. A live and archived webcast will be available in the Investors section of G1’s website at www.g1therapeutics.com.

About Trilaciclib (G1T28) 
Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function during chemotherapy. Trilaciclib is administered intravenously prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials: a trial in newly diagnosed, treatment-naive SCLC patients (NCT02499770), a trial in previously treated SCLC patients (NCT02514447), a trial in patients with triple-negative breast cancer (NCT02978716), and a trial in combination with Tecentriq® and chemotherapy in SCLC patients (NCT03041311).

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer. G1’s two clinical assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of targets for anti-cancer therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as the backbone of multiple combination regimens. In addition, G1 is advancing G1T48, a potential first- / best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics’ ability to recruit and enroll participants in its studies; competition in the industry in which G1 Therapeutics operates; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

• New patents build on previously granted composition of matter protection for acebilustat, with additional intellectual protection for use in cystic fibrosis, as well as new compositions for second generation anti-inflammatory molecules
• Acebilustat, the most advanced new candidate in the CF anti-inflammatory pipeline, is a first in-class, oral anti-inflammatory medicine currently being assessed in a landmark CF lung function preservation trial, top line results of which will be reported in mid-2018

ATLANTA, Feb. 01, 2018 (GLOBE NEWSWIRE) — Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, announced today the issuance of four new patents, extending its leadership position in development of a robust pipeline of inhibitors of Leukotriene A4 Hydrolase (LTA4H), the key rate limiting enzyme in production of the inflammatory mediator Leukotriene B4 (LTB4).  LTB4 is a potent mediator of neutrophil activity and when over-expressed, can lead to hyper-activation of neutrophils, resulting in sustained inflammation, tissue damage and reduced organ function, including in the lungs of CF patients.   By modulating the over-production of LTB4, acebilustat and second generation LTA4H inhibitors, have the potential to return neutrophil response to a more healthy state (homeostasis), thereby reducing immune mediated morbidity and mortality.  These new patents cover core intellectual property to 2034 before addition of extensions.

Said Andrew Luster, MD PhD, Chief of Rheumatology, Allergy & Immunology at Massachusetts General Hospital, and the Persis, Cyrus and Marlow B. Harrison Professor of Medicine at Harvard Medical School, “The field of LTA4H inhibitors is a largely untapped arena for treatment of human diseases. Emerging science in the field of LTA4H and LTB4 points to potential applications across many serious inflammatory diseases including CF, bronchiectasis, bullous dermatoses, NASH and cancer.”

One new patent (US patent 9,820,974 B2) covers use of the company’s flagship anti-inflammatory drug candidate, acebilustat, for treatment of cystic fibrosis (CF). This patent expands and extends the previously issued intellectual property portfolio surrounding acebilustat composition of matter. Acebilustat is the most advanced anti-inflammatory drug candidate in the CF pipeline. It is currently being studied in a Phase 2b trial (EMPIRE-CF) testing its ability to stem lung function decline and reduce pulmonary exacerbations over 48 weeks of treatment. The trial is fully enrolled and topline results are expected in mid-2018.

Three additional patents (US patents 9,822,106 B2; 9,856,249 B2; and 9,777,006 B2) cover new compositions of matter for second generation LTA4H inhibitors. These second generation compounds bolster the company’s LTA4H inhibitor platform covering novel compositions that provide an expanded array of properties to facilitate development of topical, inhaled and parenteral formulations as well as providing differential selectivity across functions of LTA4H. Additional patent filings are planned as Celtaxsys continues to extend its leadership position in the field of LTA4H inhibition.

“The expansion of our intellectual property platform represents important and continued progress for Celtaxsys, as well as for the 75,000 CF patients who are counting on companies like Celtaxsys to develop a safe and effective treatment for lung inflammation, which is still the leading cause of morbidity and mortality in CF,” said Greg Duncan, Celtaxsys CEO.

About acebilustat: Acebilustat is a once-daily oral drug candidate currently in Phase 2 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including Cystic Fibrosis.  More specifically, an overactive immune response driven by neutrophils results in excessive inflammation in the CF lung. This causes lung clogging and irreversible damage resulting in excessive morbidity and mortality in CF patients. Acebilustat modulates the neutrophil driven immune response bringing the inflammation to homeostasis, preventing overactive inflammation from occurring and thus could be potentially helpful in CF patients.  By contrast, pro-resolving agents theoretically tone down inflammation once it is overactive and already contributing to lung damage in patients. Furthermore, unlike immunosuppressive treatments, such as corticosteroids, acebilustat has not demonstrated any evidence of immunosuppression in preclinical studies or in clinical trials in humans, including healthy volunteers and CF patients.  Acebilustat is the most advanced therapy in development in the CF anti-inflammatory pipeline.  Results from an ongoing acebilustat Phase 2b lung preservation trial, conducted with the scientific and financial support of the CF Foundation, are expected in mid-2018.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract.  Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection of the lungs.  Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity.  Excessive production of a neutrophil byproduct, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient.  Paradoxically, excessive production of a neutrophil elastase can also lead to reduced bacterial clearance.  Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations.  Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority.  For more information about CF, visit: www.cff.org.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

Media Contact: Angela Walsh
awalsh@celtaxsys.com
470-206-0153 ext. 124

Canada’s Edesa Biotech Inc. is one step closer to making a drug to treat diseases in dermatology and gastroenterology a reality, with funding that includes an investment from Spain, secured with the help of the Canadian Trade Commissioner Service (TCS).

Bringing a new drug to market is a long, complex and expensive process. Edesa Biotech Inc., an emerging specialty pharmaceutical company in Markham, Ont., has already met with some international success as it develops a novel drug to treat diseases in dermatology and gastroenterology.

In September 2017, the company announced that it completed its first major round of financing with a syndicate that includes one of the top venture capital (VC) firms in Spain, an investment it obtained with assistance from the TCS. The $7 million “Series A” financing will allow the two-year-old start-up to carry out Phase 2b clinical trials on a molecule that it has licenced for the treatment of allergic contact dermatitis. The funding will also help support proof-of-concept studies using the product on hemorrhoids and anal fissures.

“There’s definitely an opportunity to improve patients’ quality of life,” says Dr. Par Nijhawan, a gastroenterologist who is the founder and CEO of the clinical-stage private company, noting that the key is that the treatment is non-steroidal, so that it can be tolerated better and used longer than current drugs. “This financing will now allow us to advance development on a series of novel treatments that provide the opportunity for significant positive patient impact in the relatively near future.”

