OncoSec Medical Inc (NASDAQ: ONCS) has revealed details about its new partnership with Merck. The two signed a Clinical Trial Collaboration and Supply Agreement (“Agreement”), and they seek to undertake an evaluation of the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO™ (tavokinogene telseplasmid) with KEYTRUDA®, which happens to be Merck’s anti-PD-1 therapy. Everything happens in KEYNOTE-C87, which is a global Phase 3 randomized clinical trial.
Details about the trial
The planned clinical trial will focus on patients’ survival after treatment with TAVO™, and it will be essential to evaluate their survival rate. There are many patients globally struggling with metastatic melanoma. The study focuses on patients in their late-stage, specifically the ones refractory to immune checkpoint therapy.
The U.S. Food and Drug Administration (FDA) has already given TAVO™ a Fast Track designation. OncoSec Medical Inc says that KEYNOTE-C87 will be crucial in helping accelerate FDA approval. The company will later focus on obtaining a full license.
The terms of the agreement are such that Merck will be entrusted with the provision of KEYTRUDA®. On the other hand, OncoSec will deliver TAVO™, which happens to be the study’s investigational drug.
Each company in the collaboration will shoulder its internal costs according to the terms of the deal. OncoSec must do its part in paying for third-party costs as stipulated by the terms of the deal.
Eligibility matters a lot in the selection of the patients. The study will settle for the ones with Stage III or IV metastatic melanoma. It is also essential that the patients in question be refractory to prior checkpoint therapy.
KEYNOTE-C87 focuses on the enrollment process of about 400 patients. The enrolment will cover areas such as Australia, E.U., U.S., and Canada.
The Interim Chief Executive Officer of OncoSec Brian Leuthner opines, “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.”