PDS Biotech Announces Plan to Initiate Phase 3 Study

PDS Biotechnology Corporation recently announced it has completed key tech transfer, scale up, and manufacturing activities required to initiate a global, multicenter Phase 3 registrational trial investigating the combination of PDS0101 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in the fourth quarter of 2023. The Phase 3 trial, named VERSATILE-003, will investigate the combination compared to KEYTRUDA monotherapy for the treatment of unresectable, recurrent/metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).

In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the US FDA in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally.

PDS Biotech’s plan to initiate the VERSATILE-003 trial follows the successful completion of an End-of-Phase 2 meeting in the third quarter of last year with the FDA, during which PDS Biotech received guidance from the FDA on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). Data reported at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting indicated the combination of PDS0101 and KEYTRUDA achieved an objective response rate of 41% and an overall survival rate of 87% at nine months in 17 evaluable patients with HPV16 and PD-L1 positive recurrent or metastatic HNSCC. Safety data reported on the first 43 patients enrolled in the trial suggested that the combination was well tolerated with no treatment-related Grade 3 or 4 Adverse Events. Based on these data, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.

“With the maturing data from VERSATILE-002, we are pleased to now have visibility into the progression free survival and potential overall survival, and we are excited to move into the final stage of development for our lead asset, PDS0101. The initiation of a randomized, controlled Phase 3 registrational trial of PDS0101 in combination with KEYTRUDA as a potential treatment for recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma is a significant milestone for the Company,” stated said Dr. Frank Bedu-Addo, PDS Biotech CEO. “Head and neck cancer remains a devastating diagnosis with a significant unmet medical need. Our goal is to advance this Phase 3 trial as expeditiously as possible to provide additional treatment options for these patients. We are proud to have achieved this milestone on the eve of Oral, Head and Neck Cancer Awareness Month.”

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) compared to KEYTRUDA monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the FDA in June 2022.

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune, Versamune plus PDS0301, and Infectimune T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune based vaccines have also 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 in pre-clinical studies to date. For more information, visit www.pdsbiotech.com.