Adagene Shares Jump After FDA Signs Off ADG116/Keytruda Combo Therapy Trial In Solid Tumors

The FDA has cleared Adagene Inc's ADAG Investigational New Drug (IND) application to proceed with a Phase 1b/2 trial of ADG116, in combination with Merck & Co Inc MRK Keytruda (pembrolizumab). 

• The global trial (ADG116-P001 / KEYNOTE-C97) will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and the Asia Pacific (APAC).
• Related Link: Adagene To Test Its Anti-CTLA-4 Monoclonal Antibodies In Combination With Keytruda In Solid Tumors.
• ADG116 is designed with a soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.
• The trial is designed to evaluate the safety, tolerability, determine the maximum tolerated dose, and assess the preliminary efficacy of the combination of ADG116 and pembrolizumab.
• The study will start dosing the first patient in early 2022 and
• Additionally, the ongoing ADG116-1003 trial is on track to expand with two combination cohorts investigating the safety and preliminary efficacy of ADG116 with either toripalimab or ADG106 in patients with advanced/metastatic solid tumors.
• Price Action: ADAG shares are up 6.71% at $9.07 during the premarket session on the last check Tuesday.