PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval
Rhea-AI Summary
PDS Biotech (Nasdaq: PDSB) adopted an amended protocol for its Phase 3 VERSATILE-003 trial to add progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer.
Median overall survival (mOS) remains the primary endpoint for full approval; the company proceeded after the FDA 30-day IND review without objection, and management said the amendment could shorten trial duration and reduce costs.
Positive
- Interim PFS added as primary endpoint for accelerated approval pathway
- Completed FDA 30-day IND review without objection
- Amendment aims to shorten trial duration and improve cost efficiency
Negative
- mOS remains primary for full approval, so accelerated approval would be conditional
- Interim PFS does not guarantee regulatory approval or replace confirmatory survival evidence
Key Figures
Market Reality Check
Peers on Argus
Peers in Biotechnology show mixed moves (e.g., CAMP +10.97%, VTVT -6.81%, CUE -3.2%), and momentum scanners only flag ALXO -3.08%, suggesting the setup around PDSB is more stock-specific than sector-driven.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 28 | Phase 2 prostate data | Positive | +1.0% | NCI-led Phase 2 PDS01ADC prostate cancer data with 9.6-month median PFS. |
| Jan 09 | FDA PFS alignment | Positive | +7.7% | FDA alignment on using PFS as primary endpoint for VERSATILE-003 Phase 3. |
| Aug 25 | VERSATILE-002 topline | Positive | +9.2% | Final VERSATILE-002 Phase 2 data showing 39.3-month median OS in CPS ≥1. |
| Jul 10 | CRC cohort expansion | Positive | -1.5% | PDS01ADC colorectal cancer cohort met criteria to expand into Stage 2. |
| Apr 08 | AACR data preview | Positive | -2.9% | Announcement of upcoming PDS01ADC clinical data presentation at AACR 2025. |
Clinical trial updates have often seen positive immediate reactions, with 3 of 5 tagged clinical events showing gains within 24 hours, though two recent data-related announcements drew negative responses.
Over the past year, PDS Biotech has repeatedly advanced its oncology pipeline, particularly PDS0101 and PDS01ADC. Key milestones include strong Phase 2 survival data in VERSATILE-002 with median overall survival of 39.3 months, protocol alignment with the FDA to use PFS for potential accelerated approval, and multiple NCI-led clinical readouts. Today’s protocol amendment adoption for VERSATILE-003 operationalizes that earlier FDA alignment and fits into this pattern of moving PDS0101 toward registrational evidence in HPV16-positive head and neck cancer.
Historical Comparison
In the past year, PDSB issued 5 clinical trial updates tagged similarly, with an average 24-hour move of 2.71%. Today’s protocol-amendment news extends the same VERSATILE program narrative, reinforcing a steady, data-driven path toward potential registration.
Clinical communications show a progression from promising VERSATILE-002 Phase 2 survival data to FDA alignment on PFS as a primary endpoint and now formal adoption of that endpoint in the Phase 3 VERSATILE-003 protocol for PDS0101.
Regulatory & Risk Context
An effective Form S-3 shelf filed on Aug 29, 2025 allows PDSB to offer up to $200.0 million of securities, including an at-the-market facility. Prior usage includes a Nov 12, 2025 424B5 offering under this shelf, and the filing highlights potential dilution from options, warrants, and convertible debentures.
Market Pulse Summary
This announcement formalizes the adoption of an amended VERSATILE-003 Phase 3 protocol that uses progression free survival as an interim primary endpoint while retaining median overall survival for full approval. It builds on prior FDA alignment and strong VERSATILE-002 data with median OS of 39.3 months. Investors may monitor future PFS readouts, financing actions under the $200.0 million shelf, and ongoing liquidity given Q3 2025 cash of $26.2 million.
Key Terms
progression free survival (pfs) medical
accelerated approval regulatory
median overall survival (mos) medical
investigational new drug (ind) application regulatory
u.s. food and drug administration (fda) regulatory
hpv16-positive medical
recurrent and/or metastatic medical
AI-generated analysis. Not financial advice.
Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer
PRINCETON, N.J., Feb. 20, 2026 (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 the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration (“FDA”). Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.
“Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck 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 PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and 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 conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) 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 PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) 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 or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, 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:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com
FAQ
What did PDS Biotech (PDSB) announce on February 20, 2026 about VERSATILE-003?
How could adding PFS as an interim endpoint affect PDS0101's approval timeline for PDSB?
Did the FDA raise objections to PDSB filing the amended VERSATILE-003 protocol?
Does the PFS interim endpoint replace median overall survival for full approval for PDS0101 (PDSB)?
What investor implications did PDS Biotech (PDSB) highlight for the protocol amendment?
