PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate

PDS Biotechnology Corporation recently announced the US FDA has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). PDS0101 in combination with KEYTRUDA is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck (known as MSD outside the US and Canada).

The FDA’s Fast Track designation program is designed to aid in the development and to expedite the review of drug candidate applications that could potentially treat serious or life-threatening conditions. In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need. Treatments granted this designation are given the opportunity to have more frequent meetings and interactions with the FDA throughout the entire drug development and review process, with the goal of moving promising new drugs more rapidly through the process. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, Fast Track designated products are eligible for Priority Review at the time of NDA or Biologics License Application submission.

“We are thrilled that the FDA has granted Fast Track designation for PDS0101 in combination with KEYTRUDA,” said Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech. “The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores the potential of the Versamune platform and the need for a new therapy that may improve outcomes for those with this devastating disease.”

PDS Biotech’s lead candidate, PDS0101, is a T cell HPV-specific immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways. These HPV-specific T cells have been shown to target tumors such as anal, cervical, head and neck, penile, vaginal, vulvar that are caused by HPV16 infection. The incidence of head and neck cancer cases has been increasing steadily over the last 10-15 years and over 90% of HPV-positive head and neck cancers are caused by HPV16. In addition to the Phase 2 VERSATILE-002 trial, PDS Biotech is also conducting three additional Phase 2 studies in advanced HPV-associated cancers, locally advanced cervical cancer, and early-stage pre-metastatic HPV-associated oropharyngeal cancer with the National Cancer Institute (NCI), The University of Texas MD Anderson Cancer Center, and Mayo Clinic, respectively.

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the company’s proprietary Versamune and Infectimune T cell activating technology platforms. We believe our Versamune-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers. Our Infectimune -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses including long-lasting memory T cell responses. For more information, visit www.pdsbiotech.com.