On July 6, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it has entered into a Clinical Trial Collaboration and Supply Agreement ("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 (Press release, OncoSec Medical, JUL 6, 2021, View Source [SID1234584630]). 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.
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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.
"We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available," said Brian Leuthner, Interim Chief Executive Officer of OncoSec. "This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO in combination with KEYTRUDA with the goal of helping more patients with cancer."
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.
About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.