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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 Biotechnology Corporation (Nasdaq: PDSB) announced that its abstract, featuring updated data from the VERSATILE-002 study, has been selected for presentation at the 2023 ASCO Annual Meeting on June 5, 2023. This Phase 2 study investigates the safety and efficacy of PDS0101 combined with KEYTRUDA® in treating patients with HPV16-positive head and neck cancer. The study focuses on two groups: ICI-naïve and ICI-refractory patients. Preliminary results show that 77% of patients had disease stabilization or tumor shrinkage, with an 87% overall survival rate at 9 months. The presentation will be part of the Head and Neck Cancer session, highlighting PDS0101's potential as a targeted therapy for this growing patient demographic.
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