On June 13, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported 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) (Press release, Alligator Bioscience, JUN 13, 2025, View Source [SID1234653851]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.