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.
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