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benzinga Corporate Catalyst Impact 85/100 ● positive

PDS Biotechnology Announces Publication Of Results From Phase 2 Trial Evaluating PDS0101, HPV16-Targeted Immunotherapy, In Combination With Pembrolizumab In JAMA Oncology, Peer Reviewed Journal Of American Medical Association

Sep 22, 2026, 12:08 PM UTC · Primary ticker $PDSB

PDS Biotechnology announced the publication of positive Phase 2 trial results for its HPV16-targeted immunotherapy, PDS0101, in combination with pembrolizumab in JAMA Oncology. The data showed significantly improved overall survival and objective response rates compared to standard of care, indicating a strong potential for the therapy in recurrent/metastatic head and neck squamous cell carcinoma.

PDS Biotechnology announced the publication of Phase 2 trial results for PDS0101 in JAMA Oncology, a highly respected peer-reviewed journal. The key finding of a 39.3 months median overall survival for ICI-naïve patients, significantly higher than the 17.9 months for standard of care, is a major positive. This data, along with improved objective response rates and a favorable safety profile, validates the therapeutic potential of PDS0101. This is a significant long-term opportunity for PDSB, especially given their stated strategy to pursue a partnership for PDS0101, which could lead to substantial licensing revenue or a lucrative acquisition. The recent PIPE financing and exclusive negotiation right granted to NantWorks further underscore the commercial interest in PDS0101, suggesting potential near-term catalysts for the stock.

$PDSB positive Positive clinical trial data publication
Source: benzinga
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