The financing syndicate, led by Lumira Capital of Toronto, a VC fund that specializes in health care investments, includes participation from Inveready Technology Investment Group of Barcelona, and Montreal’s Pharmascience Inc., a Canadian pharmaceutical company as well as two Canadian family offices.

Over the last year Peter van der Velden, managing general partner of Lumira Capital, began work on putting together a syndicate to continue the process of clinical studies and commercialization for the drug.

The common element between Nijhawan and van der Velden that led to the investment by Inveready is Aurora Polo, a trade commissioner in Barcelona whose responsibilities include the life sciences and health industries in Spain. Polo assists Canadian companies and institutions with the Spanish market in terms of trade, science and technology, and identifies potential Spanish investors that could invest in Canada.

Nijhawan, with the support of a TCS program called Going Global Innovation (GGI), started focusing on potential international investors for his drug development. GGI gives Canadian innovators up to $75,000 to help formalize agreements to undertake technology commercialization with foreign organizations. The funds may be used to offset a variety of costs they face when participating in targeted meetings with foreign collaborators.

“GGI helps ease the burden of the cost of development outside of Canada. It subsidizes your travel, but it’s still up to you to get out there and show that you can execute…It is well worth it,” says Nijhawan, who used the GGI funds to attend massive global partnering conferences that attract the “who’s who” from biotech, pharma and finance. These included the BIO International Convention, held in June 2016 in San Francisco, and BIO-Europe Spring, which was held in Barcelona in March 2017.

Meanwhile, Polo brought van der Velden to Spain in the autumn of 2016 to speak about Canadian innovation, health care and VC opportunities. Lumira is one of the largest and most active health-care VC firms in Canada, and van der Velden is also former-chair of the Canadian Venture Capital and Private Equity Association.

In Spain, he encountered officials from Inveready including Sara Secall, the company’s investment director, in a series of meetings that Polo arranged. Inveready expressed an interest in potentially investing in Canadian companies and nine months later, after Lumira provided Edesa with a financing term sheet, the two companies talked about having Inveready participate in the financing. Edesa also met Inveready through Polo. When company officials attended the BIO-Europe Spring event in Barcelona and mentioned they were looking for Series A financing, Polo included Inveready among a list of possible Spanish syndicate participants. Polo’s subsequent virtual key contact introduction led to discussions directly between the two parties.

Inveready’s decision to join the Edesa financing deal “was thanks to Aurora,” Secall says. “She’s very, very active in her role here in Spain in contacting all sorts of players in the biotech sector.” She notes that Inveready’s Series A investment in Edesa is an “outlier” for the company, which more typically invests in Spanish early stage research, with a focus on the life sciences and information and communications technologies (ICT) sectors.

“But we’re open to good opportunities that will make money for our investors, and this was an opportunity that, had we found in Spain, we would have definitively invested in,” she says, stressing that Lumira’s credentials and track record made Inveready inclined to support Edesa. “We felt that we could help the company succeed further on,” she says. “It not only has the potential of high returns for our investors and for us, but there’s a large population of patients who can benefit from this product and whatever comes next. If we can alleviate people’s pain, it all adds to the satisfaction we get.”

Secall says her company, which is currently invested in about 25 companies in the biotech health-care sector, feels there is “good science coming out of Canadian institutions,” as well as critical support from government through various programs. “It doesn’t surprise us that there are good Canadian companies that are good investment opportunities for companies such as us.”

The cost of bringing pharmaceuticals to market is humungous, Secall comments, so companies naturally look to global investors. “We’re happy that the syndicate is diverse.”

Lumira’s van der Velden says Polo’s invitation to Spain was critical to the contacts and relationships that he now has there. “And being able to translate that into an investment in a Canadian company, from our perspective that’s pretty good value,” he says. “I think it’s fantastic.”

Because this was Inveready’s first Canadian investment, it helped that the firm was able to meet with Edesa and Lumira through Polo and get a really good sense of the opportunity. “If you’re coming into a country like Canada, you want to be able to touch base with some of the local players,” van der Velden says. “For Canadian companies, being known and supported broadly outside of Canada is absolutely, fundamentally important. We want to bring best-in-class investors into best-in-class Canadian companies.”

TCS involvement is reassuring for potential foreign investors like Inveready, van der Velden notes. “The fact that the Canadian government believes we are credible helps. It gives them comfort that we’re a viable partner in the marketplace.”

Having international investors brings many advantages for syndicates, van der Velden says, from diversifying risk and increasing the breadth of future rounds of capital to bringing in “more smart people who can bring different market perspectives to the table.” It also enhances access to potential partners, buyers and key opinion leaders who know about the company and its products.

“You want to have a diversified portfolio with exposure to more ideas, more innovation and more connections,” van der Velden says. “You build a set of trusted relationships with co-investors and you look to do more with them.”

He says that the best investors tend to look outside of their own markets, and having Inveready involved in a Canadian syndicate may encourage it to get involved in other investments in Canada. For example, it has a place on Edesa’s board, meaning that company officials come to Canada for meetings, “and they might see other companies they can get involved with, if they have a good experience.”

Nijhawan says he was not familiar with Inveready when his financing round started, so the introduction from Polo was particularly productive. He says trade commissioners elsewhere in the world have been invaluable, with their knowledge of local areas. “It helps to have that connection.”

Raising money in Europe is challenging, especially for outsiders, Nijhawan says, so it’s important for potential investors to know and understand a business.

He says the largest challenges in his field remain the science and the huge amount of time required for pharmaceutical research. He advises others to believe in their product, be persistent and remain positive. “A lot of people give up after hearing ‘no’,” he says. “You have to be out there to meet people. Some meetings are unproductive, some are very productive.”

The $7 million Series A financing will fund Edesa’s development of the drug for about 2.5 years, at which point Nijhawan is hoping for more offshore investment for the Phase 3 trials for contact dermatitis, which are even more expensive and complex to carry out. “It helps to get a diverse group of people backing Edesa,” he adds. “These are very exciting times for us. We’re very enthusiastic about what we’re doing.”

From Barcelona, Spain, this story is one example of how trade commissioners located in more than 160 cities around the world help Canadian companies succeed. Read more about the Humans of the Trade Commissioner Service.

