On this weeks show, Accelerating precision medicine for cancer patients, Avivagen partners with NRC to tackle antibiotic resistance in humans, and Knight buys in on an Israeli biotech,

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,

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Montreal’s Knight Therapeutics-a specialty pharma company reports it is taking a small stake in an Israeli-based company, Protalix BioTherapeutics, through the acquisition of 6,200,000 common shares of the company at an average price of US$0.57 per share. With the purchase, Knight now owns approximately five per cent of the outstanding common shares of Protalix. The shares were purchased by Abir Therapeutics Ltd., Knight’s wholly-owned Israeli headquartered subsidiary, which owns 28.3 per cent of Medison Pharma (Medison), Israel’s third largest pharmaceutical company ranked by revenues. It is anticipated that Medison will provide selected services to Abir in order to launch innovative pharmaceuticals in Israel.  Protalix, a publicly traded biopharmaceutical company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. FDA.

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In VICTORIA, BC, Aurinia Pharmaceuticals Inc. reports it has selected Worldwide Clinical Trials as its Clinical Research Organization (CRO) for the company’s AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis (LN). Voclosporin, an investigational drug, is calcineurin inhibitor and immunosuppressant. According to the company, by inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing.  Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). With the selection of Worldwide, Aurinia will now proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.

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On the business front, Mississauga’s Aralez Pharmaceuticals announced last week that it is opening new offices in Dublin, Ireland. The company, which focuses on cardiovascular, pain and other specialty areas, says it plans to add more highly skilled jobs in Dublin by the end of 2017, and use these offices as a launching pad for expansion into the broader European Union market. The Dublin offices are Aralez's first permanent business premises outside of North America.

 

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New findings published in Nature are highlighting the potential of a new messenger RNA vaccine to protect against Zika virus. Acuitas Therapeutics Inc., a private biotechnology company based in Vancouver published the data demonstrating that single low dose immunization with a messenger RNA delivered in an Acuitas LNP carrier has the potential to protect against infection by Zika virus. The company is developing a lipid nanoparticle (LNP) delivery technology for the messenger RNA (mRNA).  In the Nature paper, Acuitas Therapeutics scientists and academic researchers including Dr. Drew Weissman, a professor of Infectious Diseases in the Perelman School of Medicine at the University of Pennsylvania showed that single low-dose immunization with mRNA-LNP encoding the pre-membrane and envelope (prM-E) glycoproteins of a Zika virus strain responsible for the 2013 outbreak elicited potent, durable and protective neutralizing antibody responses in animals. The company in collaboration with Dr. Weissman say they hope to further advance this exciting new therapeutic modality.

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In Ottawa, ON, Avivagen Inc., a life sciences company commercializing products intended to replace the antibiotics added to livestock feeds, with the help of the National Research Council of Canada (NRC) has launched a new project to establish proof-of-concept for a first human health application of its OxC-beta™ Technology. The technology is derived from Avivagen discoveries about carotenoids, compounds that give certain fruits and vegetables their bright colors and is a non-antibiotic means of maintaining optimal health and growth. OxC-beta™ Livestock is a proprietary product shown to be effective and economic in replacing the antibiotics commonly added to livestock feeds.  Specifically, the project will evaluate the efficacy of OxC-beta™ Technology (“OxC-beta”) in an established research model of an infectious disease of humans. Work will be conducted by NRC experts at its facilities based upon a jointly developed protocol and is expected to be completed in 2017. Dr. James (Jamie) Nickerson, Avivagen’s director of product validation, commented on the project and its objectives, saying the company is pleased to be working with NRC. He adds that OxC-beta has demonstrated safety and effectiveness across more than a dozen livestock trials and those results suggest it could also prove to be important to human health and well-being. Neither the NRC or Avivagen have disclosed the specific disease target at this time, in the hopes of ensuring the patentability of this potential new application for OxC-beta™ technology. What is known is that the disease target is one of the top 18 urgent, serious or concerning drug-resistance threats listed by the United States Centers for Disease Control (the “CDC”).

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Vancouver’s Aequus Pharmaceuticals has landed $100,000 in funding from the National Research Council of Canada Industrial Research Assistance Program to support the ongoing Proof of Concept clinical study of 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 US 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. In terms of the clinical study, Aequus anticipates results of this 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. Aequus 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.

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In Toronto, Trillium Therapeutics Inc, a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, has initiated dosing in its second Phase 1 clinical trial with TTI-621 in patients with relapsed or refractory percutaneously-accessible solid tumors and mycosis fungoides. Trillium is developing TTI-621 as a novel checkpoint inhibitor of the innate immune system, and the drug is currently being evaluated in an ongoing 10-cohort Phase 1b study in patients with relapsed or refractory hematologic malignancies. The two-part clinical trial is designed as a multi-center, open-label Phase 1a/1b trial, with TTI-621 being evaluated as a single-agent in patients. The escalation phase will include single or multiple doses of TTI-621 delivered by intratumoral injections, which will be followed by an expansion phase during which one or more selected dose levels of TTI-621 will be tested.

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Wrapping things up this week, in a national first,t he Terry Fox Research Institute and two leading cancer centres in Canada -- the Princess Margaret Cancer Centre in Toronto and the BC Cancer Agency in Vancouver – are partnering on an innovative pilot project to accelerate precision medicine for their cancer patients. The initiative comes at a time when other developed countries are investing heavily in strategies to improve survival from cancer through precision medicine and increased collaboration. The pilot will provide much-needed evidence on how best to roll out a broader vision for data sharing and collaborative translational and clinical research to enable precision medicine for cancer patients.  The pilot is the first phase for developing and implementing a national program that will link high-performing comprehensive cancer research centres, hospitals and universities and their clinical and laboratory programs across Canada through the Terry Fox Designated Canadian Comprehensive Cancer Centres Network. Through the pilot project, each organization will provide complementary analyses of specimens (e.g. tumour biopsies and blood samples), identify and determine ways to harmonize their research processes, set up an IT infrastructure for data sharing, and develop resources required to conduct multi-centre precision medicine clinical trials.  The initial focus will be on colorectal, ovarian, and prostate cancers, with the goal of improving the health outcomes of patients through treatment by precision medicine. Each organization is contributing $4 million over the next two years for a $12-million total investment that will see multidisciplinary teams focus on four specific research thrusts that are institutional priorities: genomics, immunotherapy, molecular imaging and data sharing.

That concludes another episode of the Biotechnology Focus Podcast. If you like our show, let us know via a twitter, you can We’re also always looking for your feedback, story ideas and suggestions so we’d love to hear from you.  You can also listen to past episodes online via our podcast portal at www.biotechnologyfocus.ca .

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