LUND, SE / ACCESS Newswire / May 9, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX) 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 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.
"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."
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
The information was submitted for publication, through the agency of the contact person set out above, at 8:45 a.m. CEST on 9 May 2025.
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 .
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Alligator Bioscience completes Phase 3 GMP manufacturing of mitazalimab, remains on track for trial initiation with partner
SOURCE: Alligator Bioscience
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/alligator-bioscience-completes-phase-3-gmp-manufacturing-of-mitazalimab-remains-on-tr-1025847
