BRIEF—Alligator completes Phase III GMP manufacturing of mitazalimab

Sweden’s immune-oncology firm Alligator Bioscience today announced the successful completion of the manufacture of the first GMP drug product batch of its lead asset mitazalimab using a new improved commercial-scale manufacturing process.

The material is intended for the planned Phase II trial in first line metastatic pancreatic cancer. The batch was produced at Thermo Fisher Scientific, a global leader in pharmaceutical manufacturing. This key milestone underpins the Phase III readiness of mitazalimab.

“The development of an improved commercial-scale process and the successful manufacturing of the Phase III GMP drug product batch marks a significant step in advancing mitazalimab toward late-stage development and further reduces the risk in the development program,” said Søren Bregenholt, chief executive of Alligator Bioscience. “We are proud to have reached this point and remain committed to bringing new treatment options to patients with pancreatic cancer in collaboration with a future partner.”