Portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB) has provided a business update and reported financial results for the second quarter of 2024.
Recent Developments
· Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC.
o This trial will be designed to investigate the combination of Versamune® HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.
- PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024.
· Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC accepted for presentation at the ESMO Congress 2024.
· Provided a survival data update from the ongoing VERSATILE-002 trial in HPV16-positive HNSCC based on data cut from May 17, 2024. o Median overall survival is 30 months, consistent with data cut as of November 30, 2023
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