On this week's show…A Canadian made Ebola vaccine enters the next phase of clinical trials, a major Canadian generics company goes into restructuring mode, a young VC fund based in Vancouver makes it known it wants to be a major player on the life sciences investment scene and two Canadian biotech company's hit endpoints in their clinical trials, good news for one company and bad news for the other. We have this and more on this week's show!

Welcome to another episode of Biotechnology Focus Podcast. I'm your host Shawn Lawrence, hear to bring you a rundown of this week's top stories on the Canadian biotech scene.

Story 1

The Ebola outbreak of the last three years has winded down, but that hasn't stopped researchers in their quest to develop new vaccines to treat it. In fact, a promising Ebola vaccine originally developed by the Public Health Agency of Canada is set to begin the next phase of clinical trials later this fall. As part of this next phase, the vaccine, VSV-EBOV, will be tested on volunteers seropositive for human immunodeficiency virus (HIV) infection. The goal of this new trial is to test evidence on the vaccine's safety and effectiveness at building a protective immune response among HIV-positive people. According to Dr. Cécile Tremblay, who led the development of the protocol for this study, the reason for this approach is that it is particularly important to study the effectiveness of the vaccine in vulnerable populations, such as those living with HIV, because often these populations because of their compromised immune systems are most at-risk during outbreaks. The new study will build on existing results that demonstrate the vaccine's safety and effectiveness. This includes promising results from Phase 1 trials in Canada conducted in 2014, a Phase 2 trial on front-line health workers, and a Phase 3 ring-vaccination trial in Guinea during the Ebola outbreak. Initial results from the ring-vaccination trial in Guinea were originally published in The Lancet in July 2015, with final results expected later in fall 2016. The new study is to be managed by the Canadian Immunization Research Network (CIRN), with trial sites in Ottawa, Montreal, Senegal and Burkina Faso. Principal investigator Dr. Tremblay (Centre de Recherche du Centre Hospitalier de l'Université de Montreal) and coordinating principal investigator Dr. Joanne Langley (Dalhousie University) will co-lead the Canada-Africa collaborative research team. The first Canadian vaccinations are anticipated for November 2016, with trials beginning in Africa next year.

Story 2 Citing pressures related to pricing, regulatory and market instability, generic drugmaker Pharmascience Inc. says it is cutting 90 positions at its Montreal head office in a restructuring move.  Dr. David Goodman, CEO of the company said it was a very difficult decision to make forced on by external factors such as pricing and regulatory pressures that have recently led to increased market instability; mainly in Quebec, the rest of Canada and globally.tFounded in 1983, ,the company currently ranks as one of the largest pharmaceutical employer's in Quebec with over 1,500 employees. It makes more than 2,000 generic, over-the-counter and other prescriptions drugs, including 45 million prescriptions that are filled annually in Canada. In the interim, the company hopes these changes will allow it to retain a competitive edge and remain an industry leader. This is the first major layoff in the company's history.

Story 3 In clinical trial news, OncoGenex Pharmaceuticals has very recently released new but disappointing data from its Phase 3 ENSPIRIT trial of custirsen for advanced or metastatic non-small cell lung cancer (NSCLC). According to the company, the trial did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone.  The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178).  Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy. The trial enrolled 664 patients at approximately 50 sites globally. According to Scott Cormack, president and CEO of OncoGenex, following negative results of previous custirsen trials, an early final analysis of the ENSPIRIT trial was conducted in an effort to conserve capital and extend the company's cash runway. He adds that the company expects data on its other candidate, apatorsen, which is currently being evaluated in the Phase 2 Borealis-2 study for the treatment of bladder cancer, by the end of the month. OncoGenex is continuing to work with MTS Health Partners who has been advising the company in the exploration of strategic alternatives since mid-August.

