ISA Pharmaceuticals BV, a Netherlands-based clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, announced on Wednesday that it has completed enrolment in its Phase two ISA101b clinical trial, named OpcemISA.

The trial, a large randomised, double blind, placebo-controlled Phase 2 clinical trial, has enrolled 194 patients. It is to assess the efficacy and safety of the addition of ISA101b to checkpoint inhibitor therapy in patients with metastatic/advanced first and second line HPV16 positive oropharyngeal cancer (OPC).

Primary endpoints will demonstrate overall response rate (ORR) and safety. Secondary endpoints include duration of response (DOR) and overall survival (OS). This trial is part of an extensive clinical development program of ISA101b in collaboration with US biotechnology company Regeneron.

Top line interim results anticipated in third quarter of 2023.