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FDA gives the green light for COM701
August 2018
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HOLON, Israel—The clinical hold placed on Compugen Ltd.’s Investigational New Drug application for COM701 by the FDA has been removed, Compugen Ltd. announced last month, adding that it can now begin a clinical study for the compound. COM701 is a first-in-class humanized hybridoma antibody that targets PVRIG in patients with advanced solid tumors. The study will be a first-in-human Phase 1 trial in patients with advanced solid tumors who have failed standard-of-care therapies, and will assess COM701’s safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy as a monotherapy and in combination with a PD-1 inhibitor. PVRIG is a novel B7/CD28-like immune checkpoint target candidate discovered by Compugen, and blocking it with COM701 has shown a strong boost to T cell activation.

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