Heat Biologics Inc. (NASDAQ:HTBX) Receives Investigational New Drug Application Approval From The FDA For PTX-35

Heat Biologics Inc. (NASDAQ:HTBX) has announced that it has received FDA clearance for the Investigational New Drug application for PTX-35, which is developed by the company’s subsidiary Pelican Therapeutics. Pelican is planning to commence the first phase soon clinical trial of PTX-35 in patients having solid tumors.

PTX-35 targets TNFRSF25 vital in the destruction of tumor

PTX-35 is a proprietary first in class agonist antibody that targets death receptor 3 (TNFRSF25). This is a receptor that is preferentially shown by the antigen-experienced T cells. Usually, TNFRSF25 agonism results in the activation of antigen-experienced memory CD8+ T cells, which is vital in the destruction of tumors. According to preclinical studies, PTX-35 has shown that it can result in improved anti-tumor effects when used in combination with other antigen-based immunotherapies. This includes the production of cytokine effector, strong proliferation of the antigen-specific T-cells as well as enhanced immune effector function.

Pelican CEO Rahul Jasula indicated that PTX-35’s mechanism of action is highly differentiated relative to other co-stimulators. He added that in preclinical models, PTX-35 has demonstrated that it can activate TNFRSF25, thus resulting in a more profound expansion of killer T cells or tumor antigen-specific cytotoxicity. As a result, it can lead to enhanced inhibition of tumor growth as well as extended survival. Jasuja added that the team has delivered a strong IND package showing preclinical efficacy of PTX-35 as well as encouraging safety profile in both non-human primates and mice.

Heat Biologics to commence PTX-35 preclinical studies

Heat Biologics CEO Jeff Wolf indicated that PTX-35 will be a first in class potential therapy that will offer a treatment alternative for solid tumors. Wolf stated that the company is about to commence its first human clinical study for PTX-35 in various solid tumors. He added that the company is looking forward to offering additional updates as it achieves expected milestones.

Wolf acknowledged the Cancer Prevention Research Institute of Texas’s efforts, which provided the company a $15.2 million grant. The grant is for supporting preclinical work in the development of PTX-35 as well as cGMP manufacturing and first phase development.