Zymeworks, ProMetic Life Sciences, Innovative Targeting Solutions all back in the news again; Saskatchewan researchers make a breakthrough on a devastating pig virus, and healthcare behemoth GE partners with STEMCELL Technologies.We have this and more on this week’s Biotechnology Focus Podcast!

Welcome to Biotechnology Focus Podcast. I’m your host Shawn Lawrence.
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We kick things off this week in the prairies, where in less than a year, University of Saskatchewan (U of S) scientists have developed and tested a prototype vaccine that could protect the North American swine industry from a virus that has killed more than eight million pigs and cost more than $400 million in lost income since 2013.
The Porcine Epidemic Diarrhea Virus (PEDV) hit the U.S. in 2013 and spread to Canada in 2014. It is a coronavirus, a virus group which includes important emerging human diseases such as SARS and MERS. It was first discovered in Europe, and has become increasingly problematic in Asian countries. Occurring only in pigs, PEDV can kill up to 100 per cent of infected piglets. Using its new containment Level 3 facility, the Universtiy of Saskatchewan Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) quickly launched a vaccine development project. The project has resulted in a prototype vaccine that protects 100 per cent of the piglets who have received it, according to  Dr. Volker Gerdts, VIDO-InterVac’s research director. The successful vaccine results have since triggered the interest of several animal health companies including Huvepharma, which has partnered with VIDO-InterVac to develop the technology for commercial production in North America. With the support of the swine industry, the vaccine is now undergoing field testing in Saskatchewan, as well as in Manitoba where it is being used to help protect piglets from a recent PEDV outbreak.
VIDO-InterVac director Andrew Potter said such a project wouldn’t be possible without this facility, adding that “This is a perfect example of why InterVac was constructed – it is one of the only facilities available internationally with the capacity to conduct vaccine development and testing on this scale for emerging infectious diseases and It helps Canada remain prepared to quickly respond to outbreaks like this,” he said.
The PEDV vaccine development project has been supported by a variety of funders including the Government of Saskatchewan (ADF), Sask Pork, and the Canadian Swine Health Network.
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The US Food and Drug Administration (FDA) has given Toronto’s Trillium Therapeutics Inc. the go-ahead to initiate a Phase 1 clinical trial for its lead drug candidate, TTI-621 (SIRPaFc), in solid tumours 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 Phase 1 dose escalation study in patients with relapsed or refractory hematologic malignancies. Patient enrollment in the Phase 1 trial is anticipated to commence by year end. The trial will be multicenter and open-label, with TTI-621 being delivered to patients with relapsed and refractory, percutaneously-accessible cancers by intratumoral injection that increase in dose and dosing frequency to characterize safety, pharmacokinetics, pharmacodynamics and preliminary evidence of antitumour activity. In addition, detailed evaluation of serial, on-treatment tumor biopsies of both injected and non-injected cancer lesions will help characterize tumor microenvironment changes anticipated with CD47 blockade.

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As part of its strategy to leverage and attract investor interest to Québec’s life sciences sector, the Fonds de solidarité FTQ has made a $15 million investment in Genesys Capital’s latest venture fund Genesys Ventures III. The fund itself will used to back companies at the seed-stage, considered by many in the industry the valley of death, to help these companies advance technologies and products for unmet medical needs. Genesys Capital is one of the largest Canadian-based venture capital firms exclusively focused on the life sciences industry. Of note, Knight Therapeutics Inc., a specialized biopharmaceutical company based in Montreal, QC is also committing $1 million to Canadian-based life sciences venture capital fund Genesys Ventures III LP. For Knight the investment is the eighth life sciences equity fund investment Knight has made to date, having committed over $125 million. In terms of the Genesys Ventures III fund, Genesys Capital says it has closed $90 million of its $125 million target for the fund, while Managing director Damian Lamb adds that the firm expects to reach its goal for Genesys Ventures III early next year. Should the fund reach this target, it would be the largest Genesys has raised in its 16-year history.
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Zymeworks is back in the news this week as the United States Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for its lead product ZW25 as a treatment for certain HER2-expressing cancers. ZW25 is a novel bi-specific antibody, developed using the company’s Azymetric™ platform, to target two different epitopes (bi-paratopic targeting) of the human epidermal growth factor receptor 2 (HER2) proteinThe protein is known to be over-expressed on the surface of many tumour types, including certain breast, gastric, lung, and ovarian cancers. ZW25 will be evaluated in the clinic for safety as well as efficacy in patients with tumours with low to moderate levels of HER2 expression. The company anticipates it will begin a Phase 1 clinical trial for ZW25 in late August of this year. Additionally, last week  the FDA granted Orphan Drug Designation to ZW25 and a second product, ZW33 for the treatment of ovarian cancer. ZW33 is a drug-conjugated version of ZW25 that is currently in development in preparation for an IND filing in early 2017. Orphan designation qualifies Zymeworks for a number of development incentives, including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 and/or ZW33 is approved for this indication.

