PDS Biotech Announces Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Rhea-AI Summary

PDS Biotechnology (NASDAQ: PDSB) has announced the acceptance of three abstracts featuring Versamune® HPV (PDS0101) for presentation at the 2025 ASCO Annual Meeting in Chicago from May 30-June 3, 2025.

The presentations include:

• VERSATILE-003: A Phase 3 randomized trial comparing PDS0101 and Pembrolizumab vs. Pembrolizumab alone for first-line treatment of HPV16-positive recurrent/metastatic head and neck cancer
• VERSATILE-002: Results on overall survival in HPV16 positive recurrent/metastatic head and neck cancer patients treated with PDS0101 and Pembrolizumab
• MC200710: Initial results of PDS0101 alone or with pembrolizumab in locally advanced HPV-associated oropharyngeal carcinoma

Positive

• Multiple clinical trial data presentations at major oncology conference
• Progress in Phase 3 trial (VERSATILE-003) for first-line treatment
• Overall survival data to be presented from VERSATILE-002 study

Negative

• None.

PRINCETON, N.J., April 23, 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 three abstracts on Versamune^® HPV (PDS0101) have been accepted for presentation at the 2025 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 30-June 3, 2025, in Chicago, Illinois.

Details of the presentation are as follows:

Title: VERSATILE-003: A Phase 3, Randomized, Open-label Trial of PDS0101 and Pembrolizumab compared with Pembrolizumab for First-Line Treatment of Patients with HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Abstract Number for Publication: TPS6111
Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDT
Session Type and Title: Poster Session – Head and Neck Cancer
Poster Board Number: 518a
Presenter: Katharine Price, M.D., Associate Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive Cancer Center, and Principal Investigator of the VERSATILE-003 clinical trial

Title: VERSATILE-002: Overall Survival of HPV16 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and Pembrolizumab
Abstract Number for Publication: 6037
Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDT
Session Type and Title: Poster Session – Head and Neck Cancer
Poster Board Number: 445
Presenter: Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at University of North Carolina, and Principal Investigator of the VERSATILE-002 Phase 2 clinical trial
    
Title: Initial results of MC200710 investigating therapeutic vaccine (PDS0101) alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV associated oropharyngeal carcinoma, a Phase 2 window of opportunity trial.
Abstract Number for Publication: 6061
Session Date and Time: Monday, June 2, 2025, 9:00 a.m.-12:00 p.m. CDT
Session Type and Title: Poster Session – Head and Neck Cancer
Poster Board Number: 469
Presenter: David M. Routman, M.D., Department of Radiation Oncology, Mayo Clinic

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.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com

FAQ

What clinical trials for PDS0101 will be presented at ASCO 2025?

Three trials will be presented: VERSATILE-003 (Phase 3), VERSATILE-002, and MC200710 (Phase 2), all focusing on PDS0101's treatment of HPV-related head and neck cancers.

What is the focus of the VERSATILE-003 Phase 3 trial for PDSB?

VERSATILE-003 compares PDS0101 combined with Pembrolizumab versus Pembrolizumab alone for first-line treatment of HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma.

When and where will PDS Biotech present its ASCO 2025 data?

The presentations will take place on Monday, June 2, 2025, from 9:00 a.m. to 12:00 p.m. CDT during the Head and Neck Cancer Poster Session in Chicago.

What types of cancer is PDSB's PDS0101 targeting in clinical trials?

PDS0101 is targeting HPV16-positive head and neck squamous cell carcinoma and HPV-associated oropharyngeal carcinoma.