ATLANTA, GA – Celtaxsys, Inc., a clinical stage drug development company focused on developing novel therapies for rare inflammatory diseases, today announced the successful completion of a Series E financing led by Invus. Additional investors in the financing include Domain Associates, Lumira Capital, Masters Capital Management, RMI Partners and the Georgia Research Alliance Venture Fund. In conjunction with the financing, Khalil Barrage, Managing Director at Invus, will join Celtaxsys’ board of directors.

Celtaxsys’ lead candidate, once-daily oral acebilustat, is currently in Phase 2 clinical testing to assess the drug’s safety and efficacy in preserving lung function in cystic fibrosis (CF) patients over the course of 48 weeks of treatment. This fully enrolled Phase 2b trial has been designed and implemented with the scientific and financial support of the Cystic Fibrosis Foundation. Top line results from this trial are expected in mid-2018. Acebilustat has been granted Orphan Drug Designation for the treatment of CF in both the United States and the European Union. The Series E proceeds will support acceleration of Phase 3 clinical and manufacturing preparatory activities.

“This financing, led by top-tier biotech investors, speaks to the investment community’s support for developing innovative anti-inflammatory medicines for CF patients. Two-week treatment with acebilustat has demonstrated reduction in sputum neutrophils, neutrophil elastase and DNA, and serum CRP in CF patients in a Phase 1b study. We believe the anti-inflammatory activity of acebilustat has the potential to preserve lung function and reduce pulmonary exacerbations in CF patients when given concomitantly with standard of care, irrespective of patient-specific CF gene mutation,” said Greg Duncan, President and CEO of Celtaxsys.

“Although new therapies that correct CFTR have markedly improved the outlook for patients with CF over the past few years, the effects of chronic inflammation in the lungs are still an important factor in the morbidity and mortality in CF patients. An effective anti-inflammatory therapy for CF patients is a significant unmet medical need,” said Professor Stuart Elborn CBE, Director of the Adult CF Center at Royal Brompton Hospital and Imperial College, London. “Acebilustat is an advanced stage development candidate in the CF anti-inflammatory pipeline and if proved to be safe and efficacious in current and future development, has the potential to be a component of foundational therapy for CF patients,” added Dr Elborn.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection of the lungs. Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity. Excessive production of a neutrophil by product, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient. Paradoxically, excessive production of a neutrophil elastase can also lead to reduced bacterial clearance. Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority. For more information about CF, visit: www.cff.org.

About acebilustat: Acebilustat is a once-daily oral drug candidate currently in Phase 2 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including Cystic Fibrosis, Non-CF Bronchiectasis, Pulmonary Hypertension, Multiple Sclerosis, Inflammatory Bowel Disease, Non-alcoholic steatohepatitis (NASH) and a variety of dermatologic diseases including Bullous Dermatoses.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

Media Contact: Angela Walsh
awalsh@celtaxsys.com
470-206-0153 ext. 124

A free app that’s all carrot, no stick — offering users loyalty points for completing quizzes and surveys about healthy living — has gotten a $1.5 million boost from the Ontario government.

The Toronto-based company behind it said “we are a nation so addicted to our phones and also incredibly addicted to our loyalty points … so why not create something much more targeted, much more efficient” and more fun than a government advertising campaign, said Andreas Souvaliotis, the CEO of Carrot Insights, in a telephone interview.

Governments typically blast out ads on television or online, “which is a bit of a blunt instrument … there’s no real ability to target populations,” he added.

The Carrot Rewards app — which already has a quarter of a million Ontarians signed up — provides information and gives users a chance to earn points by answering short surveys and builds up user profiles, and “the beauty about the app is once it knows you well, it can target you with much more specific (information),” he also said.

The points plans available include Aeroplan, Petro Points, Scene (Cineplex) and More Rewards.

None of the personal information gathered is shared, Souvaliotis said, and aggregate data will not be sold. There’s no advertising on the app.

Carrot Rewards purchases points from the plans, which it then sells to governments.

The app is already in use in British Columbia and Newfoundland/Labrador, and the federal government also jumped on board, pledging $5 million to cover the cost of the initial sign-up points and the bonus rewarded for referring friends.

The healthy messaging is provided by governments and agencies, and then behavioural scientists work to make it appealing for app users, Souvaliotis said.

Surveys and quizzes typically take less than a minute to complete.

The company makes its money on points, “and we only make money if we are making a difference, if people don’t participate … they don’t earn points and we don’t earn money,” he added.

In B.C., where Carrot Rewards has been in use for a year, “we are able to target smokers with antismoking messages instead of wasting energy targeting everybody.”

The app can also urge suburbanites to walk more, given they typically walk less than those living in urban areas.

Carrot Rewards was developed with the help of the Public Health Agency of Canada as well as health-based charities.

“This innovative digital platform is encouraging and incentivizing healthy choices, and helping to improve the overall health and well-being of people across the province,” said Minister of Tourism, Culture and Sport Eleanor McMahon in announcing the funding.

“Features such as the loyalty program, personal goal tracking and the quizzes aim to make leading a healthier life easier and show that improving your health can be fun, too.”

President Trump has named Norman “Ned” Sharpless, the director of the University of North Carolina Lineberger Comprehensive Cancer Center, to lead the National Cancer Institute.

The oncologist and geneticist will succeed Doug Lowy, who has been acting director of NCI since early 2015. Lowy is expected to remain at the institute as deputy director and a researcher.

Sharpless, 50, has done extensive work on how cells age and become malignant. He sees patients at North Carolina Cancer Hospital, which is the clinical home for UNC Lineberger.

His selection drew praise from people involved in cancer research and treatment. Derek Raghavan, president of the Levine Cancer Institute, which is part of Carolinas HealthCare System in Charlotte, called Sharpless an expert in “translational” medicine, with a deep understanding of both the research and clinical aspects of the rapidly changing cancer field.

Yet he noted that Sharpless is assuming the post “at a very tough time,” given the Trump administration’s proposed budget cut of roughly 20 percent for the National Institutes of Health. As part of that, the NCI is targeted for a $1 billion cut. The new director “has some challenges ahead of him,” Raghavan said.

Otis Brawley, chief medical and scientific officer of the American Cancer Society, said Sharpless is “very much qualified” for the position given his experience as director of a major cancer center and his strong track record as a researcher.

