PDS Biotechnology Corp (PDSB) is advancing its Versamune HPV immunotherapy program, showing promising results in HPV16-positive cancers. The company's Q3 2024 earnings call highlighted key clinical advancements and financial strategies.
VERSATILE-003 Phase III Trial
The VERSATILE-003 trial, a Phase III study evaluating Versamune HPV in combination with pembrolizumab, is slated to begin in the first quarter of 2025. The trial aims to enroll patients with HPV16-positive cancers who are not candidates for surgery, a population distinct from those included in Merck's KEYNOTE-689 trial. Interim data readout is expected approximately six months after completing enrollment, estimated to take about 18 months.
The updated trial design focuses on a two-arm study of Versamune HPV and pembrolizumab, aiming to reduce costs and time to achieve interim data while maintaining statistical power. The FDA has agreed that this approach represents the fastest path to potential approval.
VERSATILE-002 Study Results
Data from the VERSATILE-002 study demonstrated improved median overall survival and objective response rates with Versamune HPV compared to pembrolizumab alone. These findings support the potential of Versamune HPV as a targeted immunotherapy for HPV16-positive head and neck cancer.
IMMUNOCERV Trial and Cervical Cancer
Encouraging data from the IMMUNOCERV trial has prompted discussions with key opinion leaders to determine the next steps for Versamune HPV in cervical cancer. The results showed high overall survival and progression-free survival rates, positioning Versamune HPV as a potential treatment option in the cervical cancer space. The company aims to strategically position the product for optimal impact.
Financial Overview
As of September 30, 2024, PDS Biotechnology Corp reported approximately $50 million in cash and cash equivalents. For Q3 2024, the net loss was approximately $10.7 million, or $0.29 per basic and diluted share, compared to $10.8 million, or $0.35 per basic and diluted share, for Q3 2023. Research and development expenses increased to approximately $6.8 million for Q3 2024, up from $6.4 million in Q3 2023, primarily due to higher manufacturing costs.
Strategic Focus and Competitive Landscape
PDS Biotech is also exploring the addition of PDS01ADC to the VERSATILE-003 trial, conducting dose optimization studies in parallel to determine the best timing for integration. While acknowledging the impressive objective response rates from competitors like Merus in HPV-positive patients, PDS Biotech emphasizes overall survival as the key endpoint for FDA approval. Their data shows significant tumor shrinkage and durability, with 21% of patients experiencing near-complete tumor elimination.
