Alligator Bioscience Receives FDA Endorsement of Mitazalimab Phase 3 Dose for Pancreatic Cancer

Lund, Sweden – 13 June 2025 – Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback supporting the selection of the 900 µg/kg dose of its CD40 agonist mitazalimab for the planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC).

This positive regulatory feedback confirms Alligator’s dose selection and represents a key milestone in the late-stage development of mitazalimab.

“We are very pleased with the FDA’s timely and constructive response. This marks an important step forward as we finalize our Phase 3 program for mitazalimab in one of the most aggressive and underserved cancers. We are now in active partnering dialogues aiming to secure the right partner to take mitazalimab into Phase 3,” said Søren Bregenholt, CEO of Alligator Bioscience.

About Alligator Bioscience

Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company’s lead drug candidate mitazalimab is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1.

Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.

For more information, please visit alligatorbioscience.com.

Source: Alligator Bioscience