PDS Biotech Achieves Safety Requirement Milestone For the First 12 Patients in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Advanced Head and Neck Cancer

FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer achieved its preliminary safety benchmark in its first 12 patients. Enrollment in the trial, which studies PDS0101 administered in combination with KEYTRUDA^® (pembrolizumab), will now continue to full enrollment of the first stage of the study, which will assess efficacy in 17 checkpoint inhibitor (CPI) naïve patients and in an additional group of 21 patients who have also failed prior therapy with checkpoint inhibitors (CPI refractory). The trial is being conducted in collaboration with Merck & Co.

VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory). As specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) among at least four of the first 17 patients in the CPI naïve arm and at least 2 patients in the first 21 patients of the CPI refractory arm will trigger advancement to the second stage of the study and full enrollment of the planned 95 patients.

“The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence regarding the safety of PDS0101. Treatment-related adverse events (TRAEs) generally appear to be limited to transient, manageable local injection site reactions,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “There is an enormous unmet medical need for more effective treatment of advanced head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA^® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to continuing to share data from this trial as they become available.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email or visit the website at /VERSATILE-002 to learn more.

The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI). That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers. That trial has enrolled patients with anal, cervical, head and neck, vaginal and vulvar cancer, who have failed prior treatment. Objective responses measured according to RECIST 1.1 (tumor reduction of 30% or more) were reported in 83% (5/6) of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% (7/12) and objective responses in 42% (5/12). Two patients, one in each group were reported to have a complete response (no evidence of disease) at the time of reporting. Clinical responses were observed in all HPV16-positive tumor types enrolled. More information on this study can be found on PDS Biotech’s website.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. 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 breast, colon, lung, prostate and ovarian cancers. To learn more, please visit or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and locally advanced cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

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