Clinical EfficacyIn HPV16-positive subgroup, the overall response rate increased to 62.5% by RECISTv1.1 and 75% by irRECIST, well above the 12-24% typically observed with standard-of-care ICIs.
Clinical TrialsFirst trial site initiated in VERSATILE-003, a global, multi-center, randomized, and open-label pivotal trial to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab.
Regulatory ApprovalThe FDA has accepted its IND application to assess Versamune-MUC1 in combination with PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma.