PDS Biotech Announces Dramatic Increase in Overall Survival for Advanced Cancer Patients With Few Treatment Options

The National Cancer Institute recently conducted a Phase 2 clinical trial to assess the efficacy of PDS0101 triple combination in treating HPV16-positive cancer patients who had become refractory to checkpoint inhibitor (CPI) therapy. The results of the trial showed that 29 patients treated with the triple combination therapy had a median overall survival of 21 months.

PDS Biotechnology Corporation (Nasdaq: PDSB) today announced exciting interim data from a Phase 2 clinical trial of a groundbreaking triple combination therapy for advanced human papillomavirus (HPV)-positive cancers. The combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β), is being studied in both CPI-naïve and CPI-refractory patients with anal, cervical, head and neck, vaginal, and vulvar cancers. This novel therapy has the potential to revolutionize treatment for HPV-positive cancers, offering hope for those affected.

The National Cancer Institute (NCI), a part of the National Institutes of Health, is conducting a groundbreaking Phase 2 trial (NCT04287868) at its Center for Cancer Research (CCR). This revolutionary triple combination trial has the potential to revolutionize the treatment of cancer and could lead to life-saving therapies.

Interim efficacy data from 50 evaluable patients, 37 of which were HPV16-positive, revealed promising results. Despite having already failed treatment with chemotherapy and 90% having failed radiation treatment, 29 of these patients had further responded positively to treatment with CPIs – a promising sign for those struggling with this form of cancer. These results, consistent with those presented at ASCO 2022 and in October, are a step in the right direction for those seeking relief from this devastating disease.

The triple combination has proven to be highly effective in treating checkpoint inhibitor refractory patients, with a median overall survival of 21 months – more than five times the reported historical median of 3-4 months. Similarly, in CPI naïve subjects, the median overall survival has not yet been reached, but 75% remain alive at a median follow-up of 27 months – far outpacing the reported historical median of 7-11 months. The objective response rate for CPI refractory patients was also impressive, at 63% – far higher than the reported 10% for current approaches. And for CPI naïve patients, the triple combination produced an even more remarkable 88% objective response rate – significantly better than the reported 25% with FDA-approved CPIs and chemotherapy. Finally, the safety of the triple combination has remained consistent, with 48% of patients experiencing moderate treatment-related AEs and only 4% experiencing severe AEs – compared to the 70% of patients receiving the combination of CPIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

The continued consistency in the data of PDS Biotech’s PDS0101-based triple combination therapy in advanced HPV-positive cancers is showing great promise, making it a potential treatment for a previously untreatable population. Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, is pleased to see the results and looks forward to discussing the registrational pathway with the FDA. Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany, and its affiliates.

About PDS Biotechnology

PDS Biotech is leading the way in immunotherapy innovation with its groundbreaking Versamune® and Infectimune™ T cell-activating technology platforms. Our clinical-stage pipeline of targeted cancer and infectious disease immunotherapies has been designed to overcome the limitations of current immunotherapies by stimulating the production of large quantities of powerful, high-quality CD4+ helper and CD8+ killer T cells. Our lead Versamune® candidate PDS0101, has already demonstrated impressive results in Phase 2 clinical trials treating a range of HPV-positive cancers. Meanwhile, our Infectimune™ based vaccines have been proven to induce both neutralizing antibodies and long-lasting memory T cell responses in pre-clinical studies. To learn more, visit our website or follow us on Twitter.

About PDS0101

PDS Biotech is partnering with Merck & Co. and the National Cancer Institute to evaluate an innovative combination of its Versamune®-based lead candidate, PDS0101, and KEYTRUDA® in multiple clinical studies. In particular, Phase 2 studies are being conducted in both first-line and second/third-line treatment of recurrent or metastatic head and neck cancer, as well as first-line treatment of locally advanced cervical cancer. These studies represent a major step forward in developing targeted therapies for HPV-positive cancers.

Forward Looking Statements

PDS Biotechnology Corporation has made forward-looking statements about its future plans, trends, events, results of operations or financial condition. These statements are based on the current beliefs and assumptions of the Company’s management, and are subject to risks, uncertainties, and other factors. Actual results could differ from those contained in any forward-looking statement as a result of various factors, including the Company’s ability to protect its intellectual property rights and its dependence on additional financing. The Company’s product candidates, including PDS0101, PDS0203, and other Versamune® and Infectimune™ based product candidates, are currently undergoing clinical trials, and the results of these trials could have a significant impact on the Company’s future success. The Company is also actively seeking additional financing to fund its operations and to complete the development and commercialization of its product candidates. With these factors in mind, the future success of the Company is far from certain and investors should exercise caution.

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