- FDA feedback reinforces manufacturing strategy reducing regulatory risk of the program
- Feedback confirms completed and planned CMC-work as Phase 3-enabling
- Company remains on track for Phase 3 initiation during 2025
Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX.
A recent Type C CMC interaction with the FDA in December 2024 reinforced feedback received from the PEI in July 2024, confirming that the completed and planned CMC work through early 2025 enables the Phase 3 development of mitazalimab. With this feedback, Alligator initiated manufacturing of mitazalimab to be used in the Phase 3 study, and thus remains on track for initiation of Phase 3 clinical activities during 2025.
“This regulatory feedback from both the FDA and PEI demonstrates the robustness of our CMC development strategy and validates the significant progress we’ve made in advancing mitazalimab towards Phase 3” said Søren Bregenholt, CEO of Alligator Bioscience. “We are confident in our ability to continue to execute on our timeline and bring mitazalimab one step closer to addressing the urgent unmet need for patients with metastatic pancreatic cancer.”