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.

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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.

 

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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.

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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.

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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.

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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.