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Botensilimab - Agenus

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Drug Profile

Botensilimab - Agenus

Alternative Names: AGEN-1181; Anti-CTLA-4 Monoclonal Antibody AGEN1181; BOT - Agenus; Fc-enhanced CTLA-4 antibody

Latest Information Update: 15 Sep 2025

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At a glance

  • Originator Agenus
  • Developer Agenus; Immune Oncology Research Institute
  • Class Antibodies; Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; 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
  • Available For Licensing Yes

Highest Development Phases

  • Phase II/III Solid tumours
  • Phase II Adenocarcinoma; Colorectal cancer; Malignant melanoma; Non-small cell lung cancer; Pancreatic cancer; Rectal cancer; Renal cell carcinoma

Most Recent Events

  • 09 Sep 2025 France grants reimbursed compassionate access (AAC) for Botensilimab plus Balstilimab (BOT/BAL)in refractory MSS metastatic Colorectal cancer
  • 03 Sep 2025 Canadian Cancer Trials Group plans the phase III BATTMAN trial for Colorectal cancer (Inoperable/Unresectable, Second-line therapy or greater, Metastatic disease, Combination-therapy) in November 2025 (IV) (NCT07152821)
  • 18 Aug 2025 Massachusetts General Hospital in collaboration with Agenus plans an early phase I trial for non-MSI-H or pMMR Colorectal cancer with liver metastasis (Combination therapy, Second-line therapy or greater) in USA in January 2026 (IV, Infusion) (NCT07128355)

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