On June 18, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported initiation of the first clinical trial site for PTX-35 (Press release, Heat Biologics, JUN 18, 2020, View Source [SID1234561210]). Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.
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PTX-35 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 have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.
Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "We are pleased to welcome Dr. Anthony Tolcher as the lead investigator for our PTX-35 Phase 1 trial. He is a distinguished medical oncologist with over 25 years of early drug development and clinical trial expertise and a principal investigator for 20 Phase 1 clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck’s pembrolizumab (Keytruda). Dr. Tolcher has over 100 peer-reviewed publications in top scientific journals, and a proven track record of advancing multiple innovative oncology products through Phase 1. We believe NEXT Oncology under the leadership of Dr. Tolcher is an ideal site for our study and look forward to enrolling our first patient shortly."
Dr. Tolcher said, "PTX-35 is a promising product candidate that exquisitely targets TNFRSF25. This is a first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells. I believe PTX-35 may provide additional treatment options for patients when current therapy does not work in controlling their cancers. Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just beginning to see the potential for expanding new avenues and targets in harnessing the immune system for the treatment of cancer."
A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.
About NEXT Oncology
NEXT Oncology is dedicated to the advancement of Phase 1 cancer research through clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. Dr. Anthony Tolcher is a medical oncologist and co-founder of NEXT Oncology. He is dedicated to the advancement of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them. Many of the initial Phase 1 studies of new agents that 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.