PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101

Core Viewpoint - PDS Biotechnology Corporation has received a Notice of Allowance for its lead asset PDS0101, enhancing its intellectual property estate and providing significant market protections for over 20 years due to the new patent and anticipated biologics exclusivity [1][3]. Intellectual Property and Patent Details - The new patent (U.S. Application No. 16/210,750) is titled "Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes" and will grant broad composition and method of use claims [2]. - This patent strengthens the company's existing intellectual property portfolio, which includes patents granted in major markets such as the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong [2]. Clinical Development and Market Position - PDS0101 is currently in the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers, with a protocol amendment submitted to the FDA to change the progression-free survival endpoint to a primary endpoint for earlier evaluation [3]. - The company is well-positioned to advance its immunotherapy, with the potential for approximately twenty years of market exclusivity for PDS0101 [3]. Company Overview - PDS Biotechnology is focused on transforming cancer treatment through immunotherapy, specifically targeting HPV16-positive head and neck squamous cell cancers [4]. - The lead investigational product PDS0101 (Versamune HPV) is being developed in combination with standard-of-care immune checkpoint inhibitors and other therapies [4].