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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareFDAMoversTrading IdeasGeneralBriefsPhase 1 TrialPhase 2 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!