Drug Profile

Balstilimab - Agenus

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

Latest Information Update: 01 Apr 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

26 Mar 2026 Agenus terminates the phase II RaPiDS trial in Cervical cancer (Combination therapy, Late-stage disease, Second-line therapy or greater, Metastatic disease) in USA, Brazil, Mexico, Peru, South Korea, Taiwan, Thailand (IV) due to sponsor's strategic decision (NCT03894215)
24 Mar 2026 Phase-III clinical trials in Adenocarcinoma (Combination therapy, Second-line therapy or greater, Metastatic disease) in Canada (IV) (NCT07152821)
16 Mar 2026 Agenus plans a regulatory filings for botensilimab plus balstilimab in USA and European Union in 2026

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