Alligator Bioscience

• Recruitment completed for the additional cohort with 450 µg/kg of mitazalimab in combination with mFOLFIRINOX as requested by FDA ahead of Phase 3 initiation
• Alligator remains on track for mitazalimab Phase 3 initiation H1 2025

Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced an update on the on-going OPTIMIZE-1 clinical Phase 2 trial with the company’s lead asset, mitazalimab. All patients in the 450 µg/kg back-fill cohort have been enrolled.

The additional cohort was enrolled in order to provide further dose characterization following advice from the FDA, to ensure mitazalimab Phase 3 readiness.

“We are pleased to see the recruitment completed in a very swift manner, a testament to the committed work by the Alligator team and the great engagement of the study investigators and their research staff involved in the OPTIMIZE-1 trial”, said Søren Bregenholt, CEO of Alligator Bioscience. “We are committed to bringing mitazalimab to patients as soon as possible, and this back-fill cohort is an important step to complete the dose-characterization and ensure mitazalimab’s Phase 3-readiness in accordance with the guidance from FDA.”

OPTIMIZE-1, an open-label, single-arm, multicenter, Phase 1b/2 study, assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX in 1st line pancreatic cancer. On June 26, the 18-month follow-up analysis was reported, demonstrating robust data with substantial survival benefits compared to standard of care chemotherapy.