Adagene Shares Pop After FDA Clears Phase 1b/2 Trial For ADG126/Keytruda Combo Therapy In Solid Tumors

• The FDA has cleared Adagene Inc's (NASDAQ:ADAG) Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab). 
• The global trial (ADG126-P001 / KEYNOTE-C98) will evaluate patients with advanced/metastatic solid tumors.
• The ADG126-P001 trial is expected to dose the first patients soon. 
• The trial is designed to evaluate safety and tolerability and determine the recommended Phase 2 dose for ADG126 in combination with pembrolizumab. 
• Related: Sanofi Taps Adagene's 'Masking' Tech In Over $2.5B Immuno-Oncology Pact.
• The trial will begin with dose-escalation (ADG126 at 6 mg/kg) followed by dose expansion at the recommended dose for early efficacy evaluation. 
• A combination cohort of ADG126 with the anti-PD-1 therapy, toripalimab, is also initiated in Australia.
• Price Action: ADAG shares are up 23.70% at $6 during the market session on the last check Wednesday.