Biotechnology Focus Podcast

Biotechnology Focus Podcast

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  • 045 | Reaction to Budget 2017 and what it means to Canadian biotech

    Show Notes:

    In the news this week, the 2017 federal budget is out and we go one-on-one with BIOTECanada's Andrew Casey to find out if it delivers on the promise of an Innovation Agenda, the NRC and the Centre for the Commercialization of Antibodies and Biologics (CCAB) colloborate on an antibody development initiative, and Bellus Health divests itself of Thallion Pharmaceuticals.

    We have all this and more coming up on Biotechnology Focus Radio.

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

    Story 1

    Our first story this week takes us to Vancouver, where Qu Biologics Inc. reports it has identified immune factors (cytokines and growth factors) in the blood of patients with Crohn's disease that may predict response to its Site Specific Immunomodulators (SSIs) therapy. According to the company, SSIs are a unique platform of immunotherapies designed to restore the body's innate immune system.

    Their discovery was made following further analysis of Qu Biologics recently completed Phase 2 Study in Crohn's disease. The company says that when combined with patients' clinical profiles, these biomarkers seemed to coorelate with identifying patients likely to respond to SSI treatment. Dr. Hal Gunn, CEO of Qu Biologics, explained these findings could  mean that patients with Crohn's disease may now be closer to having precision treatment for their condition for the first time.  In addition, Qu Biologics' Phase 2 randomized placebo-controlled Crohn's disease trial results demonstrated that specific blood immune markers associated with immune activation and mucosal healing increased with SSI treatment and SSI response/remission. The company says it plans to initiate a follow-on clinical trial in Crohn's disease later in 2017 to confirm the value of these blood immune biomarkers in predicting and monitoring response to SSI therapy.

    Story 2 The National Research Council of Canada (NRC) and Toronto-based Centre for the Commercialization of Antibodies and Biologics (CCAB) are teaming up to advance new innovative therapies discovered out of the University of Toronto. Through this innovative collaboration between government, industry, and academia,  the NRC and the (CCAB) have over the past year already put in place over $1M in collaborative agreements to produce and test therapeutic antibodies discovered at the University. CCAB is a business development and commercialization engine whose mission is to translate UofT's large portfolio of early stage biologics into high-value assets and products. To this purpose, CCAB has partnered with NRC to biomanufacture and test hundreds of antibodies. With this announcement, the collaboration continues to grow and now leverages NRC's three programs in Human Health Therapeutics: 1. Biologics and Biomanufacturing: producing biologics, testing their ability to fight solid tumours, and determining their biomanufacturability; 2.  Therapeutics Beyond Brain Barriers: determining if specific antibodies are able to cross the blood-brain barrier, target and fight brain cancer; And 3. Vaccines and Immunotherapeutics: determining if specific antibodies are able to modulate the immune system so that it finds and destroys cancer cells.  As cancer treatment evolves rapidly toward more effective molecules, including single-domain and bi-specific antibodies, antibody-drug conjugates, and immunotherapies, these types of medicines, also called biologics, are able to specifically target cancer cells and in some cases, recruit the body's immune system to help destroy them. The goal of the collaboration is to identify the most promising antibodies, and increase their value by generating data that effectively de-risks each asset. CCAB says its objective is to then licence lead antibody candidates to seed newly formed Canadian biotechnology companies.  These new Canadian start-ups will, in turn, advance these molecules toward clinical trials in patients.  With several biotechnology companies already participating and benefitting from these programs, the collaboration between CCAB and NRC is clearly set to catalyze the country's biotech sector and generate promising new cancer treatments for Canadians.

    Alexion licenses Arbutus' LNP delivery technology In business news, Alexion Pharmaceuticals has negotiated a license to use Vancouver-based Arbutus Biopharma's lipid nanoparticle (LNP) delivery technology for one of its rare disease messenger RNA (mRNA) therapeutic candidates. As part of the deal, Arbutus will earn $7.5 million upfront from Alexion and potentially another $75 million in development, regulatory, and commercial milestones, plus single-digit sales royalties. Arbutus will also carry out technology development and provide manufacturing and regulatory support for the Alexion mRNA candidate. Arbutus Biopharma itself is currently focused on developing a cure for chronic hepatitis B virus (HBV) infection. Dr. Mark J. Murray, Arbutus' President and CEO said this transaction with Alexion illustrates the value of his company's LNP platform, which he believes has broad potential to deliver mRNA and gene editing therapeutics. He adds that Arbutus is receiving significant interest from companies that require access to the LNP platform to enable their own development programs

    BELLUS Health sells Thallion Pharmaceuticals subsidiary to Taro Pharmaceuticals BELLUS Health Inc. reports it has entered into a share purchase agreement with Taro Pharmaceuticals Inc. (Taro) for the sale of its wholly-owned subsidiary Thallion Pharmaceuticals Inc. as well as the rights to the drug candidate Shigamab™. According to Bellus, the asset, Shigamab™, is a monoclonal antibody therapy being developed for the treatment of Hemolytic Uremic Syndrome caused by Shiga toxin-producing E. coli (STEC) (sHUS), a rare disease which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children. Pursuant to the sale, Taro is acquiring all issued and outstanding shares of Thallion for a potential total consideration of CA$2.7 million, consisting of an upfront payment of CA$2.3 million and a potential future payment of CA$0.4 million contingent upon the completion of a pre-established milestone event, expected to occur within 24 months of the closing of the transaction. Additionally, BELLUS Health will receive a portion of certain post-approval revenues related to the Shigamab™ program.

    Story 5 In our feature story this week, on March 21st, the federal Liberal government officially presented their second budget since coming to power.

    In our feature story this week, on March 21st, the federal Liberal government officially presented their second budget since coming to power. In the months leading up to its release, this budget was of course billed by the Feds as the Innovation Budget, and certainly at first glance there are a few initiatives where spurring innovation or forming an Innovation Agenda for Canada is its goal.  But has this Budget measured up to its promise? Has the government truly delivered with Budget 2017 an Innovation Agenda to hitch our wagons to?

    We have with us today, Andrew Casey, CEO and president of BIOTECanada, the national organization that represents health care, agricultural, food, and research groups involved in biotechnology to find out if government has hit the mark or missed it in terms of delivering on its innovation mandate.

    Hello Andrew and welcome to the show.

    1. Going into Budget 2017, there were many surveys, consultations and open dialogue between Government and industry, on what we wanted to see from this Innovation Agenda budget. Straight to point, did Budget 2017 live up to its hype?

    1. For BIOTECanada, what was on your wishlist- what were you hoping to see in the budget?
    2. What were the asks on the wish list that were answered, and which asks weren't?
    3. Let's look deeper, in our analysis of the investment summary, the biggest program of interest seems to be the $950 million "super clusters" fund, that will be an open competition in 2017 across six innovation industries, with biotech of course being one these industries. Like with most such initiatives there is of course some worry that biotech as one of the six, may not get it proverbial portion of the pie, does BIOTECanada see it this way, or do they feel that our industry can benefit from this fund?

      5. In terms of strengthening science in government, Budget 2017 proposes to establish a new chief science advisor for Canada, what should we expect to see from the creation of this new role?

    4. There was also $6 million earmarked for stem cell research, and organizations in that field like the Stem Cell Foundation and other stakeholders seemed satisfied in that commitment, but on a grander scale, does that really compare with other leading jurisdictions in the field? Are those funds enough to capitalize on Canada's strengths in this field?
    5. What we found interesting as well in Budget 2017 was the proposal of a new procurement program, called Innovative Solutions Canada, modeled on the SBIR (Small Business Innovation Research Program) in the U.S. with $50 million to go into this program. For comparison sake, in Fiscal Year 2016, the NIH's SBIR and STTR programs south of the border will invest over $870 million into health and life science companies, so how does our commitment stack up? Is it a good first step into this arena?
    6. Glancing at the investment summary, we also noticed that basic research programs, such as the Tri-Councils, were not mentioned. Why do you think that was?
    7. Finally, another industry ask is always around supporting venture capital and Budget 2017 proposes $400 million over the next three years for a new Venture Capital Catalyst Initiative. Is this separate from the $400 million Venture Capital Action Plan from year's past?
    8. Were there any other examples where existing funding and credits were maintained or even expanded upon in Budget 2017.

