Activating Oncolytic Immunotherapies

James Burke, MD (Medical Advisor) advises the company on clinical development. James has advised Turnstone Biologics, served as Chief Medical Officer at Sillajen Biotherapeutics and Vice President of Clinical Research at Jennerex. James oversaw global clinical development for Sillajen including design and oversight of clinical trials of gene and immunotherapy agents for hepatocellular carcinoma (now in Phase 3), renal cell carcinoma, colorectal cancer, and various other solid tumors. James has over 15 years of preclinical and clinical experience in the field of gene and immunotherapy including work with various oncolytic virus platforms, tumor vaccines, and other gene therapy related agents. Prior to SillaJen and Jennerex, he was Associate Director of Clinical Research at Cell Genesys and Director of Clinical Research at a regional cancer center. James earned a BS in Biochemistry from University of California, San Diego and MD from Georgetown University. He completed a general internal medicine residency at University of California, San Diego followed by a Hematology-Oncology Fellowship at University of California, San Francisco. James is Board Certified in both Hematology and Oncology.

Georg Roth, PhD (CMC Advisor) advises the company on manufacturing. Georg served as Chief Operating Officer and Senior Vice President of Technical Operations at SillaJen Biotherapeutics, where he was responsible for managing U.S. operations and heading all technical functions for the development of oncolytic viruses. Prior to SillaJen, he worked as Vice President of Technical Operations at Jennerex, with responsibilities in process development, analytical development and manufacturing of oncolytic viruses. Georg was Director of Technical Affairs at Dynavax and also established an international consulting company specializing in bioprocess technology. He also held positions of increasing responsibility at Berlex Laboratories. Altogether Georg has over 30 years of experience in the pharmaceutical industry. Georg earned a diploma and PhD in Chemical Engineering from Technical University Berlin, Germany.

Ursula Fritsch, PharmD (Regulatory Advisor) advises the company on regulatory affairs, quality and compliance issues. Ursula served as Senior Vice President of Regulatory Affairs and Quality Assurance at SillaJen Biotherapeutics where she was responsible for managing regulatory and quality compliance. Ursula led SillaJen’s global regulatory strategy and worldwide regulatory negotiations for the company’s lead Phase 3 product (Pexa-Vec) and other projects at various stages of development. Prior to her position at SillaJen, she served as Vice President of Regulatory Affairs and Quality Assurance at Jennerex. She led the regulatory function at Onyx Pharmaceuticals, Anthera Pharmaceuticals and Peninsula Pharmaceuticals and had positions of increasing responsibility at Genentech. She has over 25 years of experience in managing regulatory affairs, compliance and quality. Ursula earned a BA from University of Nebraska and PharmD from Creighton University.

John Wallen, JD, PhD (Intellectual Property Advisor) advises the company on intellectual property matters. John specializes in creating and helping to execute the IP strategy for emerging biotech companies. He is currently VP of Intellectual Property at Avidity Biosciences and an advisor at Crinetics Pharmaceuticals and Vividion Therapeutics. Previously, he held the position of Vice President, Intellectual Property & Corporate Legal at Ambrx. John was a partner in the Technology/Intellectual Property, Life Sciences, and Patent Litigation groups of the law firm Preston Gates & Ellis LLP in San Diego. John served as a patent attorney in the law department of Johnson & Johnson. He worked for Merck, serving first as a scientist and then as a patent agent. John is a patent attorney registered with the US Patent and Trademark Office. John earned a BS in Biology from State University of New York College at Oswego, MS in Clinical Microbiology from Long Island University, JD from Seton Hall Law School, and PhD in Molecular Biology from University of Pennsylvania.

Matt Fust, MBA (Finance Advisor) advises the company on financial matters. He is currently a board member and advisor to life sciences companies. Matt retired as Executive Vice President and Chief Financial Officer of Onyx Pharmaceuticals, where he served through its acquisition by Amgen. Matt served as Chief Financial Officer at Jazz Pharmaceuticals and Perlegen Sciences. Previously, he was Senior Vice President and Chief Financial Officer at ALZA Corporation. Matt serves on the board of directors of the following publicly traded companies: Crinetics, Dermira, Atara, MacroGenics, and Ultragenyx. Matt previously served on the board of directors at Sunesis Pharmaceuticals. Matt earned a BA from University of Minnesota and MBA from Stanford University.