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Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq - Orca Bio

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Drug Profile

Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq - Orca Bio

Alternative Names: Allogeneic regulatory T cell immunotherapy with HSPC/T cells-vldq; Orca-T; TregCD34; TregGraft; TREGZI; TRGFT-201

Latest Information Update: 02 Jul 2026

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At a glance

  • Originator Stanford University
  • Developer Orca Bio
  • Class Antineoplastics; Gene therapies; Haematopoietic stem cells therapies; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease
  • New Molecular Entity No

Highest Development Phases

  • Registered Graft-versus-host disease

Most Recent Events

  • 30 Jun 2026 Registered for Graft-versus-host disease (Prevention) in USA (IV) - First global approval
  • 30 Jun 2026 Updated adverse event data from the phase III Precision-T trial in Graft-versus-host disease released by Orca Biosystems
  • 01 Apr 2026 FDA assigns PDUFA action date of 06/04/2026 for ORCA-T for prevention of Graft-versus-host disease

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