Sharpless, a native of Greensboro, N.C., earned his medical degree from the University of North Carolina at Chapel Hill and completed his residency at Massachusetts General Hospital and an oncology fellowship at Dana Farber/Partners Cancer Care in Boston. He returned to Chapel Hill as a faculty member at Lineberger in 2002 and became head of the cancer center in 2014. He is a member of the American Society for Clinical Investigation.

The appointment, which does not require Senate confirmation, came several days after the White House announced that Francis S. Collins will stay on as National Institutes of Health director. Collins also graduated from the UNC School of Medicine and did further training there.

RESEARCH TRIANGLE PARK, N.C., May 30, 2017 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that Phase 1b data from the ongoing Phase 1b/2a study of its lead CDK4/6 inhibitor trilaciclib as a first-line combination treatment in patients with extensive stage small-cell lung cancer (SCLC) will be presented in a poster session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 2 – 6 at McCormick Place in Chicago.

Details on the poster are as follows:

Title: Trilaciclib (G1T28): A cyclin dependent kinase 4/6 inhibitor, in combination with etoposide and carboplatin (EP) for extensive stage small cell lung cancer (ES-SCLC)—Phase 1b results

Abstract Number: 8568

Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Poster Number: 304

Date / Time: Saturday, June 3, 8 a.m. – 11:30 a.m. CDT

Location: McCormick Place, Hall A

Presenter: Caio Max S. Rocha Lima, M.D.; Spartanburg Regional Healthcare System

Additional information on the meeting can be found on the ASCO website: https://am.asco.org/.

About Trilaciclib (G1T28)

Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function during chemotherapy. Trilaciclib is administered intravenously prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials: a study in newly diagnosed, treatment-naive small-cell lung cancer (SCLC) patients (NCT02499770), a study in previously treated SCLC patients (NCT02514447), a study in combination with atezolizumab and chemotherapy in SCLC patients (NCT03041311) and a study in patients with triple-negative breast cancer (NCT02978716).

About G1 Therapeutics, Inc.

G1 Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer. G1’s two clinical assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of targets for anti-cancer therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as the backbone of multiple combination regimens. In addition, G1 has exclusively in-licensed G1T48, a potential first/best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of a particular type of breast cancer.

G1 is based in Research Triangle Park, NC. For additional information about G1, please visit www.g1therapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to trilaciclib’s potential ability to significantly improve treatment outcomes, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:

Investors:

Robert Uhl

Westwicke Partners

858-356-5932

robert.uhl@westwicke.com

Media:

Laura Bagby

6 Degrees Communications

312-448-8098

lbagby@6degreespr.com

RESEARCH TRIANGLE PARK, N.C., May 16, 2017 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc., a clinical-stage oncology company, today announced the pricing of its initial public offering of 7,000,000 shares of common stock at a public offering price of $15.00 per share for aggregate gross proceeds of $105,000,000. In addition, G1 Therapeutics has granted the underwriters a 30-day option to purchase up to 1,050,000 additional shares of its common stock at the initial public offering price. The shares are scheduled to begin trading on The NASDAQ Global Select Market on May 17, 2017 under the ticker symbol “GTHX.”

J.P. Morgan Securities LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Needham & Company, LLC and Wedbush Securities Inc. are acting as co-managers for the offering.

A registration statement relating to these securities has been filed with and was declared effective by the Securities and Exchange Commission on May 16, 2017. The offering will be made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the Securities and Exchange Commission and may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806 or by faxing (631) 254-7140. 

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

About G1 Therapeutics, Inc.

G1 Therapeutics is a clinical-stage biopharmaceutical company developing novel, small-molecule therapies that address significant unmet needs in the treatment of cancer. The company is advancing a pipeline of potential best-in-class and first-in-class drug candidates in multiple oncology indications. G1 is based in Research Triangle Park, NC.

Contacts                                                               
                 
Investors:
Robert Uhl
Westwicke Partners
858-356-5932
robert.uhl@westwicke.com

Media:
Laura Bagby                      
6 Degrees Communications
312-448-8098
lbagby@6degreespr.com

200 Patients Enrolled Exceeds Target, Top Line Results are Expected in  Mid-2018

ATLANTA, GA–(May 17, 2017) – Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare pulmonary diseases, announced today the full enrollment of its phase 2b clinical trial testing its flagship anti- inflammatory drug candidate, once-daily oral acebilustat, in adult CF patients (NCT02443688). The study is investigating the potential of acebilustat to reduce lung inflammation and preserve lung function over the course of 48 weeks in CF patients at a high risk for rapid lung function decline. Lung inflammation is still the leading cause of excessive morbidity and premature mortality associated with CF and there are no drugs approved for the treatment of CF lung inflammation. Topline results are expected in mid-2018.

In total, 200 CF patients of all CFTR genotypes across North America and Europe have been enrolled for 48 weeks of treatment comparing 50 mg and 100 mg doses of once-daily oral acebilustat against placebo. In this trial, acebilustat or placebo are being given concomitantly with standard CF care, including CFTR modulator therapies (Orkambi® or Kalydeco®). In addition to investigating the effect of acebilustat on lung function (FEV1 percent predicted, a standard efficacy readout for CF trials), this trial will also assess the effect of acebilustat on pulmonary exacerbations and patient reported outcomes.

“This acebilustat phase 2b trial has the potential to take the next crucial step in transforming the way we treat underlying pulmonary inflammation in CF patients, which is not currently adequately addressed, even by the best available care today,” said Steven Rowe, M.D., Professor of Medicine and the Director of the Cystic Fibrosis Research Center at the University of Alabama at Birmingham, the US Principal Investigator for the study.

The design of this trial enables evaluation of outcomes stratified by patient baseline FEV1 percent predicted, number of pulmonary exacerbations experienced in the year prior to enrollment, and whether the patient is taking concomitant CFTR modulators. The study will also assess inflammation biomarkers closely tied to acebilustat’s immunomodulatory mechanism of action, including sputum neutrophil elastase and serum C-reactive protein. Reductions in these inflammatory markers were observed in an earlier trial of once-daily oral acebilustat in CF patients. “If acebilustat exhibits adequate safety and beneficial effects in preserving lung function, the outcome of this trial could herald the coming of a new era for anti-inflammatory treatment of CF patients, one which could change CF patient treatment standards moving forward,” said Greg Duncan, Celtaxsys CEO. “The efforts of all the investigators, site staff, and, in particular, the patients enrolled in the study are highly appreciated.”

