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A global phase 3 registrational study of Mitazalimab for the treatment of Pancreatic cancer

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A global phase 3 registrational study of Mitazalimab for the treatment of Pancreatic cancer

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Mitazalimab (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Pancreatic cancer
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 06 Feb 2025 According to an Alligator Bioscience media release, the company announced successful end of phase 2 meeting with the FDA provided positive feedback and alignment on the non-clinical and clinical data packages to support the Biologics License Application (BLA), including the Phase 3 trial design, thus reinforcing earlier regulatory guidance from the Paul Ehrlich Institute (PEI) of Germany in July 2024. FDA feedback confirms that the toxicology package is adequate for the BLA submission.
    • 17 Jan 2025 According to an Alligator Bioscience media release, the company is on track for initiation of Phase 3 clinical activities during 2025.
    • 17 Jan 2025 According to an Alligator Bioscience media release, the company announced that the positive outcome of regulatory interactions with PEI of Germany and US FDA regarding the CMC development of mitazalimab. A recent Type C CMC interaction with the FDA reinforced feedback received from the PEI confirming that completed and planned CMC work through early 2025 enables Phase 3 development of mitazalimab. With this feedback, company initiated manufacturing of mitazalimab to be used in this study.

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