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Balstilimab - Agenus

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Drug Profile

Balstilimab - Agenus

Alternative Names: AGEN-2034; BAL - Agenus/Ludwig Institute for Cancer Research; RebmAb-700

Latest Information Update: 25 Jun 2025

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At a glance

  • Originator Agenus; Ludwig Institute for Cancer Research
  • Developer Agenus; Immune Oncology Research Institute; IMMUNOGENESIS; Oxford BioTherapeutics; Rottapharm Biotech
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • 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

Highest Development Phases

  • Phase III Cervical cancer
  • Phase II/III Solid tumours
  • Phase II Adenocarcinoma; Colorectal cancer; Haemangiosarcoma; Lymphoma; Malignant melanoma; Non-small cell lung cancer; Oropharyngeal cancer; Renal cell carcinoma; Soft tissue sarcoma
  • Phase I/II Pancreatic cancer; Prostate cancer; Squamous cell cancer; Triple negative breast cancer
  • Phase I Adenoid cystic carcinoma
  • Phase Unknown Rectal cancer

Most Recent Events

  • 03 Jun 2025 Balstilimab licensed to Zydus Lifesciences in India and Sri Lanka
  • 20 May 2025 Investigation in Rectal cancer (Combination therapy) in USA (IV) (NCT06780787)
  • 28 Apr 2025 Efficacy and adverse event data from the phase II/III NEOASIS trial in Solid tumours released by Agenus

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