OncoSec Medical Incorporated announced that it has entered into a Clinical Trial Collaboration and Supply Agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec's DNA-plasmid interleukin-12 (IL-12) TAVO™ (tavokinogene telseplasmid) with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87. The planned clinical trial will evaluate the overall survival of patients treated with the TAVO™ in combination with KEYTRUDA® versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy. TAVO™ has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA® or OPDIVO® (nivolumab).

KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and/or serve as a pivotal study to support a full licensure. Under the terms of the Agreement, Merck will provide KEYTRUDA®, while OncoSec will provide the investigational drug, TAVO™. Each party will be responsible for its own internal costs, with OncoSec covering third party costs.

Eligible patients must have Stage III or IV unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. KEYNOTE-C87 intends to enroll approximately 400 patients and is planned to be conducted in the U.S., Canada, EU, and Australia. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. OPDIVO® is a registered trademark of Bristol Myers Squibb.