PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Rhea-AI Summary

PDS Biotechnology (NASDAQ: PDSB) has confirmed its plans to initiate the VERSATILE-003 Phase 3 clinical trial in Q1 2025. The trial will evaluate Versamune® HPV plus pembrolizumab as a first-line treatment for recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).

The company submitted its updated clinical protocol on November 15, 2024, amending the IND application. The FDA's comment period has concluded, and the company has received Fast Track designation for the combination therapy. The trial will utilize a newly validated companion diagnostic to confirm HPV16-positive HNSCC during patient screening, marking the first investigational use of this type of diagnostic in a Phase 3 HNSCC trial.

HPV16-positive patients represent a growing subgroup requiring targeted therapies, with HPV16-positive HNSCC expected to become the dominant type in the US and EU.

Positive

• FDA Fast Track designation received for Versamune® HPV and pembrolizumab combination
• FDA clearance obtained for amended trial design
• First-ever use of companion diagnostic for HPV16-positive HNSCC in Phase 3 trial
• Trial addresses growing market of HPV16-positive HNSCC patients

Negative

• None.

Insights

Clinical Trial Expert

The FDA's tacit approval of PDS Biotech's amended Phase 3 protocol marks a crucial advancement in the company's clinical development strategy. The VERSATILE-003 trial, investigating Versamune® HPV with pembrolizumab, addresses an expanding market opportunity in HPV16-positive head and neck cancer treatment.

Three key elements make this development particularly significant:

• The Fast Track designation suggests the FDA recognizes the urgent unmet medical need and the therapy's potential to address it
• The incorporation of a validated companion diagnostic represents a strategic advantage, potentially streamlining patient selection and improving treatment outcomes
• The focus on HPV16-positive HNSCC, projected to become the dominant subtype in major markets, positions the therapy at the forefront of a growing therapeutic need

The companion diagnostic integration is particularly noteworthy as it represents the first such application in a Phase 3 HNSCC trial. This approach could establish a new standard for patient selection in head and neck cancer treatment, potentially improving response rates and commercial success probability.

Market Research Analyst

The strategic positioning of VERSATILE-003 in the first-line treatment setting for R/M HPV16-positive HNSCC represents a significant market opportunity. With HPV16-positive HNSCC projected to become the dominant subtype, PDS Biotech is targeting a rapidly expanding market segment.

The companion diagnostic strategy is particularly compelling from a commercial perspective:

• It creates a potential dual revenue stream through both therapeutic and diagnostic products
• Enables precise patient selection, potentially leading to better efficacy data and stronger market positioning
• Establishes a competitive barrier through standardized patient identification

The Fast Track designation not only accelerates the regulatory pathway but also signals potential market advantages, including:

• Earlier market entry possibility
• Enhanced competitive positioning against existing treatments
• Increased visibility among healthcare providers and payers

FDA-cleared amended trial design; First site initiation expected Q1 2025

PRINCETON, N.J., Feb. 05, 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 reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune^® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.

PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune^® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

“The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune^® HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

“HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating 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
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Email: jmccargo@6degreespr.com

FAQ

When will PDS Biotech (PDSB) start the VERSATILE-003 Phase 3 trial?

PDS Biotech plans to initiate the VERSATILE-003 Phase 3 trial in the first quarter of 2025.

What is the purpose of PDS Biotech's VERSATILE-003 Phase 3 trial?

The trial will evaluate Versamune® HPV plus pembrolizumab as a first-line treatment for recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).

Has PDSB received FDA Fast Track designation for its HNSCC treatment?

Yes, PDS Biotech has received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC.

What diagnostic tool will PDSB use in the VERSATILE-003 trial?

The trial will use a recently validated companion diagnostic to confirm HPV16-positive HNSCC during patient screening, marking the first such use in a Phase 3 HNSCC trial.

When did PDSB submit its updated clinical protocol for VERSATILE-003?

PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application.