This trial has been made possible by financial and operational support from Cystic Fibrosis Foundation (CFF) Therapeutics, the CFF’s nonprofit drug discovery and development affiliate focused on advancing novel therapies for CF patients.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial colonization of the lungs. Chronic bacterial colonization of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response with the overabundance of neutrophils in the lungs further compromising  a patient’s breathing capacity. Somewhat paradoxically, excessive production of a neutrophil byproduct, neutrophil elastase, leads to reduced bacterial clearance. Most importantly, elastase is the key driver of irreversible damage to the lungs. Over time, this cycle of infection and inflammation leads to lung function decline and increased pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority.

About acebilustat (formerly CTX-4430): Acebilustat is a once-daily oral immunomodulatory drug candidate being tested for the  treatment of inflammatory diseases. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTA4H and LTB4 have been strongly implicated in the pathogenesis of many diseases involving inflammation, including cystic fibrosis. Acebilustat is presently being evaluated in a CF phase 2b lung function preservation trial, which is supported by the CF Foundation. This trial is assessing acebilustat’s potential to preserve CF patient breathing capacity by enhancing airway clearance and reducing the irreversible damage associated with an overactivated neutrophil driven inflammatory immune response.

About Celtaxsys: Celtaxsys, Inc. is a privately-held pharmaceutical discovery and development company focused on advancing medicine to treat patients suffering from rare, orphan designated diseases. The company is developing a sustainable pipeline of first-in-class anti- inflammatory immunomodulators, including its flagship compound, acebilustat (formerly CTX-4430). Our platform of follow-on candidates are covered separately under new intellectual property and exhibit differentiated properties that enable optimization of treatment for other inflammatory diseases. For more information, please visit: www.celtaxsys.com.

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that the first patient has been dosed in AURORA, the Company’s Phase 3 confirmatory clinical trial evaluating voclosporin for the treatment of lupus nephritis (LN), an autoimmune disease caused by lupus that involves extreme inflammation and failure of the kidneys.

“Dosing our first patient today is an important milestone for the Company,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Our Phase 3 trial design is nearly identical to that of our successful Phase 2 AURA trial which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN. We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them.”

AURORA is a 52-week global double-blind placebo controlled study, designed to demonstrate that voclosporin added to the current standard of care of mycophenolate mofetil (MMF) can increase overall renal response rates in the presence of extremely low steroids. The primary endpoint is complete renal response at 52 weeks. This trial will recruit ~320 patients and is intended to support full marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.

“Lupus nephritis is a devastating disease which if not managed, can be life-threatening. There is no approved medication to treat the condition which mostly affects women in their childbearing years,” said Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine at University of North Carolina School of Medicine and principal investigator for the study. “The AURA Phase II results showed great promise and if replicated in Phase 3, voclosporin has the potential to change the current treatment paradigm for LN.”

About AURORA

The AURORA study is a 52-week global double-blind placebo controlled Phase 3 study that will compare the efficacy of one dose of voclosporin (23.7mg BID) to placebo when added to current standard of care of mycophenolate mofetil (MMF, also known as CellCept®) in achieving renal response (formerly referred to as complete remission) in patients with active LN. Both arms will also receive low doses of corticosteroids as part of background therapy after a stringent taper. For further questions on the trial or interest in participating, please see our website (http://www.auriniapharma.com/for-patients-physicians/clinical-trials) or contact us at clinicaltrials@auriniapharma.com.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical trial data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule which results in a more predictable pharmacokinetic and pharmacodynamic relationship with potential for flat dosing. In addition, Voclosporin is more potent than and has an improved metabolic profile versus cyclosporine. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.

About Lupus Nephritis (LN)

LN, an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder that affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has a strong surrogate marker, proteinuria, which correlates with meaningful longer term clinical outcome. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Aurinia

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN. The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com

Forward Looking Statements

This press release contains forward-looking statements, including statements related to Aurinia’s ability to execute a successful Phase III program and voclosporin potentially shifting the treatment paradigm for LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of the AURA-LV clinical study set forth in this release may change based on further analyses of such data, and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2016 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170517006240/en/

Aurinia Pharmaceuticals Inc.

Investor Contact:

Celia Economides

VP, Public Affairs

ceconomides@auriniapharma.com

or

Media Contact:

Christopher Hippolyte, 212-364-0458

Christopher.hippolyte@inventivhealth.com

Source: Aurinia Pharmaceuticals Inc.

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the appointment of George M. Milne, Jr., Ph.D. to its board of directors. Prior to his retirement, Dr. Milne served as Executive Vice President of Global Research and Development and President of Worldwide Strategic and Operations Management at Pfizer. Dr. Milne serves on multiple corporate boards including Charles River Laboratories where he is the lead director and Amylyx Pharmaceuticals and is Venture Partner at Radius Ventures.

“George has made significant contributions to the pharmaceutical sector during his successful career. His experience in the board room will prove extremely valuable as we approach the next crucial stage of development as a company working to advance voclosporin to market while exploring potential additional indications for the compound,” said Richard M. Glickman, Chief Executive Officer of Aurinia.

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

“Aurinia has demonstrated its leadership in advancing a viable treatment option for patients suffering from lupus nephritis,” added George Milne. “I look forward to working alongside this exceptional team and sharing my expertise as we pursue a successful future for the company.”

Additionally, the company announced that Dr. Greg Ayers has resigned from Aurinia’s board of directors, effective immediately. “On behalf of the board of directors, I thank Greg for his service and contributions and wish him well in future endeavors,” added Dr. Glickman.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical trial data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule which results in a more predictable pharmacokinetic and pharmacodynamic relationship with potential for flat dosing. In addition, Voclosporin is more potent than and has an improved metabolic profile versus cyclosporine. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.

About Lupus Nephritis (LN)

LN, an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder that affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has a strong surrogate marker, proteinuria, which correlates with meaningful longer term clinical outcome. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Aurinia

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. Aurinia is currently developing voclosporin, an investigational drug, for the treatment of LN. Aurinia is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.

Forward Looking Statements

This press release contains forward-looking statements, including statements related to Aurinia’s plans to advance voclosporin to market and explore additional indications for the compound, Dr. Milne’s expected impact on Aurinia’s progress, the belief that voclosporin is a potentially best-in-class CNI and a viable treatment option for patients suffering from LN with potential to improve near- and long-term outcomes in LN, and the belief that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of its clinical studies may change based on further analyses, the risk that Aurinia will not successfully complete its clinical programs and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2016 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170509005688/en/

Aurinia Pharmaceuticals Inc.