Story 4 Our next story highlights how Artificial intelligence could prove to be a useful drug discovery tool, as the Ontario Brain Institute (OBI) and the Movement Disorders Clinic (MDC) at Toronto's University Health Network (UHN) have embarked on Canada's first ever Parkinson's disease research project, in a unique twist using the recently launched IBM Watson for Drug Discovery. IBM Watson is the first commercially available cognitive computing capability and has been lauded as a tool that will lead to a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, understands complex questions posed in natural language, and proposes evidence-based answers. Further, Watson continuously learns, gaining in value and knowledge over time, from previous interactions. Drawing from its body of nearly 31 million sources of relevant literature, IBM's cloud-based cognitive enterprise solution analyzes scientific knowledge and data using machine learning and natural language processing. MDC researchers, along with members of the Informatics and Analytics team at OBI, say they will use Watson to accelerate the drug discovery process and determine which drugs could potentially be re-purposed in the fight against Parkinson's disease. Currently, bringing a drug to market takes nearly 10 years and approximately $2.6 billion. Beyond that, 88 percent of new drugs fail in Phase 1 because of a lack of efficacy and safety. As Lauren O'Donnell, vice president, IBM Watson Health Life Sciences puts it, drug researchers today are challenged by the sheer volume and pace of emerging data. Watson for Drug Discovery can change that, by empowering researchers with cognitive tools that will help to speed drug discovery, and increase the likelihood of bringing effective therapies more rapidly to patients. Dr. Lorraine Kalia, a movement disorders neurologist and neuroscientist at the Krembil Neuroscience Centre at UHN, agrees that cognitive technology like IBM Watson has the potential to make discoveries that can directly impact the health of Canadians. She says that the platform will give her team the ability to look at connections that researchers might not have found without dedicating weeks or months of time include identifying compounds for the disease.

Story 5

You might remember that in an earlier episode we told you about a rare disease that turns human tissue to bone, and an innovative company based in Quebec called Clementia Pharmaceuticals that is working to find a cure. Well just this month, Clementia has released top-line results from its Phase 2 clinical trial investigating palovarotene, a retinoic acid receptor gamma agonist (RAR?), for the treatment of this debilitating disease fibrodysplasia ossificans progressive or (FOP). FOP is an extremely rare but serious disease in which an accumulation of heterotopic ossification (HO, extraskeletal bone) in muscle and soft tissue progressively restricts movement by locking joints leading to loss of function, physical disability, and risk of early death. Several positive trends were detected in the 40-subject placebo-controlled trial, including palovarotene-related reductions in the proportion of subjects who developed new HO, reductions in volume of new HO, reductions in patient-reported pain associated with flare-ups, and reductions in the time to resolution of FOP-related flare-ups though none reached statistical significance. Additionally, Palovarotene was well-tolerated, with all subjects completing the 12-week trial and enrolling into the open-label extension trial. The full results of the trial are expected to be published next year. In the meantime, Clementia says it will continue to gather important additional data in the Phase 2 extension trial and in the ongoing observational Natural History Study. Data from these studies will inform the design of a Phase 3 registration trial, which is expected to start in 2017.

Story 6 Fresh off its most recent hiring of Karimah Es Sabar as its new CEO, Quark Venture, a Vancouver-based venture capital firm has launched a new US$500-million ($656 million) biotechnology fund with China's GF Securities. The fund called the Global Health Sciences Venture Fund will invest globally in a diversified portfolio of biotechnology and health sciences companies. It is already being called by some the largest of its kind in Canada. Impressively,   investments have already started with the first close of US$100 million. Moreover , Quark Venture also recently announced a US$30 million investment in Vancouver-based MSI (Methylation Sciences Inc.), a clinical-stage pharmaceutical company, that is advancing a therapy for adjunctive treatment of Major Depressive Disorder. Es Sabar says she hopes to use the fund to help support world biotechnology and health sciences companies that are driving game changing innovations in drug development, medical devices, health IT and emerging convergent technologies. She adds that the decision to make Vancouver the headquarters for Quark Venture and the Global Health Sciences Venture Fund, validates Canadian innovation, while recognizing the strength of both province's and nation's life science industry, as well as the quality of its technologies.

With that we've come to the end of another program.  A big thanks to our technical director and production manager Laskey Hart and to the rest of the Biotechnology Focus research team. Be sure to check back next week to see all the latest news happening on the Canadian biotech scene. And if you like our show, you can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .We're also always looking for your feedback, story ideas and suggestions so we'd love to hear from you. Simply reach out to us on twitter: @BiotechFocus  or by email [email protected]. 

For all of us here at Biotechnology Focus, thank you for listening.