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.

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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.

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