Investors & Media:

Celia Economides

Head of IR & Communications

ceconomides@auriniapharma.com

Source: Aurinia Pharmaceuticals Inc.

RESEARCH TRIANGLE PARK, N.C. — G1 Therapeutics, Inc. (“G1” or the “Company”), a clinical-stage oncology company, today announced the commencement of the initial public offering of shares of its common stock pursuant to a registration statement on Form S-1 filed with the Securities and Exchange Commission (the “Commission”). The offering consists of 6,250,000 shares of common stock being offered by the Company. In addition, the Company is expected to grant the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the public offering price, less the underwriting discount. The current expected initial public offering price is between $15.00 and $17.00 per share. G1 plans to list its common stock on the NASDAQ Global Market under the ticker symbol “GTHX”.

The Company intends to use the net proceeds from the offering to fund the development of its two clinical-stage product candidates and a preclinical-stage product candidate, for drug manufacturing expenses, and for working capital and other general corporate purposes.

J.P. Morgan Securities LLC and Cowen and Company, LLC will serve as joint book-running managers for the offering. Needham & Company, LLC and Wedbush Securities Inc. will serve as co-managers.

This offering will be made only by means of a prospectus. A copy of the preliminary prospectus can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by calling (631) 274-2806 or by faxing (631) 254-7140.

The registration statement relating to these securities has been filed with the Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements with regard to G1’s proposed initial public offering. Words such as “expects”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the initial public offering discussed above will be completed on the terms described. Completion of the proposed initial public offering and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failure of customary closing conditions and the risk factors and other matters set forth in the prospectus included in the registration statement, in the form last filed with the Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

About G1 Therapeutics, Inc.

G1 Therapeutics is a clinical-stage biopharmaceutical company developing novel, small-molecule therapies that address significant unmet needs in the treatment of cancer. The company is advancing a pipeline of potential best-in-class and first-in-class drug candidates in multiple oncology indications. G1 is based in Research Triangle Park, NC.

Investors:
Robert Uhl
Westwicke Partners
858-356-5932
robert.uhl@westwicke.com

Media:
Laura Bagby
6 Degrees Communications
312-448-8098
lbagby@6degreespr.com

MONTREAL, May 1, 2017 /CNW/ – enGene Inc. announced today that Theresa Podrebarac, MD, has joined the company as Chief Medical Officer. In her new position, Dr. Podrebarac will be responsible for designing and executing clinical development plan for enGene’s pipeline of products, as well as effectively positioning these novel therapeutics in the marketplace.

“I am delighted to welcome Dr. Podrebarac to enGene. Her impressive track record in translational medicine and predictive biomarkers together with her in-depth experience in drug development, especially in the advancement of novel drugs and biologics for various immunology indications, will be invaluable to enGene as we move several of our pre-clinical product candidates towards the clinic,” said Dr. Anthony Cheung, President and CEO of enGene. “Dr. Podrebarac also brings vital strength to enGene’s senior leadership team as we transition into a clinical stage company. She will provide important clinical and strategic perspective to the team as we expand our unique oral gene therapy platform to deliver new protein drug targets.”

“enGene’s innovative approach could revolutionize how we achieve local delivery of biologics to the gastrointestinal tract,” Dr. Podrebarac said. “I am extremely excited and privileged to be working with such a dedicated team committed to developing new technology as medicines for patients and their families coping with inflammatory bowel disease.”

Dr. Podrebarac is a 15-year industry veteran with extensive pharmaceutical drug development expertise from large pharma and biotech companies. She joins enGene from AbbVie where she served as Vice President, Immunology Clinical Development. At AbbVie, she led the Immunology Therapeutic Council to develop the future vision for the company’s portfolio and introduced integrated biomarker techniques and quantitative decision tools to early clinical development. Previously, she was Vice President of Early Clinical Development and Immunology at Biogen, where she successfully led the strategy to develop several compounds in autoimmune and fibrotic diseases. She has also supported the approvals of Tysabri™ for multiple sclerosis, Rituxan™ for rheumatoid arthritis, and championed the development of tools and techniques for early clinical proof of concept in diseases including inflammatory bowel disease. Prior to Biogen, Dr. Podrebarac served as Vice President and Head of Rheumatology Global Clincal Development at EMD Serono where she led a global team of physicians and scientists within the clinical development unit and provided strategic leadership to the Autoimmunity, Inflammation and Emerging Therapies Unit.

Dr. Podrebarac is a board certified rheumatologist who earned her medical degree from the University of Western Ontario and completed post-doctoral training in T cell immunology at Harvard University and Brigham and Women’s Hospital in Boston.

About enGene

enGene Inc. is a biotechnology company developing a robust proprietary gene-therapy platform for localized delivery of immune-modulating proteins to mucosal cells lining the gut for the oral treatment of various immune disorders. enGene has developed a unique gut-optimized gene delivery formulation into an orally available “Gene Pill”, which has the potential to be a game-changing platform to provide oral delivery of a wide range of protein drugs. enGene has established global strategic alliances with two of the world’s largest pharmaceutical companies.

SOURCE enGene

For further information: Dr. Anthony Cheung, President and CEO, enGene Inc., acheung@engeneinc.com, Office: (514) 332-4888, ext. 204

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (“Zymeworks”) today announced the pricing of its initial public offering of 4,500,000 common shares at a price to the public of U.S.$13.00 per share. In addition, Zymeworks has granted the underwriters a 30-day over-allotment option to purchase up to an additional 675,000 common shares at the initial public offering price, less underwriting discounts and commissions. Zymeworks expects to use the net proceeds from the offering to further develop and advance its pipeline of product candidates and to increase its liquidity.

The New York Stock Exchange has approved, and the Toronto Stock Exchange has conditionally approved, the listing of the common shares. The common shares are expected to begin trading on the New York Stock Exchange and on the Toronto Stock Exchange on an “if, as and when issued basis” on April 28, 2017 under the ticker symbol “ZYME.” The offering is expected to close on or about May 3, 2017, subject to the satisfaction of customary closing conditions.

Citigroup Global Markets Canada Inc., Barclays Capital Inc. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. Canaccord Genuity Corp. is acting as lead manager. Cormark Securities Inc. is acting as co-manager. MTS Securities, LLC served as financial advisor to Zymeworks in the offering.