    Well Andrew, thank you for joining us today on our show and for your breakdown of #BUDGET2017, it's always a pleasure for us to talk with you and get your insights on key industry topics.

     

    26 min
  • 044 | NeuroCDRD, the invention of a new molecular barcode technology and a huge public offering

    In the news this week, the launch of NeuroCDRD – a new initiative to accelerate development of treatments for neuro diseases; OICR researchers invent a new molecular barcode technology; and Aurinia Phramceuticals prices a US$150.5 million public offering of common shares. We have all this and more coming up on Biotechnology Focus Radio.

    Story 1

    Our first story this week highlights Calgary, AB's Oncolytics Biotech® Inc. The company has entered into a collaborative research project  with cancer charity Myeloma UK and multi-national biotech firm, Celgene.  In the joint initiative Myeloma UK has launched MUK eleven, a first-of-its-kind immunotherapy trial that aims to modulate the immune system to target myeloma. The Phase 1b trial will study Oncolytics immuno-viral therapy and lead product REOLYSIN®, in combination with Celgene Corporation's immunomodulatory drugs (IMiDs), Imnovid® (pomalidomide) or Revlimid® (lenalidomide), as a rescue treatment in relapsing myeloma patients. MUK eleven's chief investigator Gordon Cook, Consultant Haematologist at Leeds Teaching Hospitals Trust  says this trial is about taking a new approach of activating a patient's own immune system to target their myeloma (immunotherapy) using a natural virus and lenalidomide or pomalidomide. REOLYSIN will be combined with Celgene's Imnovid® or Revlimid® in patients whose myeloma is progressing while on these IMiD treatments. The dose escalation trial will look at the safety and tolerability of these combinations, and will investigate whether the addition of REOLYSIN extends disease control in this patient group.

    This clinical study expands on earlier pre-clinical work by Professor Cook that demonstrated that REOLYSIN has dual modes of action against multiple myeloma; being both directly cytotoxic and also activating immune effector cells to target and destroy cancer cells. Further, this immune-mediated activity can be enhanced by immunomodulatory agents to eliminate disease.

    The trial will aim to recruit 44 patients across up to six Myeloma UK Clinical Trial Network centres in the UK. MUK eleven is part of the Myeloma UK Clinical Trial Network, a portfolio of early stage trials coordinated by the Clinical Trials Research Unit at the University of Leeds, focused on testing and speeding up access to promising new treatments for patients.

    Story 2

    In a unique public-private partnership, Montreal's Cyclenium Pharma Inc. and Toronto's Hospital for Sick Children (SickKids) have entered into a research agreement designed to facilitate the discovery of novel modulators for multiple new and existing biological targets of pharmacological interest across a variety of disease areas, including cardiovascular, immunology and oncology.  Cylenium is a company focused on discovery and development of novel drug candidates through the use of its proprietary macrocyclic chemistry. The collaboration will give SickKids researchers immediate access to the company's QUEST Library™ of next generation macrocyclic molecules and associated chemical hit and lead optimization capabilities. The initial objective of the partnership is to identify compounds capable of interacting with specific therapeutic targets being studied at SickKids, thereby providing tools to improve the understanding of their involvement in the pathophysiology of specific diseases, with the ultimate goal of discovering novel therapeutic or diagnostic agents.

    Cyclenium president, CSO and CEO Dr. Helmut Thomas.adds that his company's library will be made available to researchers through the SickKids Proteomics, Analytics, Robotics & Chemical Biology Centre (SPARC BioCentre). The SPARC BioCentre is a high-throughput drug screening facility at SickKids. One of the first studies to be initiated involves targets implicated for the treatment of cancer and immune disorders.

    For Cyclenium, this is the latest in an extensive series of international discovery collaborations established with prominent companies and research institutions to explore the exciting potential of its unique macrocycle chemistry technology, including Astellas Pharma, Haplogen GmbH, Fundación MEDINA, German Cancer Research Center (DKFZ), McGill University/Goodman Cancer Research Centre, Institute for Research in Immunology and Cancer (IRIC)/Université de Montréal, and Southern Research Institute.

    Story 3

    Clinical-stage drug developer Aurinia Pharmaceuticals last week announced the pricing of secondary public offering for gross proceeds of approximately $150.5 million US. As part of the offereing the company is selling 22.3 million shares at $6.75 per share. Leerink Partners LLC and Cantor Fitzgerald & Co. are acting as joint book-running managers for the Offering, that is expected to close March 20th. The cash will be very beneficial as the Victoria-based company intends to initiate a Phase 3 trial for its lead drug candidate, voclosporin, in treating lupus nephritis. The trial will commence in the second quarter. The drug successfully went through a positive 48-week data phase 2b trial in 2016 and 2017, and seems on track to becoming the first drug to demonstrate a clear benefit for the disease.

    As an aside, Aurinia's stock had hit an all-time high of $10.50 per share on March 13, the eve of the public offering announcement. By offering its shares at $6.75 the next day, new investors received a 36 percent discount. Canada's Motley Fool reported that while it may seem as if investors are getting a raw deal, it should be noted that the stock began 2017 at just $2 per share. Motley Fool further commented that there are only 53.45 million shares outstanding today, and the company ended 2016 with less than $40 million in cash. In other words, while the number of shares will be diluted by 41.7%, the company will more than quadruple its cash.

    Story 4

    In Toronto,  a team of cancer researchers have identified a protein biomarker expressed on the surface of tumour cells in high-grade serous ovarian cancer, the most common and lethal subtype of the disease.

    The findings, featured on the cover of the March 7 issue of Cell Reports, show that patients with high levels of the biomarker, CD151, have a poor prognosis, says lead author Mauricio Medrano, a molecular biologist and research associate at Princess Margaret Cancer Centre, University Health Network.

    "Ovarian cancer is many diseases," says Dr. Medrano. "By identifying CD151 and its underlying role in cancer cell survival, we hope to develop a therapy to target it. As a marker for poor prognosis, with further research, there is the potential to develop a clinical screening tool to help personalize cancer treatment for patients."

    The research was led by principal investigator Dr. Robert Rottapel, senior scientist and Professor, Departments of Medical Biophysics and Immunology, University of Toronto.

    In lab experiments, the research team used cell lines derived from 40 patient tumour samples to identify that CD151 contributes to the survival of cells of high-grade serous ovarian cancer origin. The team further analysed tissue samples from a cohort of approximately 1,000 patients to establish the correlation of high levels of CD151 to poor prognosis.

    Dr. Medrano says the study provides a lot of new information about other possible targets, not only CD151, that could be important and can provide new ideas for how to target ovarian cancer."

    The research was supported by the Ontario Institute for Cancer Research, Ovarian Cancer Canada, the Canadian Ovarian Cancer Research Consortium's biobank funded by the Terry Fox Research Institute, and The Princess Margaret Cancer Foundation.

    Story 5

    Also In Toronto, Researchers at the Ontario Institute for Cancer Research (OICR), together with international collaborators, have invented a technique to avoid a major problem with common laboratory techniques and improve the sensitivity of important cancer tests. The findings, recently published in the journal Nature Protocols, describe a process by which the sensitivity of DNA sequencing can be improved. The technology, called SiMSen-Seq, could aid in detecting the recurrence of cancers, catching possible disease relapses faster than current methods and improving patient outcomes.

    Essentially the scientists have created a DNA barcode with a hairpin structure that as Dr. Paul Krzyzanowski, Program Manager of OICR's Genome Technologies Program explains opens up to be read when heated and contracts when cooled. This allows researchers to 'hide' the barcode and analyze more patient DNA fragments in a single reaction he says.

    Cirrently, for DNA sequencing, scientists often use a technique called polymerase chain reaction (PCR) to increase the amount of DNA available from a sample. However, PCR can introduce mistakes that can limit researchers' ability to detect real mutations in the original DNA molecules. To track the original molecules in a sample, molecular tags called DNA barcodes are added. This technique is essential for sensitive detection of mutations but can lead to other errors, as components of the tags can interfere with each other and affect the final results.

