Drug Profile

Balstilimab - Agenus

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

Latest Information Update: 01 Sep 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; Scripps Health
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-melanoma skin neoplasms; Non-small cell lung cancer; Rectal 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
Clinical Phase Unknown Fallopian tube cancer; Ovarian cancer; Peritoneal cancer

28 Aug 2026 Efficacy, adverse events and pharmacodynamics data from the phase Ib trial in Colorectal cancer released by Agenus
26 Aug 2026 Efficacy and adverse events data from the phase-II NEST-1 trial in Colorectal cancer released by Agenus
18 Aug 2026 Phase-II clinical trials in Rectal cancer (Combination therapy, Early-stage disease) in USA (IV) (NCT07735624)

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