PDS Biotechnology Corporation filed a protocol amendment with the U.S. Food & Drug Administration on January 9 2026 to change the primary endpoint of its VERSATILE‑003 Phase 3 study from overall survival (OS) to progression‑free survival (PFS). The amendment keeps OS and safety as confirmatory endpoints for full approval while positioning the study to generate earlier, statistically robust data that could support an accelerated approval pathway.
The VERSATILE‑003 trial evaluates PDS0101 (Versamune HPV) in combination with pembrolizumab in patients with HPV16‑positive recurrent or metastatic head and neck squamous cell carcinoma. By shifting to PFS, the study can assess treatment benefit sooner and with greater power, potentially shortening the overall trial duration and expediting regulatory review. The company maintains OS and safety as confirmatory endpoints, ensuring that full approval will still be based on definitive survival benefit and safety data.
Results from the preceding VERSATILE‑002 Phase 2 study underpin the amendment. PDS0101 plus pembrolizumab produced a median OS of 39.3 months and durable PFS in this patient population, outperforming historical outcomes for pembrolizumab alone or with chemotherapy. The strong surrogate signals from VERSATILE‑002 give the company confidence that a PFS‑based accelerated approval is realistic, while the retained OS endpoint preserves the ability to demonstrate long‑term benefit for full approval.
The market for HPV16‑positive head and neck cancer is sizable, with an estimated addressable population of several hundred thousand patients worldwide. PDS Biotech faces competition from other immuno‑oncology programs, including pembrolizumab monotherapy and combination regimens with chemotherapy or targeted agents. By positioning Versamune HPV as a first‑line combination, the company seeks to capture a meaningful share of this growing market and differentiate its product through a novel vaccine‑based immunotherapy platform.
CEO Frank Bedu‑Addo said the protocol amendment “is an exciting next step in our mission to make this promising treatment available to patients in need.” He added that the change “shortens the duration of VERSATILE‑003 and could accelerate our regulatory submission.” PDS Biotech’s financials show a net loss of $0.19 EPS for Q3 2025, but the company has maintained a robust cash position to fund ongoing trials and development. The announcement was well received by investors, reflecting confidence in the company’s strategic regulatory approach and the potential upside of an accelerated approval pathway.
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