On June 22, 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 that the first patient has been treated in the Company’s first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics’ Pelican Therapeutics subsidiary (Press release, Heat Biologics, JUN 22, 2020, View Source [SID1234561318]).
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This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels of PTX-35 will be explored until optimal immunological dose or maximum tolerated dose is established. The objectives of the study include safety evaluation, determination of the recommended Phase 2 dose as well as exploratory analyses of clinical benefit and immunological effect of PTX-35. This trial is supported by a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
Jeff Wolf, CEO of Heat Biologics, commented, "This is an important milestone as we advance our first antibody product candidate into clinical development. I am very pleased with our team’s effort in accelerating the development of PTX-35 as well as the speed of execution to initiate our first-in-human study following FDA clearance of our Investigational New Drug (IND) Application. I believe that PTX-35, our potential first-in-class T-cell co-stimulatory antibody, will offer a differentiated approach to benefit cancer patients."
About PTX-35
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.
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.