Since the outbreak of the COVID-19 pandemic, many pharmaceutical companies have joined the race of developing novel vaccines, and US-based Heat Biologics Inc. (NASDAQ:HTBX) is one of them. The company’s PTX-35, the first antibody product candidate, has successfully undergone the first-in-human Phase 1 clinical trial evaluating. It has treated the first patient.
The study will be enrolling up to 30 patients who should have advanced solid tumors refractory to standard of care. The objectives of the study are broad, according to the CEO of Heat Biologics, Jeff Wolf. They include the determination of the endorsed Phase 2 dose, safety evaluation, and the exploration of clinical benefit analyses.
PTX-35 Will Offer a Differentiated Methodology of Helping Cancer Patients
Heat Biologics has always been at the lead of developing first-in-class therapies to modulate the immune system. Just like many other companies, it has multiple product candidates in different stages of the trial, including HS-130, which is in the Phase 1 stage of the trial.
As a potential first-in-class antibody T-cell co-stimulator, PTX-35 will reportedly provide an enhanced approach to the benefit of cancer patients. It will also allow the company to initiate its first-in-human study following FDA clearance of the Investigational New Drug (IND) Application.
Wold says, their project has received overwhelming support. The first was $15.2 million worth of grant from the Cancer Prevention and Research Institute of Texas (CPRIT). This will go into various stages of evaluation of PTX-35, including pre-clinical development, manufacturing, and Phase 1 clinical development.
Heat Biologics’ Collaboration with Waisman Biomanufacturing
Waisman’s specialization is in the development of various biologics for early-stage clinical trials. This is the sole reason Heat Biologics’ has reached for a collaboration given that is COVID-19 vaccine is in Phase 1 trials in humans. On the other hand, the company’s proprietary gp96 platform is uniquely designed to provide broad protection against COVID-19.
The two companies have previously worked together in the manufacturing project of Heat’s HS-130. Hence, they confident about the final results of their target; the COVID-19 vaccine.
However, Heat says the older people and those with underlying conditions like diabetic are not likely to benefit from the Covid-19 vaccines.