    Dr. Krzyzanowski led the development of analysis pipeline software used in SiMSen-Seq which flags errors in sequencing results and corrects them computationally. Current genome sequencing technologies return results with error rates of about one per cent, meaning that for researchers to be certain that a mutation exists it has to be detected in a sample at a rate of greater than one per cent. Dr. Krzyanowski says that the SimSen-Seq technology has lowered this error rate 100-fold, meaning that the recurrence of cancers could be detected at lower levels and earlier than before, allowing patients to receive additional treatment sooner.

    His team has already patented the technique, and while it can conceivably be performed in any molecular biology lab, the group also hopes to make their expertise in using the method available to the research community. Those interested in accessing this service can do so through OICR's Collaborative Research Resources directory.

    Story 6

    In our final story, three leading players in Canada's health sciences sector are joining forces to create a novel drug development platform that will help advance new therapeutics for some of the most debilitating conditions such as amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and Parkinson's disease.

    The initiative, under the banner of 'NeuroCDRD', is jointly led by The Centre for Drug Research and Development (CDRD), the Montreal Neurological Institute and Hospital at McGill University (MNI), and Merck. Its initial focus is the creation of a high-content hiPSC (human-induced pluripotent stem cell) screening platform that will help researchers better model neurological disease.

    Development of new drugs for neurological diseases has long been hampered by the lack of predictive humanized models, and many treatments that have looked promising in animal studies have in turn failed in subsequent human clinical trials. To mitigate this challenge, this new collaboration will use the MNI's renowned hiPSC platform and bring together experts from MNI's neurological and CDRD's drug screening and assay development teams to develop a new generation of disease-specific research models using patient-derived hiPSCs. The idea is to significantly reduce research timelines and costs, making it possible to develop future hiPSC models for neurological diseases with smaller patient populations.

    As Gordon McCauley, President and CEO of CDRD explains this collaborative initiative not only combines the cutting-edge science of academia, that it will also benefit from CDRD's translational abilities, and the commercial resources of a top industry partner like Merck. "By working together, we are a catalyst for Canadian life sciences leading the world," he said.

    And that wraps up another weekly episode of the Biotechnology Focus RADIO. A special shout out to Laskey Hart who works tirelessly to produce each weeks show, and to the Biotechnology Focus research team for tracking this weeks stories.  As we're always on the lookout for your story ideas and podcast suggestions we'd love to hear from you our listeners, to let us know what's hot on the Canadian biotech scene.  Be sure reach out to us via twitter @biotechfocus, or by email at  [email protected] with your suggestions. And of course, you can also catch up on past episodes online via our podcast portal at www.biotechnologyfocus.ca .

    14 min
  • 043 | This Week in Biotech: Canadian Regenerative Medicine Alliance, and Genetic Discrimination Act Bill gets passed

    Coming up on Biotechnology Focus Radio: The launch of a new Canadian Regenerative Medicine Alliance, Canada's House of Commons passes the Genetic Discrimination Act Bill S-201, and a One-Two Punch that May Floor the Worst Infections by stopping antibiotic drug resistance.

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

    Our first story this week takes us to Toronto, where Antibe Therapeutics Inc. reports it has signed an exclusive licensing and distribution agreement with a pharmaceutical company, Laboratories Acbel SA (Acbel), for its lead product ATB-346. ATB-346 is an anti-inflammatory drug, designed to spare the gastrointestinal tract of the ulcers and bleeding normally associated with NSAIDs. The agreement covers distribution in Greece, Romania, Serbia, Bulgaria, Albania, Algeria and Jordan. Antibe will receive an upfront, non-dilutive payment of $1.1 million, and is entitled to receive a 5 per cent royalty on net sales of ATB-346 in these countries. The agreement has a 30-year term with contemplated renewals thereafter. Acbel, through its affiliates and partners, is the largest seller of naproxen in this region, which represents approximately one per cent of the global market for nonsteroidal anti-inflammatory drugs (NSAIDs). The global market for NSAIDs is in excess of US$12 billion (Evaluate Pharma). In a recent Phase 2 clinical trial, ATB-346 was found to be highly effective in reducing the pain associated with osteoarthritis of the knee. Antibe says it will now initiate two larger Phase 2 double-blind trials: a placebo-controlled dose-ranging study to determine the go-to-market dose, and an active comparator trial to demonstrate superior GI safety. Antibe also has two other therapeutic candidates in development: ATB-352 and ATB-340. ATB-352 is a non-addictive analgesic for treating severe acute pain and ATB-340 is a GI-safe derivative of aspirin. Antibe intends to leverage data across its programs to secure licensing agreements whenever possible.

    In regulatory news Canada's House of Commons has passed Bill S-201 (An Act to Prohibit and Prevent Genetic Discrimination in Canada), as it was presented, by the Standing Committee on Justice and Human Rights on Wednesday March 8, 2017. According to Bev Heim-Myers, chair of the Coalition for Genetic Fairness and CEO of the Huntington Society of Canada (HSC), while the Bill will still have to go to the Senate, all indications point to it being fully supported. Heim-Myers adds that Canada has finally caught up to other western jurisdictions in regards to protection of genetic information and Canadian legislation has caught up to science. Since the Genome Project was launched in the early 1990s, Canada had been the only G7 country that had not taken steps to prevent genetic discrimination. With this decision, this changes.

    Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs) that aim to "reboot" the body's innate immune system, has reported positive genetic analyses of their recently completed Phase 2 clinical studies in Crohn's Disease (CD) and Ulcerative Colitis (UC). These findings suggest that, for the first time in the field of inflammatory bowel disease (IBD), personalized medicine and the application of genetic testing may identify patients highly likely to respond and go into remission with treatment. The analyses identified common IBD-related genotypes with a high likelihood of response to SSI, suggesting that genetic testing may identify a large subset of CD patients (representing approximately 60% of the CD population) with a greater than 80% likelihood of responding to QBECO treatment, the large majority of which achieved remission on SSI treatment. Dr.

    Hal Gunn, CEO of Qu Biologics, stated, "We are very excited about the possibility of identifying CD and UC patients highly likely to respond to SSI treatment, which would substantially de-risk future trials and be an important advance for patients who currently face the uncertainty of knowing whether current immunosuppressive IBD treatments, which can be associated with significant side effects, will work for them or not." Dr. Shirin Kalyan, Qu's Director of Scientific Innovation, added, "Unlike current IBD treatments that suppress immune function, we believe that SSIs, which restore innate immune function, treat the underlying cause of IBD. Consequently, unlike other treatments, we were able to identify IBD-related genotypes highly responsive to SSI therapy. It is exciting that the genotypes correlated with SSI response are highly relevant to SSIs' mechanism of action." Based on the promising results of Qu Biologics' recently completed Phase 2 study in CD, a follow-on Phase 2 study in moderate to severe CD is planned to confirm these findings. Study initiation is anticipated in late 2017. If the genetic analysis results are confirmed in follow-on studies, Qu Biologics' QBECO SSI has the potential to become first-line therapy for a majority of IBD patients.

    In funding news, the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) is providing TechAlliance of Southwestern Ontario with up to $1.32 million to deliver on a new incubation program, called BURST, which will provide 30 innovative technology entrepreneurs in southwestern Ontario with mentoring and business guidance, seed funding, exposure to potential investors and access to a dedicated working space in Western University's Discovery Park. As entrepreneurs establish and grow their businesses with help from this program, it is expected that up to 45 new full-time jobs will be created. Building on London's history of innovation in health sciences, a unique partnership with the London Medical Network will also be established to help eligible medical technology companies receive funding. The announcement was made on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for FedDev Ontario.

