Full Press Release Details
PDS Biotech to Present Updated Immune Response Data from Combination of PDS0101 and KEYTRUDA (pembrolizumab) in Head and Neck Cancer Patients at
Data from ongoing VERSATILE-002 trial to highlight HPV16-specific T cell responses in subjects receiving PDS0101 and KEYTRUDA for recurrent or
metastatic HPV16-positive head and neck cancer
Florham Park, NJ, July 25, 2023 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer
immunotherapies and infectious disease vaccines based on the Company's proprietary T cell activating platforms, today announced that an abstract detailing immune response data from the VERSATILE-002 Phase 2 clinical trial investigating PDS0101 in
combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer has been accepted for presentation at the European Society for
Medical Oncology Congress 2023 (ESMO Congress 2023). ESMO Congress 2023 is being held October 20-24, 2023 in Madrid.
The abstract, titled, "Polyfunctional HPV16-Specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic
HPV16-positive head and neck squamous cell carcinoma (HNSCC)," reports on the ability of PDS0101 in combination with KEYTRUDA to induce the right type of HPV16-specific multifunctional T cell responses in the treatment of advanced HPV16-positive
head and neck cancer. PDS0101 is designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. The immunological clinical data demonstrates the immunotherapy's potential to generate clinically-relevant multifunctional
HPV16-targeted CD8 and CD4 T cells with minimal toxicity in advanced head and neck cancer patients.
"We are pleased to present biomarker data from the VERSATILE-002 clinical trial among a gathering of the world's leading members of the clinical and scientific
oncology community at ESMO Congress 2023," stated Lauren V. Wood, M.D., PDS Biotech's Chief Medical Officer and a co-author of the study. "The incidence of HPV-positive head and neck cancers is growing rapidly, and there is currently a lack of
effective targeted therapies to address this population. To date, multiple studies in early-stage and advanced cancer patients have demonstrated the ability of PDS0101 to induce
high levels of active and potent HPV16-specific CD4 and CD8 multifunctional T cells, as well as long-lasting memory CD8 T cells, substantiating the potential for PDS0101 combined with KEYTRUDA to expand the range of treatments addressing
HPV16-positive head and neck cancers."
Abstract Title: Polyfunctional HPV16-Specific T
cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC)
Abstract Number: 6982
Presenting Author: Dr. Kevin Harrington, Ph.D.,
Professor of Biological Cancer Therapies, The Royal Marsden
Authors: K. Harrington, J. Weiss, K. Price, J.
Kaczmar, D. Schaaf, N. Riebel, S. Jones, A. Cotty, S. McCarthy, L. Wood
For patients interested in enrolling in this clinical trial, please contact NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615)
and/or the Web site: https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.
PDS0101, PDS Biotech's lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack
against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate
multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101with other treatments can demonstrate significant disease control by
reducing or 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-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 immune checkpoint inhibitor (ICI)-na ve and ICI-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.
Interim efficacy and safety data will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-na ve patients. Preliminary data from
the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed.
KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
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 , 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 and shrink 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
Forward Looking Statements
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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,
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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 the Company's 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. 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 other risks,
uncertainties, and other factors described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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.
KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
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