PDS Biotechnology Submits Protocol Amendment To FDA For Its Phase 3 VERSATILE-003 Study

PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration ("FDA") for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.