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PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.
PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.
Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.
Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.
PDS Biotech's VERSATILE-002 Phase 2 clinical trial for first-line recurrent/metastatic HPV16-positive head and neck cancer met primary study endpoints with a 30-month median overall survival, impressive response rates, and a planned Phase 3 trial in 2024. The trial evaluated the combination of Versamune® HPV + KEYTRUDA® (pembrolizumab) and showed promising results. The Company also announced a two-part registrational trial focusing on a triple combination therapy.
PDS Biotechnology (Nasdaq: PDSB) will participate in two investor conferences in May 2024. The first is the Citizens JMP Life Sciences Conference on May 13 in New York, where the company will present and hold 1:1 meetings. The second event is the A.G.P.'s Virtual Healthcare Company Showcase on May 21, featuring a fireside chat with A.G.P.’s Jim Molloy and Scott Henry.
PDS Biotech, a late-stage immunotherapy company, will announce its first quarter 2024 financial results on May 15, 2024. They will also discuss positive data from their VERSATILE-002 Phase 2 clinical trial during a Key Opinion Leader Event on May 8, 2024.
PDS Biotechnology announced details of a virtual Key Opinion Leader (KOL) event focusing on updated Phase 2 trial results and unmet needs in advanced head and neck cancer. The event will discuss the positive data from the VERSATILE-002 trial and plans for a triple combination trial. Panel participants include renowned experts in the field.
PDS Biotech appointed Stephan Toutain as Chief Operating Officer, bringing over 30 years of operational experience in the pharmaceutical industry. Mr. Toutain's expertise in drug development, commercialization, and oncology will be important as PDS Biotech advances its lead program into a pivotal clinical trial. In addition to his appointment, PDS Biotech granted Mr. Toutain a nonstatutory stock option to purchase 200,000 shares of PDS Biotech common stock as an inducement to his employment.
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