PDS Biotechnology Corporation (Nasdaq: PDSB) has provided an update on its clinical programs and reported its financial results for the third quarter of 2024. The company is focused on developing immunotherapies that target and kill cancers, as well as vaccines for infectious diseases.
VERSATILE-003 Phase 3 Trial Update
The VERSATILE-003 trial is a Phase 3 study evaluating Versamune® HPV in combination with pembrolizumab compared to pembrolizumab alone as a potential first-line treatment for recurrent or metastatic HPV16-positive head and neck squamous cell cancer (HNSCC). According to Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, minor modifications have been made to the trial design based on investor feedback and discussions with key opinion leaders, with the goal of reducing overall costs and time to achieve an interim data readout and trial completion.
The updated Investigational New Drug (IND) application has been submitted to the U.S. Food and Drug Administration (FDA), and the company anticipates a clearance decision by mid-December, which would allow for site activation to begin in the first quarter of 2025. The revised trial design will include approximately 350 patients, maintaining a 2:1 randomization and median overall survival as the primary endpoint. The design also allows for potential earlier interim readouts and study completion, with reduced execution costs.
IMMUNOCERV Phase 2 Trial Results
Data from the IMMUNOCERV Phase 2 clinical trial, which evaluated Versamune® HPV with chemoradiation in patients with locally advanced cervical cancer, were presented at the American Society for Radiation Oncology (ASTRO) annual meeting. The data demonstrated promising clinical activity and a favorable safety profile. PDS Biotech is exploring next steps for Versamune® HPV in cervical cancer, based on ongoing research in various HPV-positive cancers.
Additional Developments
Updated results from the VERSATILE-002 Phase 2 clinical trial in recurrent or metastatic HPV16-positive HNSCC patients treated with Versamune® HPV and pembrolizumab were presented at the European Society for Medical Oncology (ESMO) Congress 2024. Additionally, the rationale and design of a recurrent prostate cancer trial combining Xtandi® + PDS01ADC versus Xtandi® alone were presented at the 12th Annual Meeting of the International Cytokine and Interferon Society.
Third Quarter 2024 Financial Results
PDS Biotech reported a net loss of approximately $10.7 million, or $0.29 per basic and diluted share, for the three months ended September 30, 2024, compared to a net loss of $10.8 million, or $0.35 per basic and diluted share, for the three months ended September 30, 2023. Research and development expenses increased to approximately $6.8 million for the three months ended September 30, 2024, from $6.4 million for the three months ended September 30, 2023. General and administrative expenses decreased to approximately $3.4 million for the three months ended September 30, 2024, from approximately $4.1 million for the three months ended September 30, 2023. Cash and cash equivalents totaled approximately $49.8 million as of September 30, 2024.
