Key Highlights
- PDS Biotech amended its Phase 3 VERSATILE-003 trial to include progression-free survival (PFS) as an interim primary endpoint.
- The protocol update creates a potential accelerated approval pathway for PDS0101 in HPV16+ recurrent or metastatic head and neck cancer.
- The FDA did not object during its 30-day review period, allowing the amended study design to move forward.
Shares of PDS Biotechnology Corporation (NASDAQ:PDSB) drew attention after the company announced it had amended the protocol for its Phase 3 VERSATILE-003 clinical trial. This creates a potential pathway for accelerated approval of its lead immunotherapy candidate, PDS0101.
The amendment introduces progression-free survival (PFS) as an interim primary endpoint. Median overall survival will remain the trial’s primary endpoint for full approval, consistent with prior regulatory discussions following a Type C meeting with the U.S. Food and Drug Administration.
Importantly, the U.S. Food and Drug Administration did not object to the amended protocol during its standard 30-day review period after the company filed the update under its Investigational New Drug application. With the review complete, PDS Biotech is proceeding under the revised study design.
Potential to Shorten Timeline
The VERSATILE-003 trial is evaluating PDS0101 in combination with a standard-of-care immune checkpoint inhibitor for patients with HPV16+ recurrent and/or metastatic head and neck squamous cell carcinoma. By adding PFS as an interim endpoint, the company may be able to evaluate efficacy earlier, potentially reducing the time required for regulatory submission.
President and CEO Frank Bedu-Addo stated that incorporating PFS as an interim primary endpoint could shorten the trial’s duration while improving cost efficiency, a key consideration as biotechnology companies navigate tighter capital markets.
Financial Context
The strategic adjustment comes at a financially sensitive time for PDS Biotech. While the company reports a current ratio above 2.09, indicating liquid assets exceed short-term liabilities, it continues to operate with negative free cash flow.
The stock trades near its 52-week low at $0.66, down 54% over the past 12 months, giving the company a market capitalization of $36 million.
Despite these pressures, management maintains that the amendment strengthens both the regulatory and operational positioning of the VERSATILE-003 program.
Broader Development Pipeline
Beyond head and neck cancer, PDS Biotech is advancing additional immunotherapy programs. The company is developing a triple-combination regimen that includes PDS01ADC, an IL-12-fused antibody-drug conjugate. It has recently secured additional intellectual property protections for PDS0101 in the United States and internationally.
Based in Princeton, New Jersey, PDS Biotech describes itself as a late-stage immunotherapy company focused on targeted cancer treatments. The latest protocol amendment underscores its effort to accelerate value creation while navigating the capital-intensive realities of late-stage clinical development.