Portfolio company PDS Biotechnology Corporation (Nasdaq: PDSB) has provided a business update and reported financial results for the third quarter of 2024.
PDS Biotech is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines.
Recent Developments
· Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive first-line recurrent and/or metastatic HNSCC
Updated trial design to include approximately 350 patients
·VERSATILE-002 results have shown broadly improving clinical responses across multiple parameters with increases in patient size and duration of patient follow up over the last year, demonstrating durability of the anti-tumour responses
· The design, which is informed by the observed durability of the clinical responses, retains statistical power and remains within the confines of PDS Biotech’s agreement with the FDA on registrational design
· In September 2024,PDS Biotech provided updated results from the PDS Biotech VERSATILE-002 Phase 2 clinical trial in recurrent and/or metastatic HPV16-positive HNSCC patients treated with the combination of Versamune® HPV and pembrolizumab presented at European Society for Medical Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial.
In October 2024, PDS Biotech provided updated results from the PDS Biotech IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy presented at the ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD Anderson Cancer Center.
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