Alligator Bioscience's Mitazalimab Receives Positive FDA Feedback, Phase 3 Initiation on Track
Key Insights
Alligator Bioscience (search) completed an End-of-Phase 2 interaction with the FDA, receiving positive feedback on its clinical development strategy for mitazalimab.
The FDA confirmed that the existing toxicology data package is adequate for the Biologics License Application (BLA) submission, reducing program risk.
Mitazalimab, combined with mFOLFIRINOX, is being developed as a first-line treatment for metastatic pancreatic cancer (search), with Phase 3 initiation planned for 2025.
Alligator Bioscience (search) has announced the successful completion of its End of Phase 2 (EOP2) interaction with the US Food and Drug Administration (FDA) regarding mitazalimab, a drug candidate being developed as a first-line treatment for metastatic pancreatic cancer (search) in combination with mFOLFIRINOX. This positive outcome strengthens the prospects for initiating Phase 3 trials in 2025.
The EOP2 meeting with the FDA yielded positive feedback and alignment on the non-clinical and clinical data packages required to support the Biologics License Application (BLA). This reinforces earlier regulatory guidance received from the Paul Ehrlich Institute (PEI) of Germany in July 2024. A Type C Chemistry, Manufacturing, and Controls (CMC) interaction with the FDA in December 2024 further confirmed that the CMC work completed and planned through early 2025 is Phase 3-enabling.
OPTIMIZE-1 Study Update
Alligator Bioscience (search) expanded patient recruitment in the ongoing OPTIMIZE-1 study during 2024 by enrolling an additional 15 patients at the 450 µg/kg dose level, following FDA guidance from December 2023. Results from this cohort, along with a 24-month follow-up on the 900 µg/kg dose group, are expected in Q1 2025. The company updated the FDA on these activities, and no new information emerged that would affect the Phase 3 dose selection.
Management Commentary
"The successful outcome of our End-of-Phase 2 FDA interaction marks a critical milestone in our development program," said Søren Bregenholt, CEO of Alligator Bioscience (search). "With clear regulatory alignment on our Phase 3 trial and robust CMC progress, mitazalimab is well-positioned for Phase 3 initiation during 2025. We remain committed to addressing the unmet medical need of patients with metastatic pancreatic cancer (search)."
About Mitazalimab
Mitazalimab is a CD40 receptor (search) agonist antibody being developed by Alligator Bioscience (search) as a tumor-directed immuno-oncology agent. It is designed to promote the priming of tumor-specific T cells and reverse the immunosuppressive nature of the tumor microenvironment. Previous Phase 2 trial (OPTIMIZE-1) data showed unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer (search) patients.
CMC Development
Regulatory feedback from both the FDA and PEI has validated Alligator Bioscience (search)'s CMC development strategy, confirming that completed and planned CMC work through early 2025 enables the Phase 3 development of mitazalimab. The company has initiated manufacturing of mitazalimab for use in the Phase 3 study and remains on track to begin Phase 3 clinical activities in 2025.