    In Hamilton, ON, McMaster University researchers say they have found a new way to treat the world's worst infectious diseases, the superbugs that are resistant to all known antibiotics. The McMaster team published their findings in the journal Nature Microbiology last week. Eric Brown, senior author of the paper, a professor of biochemistry and biomedical science at McMaster's Michael G. DeGroote School of Medicine and a scientist of the Michael G. DeGroote Institute for infectious Disease Research says his team looked for compounds that would mess with these antibiotic resistant bacteria, focusing on Gram-negative bacteria which are resistant to all antibiotics including last resort drugs, such as colistin, and lead to pneumonia, wound or surgical site and bloodstream infections, as well as meningitis in healthcare settings.

    Brown explains that Gram-negative bacteria have an intrinsically impenetrable outer shell that is a barrier to many otherwise effective antibiotics, and this makes these infections deadly, particularly in hospital settings. His team tested a collection of 1,440 off-patent drugs in search of one that might compromise that barrier in the superbugs.

    "These pathogens are really hard nuts to crack, but we found a molecule that shreds that shell and allows antibiotics to enter and be effective," Brown said.

    The scientists discovered the antiprotozoal drug pentamidine disrupts the cell surface of Gram-negative bacteria, even the most resistant. The anti-fungal medication was particularly potent when used with antibiotics against multidrug resistant bacteria.

    Moreover, Pentamidine, when used with other antibiotics, was found to be particularly effective against two of the three pathogens which the WHO has identified as having the most critical priority for development of new antibiotics. Those were Acinetobacter baumannii and the enterobacteriaceae. The combo therapy also had some impact on the third most critical bacteria, Pseudomonas aeruginosa according to Brown.

    Brown continued saying These discoveries were found to be effective in the lab and in mice, but more work is needed to offset potential side effects and ensure human safety. Brown adds that his lab is continuing to test more compounds as well.

    "One of the things we want to pursue further is why this is working so well," he said.

    The study was supported by grants from the Canadian Institutes of Health Research, the National Sciences and Engineering Research Council and Cystic Fibrosis Canada, among others.

    http://bit.ly/2m3hZq2

     

    In our final story , a group of Canadian Stem Cell & Regenerative Medicine Leaders have announced that they are Joining Forces to Advance Canada's Position in the Field, with the launch late last week of a new national group called the Regenerative Medicine Alliance of Canada. The founding members include: CCRM; The Centre for Drug Research and Development (CDRD); CellCan; Medicine by Design; Ontario Institute for Regenerative Medicine; ThéCell; Canadian Stem Cell Foundation, and Stem Cell Network. The goal of this new Regenerative Medicine Alliance of Canada or (RMAC) will be to advance Canada's stem cell science and regenerative medicine sector by aligning national activity in the field. Its members say they plan to work collaboratively to share information and identify strategies that will benefit the growth of Canada's regenerative medice expertise. The initial concept for this alliance was conceived by members of the regenerative medicine community during a workshop on the state of regenerative medicine in Canada. The workshop was held by the Council of Canadian Academies in 2016. Their newly released report notes the importance of strategic coordination amongst the stem cell and regenerative medicine community. Bolstering and aligning programs, training, policy and communication will also be central themes addressed by RMAC. According to the Alliance, With the global market for regenerative medicine iexpected to exceed US$49 billion by 2021, the need to keep Canada well positioned to compete by moving its innovative treatments and therapies out of the lab and into the clinic has never been greater. Countries around the world, including the U.S., Japan and the U.K., have already taken bold steps through investment and regulatory modernization to capture a significant piece of the market. RMAC will serve as a mechanism to support strategic activity across the regenerative medicine sector in Canada. The RMAC will act voluntary organization comprised of national, provincial and regional organizations. All members have mandates relevant to stem cell research and/or regenerative medicine.

    Well that wraps up another episode of the Biotechnology Focus Podcast. We hope you enjoyed it. Be sure to let us know what you think, and we're also always looking for story ideas and suggestions for

    future shows, and of course we'd love to hear from you as well, simply reach out to us via twitter @biotechfocus, or by email at the following email address [email protected]. And

    11 min
  • 042 | Bellus Health back in the game, BC Cancer Agency makes two breakthrough discoveries, and RepliCel Life Sciences gets a little help from its friends.

    Ahead on Biotechnology Focus Radio : Bellus Health back in the game with a new therapeutic asset, BC Cancer Agency scientists make two breakthrough discoveries, and RepliCel Life Sciences gets by with a little help from its friends.

    We have this and more in store for you on this week's show.

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

     

    Our first story this week takes us to CALGARY, AB where a team of Canadian physicians and researchers are believed to be the first in the world to have used gene therapy to treat a patient with Fabry disease, a rare inherited enzyme deficiency that can damage major organs and shorten lifespan. Specifically, people with the disease have a gene called GLA that doesn't function as it should; as a result their bodies are unable to make the correct version of a particular enzyme that breaks down a fat called Gb3. A buildup of Gb3 can lead to problems in the kidneys, heart and brain. In their experimental trial, the researchers led by Dr. Aneal Khan, a Alberta Health Services medical geneticist and member of the Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary collected a quantity of a Fabry patient's own blood stem cells then used a specially engineered virus to augment those cells with copies of the fully functional gene that is responsible for the enzyme. The altered stem cells were then transplanted back into the patient on Jan. 11, 2017. While Dr. Khan says it's too soon to say whether this therapy will ultimately be a long-term treatment for the disease, based on the team's success in animal trials, he is hopeful it will be a beneficial to patients Dr. Jeffrey Medin, a researcher with the Medical College of Wisconsin and the project's principal investigator, adds that the trial is a major step forward in treating inherited genetic diseases in adults. The treatment, which has been approved by Health Canada for experimental purposes, is also believed to be the first trial in Canada to use a lentivirus in gene therapy. In this case, the specially modified virus was stripped of its disease-causing capability and augmented with a working copy of the gene that's responsible for the missing enzyme. The project is being funded by the Canadian Institutes of Health Research and the Kidney Foundation of Canada. The Queen Elizabeth II Health Sciences Centre in Halifax and the University Health Network in Toronto are also recruiting people with Fabry disease for the trial.

    In R&D news, a team of BC Cancer Agency scientists has made two exciting drug discoveries that could potentially allow for new approaches to target various cancers more specifically, through the exploitation of mutations found only in cancer cells and not normal cells. The first discovery, which has already led to a clinical trial, exploits the inability of BRCA1/2 deficient cancers to repair their own DNA. The second discovery is of a drug-like molecule that can alter the way cells translate genetic information into proteins. Both discoveries were made by Dr. Sam Aparicio, head of the Department of Breast and Molecular Oncology, and his research team at the BC Cancer Agency.The first success in this area is a discovery published in Nature Communications, where Dr. Aparicio's team has discovered that the drug, CX-5461, originally developed for cancers of the blood and lymph system, can be repurposed as a drug treatment for breast cancer. Still early in its clinical development life cycle, CX-5461 has been shown through Dr. Aparicio's latest work, to bind to the DNA of certain regions of the genome causing it to fold up and interrupt the DNA copying process. Thus, the compound is selectively active in tumours from patients with mutations in the BRCA1/2 gene, known to cause a strong familial predisposition to breast cancer, and account for approximately 15 per cent of the population with the disease. The study is currently in Phase 1 of a multi-centre clinical trial coordinated by Canadian Cancer Trials Group, which began in June of 2016. Phase two will accept even more patients to determine whether the activity found through preclinical studies is reflected in responses in patients. Both Dr. Aparicio and Dr. Karen Gelmon, senior scientist, medical oncologist and the clinical trial lead for the study add that if the trial is successful, they then hope to expand testing to other types of cancer in the near future. In addition to the CX-5461 findings, a second paper published in Nature Communications communicates the discovery of a different prototype drug, a compound called 'T3', engineered to alter the way that cells translate DNA, through splicing of RNA, into proteins. According to the researchers, this small, yet highly-potent drug-like molecule, currently in lab-testing, is being used to understand how different breast cancer cells might be susceptible to having RNA splicing interrupted. The drug molecule interferes with the molecular machinery that stiches gene sequences together to make fully functional proteins. Mutations in RNA splicing genes and defects in splicing have been found in diverse cancers, including breast cancer. The prototype drug molecules are allowing Dr. Aparicio and his team to seek out situations where cancer cells are uniquely susceptible to interference with RNA splicing. As alluded to, both drug development studies are currently centered in breast cancer treatment, but hope to expand to other types, including prostate and ovarian. Dr. Aparicio and his team's work was supported with strategic funding from the BC Cancer Foundation.