A registration statement relating to the common shares was declared effective by the U.S. Securities and Exchange Commission on April 27, 2017. A final base PREP prospectus has been filed with, and a receipt has been issued by, the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada containing important information relating to the common shares.

The offering is being made only by means of a prospectus. The prospectus contains important detailed information about the securities offered. A copy of the U.S. final prospectus, when available, related to the offering may be obtained from Citigroup Global Markets Canada Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (800) 831-9146, or by email at prospectus@citi.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (888) 603-5847, or by email at Barclaysprospectus@broadridge.com; or Wells Fargo Securities, LLC, Attn: Equity Syndicate, 375 Park Avenue, New York, NY 10152, by telephone: (800) 326-5897, or by email at cmclientsupport@wellsfargo.com. Copies of the registration statement and U.S. final prospectus may also be obtained, when available, from www.sec.gov. A copy of the supplemented PREP prospectus, when available, related to the offering may be obtained from Canaccord Genuity Corp., Attn: Equity Capital Markets, 161 Bay Street, Suite 3000, Toronto, ON M5J 2S1, or by email at Ecm@canaccordgenuity.com; or Cormark Securities Inc., 200 Bay St Suite 2800, Toronto, ON M5J 2J2, by telephone: 416-943-6414, or by email at ssmoroz@cormark.com. A copy of the supplemented PREP prospectus may also be obtained, when available, from www.sedar.com.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Zymeworks

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

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements with regard to the use of proceeds from the offering and the expected closing of the offering. Words such as “expects”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the offering discussed above will be completed on the terms described. Completion of the proposed offering and the terms thereof are subject to numerous factors, many of which are beyond Zymeworks’ control, including, without limitation, failure of customary closing conditions and the risk factors and other matters set forth in Zymeworks’ filings with the U.S. Securities and Exchange Commission and the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada. Zymeworks undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

Zymeworks Inc.

Investor Inquiries:

David Matousek, 604-678-1388

Senior Manager, Investor Relations & Corporate Communications

ir@zymeworks.com

• enGene’s proprietary PD-L1 gene therapy is being developed as potential novel therapy for acute GvHD
• Late-breaking abstract on preclinical data from PD-L1 program will be presented at Digestive Disease Week (DDW) 2017 in Chicago

MONTREAL, April 28, 2017 /CNW/ – enGene Inc., a biotechnology company developing a robust platform to deliver genes to mucosal cells lining the gut, today announced that data from preclinical studies demonstrated successful expression of programmed death-ligand 1 (PD-L1) protein in the gut showing therapeutic efficacies in mouse models of inflammatory bowel disease (IBD) and graft-versus-host disease (GvHD). This study has been selected for presentation at the DDW 2017 conference, the world’s most prestigious meeting of GI professionals, attracting 15,000 physicians, researchers and academics.

“We have shown robust therapeutic response in animal models for acute GvHD and IBD, and we will focus initially on developing our PD-L1 gene therapy as a novel treatment modality to address the significant unmet medical needs in patients suffering from acute GvHD,” said Dr. Anthony Cheung, CEO and President of enGene. “This program is wholly owned by enGene and it has now been on-boarded to our proprietary pipeline.”

PD-L1 has been shown to play a critical role in suppressing inflammatory T-cell proliferation and promoting tolerogenic immune response. Several antibody-based inhibitors of PD-L1 have been approved as treatments for malignancies. However, PD-L1 inhibition is associated with many immune-related side effects in patients, including colitis and diarrhea. Such clinical observations suggest that PD-L1 is vital in maintaining proper immune balance in the gut and has led enGene’s scientists to hypothesize that gut-localized expression of PD-L1 protein could provide a novel approach to suppress intestinal inflammation associated with IBD and GvHD.

enGene’s proprietary dually-derivitized oligomeric chitosan (DDX) platform allows for packaging of plasmid DNA into nanoparticles for in vivo delivery to gut mucosal tissues. DNA plasmids that express a version of PD-L1 protein were formulated into nanoparticles with DDX. In vivo expression of PD-L1 in the colon of mice was confirmed following enema administration of the nanoparticles. In a T-cell transfer model of IBD, localized expression of PD-L1 gene in the colon achieved by enGene delivery technology led to significant therapeutic benefits. Target engagement assessment showed a significant increase in FOXP3 expression in regulatory T cells found in IBD mice treated with nanoparticles that localized PD-L1 protein expression in the colon. In addition, striking therapeutic response was noted in an acute GvHD mouse model.

enGene’s late-breaking abstract presentation at DDW

Title: Successful Treatment of Murine Colitis and Acute GvHD by Gut-localized PD-L1 Expression

Date and time: May 7, 2017; 12:00 – 2:00 p.m. CDT

Location: MCP South Hall, McCormick Place

Presentation #: 2723327

About enGene

enGene Inc. is a biotechnology company developing a robust, proprietary non-viral vector platform to deliver genes to mucosal cells lining the gut. The vector system can be administered to the intestine via the oral or enema route. enGene has developed a unique gut-optimized gene delivery formulation into an orally available “Gene Pill”, which has the potential to be a game-changing platform to provide oral delivery of a wide range of protein drugs. Its initial focus is enabling localized delivery of immune-modulating proteins to the gut for treating various immune disorders. enGene has established global strategic alliances with two of the world’s largest pharmaceutical companies.

SOURCE enGene

For further information: Dr. Anthony Cheung, President and CEO, acheung@engeneinc.com, Office: (514) 332-4888, ext. 204

RELATED LINKS

http://www.engeneinc.com

WOODRIDGE, IL – March 22, 2017- Endotronix, Inc., a digital health medtech company providing innovative solutions for patients who suffer from advanced heart failure, today announced the expansion of their management team. Recent hires include experienced medtech executives Katrin Leadley, MD, Chief Medical Officer (CMO), Richard Powers, Chief Information Officer (CIO), and Mike Dilworth, Vice President of Manufacturing and Operations, who bring a wealth of heart failure expertise as the company prepares for upcoming clinical and commercialization milestones.

The Cordella™ Heart Failure System consists of a cloud-based patient management system and a wireless implantable pulmonary artery (PA) sensor that enables proactive management and early detection of worsening heart failure. The data-driven system promotes ongoing therapeutic interventions to improve quality of life, reduce hospital readmissions, and lower care costs for at-home patient care. The myCordella Patient Management Platform is currently in early clinical use and first-in-human use of the Cordella PA Sensor is expected in Q3 2017.

