Anthony Tolcher, MD, FRCPC, a medical oncologist and co-founder of research organization NEXT Oncology has been appointed the lead investigator for a Phase I clinical trial investigating Heat Biologics’ investigational therapy called PTX-35, a novel potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen experienced T cells. The preclinical research and Phase I clinical trial have been supported by a $15.2 million grant award by the Cancer Prevention and Research Institute of Texas (CPRIT).
The update recognizes Dr. Tolcher and his Next Oncology, which is a dedicated to the advancement of Phase I cancer research via clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. TrialSite News provides a brief breakdown.
What is PTX35?
PTX35, developed by Heat Biologics, is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction.
Preclinical studies reveal that the investigational product, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor proprieties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. Moreover, a favorable safety profile was evidenced in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.
Principal Investigator Position
Dr. Tolcher opted to join this study as in part it “exquisitely targets TNFRSF25” as a “first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells.” Dr. Tolcher went on to communicate that this novel target could potentially represent a new treatment option for those patients that are not receiving the benefits from their existing cancer therapies. Tolcher commented, “Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just at the beginning to see the potential for expanding new ventures and targets in harnessing the immune system for the treatment of cancer.”
A Key Opinion Leader & Rock Star Cancer Researcher
The co-founder of NEXT Oncology, he will be the lead investigator for the Phase I PTX-35 study. Dr. Tolcher, a distinguished oncologist with over 25 years of early drug development and clinical trial expertise, he has served in the position of principal investigator for 20 Phase I clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck’s pembrolizumab (Keytruda®). Dr. Tolcher has produced over 100 peer-reviewed publications in top scientific journals.
Why is NEXT Oncology an ‘Ideal Site’ for the Phase I study?
Based on the levels of experience with early state, Phase I oncology focused clinical trials Dr. Tolcher brings the experience, expertise and wisdom required for an early stage trial. Dedicated to the advancement of Phase I cancer research through clinical trials of anticancer agents, the research site seeks to contribute to innovative developments in cancer treatment. San Antonio-based Next Oncology is on a mission to advance new anticancer agents for patients whose current cancer therapy is no longer working to benefit them.
What are some FDA approved oncology-based therapies having Dr. Tolcher contributed to via Phase I research?
Dr. Tolcher was involved in were subsequently approved by FDA, including pembrolizumab (Keytruda®), copanlisib (Aliqopa®), trastuzumab emtansine (Kadcyla®), regorafenib (Stivarga®), liposomal vincristine (Marqibo®), cabazitaxel (Jevtana®), carfilzomib (Kyprolis®), gefitinib (Iressa®), erlotinib (Tarceva®) and eribulin (Halaven®). He is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology, and chaired the Developmental Therapeutics Review Committee for the American Society for Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals.
About the Sponsor
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The company’s gp96 platform is designed to activate immune responses against cancer or pathogenic antigens. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in Phase 2, HS-130 in Phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 in Phase 1.
The company, publicly traded, was formed back in 2008 and has secured at least $50 million. Initiating an IPO in 2013, the company like many pre-revenue, research and development-based biotech survive from either venture capital or public funding with the hopes of a commercial breakthrough.
Anthony Tolcher, MD