    In Business new, two European firms are teaming up with Vancouver based regenerative medicine company, RepliCel Life Sciences Inc.to assist RepliCel in getting its commercial-grade RCI-02 dermal injector prototypes manufactured and tested. One of the partnering firms, AMI, is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of Germany and Switzerland. AMI develops, manufactures and distributes their medical products throughout the world. All of them are made according to the highest quality standards and enable doctors to take even better care of their patients. The second partner, Art of Technology (AoT), is based in Zurich Switzerland and is an independent contract developer specializing in the design, development and miniaturization of complex customer specific electronic devices and embedded systems for use in industrial, medical and space applications. The RCI-02 injector itself was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes. According to RepliCel president and CEO, Lee Buckler, it is the world's first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection anaesthetising, and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances including cells, dermal fillers, drugs or biologics intradermally (dermis), subcutaneously (fat) or intramuscularly (muscle) via an array of needle configurations ranging from a single needle to a 16 needle configuration (4×4) on one head. Buckler adds that the execution of these agreements covers what RepliCel believes to be the final stages needed to prepare RCI-02 for a market authorization application in the form of a CE mark in Europe. The company hopes to have the device ready for a CE mark application and in the hands of a licensing and commercial partner next year.

    Our next story takes us to the Maritime provinces where the Terry Fox Research Institute is investing $5-million in support of New Brunswick researchers and their colleagues at other cancer centres in Canada to study how new precision medicine tools could improve, and potentially save the lives of patients diagnosed with the incurable cancer of the blood and bone marrow, known as multiple myeloma. The initiative is known as the Multiple Myeloma Molecular Monitoring (M4) Study, and Dr. Tony Reiman, a medical oncologist and professor at the University of New Brunswick, will lead the team, which comprises researchers and clinicians at multiple sites including Vancouver, Calgary, Toronto and Montreal. Dr. Reiman says that he hopes the five-year study will result in game-changing new approaches to identifying, treating and monitoring the disease in patients, including those who are at high risk of relapse. His team in Saint John will organize all the participating centres as well as conduct its own research and receive and bank specimens (blood and marrow) from the 250 myeloma patients that will participate in the project. Additionally, M4 study team members will use tests based on advanced techniques like immunoglobulin gene sequencing, multiparameter flow cytometry, PET scans, circulating tumour DNA analysis, and novel drug resistance assays to evaluate the patient specimens and other biosamples. Principal investigators at the partner sites are: Drs. Donna Reece and Suzanne Trudel, Princess Margaret Cancer Centre; Dr. Nizar Bahlis, University of Calgary; and Dr. François Bénard, BC Cancer Agency. Patients will be recruited by the study investigators at their own sites. Principal investigators Drs. Reece and Trudel (PM) explain their role in M4 study in the following audio.

    BrainStorm Cell Therapeutics Inc., a HACKENSACK, N.J.- based company developing adult stem cell technologies for neurodegenerative diseases, has signed an agreement with CCRM in the hopes of furthering its market authorization request for NurOwn®.  For our new listeners, CCRM is a Toronto-based company focused on developing and commercializing regenerative medicine technologies, specifically cell and gene therapies. Through the agreement, CCRM will help Brainstorm explore opportunities to access Health Canada's early access pathway for treatment of patients with Amyotrophic Lateral Sclerosis (ALS).  If NurOwn® qualifies for Health Canada's "Notice of Compliance with Conditions" pathway, it could be authorized in Canada for distribution in early 2018. Through the agreement, the company will work Patrick Bedford, manager of clinical translation and regulatory affairs at CCRM. Stacey Johnson (@msstaceyerin) , director, communications and marketing at CCRM and editor of Signals Blog discussed this deal recently via her regular Right Turn column Be sure to check it out at http://www.signalsblog.ca/right-turn-new-stem-cell-product-for-als-seeking-approval-in-canada/.

    For our final story, nearly a year since it's failed KIACTA™ Phase 3 trial and subsequently being forced into pulling the plug on its KIACTA program, BELLUS Health is back from the brink as the Montreal-based company announced a new partnership and licensing deal with The NEOMED Institute to take over the development and commercialization activities for a potential new treatment for chronic cough. According to Bellus stakeholders,, this is a transformative transaction as this exclusive worldwide license agreement adds to the company's pipeline a potentially best-in-class drug candidate, BLU-5937, an asset which was formerly known as NEO5937.  Its development through  the P2X3 antagonist program was initiated by AstraZeneca scientists in Montreal, and assigned to NEOMED in October 2012 when the NEOMED Institute was first launched. It was selected as a drug candidate to advance towards the clinic based on development efforts and extensive pre-clinical work in chronic cough done at NEOMED. According to Roberto Bellini, president and CEO of the company, the drug now going by its new name BLU-5937  will be a core focus of BELLUS's drug development efforts. About the condition, Chronic cough is a cough that lasts eight weeks or longer and significantly impacts quality of life, with significant social (exclusion, embarrassment, difficulty speaking), physical (sleep deprivation, rib fracture, vomiting) and psychosocial (anxiety, depression) repercussions. It is estimated that in the U.S. alone, more than 2.7 million patients suffer from chronic cough that is not controlled by currently available medications. How BLU-5937 works to treat it, is it acts on a clinically validated target in the chronic cough pathway, the P2X3 receptor. Both the company and NEOMED believe BLU-5937 has the potential to become a best-in-class treatment option because of its superior potency and selectivity for the P2X3 receptor. These properties suggest BLU-5937 will be effective and less likely to cause a problematic side effect seen with less-selective drugs: taste disturbances that are significant enough to affect drug compliance. Under the terms of the agreement, BELLUS Health will pay NEOMED an upfront fee of $3.2 million, consisting of $1.7 million in cash with $1.5 million worth of BELLUS Health common shares (Approximately 5,802,177 shares). NEOMED will also be entitled to receive a royalty on net sales-based revenues. Additionally, in lieu of milestone payments, a certain portion of all other revenues received by BELLUS Health from BLU-5937 will be shared with NEOMED according to a pre-established schedule whereby the shared revenue portion decreases as the program progresses in development.

    Well that wraps up another episode of the Biotechnology Focus Podcast. We hope you enjoyed it. Be sure to let us know what you think, and we're also always looking for story ideas and suggestions for future shows, and of course we'd love to hear from you as well, simply reach out to us via twitter @biotechfocus, or by email at the following email address  [email protected]. And remember, you can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .

    For all of us here at Biotechnology Focus, thanks for listening

    15 min
  • 041 | A big money raise by Fusion and BioTalent Canada's newest report hits the streets

    Coming up on Biotechnology Focus Radio :  Toronto's Fusion Pharmaceuticals closes a US$25M Series A financing round led by Johnson & Johnson Innovation and BioTalent Canada releases Paving the Way, its latest labour market report. We have this and much more for you on this week's show.

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

    Story 1

    Our first story this week has roots in Canada's two biggest cities, with Enigma Biomedical Group, a Toronto based company focusing enhancing access to key technologies particularily those dealing with molecular imaging and medicine, reaching a clinical research agreement with the McGill University Research Centre for Studies in Aging in Montreal, in support of multiple projects to take place over the next several years. As part of the agreement, Enigma will provide funding for various research projects, and through its US entity Cerveau Technologies, Inc. The research projects are for studies of an early stage imaging agent (MK-6240) to be used in Positron Emission Tomography (PET) scans for assessing the status and progression of neurofibrillary tangles (NFTs) in the brain. What are NFTs exactly, well they are made up of aggregated tau protein and are a hallmark of several neurodegenerative diseases, including Alzheimer's disease. According to Dr. Serge Gauthier, Director of the AD & Related Disorders Research Unit of the McGill University Research Center for Studies in Aging, the ability to visualize and quantify tau in the brain will further facilitate therapeutic research in the field of Alzheimer's disease. Cerveau Technologies  will supply the MK-6240 precursor needed for the initiatives.