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The Ontario Institute for Cancer Research (OICR), Thermo Fisher Scientific and Queen’s University are collaborating on a research study to help bring more targeted diagnosis and treatment to breast cancer patients in the future. The study, led by Dr. John Bartlett, director of OICR’s Transformative Pathology Program, and Dr. Harriet Feilotter, Department of Pathology and Molecular Medicine, Queen’s University, aims to identify mutations and copy number changes found in breast cancer samples and establish whether these abnormalities correlate with on-market drugs, available clinical trials or published studies. OICR-affiliated researchers and collaborators at Queen’s University and Sunnybrook Health Sciences Centre will process the same breast cancer samples to establish whether the results are reproducible at different sites. This study will also characterize more than 400 additional retrospective breast cancer samples supporting ongoing clinical research efforts of Dr. Bartlett’s team at OICR, which strives to improve the clinical management of the disease. Collaborators Drs. Martin Yaffe and Arun Seth at Sunnybrook Health Sciences Centre will provide laboratory space and additional technical support for the study. Dr. Yaffe is also co-leader of OICR’s Smarter Imaging and Imaging Translation Programs. The study will use Thermo Fisher’s Oncomine Comprehensive Assay, a targeted, next-generation sequencing (NGS) research tool that analyzes 143 genes relevant to cancer and which is the NGS assay used for the NCI-MATCH study in the United States. The data generated can be further studied with the Oncomine Knowledgebase Reporter, which is a curated set of published evidence that matches driver genetic variants with relevant information, such as on-market drugs, available clinical trials, or published studies. The findings of the OICR study will be used to assess the technology and could inform subsequent clinical trials. Drs. Feilotter and Bartlett have also engaged six laboratories in Ontario, including at Hamilton Health Sciences, London Health Sciences Centre, Ottawa General Hospital, Sunnybrook Health Sciences Centre, Sudbury Health Science North and University Health Network to look at the robustness and reproducibility of the assay across different cancer samples. This collaboration could extend the findings of this study beyond breast cancer to other common cancers.
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Vancouver’s Innovative Targeting Solutions has teamed up with yet another major life science company, this time striking a research collaboration deal with Janssen Biotech, Inc. (Janssen), through Johnson & Johnson Innovation.  The deal will allow Janssen to utilize Innovative Targeting Solutions' proprietary HuTARG™ research platform to discover antibody candidates useful for modulating immune responses in autoimmunity or cancer. The HuTARG™ protein engineering platform is able to engineer both T-cell receptors and fully human antibodies that bind major histocompatibility complex (MHC)/peptide complexes displaying fragments of intracellular proteins of interest.  Essentially, it allows researchers to generate and engineer fully human antibodies. The technology underlying the platform is based upon the natural process of V(D)J recombination, employed by the human immune system to produce a diverse repertoire of antibodies. Details of the collaboration including the specific targets, number of targets, and specific therapeutic indications have not yet been disclosed nor have financial details. In June, ITS announced a research collaboration with Merck, to utilize the HuTARG™ research platform to help identify and develop biologic therapeutic candidates directed towards targets that have historically been a challenge for biologic therapies, and just two weeks ago, ITS also partnered with another Vancouver-based company known for its own string of deals with pharma, Zymeworks. Other disclosed ITS collaborators include Novartis and Amgen.
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A few months ago, Biotechnology Focus spoke with Phil Vanek (of GE Healthcare) and Michael May (of CCRM) about BridGE@CCRM, the centre they co-created at the MaRS West Towere to help accelerate the creation of cellular therapeutic tools. Now GE is taking another step in its mission to bring the right infrastructure to the global cell therapy industry, with another unique partnership here in Canada, signing an exclusive licensing agreement with Vancouver-based STEMCELL Technologies Inc., to develop and commercialize cGMP grade versions of STEMCELL’s T-Cell reagents for the isolation, activation, and culture of T-cells in clinical applications. Both parties say these reagents are critical tools in the development and manufacturing of cell and gene therapies intended for administration to patients.

The following proprietary reagents from STEMCELL Technologies will be qualified as cGMP-grade materials and licensed by GE Healthcare:  ImmunoCult™ Human CD3/CD28 T-Cell Activator, ImmunoCult™ Human CD3/CD28/CD2 T-Cell Activator, EasySep™ Release Human CD3 Positive Selection Kit and the ImmunoCult™–XF T-Cell Expansion Medium.

According to Allen Eaves, president and CEO of STEMCELL Technologies Inc. this partnership with GE will give STI customers the confidence of a path to the clinic with a suite of critical cGMP grade T-cell reagents as well as help the industry evolve and make these promising therapies, such as CAR-T cells and TCR-engineered T cells, a clinical reality.

The agreement closely follows GE’s acquisition of Biosafe Group SA, as well as many other investments in the space to make available a turnkey, scalable, flexible manufacturing solution that will enable access to these critical therapies.
With that we’ve come to the end of this week’s program. We hope you enjoyed it. A big thanks to our production manager Laskey Hart and the rest of the Biotechnology Focus team. You can find past episodes online at www.biotechnologyfocus.ca and we’re always looking for your feedback, story ideas and suggestions so we’d love to hear from you. Simply reach out to us on twitter: @BiotechFocus  or by email [email protected].
For all of us here at Biotechnology Focus, thank you for listening.