| Source: PDS Biotechnology Corporation
Event to Discuss the Changing Landscape of HNSCC in context with the Merck KN-689 study and the Rapidly Increasing Incidences of HPV16-positive HNSCC in the United States and Europe
Webinar to be held Tuesday, June 17, 2025, 12:00 PM ET
PRINCETON, N.J., June 09, 2025 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that it will host a virtual key opinion leader (KOL) event featuring Kevin Harrington, MBBS, PhD (The Institute of Cancer Research, United Kingdom) and Katharine A. Price, MD (Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center), to discuss the unmet need and current treatment landscape for recurrent/metastatic HPV16-positive (head and neck squamous cell carcinoma) HNSCC.
The event will review the changing landscape of HNSCC in context with Merck’s KEYNOTE-689 (KN-689) study and the rapidly increasing incidences of HPV16-positive HNSCC in the US and Europe. The event will also include a review of Versamune® HPV, which is currently being evaluated in a Phase 3 clinical trial in combination with pembrolizumab as a first-line treatment for R/M HPV16+ HNSCC, as well as in Phase 2 clinical trials for the treatment of various types of HPV16-positive cancers. Versamune® HPV is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. The panel will discuss the emerging treatment landscape in 1L R/M HNSCC and the view of HPV-positive and HPV-negative HNSCC as two distinct diseases with different underlying causes, pathology, and contributions to the development of HNSCC, as well as identification and treatment of HPV16+ HNSCC.
The event will be moderated by Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. A live question and answer session will follow the formal presentations.
Webcast and Registration Details
Date: Tuesday, June 17, 2025
Time: 12 p.m. – 1:30 p.m. ET
Registration: Click here
About Our Speakers
Kevin Harrington, MBBS, PhD, is Head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in the United Kingdom. In addition to expertise in radiotherapy and chemoradiotherapy, he is an authority on therapeutic approaches to treat metastatic head and neck cancer. Dr. Harrington is a Professor of Biological Cancer Therapies at The Institute of Cancer Research. He was the principal investigator for KEYNOTE-048, the pivotal clinical trial that supported the U.S. Food and Drug Administration approval for the use of pembrolizumab and pembrolizumab + chemotherapy in the first-line treatment of recurrent and/or metastatic HNSCC. Dr. Harrington was an investigator for the VERSATILE-002 clinical trial. He studied medicine at St. Bartholomew’s Hospital in London and began focusing on head and neck cancer as a Ph.D. student at Hammersmith Hospital. Dr. Harrington completed post-doctoral research in molecular medicine at the Mayo Clinic, before being appointed as a Consultant Oncologist at The Royal Marsden National Health Service Foundation in 2001. He has published more than 600 articles on cancer treatment.
Katharine A. Price, MD, is a medical oncologist who specializes in treating patients with cancers of the head and neck, including squamous cell cancers of the upper aerodigestive tract and salivary gland cancers. Dr. Price’s primary research interests include new, deintensified treatments for patients with throat (oropharyngeal) cancer related to human papillomavirus (HPV). She also investigates new therapies for patients with squamous cell cancer of the head and neck, treatments for salivary gland cancer, and cancer survivorship. Dr. Price is an investigator for the VERSATILE-002 study and is the global principal investigator for the VERSATILE-003 study. Dr. Price is also interested in health equity and is working to improve access to cancer screening and treatment for diverse patient populations and awareness of the importance of HPV vaccination to prevent cancer.
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
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 Versamune® HPV, PDS01ADC and other Versamune® 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 Versamune® HPV, PDS01ADC and other Versamune® 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; the Company’s ability to continue as a going concern; 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 of PDS Biotechnology Corporation.
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