     

    Story Our next story takes us to HALIFAX, Nova Scotia, where Appili Therapeutics has announced it is receiving $2,803,148 from the Atlantic Canada Opportunities Agency (ACOA), under the Atlantic Innovation Fund (AIF). This funding will enable Appili to take its first drug, ATI-1501 – a taste-masked, oral antibiotic that treats anaerobic infections like Clostridium difficile – through clinical trials, including human clinical trial, and to be ready for market approval.  Of note, the drug is a reformulation of metronidazole, a front-line treatment for anaerobic bacterial infections. Over 10 million metronidazole prescriptions are issued in the U.S. annually. The company hopes to begin these clinical trials this year and is presently manufacturing the clinical batch of ATI-1501 to good manufacturing practices (GMP), the standard required by the Health Canada and the U.S. Food and Drug Administration (FDA). As for why the company is focused on reformulating metronidazole, well, the bitter taste of these tablets often results in poor patient compliance, which leads to the spread of infections and recurrent infections within the patients. In particular, reluctance to complete the prescribed course of antibiotics is highly problematic among children and the elderly with swallowing issues, who must crush and re-suspend tablets to ingest the metronidazole. The company says that ATI-1501 has been optimized to improve palatability, which should significantly reduce the instances of patient reluctance to take the drug.  How it works is once it is ingested, it kills anaerobic bacteria by interfering with their DNA, leading to bacterial cell death thus clearing up the infection.

    Story Across the country, in Vancouver BC, Zymeworks Inc. reports that the U.S. Food and Drug Administration has granted an orphan drug designation to its lead product candidate, ZW25, as a treatment for gastric cancer, including cancer of the gastroesophageal junction. The FDA grants orphan drug designation to biological products that are intended to treat a rare disease or condition, which is generally defined as affecting a patient population of fewer than 200,000 people in the United States. Orphan drug designation provides the sponsor certain financial incentives, including tax credits, the waiver of associated application fees, and a period of marketing exclusivity if the product candidate receives the first marketing approval for the indication for which it has such designation. The drug is currently being evaluated in an adaptive Phase 1 clinical trial in the U.S., based on the company's Azymetric platform. It is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and enhanced effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models. This marks the drugs second orphan drug designation, in addition to ovarian cancer, which was granted last year.

    Story

    Last week, BioTalent Canada released its latest labour market report, title Paving the Way. Funded in part by the Government of Canada's Labour Market Integration Program, the report surveyed skilled newcomers, immigrant serving agencies (ISAs) and employers, and made recommendations on how internationally educated professionals (IEPs) can better connect to jobs in Canada's bio-economy. Key report findings included that internationally educated professionals arrive with the knowledge and skills needed by Canada's bio-economy, with Two-thirds (67.6%) of those surveyed reporting having a minimum of a master's degree and over half (56.8%) indicated that they have worked in biotech industry prior to immigrating to Canada. And yet the report also found that many talented newcomers continue to have their skills and experience overlooked by hiring managers. Rob Henderson, president and CEO of BioTalent Canada, says this is quite troubling as ours is a sector that struggles with access to talent, so it should be crucial for businesses to recognize newcomers as an important talent pool. The report highlights some of the obstacles hindering internationally educated professionals from entering into Canada's biotechnology sector workforce, such as 51.9% saying they were finding it difficult to finding jobs in their own field, and 46.5% saying a lack of Canadian experience was an obstacle.  The report also suggests that Pre-screening for education experience validation may be a solution for skilled IEPs to connect to employers with Biotechnology employers that were surveyed supporting the concept of having access to pre-screened candidates. Moreover, a skills validation process would be an effective method of fast-tracking newcomers to biotech jobs in Canada. The full report is available online, to download a copy or view it, visit  biotalent.ca/PavingtheWay. Story

    Our final story takes us to Toronto, where Fusion Pharmaceuticals , a company first financially seeded by Fight Against Cancer Innovation Trust (FACIT) Inc., has closed a US$25M Series A financing, with Johnson & Johnson Innovation – JJDC, Inc. (JJDC) as the lead investor. Additional, new investors in the Series A round also included venture groups TPG Biotechnology Partners, HealthCap and Genesys Capital, as well as founding investor FACIT.  The financing is also strengthened by HealthCap's specialized expertise having pioneered a new wave of successful radiotherapeutic companies. Fusion will use the financing proceeds to advance its lead program, FPX-01, into human clinical trials. FPX-01 is an antibody-targeted radiotherapy that seeks out a specific biomarker present on nearly all types of treatment-resistant cancers. Fusion's technology, targeted alpha-particle emitting radiotherapeutics, combine the precision of molecular targeting agents such as antibodies with the potency of alpha-particle emitting radioisotopes to specifically attack and eradicate cancer cells. Alpha-particle emitting medical isotopes attack cancer cells using multiple mechanisms, including causing the type of DNA damage that the cancer cell cannot easily repair, reducing the likelihood of developing drug resistance. At the same time, alpha particle-emitting agents offer improved safe-handling features and can be administered in conventional cancer treatment facilities unlike previous generations of radiotherapeutics. In addition, Fusion is building its pipeline through access to a centyrin protein targeting platform in two licensing agreements with Janssen Biotech in transactions facilitated by J&J Innovation. The company itself is a spinout from the Centre for Probe Development and Commercialization (CPDC), which is a Centre of Excellence for Commercialization and Research Centre (CECR) located at McMaster University. The CPDC has facilities and major partnerships in Hamilton, Boston, Toronto and Ottawa. The company also received OICR funding support from its inception. As OICR's commercialization partner, FACIT provided corporate leadership (through its Executive-in-Residence program) as well as seed funding to launch Fusion and to attract the strategic partners, investors and the larger capital infusion necessary to grow the company, and continue its research around radiotherapeutics.   The company is led by Dr. John Valliant, who is the founder of both Fusion and CPDC. He was selected as one of the Canada's top 40 under 40 in 2010

    Well that wraps up another episode of the Biotechnology Focus Podcast. We hope you enjoyed it. Be sure to let us know what you think, and we're also always looking for story ideas and suggestions for future shows, and of course we'd love to hear from you as well, simply reach out to us via twitter @biotechfocus, or by email at the following email address  [email protected]. And remember, you can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .

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

    10 min
  • 040 | Future of made-in-Canada CAR-T cells looks bright, Roche Canada and Merck launch their own individual collaborative cancer research initiatives, and more

    Coming up on Biotechnology Focus Radio : The future of made-in-Canada CAR-T cells looks bright, Roche Canada and Merck each launch their own individual collaborative cancer research initiatives, and using immunotherapies to kill brain cancer

    Welcome to another episode of Biotechnology Focus Radio. I'm your host Shawn Lawrence, here to give you a rundown of this week's top stories on the Canadian biotech scene. As you can tell by our teaser intro, cancer research and new initiatives into new therapies to tackle the disease figure prominently in our news headlines this week, and this is not a coincidence as February happens to be National Cancer Prevention Awareness Month.

