Alligator’s lead asset, mitazalimab, is a phase 3-ready second generation CD40 agonist with a best-in-class efficacy-safety profile. Phase 2 data in first line pancreatic cancer showed unprecedented long-term survival benefits with a tripling of 24-month survival over SoC alone, a manageable safety profile, and biomarker data underpinning the MoA.
Mitazalimab has orphan drug status in the US and Europe, and a clear path to regulatory approval in the first line mPDAC setting has been established with FDA and EMA.
Several investigator-led phase 2 studies are ongoing or planned in mPDAC, Biliary Tract Cancer and other cancers.
In addition, we are developing ATOR-4066 a pre-clinical bispecific CD40xCECAM5 showing strong tumor-specific immune activation. ‘4066 has recently entered IND-enabling studies. The molecules is based on our proprietary Neo-X-Prime™ concept and proprietary bsAb format, RUBY™.
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