PDS Biotech Completes First Stage of Enrollment in Checkpoint Inhibitor Refractory Arm of Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

FLORHAM PARK, N.J., Dec. 15, 2022 (GLOBE NEWSWIRE) -- (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the completion of enrollment in the first stage of the checkpoint inhibitor refractory group of its VERSATILE-002 Phase 2 study for the potential treatment of recurrent and/or metastatic human papillomavirus (HPV16)-positive head and neck cancer. 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine.

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab (KEYTRUDA^®) in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations 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 has failed treatments including checkpoint inhibitor therapy (CPI refractory).  

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. During PDS Biotech’s recent Head and Neck Cancer Key Opinion Leader (KOL) Roundtable, Dr. Weiss highlighted data observed from 17 patients, including an objective response rate of 41%, clinical benefit rate of 77%, and an overall survival rate of 87% at nine months.

“We are very pleased to have completed enrollment among checkpoint inhibitor refractory patients in this first stage for this group in our VERSATILE-002 Phase 2 study,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “This important milestone follows continued positive progress with the Phase 2 study, including data presented at ASCO 2022 and updated at our recent Head and Neck Cancer KOL Roundtable demonstrating the potential of PDS0101 in combination with pembrolizumab as a treatment for recurrent or metastatic HPV16-positive head and neck cancer. Currently, there are no approved therapies for CPI refractory head and neck cancer, with patients typically surviving less than a year. Our intent with VERSATILE-002 is to investigate the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.” 

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune^® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune^® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. 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. 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-positive 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, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.  A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16-positive head and neck cancer patients is being conducted at the Mayo Clinic.  

KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 

About VERSATILE-002

VERSATILE-002 is a single-arm Phase 2 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). The combination is being evaluated in CPI-naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022. As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune^® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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