Drug Profile

Balstilimab - Agenus

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

Latest Information Update: 15 Sep 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

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

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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