PDS Biotech Adds PFS Interim Primary Endpoint to Phase 3 VERSATILE-003 Trial for PDS0101 in HPV16-Positive Head and Neck Cancer

Reuters

Feb 20

PDS Biotech Adds PFS Interim Primary Endpoint to Phase 3 VERSATILE-003 Trial for PDS0101 in HPV16-Positive Head and Neck Cancer

PDS Biotechnology Corporation announced it has adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101 (Versamune HPV) in HPV16-positive recurrent and/or metastatic head and neck cancer. The amendment adds progression-free survival $(PFS)$ as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival remains the primary endpoint for full approval. The company said it is proceeding with the amended protocol after the FDA’s 30-day review period elapsed without objection. No trial results were reported in the announcement, and no presentation of results was specified.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PDS Biotechnology Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9657887-en) on February 20, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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The amendment adds progression-free survival <a href=\"https://laohu8.com/S/PFS\">$(PFS)$</a> as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival remains the primary endpoint for full approval. The company said it is proceeding with the amended protocol after the FDA’s 30-day review period elapsed without objection. No trial results were reported in the announcement, and no presentation of results was specified.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PDS Biotechnology Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9657887-en) on February 20, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SG9999014013.SGD","symbol_name":"United Global Durable Equities Fund Dis SGD","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260220:nNDL9dHm2J:1","article_id":"2612262758","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2612262758","pubTimestamp":1771594229,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"PDS Biotech Adds PFS Interim Primary Endpoint to Phase 3 VERSATILE-003 Trial for PDS0101 in HPV16-Positive Head and Neck Cancer. PDS Biotechnology Corporation announced it has adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101  in HPV16-positive recurrent and/or metastatic head and neck cancer. The amendment adds progression-free survival  as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival remains the primary endpoint for full approval. The company said it is proceeding with the amended protocol after the FDA’s 30-day review period elapsed without objection. No trial results were reported in the announcement, and no presentation of results was specified.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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The amendment adds progression-free survival $(PFS)$ as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival remains the primary endpoint for full approval. The company said it is proceeding with the amended protocol after the FDA’s 30-day review period elapsed without objection. No trial results were reported in the announcement, and no presentation of results was specified.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PDS Biotechnology Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. 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