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 ADAG Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's 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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