    Story 1

    On that note, our first story takes us to Ottawa, ON, where a team of researchers at the Children's Hospital of Eastern Ontario (CHEO) have made a discovery, featured in Nature, center around a promising combination of immunotherapies that are able to deliver a one-two punch to brain cancer tumours in mice.  Led by Dr. Robert Korneluk, distinguished professor at the University of Ottawa and senior scientist at the CHEO Research Institute, the Ottawa reseach team was able to show in mice that a combination of drugs known as SMAC Mimetics and immune checkpoint inhibitors (ICIs) amplifies kill rates of cancer tumour cells in laboratory testing. The research team also discovered a new mechanism by which the combination promotes long-term immunity against glioblastoma tumours. The combination therapy also proved to be highly effective against breast cancer and multiple myeloma. According to Dr. Korneluk, these findings represent a significant evolution in the field of immunotherapy, for the first time showing the synergistic tumour-killing impact of combining SMAC Mimetics with immune checkpoint inhibitors for glioblastoma. As part of this latest project SMAC Mimetics known as LCL161 and Birinapant were combined with ICI antibodies targeting PD-1 and CTLA-4 immune checkpoints. The findings have their roots in research conducted back in 2014, when a team of scientists led by Dr. Korneluk discovered that combining SMAC Mimetics with immune stimulators or live virus therapies had a synergistic or amplified tumour-killing effect that was greater than either agent on its own. Today's news shows that SMAC Mimetics also have a powerful synergistic effect with ICIs, relatively new drugs that are showing great promise in the clinic. Eric Lacasse, a scientist at the CHEO Research Institute, adds that two drug companies have initiated human clinical trials this year to assess the impact of this combination of SMAC Mimetics and ICIs on patients with a variety of cancers. Although it could be years before any clinical trials begin for adults or children with the deadly brain cancer, glioblastoma, we're looking forward to seeing how scientific evidence from these experimental treatments adds to our knowledge. It's an exciting, exploratory field and we hope we've hit a home run." Shawn Beug was the lead author of both the 2014 and 2017 papers, and the research was funded by the Canadian Cancer Society Research Institute, Brain Canada (with financial support from Health Canada through the Canada Brain Research Fund) and the Canadian Institutes of Health Research. In addition, the work was supported by donations to the Ottawa Regional Cancer Foundation, the Kiwanis Medical Foundation and the CHEO Foundation.

    Story 2 Continuing with the Cancer Research theme, Hoffmann-La Roche Limited (Roche Canada) reports that Toronto's Princess Margaret Cancer Centre has joined the company's global cancer immunotherapy Centres of Research Excellence (imCORE) Network. The network brings together the world's leading scientific and clinical experts in cancer immunotherapy to collaborate on the investigation and development of promising new treatment approaches for the disease. As part of gaining a better understanding immune biology and cancer, and to ultimately improve treatment options, this includes initiating pre-clinical and clinical research based on the latest scientific discoveries in cancer immunotherapy and to aggregate, as well as share data within the Network to help accelerate research for people living with cancer.  The imCORE Network is comprised of 21 academic centres, inclusive of Princess Margaret Cancer Centre, from nine countries across the globe.  

    Dr. Lillian Siu, medical oncologist at Princess Margaret Cancer Centre and Site Lead for the imCORE Network explains why the imCORE newtwork is exciting in the follow audio clip.

    http://stream1.newswire.ca/media/2017/02/14/20170214_C8704_VIDEO_EN_881863.mp4

    As a part of a global announcement regarding the launch of the imCORE Network, Roche has also made a commitment to invest up to 100 million Swiss Francs (more than $130 million Canadian dollars) to support basic and clinical research collaborations related to cancer immunotherapy.

    Story 3

    In an exciting public/private partnership, stakeholders in Quebec have launched a new research, development and investment hub to help accelerate the fight against cancer. The hub, called Oncopole is backed by a $15-million investment by Merck that will be administered over three years and overseen by the Fonds de recherche du Québec – Santé (FRQS). Through its model, Oncopole brings together various stakeholders under one flagship hub in oncology. It's conception was structured with the involvement of more than 50 experts from the scientific community over the past year, who helped to identify its priorities. Recognizing the range of resources and infrastructures currently available as well as the strategic positioning of many researchers in Québec, the Hub will aspire to strengthen the research and innovation ecosystem in the province. Some functions of Oncopole will include enabling the incubation and creation of companies that will capitalize on innovation; and positioning cancer care in Québec among the best in the world in terms of clinical outcome, patient experience and system efficiency. Based on a thorough analysis of the various hosting possibilities identified across Québec, the Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal was selected as the establishment which will host the Oncopole's coordinating offices. Additionally, the FRQS and Merck hope that this initial investment will attract other partners to join the Oncopole and make it a truly collaborative initiative.

    Story 4

     

     

    Switching gears to the bioindustrial sector, the Biotechnology Innovation Organization (BIO) announces that registration and housing are now open for the 2017 World Congress on Industrial Biotechnology. The conference, now in its 14th year brings brings together from across the globe business leaders, investors, academics and policymakers in the biofuels, biobased products, renewable chemicals, synthetic biology, food ingredients and biomass sectors. Industrial and environmental biotechnology is at the forefront of the biobased economy, generating good-paying jobs and making cleaner products and processes. This year event will be held July 23-26, 2017 at the Palais des congrès de Montréal in Montréal, Canada. According to Brent Erickson, executive vice president, Industrial and Environmental at BIO, two new tracks-Flavors, Fragrances and Food Ingredients and Agricultural Crop Technologies and Biomass Supply-have been added to this year's programming, representing the extended value chain of industrial biotechnology. He adds that the decision to bring the World Congress back to Montréal had very much to do with the success of past events, and the local industries continues support of what has grown into the world's largest industrial biotechnology conference. In 2016, the BIO World Congress on Industrial Biotechnology drew around 907 industry leaders from 529 companies, 32 countries and 31 states, as well as the District of Columbia and hosted a record 1,961 partnering meetings. For more information on the conference visit http://www.bio.org/worldcongress.

    Story 4

    In our final story this week, BioCanRx, and its partners, are investing $11 million to support 16 collaborative research projects in novel therapies to cure cancer. including research aimed at developing Canada's clinical Chimeric Antigen Receptor modified T cell (CAR-T) manufacturing capabilities.

    Considered a powerful new tool in the fight against cancer, CAR-T is on the cutting edge of cancer therapeutics, showing promise in paediatric and adult patients with certain blood cancers such as acute lymphoblastic leukemia and lymphoma.

    While promising, the development of such therapies require sophisticated manufacturing and expertise. Canada currently does have the basic laboratory infrastructure in place, and with this funding could take significant steps towards fully developing the expertise and capacity required to deliver this technology.

    The BioCanRx investment is going to research projects that will advance several innovative engineered T cell designs, to accelerate delivery of these novel concepts into clinical testing in Canada.

    Dr. John Bell, Scientific Director, BioCanRx adds his CAR-T manufacturing initiative is unique in that it represents the Canadian academic community recognizing a gap and stepping up to drive Canadian solutions to meet grassroots efforts taking place in the U.S., China and Europe. He discusses CAR-T cell manufacturing in Canada in the following audio provided by BioCanRX:

    https://biocanrx.com/wp-content/uploads/custom%20images/BioCanRx_Dr_JohnBellCART3.mp4

    To help ensure CAR-T cell therapy is brought to patients safely and effectively, BioCanRx is funding a companion Clinical, Social, and Economic Impact project. It will review the existing base of knowledge and involve patient consultation to design a rigorous CAR-T clinical trial protocol ready to implement once the products are ready for a phase 1 clinical trial.

    Dr. Manoj Lalu, associate scientist, assistant professor, Clinical Epidemiology and Regenerative Medicine Programs, Ottawa Hospital Research Institute, The Ottawa Hospital and Department of Anesthesiology and Pain Medicine, University of Ottawa discusses CAR-T therapy clinical trial design in the following audio clip.

    https://biocanrx.com/wp-content/uploads/custom%20images/Dr.%20Lalu%20-%20BioCanRx.mp4

    To access the full list of the 16 projects funded, be sure to visit https://biocanrx.com/project-dashboards.

     

    Well that wraps up another episode of the Biotechnology Focus Podcast. We hope you enjoyed it. Be sure to let us know what you think, and we're also always looking for story ideas and suggestions for future shows, and of course we'd love to hear from you as well, simply reach out to us via twitter @biotechfocus, or by email at the following email address  [email protected]. And remember, you can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .

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

    14 min
  • 039 | MaRS West Tower turnaround, CQDM and Brain Canada team up, and more

    On this weeks show, and amazing turnaround in the fortunes of the MaRS West Tower, CQDM and Brain Canada team up once again, and a significant step in the fight against cancer.

    We have all this and more on this week's Biotechnology Focus Radio Show Podcast.

