PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101
Rhea-AI Summary
PDS Biotech (Nasdaq: PDSB) announced a U.S. Notice of Allowance for a patent covering PDS0101 (U.S. Application No. 16/210,750) titled “Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes.” The patent will grant composition and method-of-use claims and adds to an existing global IP estate. Combined with anticipated U.S. biologics exclusivity, the company expects approximately 20 years of market protection for PDS0101. PDS0101 is in the Phase 3 VERSATILE-003 trial for HPV16-positive head and neck cancer. The company submitted a protocol amendment to FDA proposing PFS as an earlier primary endpoint to support potential accelerated approval while median overall survival remains the primary endpoint for full approval.
Positive
- U.S. Notice of Allowance for PDS0101 patent (App No. 16/210,750)
- ~20 years of combined market protection with anticipated biologics exclusivity
- Phase 3 VERSATILE-003 ongoing in HPV16-positive head and neck cancer
- Protocol amendment filed with FDA proposing earlier PFS primary endpoint
Negative
- PFS change is proposed and not guaranteed to secure accelerated approval
- mOS remains the primary endpoint for full approval, delaying definitive outcome
News Market Reaction
On the day this news was published, PDSB gained 4.03%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.3% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $53M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PDSB was down 1.53% while peers like CUE, PYPD, MAIA, CAMP, and VTVT showed gains (e.g., CUE up 17.41%), indicating stock-specific trading rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 09 | Clinical trial design | Positive | +7.7% | FDA alignment on PFS as primary endpoint for potential accelerated approval. |
| Dec 09 | IP expansion | Positive | +18.0% | New Japanese patent adds composition-of-matter and use protections for PDS0101. |
| Dec 02 | Regulatory meeting | Positive | +7.0% | FDA Type C meeting scheduled to discuss PFS-based accelerated approval path. |
| Nov 13 | Earnings & clinical | Negative | -12.3% | Q3 loss and going-concern pressures despite positive VERSATILE-002 efficacy data. |
| Nov 11 | Equity offering | Negative | +8.8% | Dilutive registered direct financing to fund trials and corporate purposes. |
Recent PDSB news, particularly clinical and IP milestones, has usually produced aligned price moves, with a notable divergence on the November 2025 financing.
Over the last few months, PDSB has focused on strengthening PDS0101’s clinical and intellectual property position. On Nov 11, 2025, it announced a registered direct offering to fund the Phase 3 VERSATILE-003 trial. Subsequent updates in November and December 2025 detailed positive VERSATILE-002 data and FDA interactions to use PFS as a surrogate primary endpoint for potential accelerated approval. Additional patents, including a new Japanese patent on Dec 9, 2025, expanded global protections. The current U.S. patent allowance further builds on this IP strategy.
Regulatory & Risk Context
An effective Form S-3 shelf filed on Aug 29, 2025 allows PDSB to issue up to $200.0 million in various securities, including up to $20.0 million via a dedicated sales agreement and up to $50.0 million under an existing ATM, of which $5.7 million had been used. This structure provides flexibility to raise additional capital, with potential dilution from options, warrants, and convertible debentures already disclosed.
Market Pulse Summary
This announcement expands PDS0101’s U.S. intellectual property with a newly allowed patent covering cationic lipid-based methods and compositions, complementing protections already granted in multiple regions. Combined with anticipated U.S. biologics exclusivity, the company cites market protections extending over 20 years while VERSATILE‑003 progresses as a Phase 3 trial in HPV16‑positive head and neck cancers. Investors may monitor future regulatory milestones, any additional use of the $200.0 million shelf registration, and updates on accelerated approval plans for further context.
Key Terms
cationic lipids medical
type I interferon genes medical
biologics exclusivity regulatory
progression free survival medical
median overall survival medical
accelerated approval regulatory
AI-generated analysis. Not financial advice.
Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years
PRINCETON, N.J., Jan. 22, 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 that the U.S. Patent Office has issued a Notice of Allowance for the Company’s lead asset, PDS0101.
Once issued, the new patent (U.S. Application No. 16/210,750), titled “Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes,” will grant broad composition of method of use claims. It enhances the Company’s robust intellectual property estate, which includes previously granted patents in the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong.
"This patent reinforces the value of our proprietary Versamune® platform and our lead asset PDS0101 as we advance through late-stage development," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "With VERSATILE-003 progressing and a robust intellectual property portfolio now extending across multiple major markets, we are well-positioned to bring this promising immunotherapy to patients with head and neck cancers."
The new patent, combined with anticipated U.S. biologics exclusivity, should provide approximately twenty years of market protections for PDS0101, which is currently being evaluated in the Phase 3 VERSATILE-003 clinical trial in HPV16-positive head and neck cancers. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration (“FDA”) for the clinical trial that would provide the basis for accelerated approval of PDS0101. The amendment proposes changing the progression free survival (“PFS”) endpoint to a primary endpoint that can be evaluated earlier with significant statistical power. Median overall survival (“mOS”) remains the primary endpoint for full approval as originally recommended by FDA.
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 announce about the PDS0101 U.S. patent on January 22, 2026?
How long will PDS0101 be protected after the new patent and biologics exclusivity?
What is the clinical status of PDS0101 (Nasdaq: PDSB) as of January 22, 2026?
What change did PDS Biotech propose to the VERSATILE-003 trial protocol with the FDA?
Does the proposed protocol amendment affect the full approval endpoint for PDS0101?
