On May 9, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported 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 (Press release, Alligator Bioscience, MAY 9, 2025, View Source [SID1234652817]). The material is intended for the planned Phase 3 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 3 readiness of mitazalimab.

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"The development of an improved commercial-scale process and the successful manufacturing of the Phase 3 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, CEO 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."