ADAG - Adagene Merck gets FDA clearance to advance ADG126/Keytruda combo in solid tumor study

Adagene (NASDAQ:ADAG) said it received FDA clearance to proceed with a phase 1b/2 trial of ADG126, in combination with the Merck's (NYSE:MRK) Keytruda (pembrolizumab) in solid tumors. The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific. "The FDA clearance of this trial represents a major step forward in our wholly-owned CTLA-4 program. It builds on a strong safety profile for ADG126 SAFEbody and its parental antibody ADG116, respectively, as a single agent and the ability to achieve doses that may unlock the full potential of CTLA-4 as a proven target for strong ADCC-mediated Treg depletion in the TME," said Adagene's Co-Founder, Chairman and CEO Peter Luo.

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Adagene, Merck gets FDA clearance to advance ADG126/Keytruda combo in solid tumor study