024: Genome Canada funding, DelMar Pharma joins NASDAQ, Transition gets acquired & HOT BUTTON SURVEY Extended

Biotechnology Focus Podcast

Genome Canada names its latest GAPP Recipients, DelMar Pharma lists on NASDAQ, and OPKO health acquires Toronto’s Transition Therapeutics. We have this and more on this week’s Biotechnology Focus Podcast!

Welcome to Biotechnology Focus Podcast. I’m your host Shawn Lawrence.

Story 1 We start this week’s show in the biotech business world with a longtime player on the Toronto Life Science scene being acquired. Miami based OPKO Health says it is buying clinical stage Toronto-based biotechnology company Transition Therapeutics, in an all-stock transaction valued at about $60 million. Through the acquisition of Transition, OPKO will take over the full clinical portfolio of the company including a treatment for type 2 diabetes and obesity, a treatment for low testosterone and a third neuropsychiatric drug candidate that targets patients with Alzheimer’s disease and Down syndrome. The first product, Transition’s lead metabolic drug candidate TT401, is a once- or twice-weekly oxyntomodulin for type 2 diabetes and obesity that the company calls the most advanced candidate among glucagon-like peptide 1 (GLP1)/glucagon receptor dual agonists. In a recently completed Phase 2 study of 420 patients with type 2 diabetes, subjects receiving the highest dose of TT401 peptide once weekly demonstrated significantly superior weight loss compared with currently approved extended release exenatide and placebo after 12 and 24 weeks of treatment. TT401 also provided a reduction in HbA1c, a marker of sugar metabolism, similar to exenatide at weeks 12 and 24. Transition had regained full development and commercialization rights to TT401 in April of this year after Eli Lilly and Co pulled out of an existing development partnership that had the two companies working together on what they called at the time a next generation diabetes drug. In doing, Lilly opted to not advance the compound into Phase 3. The assets is a fit for Opko as it already has a couple of development stage oxyntomodulin in its pipeline – including MOD-6031, a long lasting version, and TT401 fits nicely as a complimentary shorter term treatment. The second product included in the deal is Transition’s TT701, a once-daily oral selective androgen receptor modulator for patients with androgen deficiency. In terms of its clinical showing, In a 12-week study of 350 male subjects, TT701 showed significantly decreased fat mass and increased lean body mass and muscle strength without significantly changing prostate specific antigen levels. The third product is ELND005, a neuropsychiatric drug candidate that is an orally administered small molecule. It has completed Phase 2 clinical studies in Alzheimer’s disease and Down syndrome patients, however it failed in this trial. This is probably why many news outlets reported that only two products were being acquired in this deal. It will be interesting to see what Opko Health has in mind for its future clinical development. Both companies expect the transaction to close during the second half of 2016, subject to approval of Transition Therapeutics stockholders and other customary conditions.

Story 2

Our next business story involves DelMar Pharmaceuticals, a BC-based company developing and commercializing cancer therapies in new orphan drug indications. The company commenced trading on July 12 on the NASDAQ Capital Market under the trade symbol DMPI.In honor of the listing, the company also got to ring the Opening Bell at the NASDAQ MarketSite in Times Square, New York City, on July 14, 2016. Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals commented that listing on NASDAQ will better position the company in broadening its shareholder base, increase its appeal to institutional investors, and provide improved liquidity. The company’s lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. It has been extensively studied by the U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumour types via a novel mechanism of action that could provide improved treatment options for patients. And now for a quick break, and when we return, and when we come back we’ll talk about Health Canada’s plan to protect Canadians against the increasing risk of antimicrobial resistance.

If you could have a face-to-face conversation with government to discuss the life science industry, what would you say? Biotechnology Focus would like to give you the chance to engage with government and have your voices heard via our special “Hot Button Issues survey”. We kicked off the survey June 24, and response thus far has been terrific, so much so that we’ve decided to extend its run time through to Friday July 22. We want to hear from you on such hot topics as reimbursement of new technologies, funding challenges like access to capital, intellectual property, procurement, the state of the industry and more. This survey is open to everyone in the industry, including the business sector, academics, research institutions, service providers and more. It’s also open to individuals at all levels, from the C-level to support staff. The timing for this survey couldn’t be more right as the Federal government has just launched a call to help shape Canada’s “Innovation Agenda”, and, Canada’s Minister of Innovation, Science and Economic Development Navdeep Bains has asked us all to step up and voice our opinions, to help further shape the future of Canada’s knowledge based economy. This survey is your chance to get involved! Your answers will be featured in a special high profile issue that will be sent to Deputy Ministers, Assistant Deputy Ministers, Cabinet, Directors and Generals, working in Health Canada, Industry Canada, Agriculture & Agri-Food, Foreign Affairs & Internationals trade, the Privy Council, as well as other public sector executives in federal and most provincial departments. So, don’t miss this opportunity to participate and have your voices heard. Simply visit www.surveymonkey.com/r/biotechfocus. Remember, Friday July 22, the survey closes.

