ISA Pharmaceuticals has completed participant enrolment in the Phase II OpcemISA clinical trial of ISA101b in Human Papilloma Virus type 16 (HPV16) induced oropharyngeal cancer (OPC).
The Phase II clinical trial has been designed for evaluating the safety and efficacy of the addition of ISA101b to the checkpoint inhibitor therapy in metastatic/advanced first and second line HPV16 positive OPC patients.
Nearly 194 participants have enrolled in the OpcemISA trial, which is said to be a large placebo-controlled, double blind, randomised Phase II clinical trial.
The overall response rate (ORR) and safety of the therapy will be demonstrated in the trial’s primary endpoints.
Overall survival (OS) and duration of response (DOR) will be the secondary endpoints of the trial.
ISA Pharmaceuticals chief medical officer Dr Leon Hooftman said: “This large proof of concept trial of ISA101b has the potential to demonstrate, for the first time, that the combination of an HPV16-directed therapeutic vaccine with checkpoint inhibitor immunotherapy improves the short-term outcome and longer-term survival of difficult to treat head and neck cancer patients.
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“The completion of enrolment is a major milestone for ISA Pharmaceuticals as it continues development of its SLP technology platform.
“We look forward to presenting top line interim data from this trial in the third quarter of next year.”
The company stated that the OpcemISA trial is part of ISA101b’s extensive clinical development programme, along with biotechnology company Regeneron.
ISA101b received Fast Track designation from the US Food and Drug Administration (FDA) to treat recurrent and metastatic HPV16 positive OPC in September last year.