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

     

    Story CQDM and Brain Canada are join forces again in the funding of two new research projects to address unmet needs in brain research. Together, the two organizations are awarding a total of $3 million to the projects which will oversee the development  cutting-edge tools, technologies and platforms designed to accelerate the discovery of new drugs for brain and nervous system disorders. The two distinguished research teams will unite nine researchers from seven public and private organizations across Canada. The first project is led by Edward Fon at the Montreal Neurological Institute and Hospital (MNI) joined by multi-provincial collaborators from McGill University, Université Laval and University of British Columbia. The second project led by Jean-Martin Beaulieu at University of Toronto is a public-private collaboration with the Research Institute of the McGill University Health Centre and ImStar Therapeutics in Vancouver. Additionally, these researchers will benefit from CQDM's unique mentoring program. They will have the opportunity to collaborate with influential senior scientists from the pharmaceutical industry who bring expertise and support to the projects, to help better align research with the needs of industry and patients. The Brain Canada funds are provided through a partnership with Health Canada, known as the Canada Brain Research Fund.

    Story Princess Margaret Cancer Centre scientists have discovered a distinct cell population in tumours that inhibits the body's immune response to fight cancer. According to principal investigator Pamela Ohashi, director, Tumour Immunotherapy Program at the cancer centre, University Health Network. Dr. Ohashi holds a Canada Research chair in Autoimmunity and Tumour Immunity, the findings, published online in Nature Medicine, are critical to understanding more about why patients will or will not respond to immune therapies.  Specifically, Dr. Ohashi and her team uncovered a potential new approach to modulate the immune response to cancer. She adds that by looking at tumour biology from this different perspective, researchers will have a better understanding of the barriers that prevent a strong immune response. This can help advance drug development to target these barriers.

    Dr. Ohashi discusses her team's discovery of a new population of cells that regulate immune response in the following audio clip.

    https://www.youtube.com/watch?v=l-vbE-DRTdY

    Dr. Ohashi's research team along with international collaborators analyzed more than 100 patient samples from ovarian and other cancer types to discover a distinct population of cells found in some tumours. This population of cells suppresses the growth of cancer-fighting immune cells, thereby limiting the ability of the immune system to fight off cancer. For patients, down the road Dr. Ohashi envisions a new era of combined therapies to simultaneously target and kill these suppressive cells while augmenting the immune response against cancer.  The team's next avenue of research will be focused on identifying a "biomarker" that can identify this distinct suppressive cell elsewhere in the body – for example, in blood or other samples – as a potential predictive clinical tool to determine when these cells are present in patients, which currently cannot be done.

    Dr. Ohashi's research was funded by the Canadian Institutes of Health Research and The Princess Margaret Cancer Foundation.

    Story Aequus Pharmaceuticals has landed $100,000 in federal funding through the National Research Council's Industrial Research Assistance Program. The company plans to use funds towards an ongoing proof-of-concept clinical study for its lead product candidate, AQS1301, a once-weekly transdermal aripiprazole patch. Aripiprazole is an atypical antipsychotic and the active ingredient in Abilify®, a leading medication in the U.S. used for the treatment of a number of psychiatric disorders including bipolar I disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder. Aripiprazole is currently available in once-daily oral tablets and a once-monthly injectable form, however, medication adherence continues to be a significant challenge for patients. Offering the medication in a patch form potentially could make it more convenient to use, and improve patient adherence says Anne Stevens, COO and director of Aequus Pharmaceuticals . The product is currently in clinical development, butAequus expects to confirm its regulatory development plan in a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) in the second half of 2017. Aequus anticipates results of the current repeat dose, 28-day study in the first quarter of 2017. The results will be used to inform the final design of the patch to be advanced into the regulatory phase of its clinical trials.

    Story

    Genome British Columbia is making an investment into Augurex Life Sciences through its Industry Innovation (I²) funding program. The company was founded on an invention shared between the University of Alberta and the University of British Columbia in 2006. The funding is repayable and is allocated to promising technologies (products, processes or services) at the early stages of commercial development, and aims to provide risk capital that is concurrently matched by other public or private funding sources. The investment will go towards helping the company launch several blood test products from its pipeline and advance its overall therapeutic program. With a focus on autoimmune diseases affecting joints such as rheumatoid arthritis (RA), Augurex has already developed its first blood test, called JOINTstat™, which measures the 14-3-3η(eta) protein in blood for early RA diagnosis, joint damage risk monitoring, and also predicts RA development in people with joint pain. Since this is a very early contributor to disease and correlates with joint damage prognosis, it facilitates the identification of patients for early RA intervention and tighter control of treatment so that clinical and remission targets can be reached; the highest priorities in rheumatology care. Additionally, a portfolio of 14-3-3η-centric biomarkers has emerged from Augurex's work, with demonstrated applications in multiple autoimmune diseases with joint involvement. As an aside, JOINTstat has since been studied in over 4,000 patients, and is Health Canada approved. It was launched in Canada by LifeLabs and has been in clinical use since late 2013 in the U.S. Recently, the test was also CE marked and TGA approved making it certified for clinical use in Europe and Australia. 

    Story

    California Capital Equity, LLC, has increased its equity position in Laval, QC's ProMetic Life Sciences, exercising 44,791,488 share purchase warrants at a price of $0.47 per share for total proceeds of $21,051,999.36. The venture capital firm  based in LosAngeles, CA, specializes in providing growth and development capital to start-up through mezzanine stages. The firm's equity and debt investments are typically in small and medium sized companies. It first invested in ProMetic in 2008. Dr. Patrick Soon-Shiong, CEO of California Capital Equity cited the company's robust proprietary therapeutic platforms and promising growth potential as key factors behind the firm's latest investment.

     Story

    Our final story this week, In an amazing turnaround for what once was a struggling center for innovation and entrepreneurship, that once upon a time event required the government of Ontario to step in and offer bridge financing to keep it afloat, MaRS Discovery District now reports that it has completed a significant private financing of its West Tower, with proceeds of this transaction to be used to repay most of the Ontario government's interest-bearing loans to MaRS. The caveat, is the repayment comes almost three years ahead of schedule.  Taking part in the private financing are Manulife, Sun Life Financial and iA Financial Group, who together led the $290-million transaction by investing in 19-year bonds issued by Phase II Investment Trust.

    According to Ilse Treurnicht, CEO of MaRS, the West Tower is now fully leased, and could soon generate the operating income required to be entirely self-sustaining, putting MaRS on stable footing. Last year we featured two of the more noteworthy tenants at the building, Johnson & Johnson's JLABS @ Toronto, and the Bridge@CCRM in our June/July issue of Biotechnology Focus. And now, offering over 1.5 million square feet of state-of-the-art lab and office space in the heart of Toronto's Discovery District, the MaRS Centre is now home to more than 140 research labs and companies spanning the entire innovation ecosystem, including Multinational medical firms such as Johnson & Johnson's JLABS @ Toronto, which itself houses over 40 biotech and health startups, Merck, growing  life science firms such as Synaptive Medical, Deep Genomics, Interface Biologics, Highland Therapeutics, and Triphase Accelerator; and life science incubators like Blueline Bioscience. Leading research groups from the University of Toronto (which owns a 20% stake in the West Tower), University Health Network (including Princess Margaret Cancer Centre), Ryerson University and the Ontario Institute for Cancer Research also call the West tower home. The facility has even attracted other major tenants like Autodesk, Facebook, Merck, PayPal, Etsy, Airbnb, IBM, CIBC and RBC.

    In all, ventures within the MaRS network raised $2.6 billion in capital and generated $1.3 billion in revenue between 2008 and 2015, and today employs more than 5,200 people.

    Well that wraps up another episode of the Biotechnology Focus Podcast. We hope you enjoyed it. Be sure to let us know what you think, and we're also always looking for story ideas and suggestions for future shows, and of course we'd love to hear from you as well, simply reach out to us via twitter @biotechfocus, or by email at the following email address  [email protected]. And remember, you can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .

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

    11 min

About Biotechnology Focus Podcast

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On the Biotechnology Focus Podcast we bring you the latest news, insights, and interviews from Canada's Biotechnology sector.