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TBS 2025

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Drug Profile

TBS 2025

Alternative Names: KVA-001; KVA-002; KVA-12.1; KVA-12123; TBS-2025

Latest Information Update: 25 Aug 2026

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At a glance

  • Originator GigaGen
  • Developer TuHURA Biosciences
  • Class Antibodies; Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants; VISTA inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase I/II Solid tumours
  • Preclinical Acute myeloid leukaemia; Colorectal cancer; Non-small cell lung cancer

Most Recent Events

  • 14 Aug 2026 TuHURA Biosciences anticipates to receive orphan drug designation in Acute myeloid leukaemia in second half of 2026
  • 15 Jun 2026 TuHURA Biosciences files an IND application with the US FDA in USA for Acute myeloid leukemia and other Haematological malignancies
  • 15 May 2026 TuHURA Biosciences plans a meeting with the FDA to discuss the development plan for phase Ib/II trial of TBS-2025 in NPM1 mut r/r Acute Myeloid Leukemia in June 2026

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