“I am delighted to welcome Katrin, Richard, and Mike to the Endotronix team,” commented Harry Rowland, CEO of Endotronix. “Their leadership and expertise will be invaluable as we advance towards our upcoming clinical milestones and commercialization of the Cordella System, which we anticipate late next year.”

Dr. Katrin Leadley, a well-published author, has over 20 years of clinical and industry experience with a proven record of providing medical and scientific leadership expertise at early stage and public companies. Prior to Endotronix, Dr. Leadley held CMO roles at HeartWare (acquired by Medtronic in 2016) and JenaValve Technology as well as senior level clinical positions at Boston Scientific and Advanced Stent Technologies. As CMO, Dr. Leadley will be leading Endotronix’s clinical and regulatory affairs.

Richard Powers joins the Endotronix team after an impressive tenure at CardioMEMS, culminating as Chief Information Officer. He created their cloud-based web systems and managed the program through transition to St. Jude Medical in the 2014 acquisition. More recently, he ran a consulting business and was Chief Technology Officer at WebOps. As CIO, Richard will be leading Endotronix’s development and implementation of the myCordella Patient Management Platform.

Mike Dilworth is a seasoned manufacturing and operations executive in the healthcare industry. Most recently, Mike was Senior VP of Manufacturing Operations at Nanosphere (acquired by Luminex Corporation in 2016). Prior to that he held VP of Manufacturing roles at Plasma Surgical, Abbott Nutrition, and Ciba Vision Corporation.

Other recent changes include: Nicolas Chronos, MD, former Endotronix Chief Medical Officer and practicing cardiologist, will become Executive Vice President of Strategy and Clinical Affairs; Michael Nagy, former Endotronix Vice President of Engineering, will become Chief Operations Officer; and following the close of Seroba Life Science’s €100M fund and investment in Endotronix, Jennifer McMahon, Associate at Seroba, will join the Board of Directors.

About Endotronix
Endotronix, Inc., a digital health medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from advanced heart failure. The company’s solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. Learn more at www.endotronix.com

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting, LLC
+1 (847) 951-7430
carla@sprigconsulting.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the closing of its previously announced underwritten public offering of 25,645,000 common shares, including 3,345,000 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares (the “Offering”). The shares were sold at a public offering price of US$6.75 per share. The gross offering proceeds to the Company from this Offering are approximately US$173.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Leerink Partners LLC and Cantor Fitzgerald & Co. (collectively, the “Underwriters”) acted as joint book-running managers for the Offering.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ. The Company intends to use the net proceeds of the Offering for research and development activities, including Phase 3 clinical trial activities for lupus nephritis, and working capital purposes.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the “SEC”) on November 5, 2015 (the “Registration Statement”), and the Company’s existing Canadian short form base shelf prospectus (the “Base Shelf Prospectus”) dated October 16, 2015. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the “Offering Documents”) have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplements are available upon request by contacting Leerink Partners LLC; Attention: Syndicate Department; One Federal Street; 37th Floor; Boston, MA, 02110, or by phone at 1-800-808-7525, ext. 6142, or by email at syndicate@leerink.com or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 5th Floor, New York, New York 10022, or by telephone at 212-829-7122, or by e-mail at prospectus@cantor.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the 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 AURINIA

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

View source version on businesswire.com: http://www.businesswire.com/news/home/20170320006146/en/

Investors:

Aurinia Pharmaceuticals Inc.

Celia Economides

Head of IR & Communications

ceconomides@auriniapharma.com

or

Media:

Christopher Hippolyte, 917-826-2664

Christopher.hippolyte@inventivhealth.com

Source: Aurinia Pharmaceuticals Inc.

TORONTO, March 9, 2017 /PRNewswire/ – Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval and the corresponding medical device license (#98667) to sell its ExactVu™ high resolution micro-ultrasound system.

“We are very pleased to received our license and regulatory approval from Health Canada allowing our ExactVu micro-ultrasound system to be commercially available in Canada,” says Randy AuCoin, Exact Imaging’s President and CEO. “We are especially excited to also announce our first Canadian sale to Dr. Gregory Czarnota and Sunnybrook Health Sciences Centre and Sunnybrook Research Institute in Toronto, ON. Dr. Czarnota’s important clinical research in apoptosis is trying to better understand the molecular mechanisms by which diseased cells die and therefore, how therapy can be most effectively applied. We are privileged to have our ExactVu platform being used in Sunnybrook’s clinical practice as well as in its innovative research efforts.”

“The unmatched resolution of the ExactVu micro-ultrasound system will provide important capabilities to our urologists in helping them actually visualize and distinguish suspicious tissue – and therefore allows us to actually target our prostate biopsies,” said Dr. Czarnota, Director of the Odette Cancer Research Program, Sunnybrook Research Institute and Radiation Oncologist at Sunnybrook Health Sciences Centre. “Furthermore, the ExactVu’s high resolution imaging also generates rich RF (or radio frequency) data which our research teams can evaluate and correlate with pathology to apply against our models to better understand apoptosis and how cancerous cells respond to therapy. We see very exciting potential in the ExactVu system and look forward to our collaboration with the team at Exact Imaging.”

Dr. Czarnota discovered that high-frequency ultrasound could be used to detect apoptosis or cell death. This finding has since been applied to important questions in oncology and organ transplantation. Dr. Czarnota’s research group is investigating a number of spectroscopic parameters for characterizing tumors and tumor responses to chemotherapy and radiation therapy at high frequencies and intends to use the ExactVu for such purposes. Specific applications include developing methods to generate color-coded ultrasound parametric maps to aid in assessing tumor responses to therapy. Since these spectroscopic signals are potentially linked to nuclear structure and chromatin structure which differs between normal and neoplastic tissue, there is potential to develop our spectroscopic methods not only into a method to track tumor responses but a potentially important diagnostic tool.

About Exact Imaging:

Exact Imaging (www.exactimaging.com) is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and being an extension of the current urological workflow. Using the Exact Imaging platform, urologists will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic biopsy protocols. The ExactVu™ micro-ultrasound system has recently been granted regulatory approval in the European Union (CE Mark), the United States (FDA 510(k) and Canada (Health Canada license).

SOURCE Exact Imaging

Related Links

www.exactimaging.com

Learn More-External Link