Drug Profile

Balstilimab - Agenus

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

Latest Information Update: 05 May 2026

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

27 Apr 2026 Agenus plans a phase II trial for Colorectal cancer (Combination therapy) in May 2026 (IV) (NCT07551596)
24 Apr 2026 Agenus plans a phase-II trial for Colorectal cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (IV), (NCT07550088)
20 Apr 2026 Efficacy and adverse event data from a phase II trial in Adenocarcinoma released by Agenus

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