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Orca T - Orca Bio

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Drug Profile

Orca T - Orca Bio

Alternative Names: Orca-T; TregCD34; TregGraft; TRGFT-201

Latest Information Update: 20 May 2025

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At a glance

  • Originator Orca Bio; Stanford University
  • Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Haematological malignancies
  • New Molecular Entity No

Highest Development Phases

  • Phase III Acute myeloid leukaemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase I/II Lymphoid leukaemia; Myelofibrosis

Most Recent Events

  • 12 May 2025 Orca Bio plans to file Biologics License Application (BLA) to USFDA for Orca T in 2025
  • 17 Mar 2025 Efficacy and adverse event data from the phase III Precision-T trial in Myelodysplastic syndromes, Precursor cell lymphoblastic leukaemia-lymphoma and Acute myeloid leukaemia released by Orca Biosystems
  • 09 Dec 2024 Orca Bio announces intention to submit BLA to regulatory body

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