On January 22, 2026 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, reported that the U.S. Patent Office has issued a Notice of Allowance for the Company’s lead asset, PDS0101.
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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.
(Press release, PDS Biotechnology, JAN 22, 2026, View Source [SID1234662168])