And welcome back to the Biotechnology Focus Podcast, and to get us started on the second half our show we have some exciting funding news related to a partnership between a major charitable organization and an Ontario clinical stage company.

Story 3 The funding partnership involves Sernova Corp., a company based in London Ontario that is developing disruptive regenerative medicine technologies for the long-term treatment of chronic diseases including diabetes and hemophilia. They have entered into a research funding agreement with JDRF, a leading global organization that provides funds to type 1 diabetes research and is an advocate of such research. JDRF is providing Sernova up to $2.45 million and these funds will be used to advance human clinical trials of Sernova’s CPS technologies for treatment of hypoglycemia unawareness patients with severe type 1 diabetes at a major transplantation center in the U.S. Type 1 Diabetes is a life-threatening disease in which the body’s immune system mistakenly attacks and kills the pancreatic cells that produce insulin—a hormone that is essential for life because of its role to help the body use glucose. The goal of the study is to provide patients with hypoglycemia unawareness a novel cell therapy treatment utilizing Sernova’s proprietary Cell Pouch System™, a highly vascularized, cell macro-encapsulated implantable and scalable device to reduce or eliminate the need for injections of exogenous insulin. JDRF has previously provided funding to advance the development of Sernova’s technologies through a preclinical collaboration with Massachusetts General Hospital and according to Derek Rapp, JDRF president and CEO, JDRF is excited about this collaboration as well. Initiation of the clinical trial is scheduled for the second half of 2016.

Story 4 In an effort to protect Canadians against the increasing risk of antimicrobial resistance, Health Canada is taking the first steps towards implementing a new Federal Action Plan on Anti-Microbial Resistance. Antimicrobial resistance occurs when an antimicrobial drug – an antibiotic, antifungal or antiviral drug – is no longer effective at controlling an infection it was once used to treat. This can cause an increased risk of infection, longer infection times, and a greater risk of death. The decreasing effectiveness of antimicrobial drugs is having a significant impact on our ability to protect Canadians from infectious diseases. It also has profound impacts on our healthcare system, global trade, agriculture, environment and health sectors. As part of Health Canada’s action plan, the department is seeking feedback on a regulatory proposal that it hopes will strengthen rules governing the importation, sale and use of antimicrobial drugs in livestock. This covers Surveillance – Detecting and monitoring trends and threats to inform strategies to reduce the risks and impacts of antimicrobial resistance, Stewardship – Conserving the effectiveness of existing treatments through infection prevention and control guidelines, education and awareness, regulations, and oversight, and finally Innovation – Finding new solutions to counteract loss in antimicrobial effectiveness through research and development. According Canada’s Ministry of Health the proposed changes to the Food and Drug Regulations would restrict the importation of certain veterinary drugs, require drug manufacturers to follow stricter rules, require provision of sales information to regulators to allow for improved monitoring of antimicrobial use, and introduce an easier way for manufacturers to sell low-risk veterinary health products. Consultations on the proposed regulatory changes are already underway, running for a 75 day period, ending on September 8, 2016. The proposal was published in the Canada Gazette, Part I, on July 2, 2016.

Story 5 Our final story of the week features Genome Canada announcing the recipients of Round 5 funding under its Genomic Applications Partnership Program. GAPP partners academic researchers with users in the private and public sectors to promote genomics-derived solutions to address challenges or opportunities facing users. The projects are expected to have considerable economic and social impacts in the near term, spurring innovation, commercialization and growth in Canada. Further, through a Genome Canada and Mitacs partnership, GAPP supports training the next generation of graduate students and post-doctoral fellows. Several of the projects announced in this funding round involve research internships, which will prepare Canada’s next entrepreneurs through hands-on experience. As part of the round, a total of $5.3 million in federal funding through Genome Canada will go to five projects, with an additional $11.6 million invested through partners including provinces, private and public sector organizations. The five projects in this round are: Dr. Casey Hubert, University of Calgary, who is working with the Nova Scotia Department of Energy to derisk offshore oil and gas exploration in the province using innovative genomic approaches. Dr. Christoph Borchers, University of Victoria and Dr. Gerald Batist, McGill University, who are working with the pharmaceutical company AstraZeneca to validate new technology that will help healthcare professionals match the right cancer treatment to the right patient. Dr. Charles Goulet, Université Laval, who is working with Vineland Research and Innovation Centre to use variation in aroma-related genes to develop more flavourful tomatoes. Dr. Elizabeth Edwards, University of Toronto, who is working with SiREM to use specific microbes to accelerate the rate of biodegradation and enable less expensive cleanup of contaminated industrial sites. And Dr. Xiao-Yan Wen, St. Michael’s Hospital in Toronto, who is working with Edge Therapeutics Inc. to develop drugs for preventing intracerebral hemorrhage – a form of brain hemorrhage responsible for 10 per cent of all strokes. You can find out all the details of these GAPP Round 5 projects via a backgrounder on the Genome Canada website.

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