inCVAX: An in situ Autologous Cancer Vaccine
Immunophotonics, Inc. is developing inCVAX as an in situ autologous cancer vaccine for the treatment of metastatic cancers. inCVAX is local treatment of an accessible tumor that is intended to stimulate a patient’s immune system. Initial clinical and nonclinical data suggests that inCVAX induces a systemic response, with tumor reduction being observed at the treated tumor as well as distant metastases. A description of inCVAX will be provided in the context of the current general approaches to cancer immunotherapy.
Speaker: Joseph Raker, PhD
Dr. Raker is a fully trained synthetic organic/medicinal chemist with 15+ years’ experience in the pharmaceutical industry. He was previously responsible for multiple GMP/CMC projects at Kinentia Biosciences and AMRI Burlington and has extensive experience leading international medicinal chemistry teams for a variety of disease indications. He has significant experience and expertise in lead generation/optimization, sterile fill finish process development, analytical method development, program management and regulatory/compliance oversight. Dr. Raker received a B.S. in chemistry from Utica College of Syracuse University and his Ph.D. in organic chemistry from The Pennsylvania State University.
Manufacturing, Regulatory, and Clinical Considerations for Translation of CAR-T Cell Therapies to the Market
Research began on Chimeric Antigen Receptor T-cell therapies in the 1980s, with the first publication from Zelig Eshhar of a functional CAR T-cell in 1989. Not uncommon in cell and gene therapies, the translation of these ‘living drugs’ from bench top to bedside has been arduous. In 2010, the effective clinical treatment with anti-CD19 CAR T cells was reported after a patient with advanced-stage lymphoma experienced a partial remission of lymphoma and long-term eradication of normal B-cells and this opened the floodgates to clinical trials with CAR T-cells, particularly for the treatment of blood-borne cancers that over-express CD19. Since then, over 105 INDs have been approved in the US from more than 15 sponsors—providing an opportunity for guidance from CBER into best practices. This talk will provide an overview of the regulatory and clinical pathway for CAR T-cell therapies, as well as that most problematic issue for commercialization of immunotherapies; production.
Speaker: Sara Mary Hall
A scientist by training with over twenty years experience in Silicon Valley in fundraising, partnering, intellectual property and business development, regulatory/clinical issues, and successful exits, Sara has co-founded and led three private and led a fourth, public biotech. Sara is currently working with KCALSI on the formation of two proof of concept funds for the region: the E2PoC, a Proof of Concept Fund for Emerging Entrepreneurs, and a life sciences fund focused on the nexus of human and animal drug development. She serves on the Board of Directors of KU Innovation and Collaboration, the commercialization arm of KU/KU Med, and BioKansas, and is deeply involved in regional initiatives for women and girls in the sciences and, as a professional violinist, in the addition of the Arts to STEM curricula (aka STEAM). The winner of two R&D 100 awards for scientific innovation while still at the bench, Sara is a creative, experienced, and driven executive with a specialty in and passion for first-in-class therapies and concepts.
Kauffman Foundation Conference Center
4801 Rockhill Rd, Kansas City, MO 64110
Or join virtually via “Zoom”