Drug Profile

Pumitamig - BioNTech

Alternative Names: BMS-986545; BNT-327; PM-8002

Latest Information Update: 10 Apr 2026

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At a glance

Originator Biotheus
Developer BioNTech; Biotheus; Bristol-Myers Squibb; Duality Biologics; Genmab
Class Antineoplastics; Bispecific antibodies; Immunotherapies
Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants; Vascular endothelial growth factor A inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Small cell lung cancer
New Molecular Entity Yes

Phase III Non-small cell lung cancer; Small cell lung cancer; Triple negative breast cancer
Phase II/III Adenocarcinoma
Phase II Glioblastoma; Liver cancer; Malignant-mesothelioma; Neuroendocrine tumours; Solid tumours
Phase I/II Colorectal cancer; HER2 positive breast cancer; Lung cancer; Renal cell carcinoma

10 Apr 2026 Phase-II/III clinical trials in Adenocarcinoma (First-line therapy, Combination therapy, Metastatic disease, Late-stage disease) in United Kingdom, South Korea, China (IV) (NCT07221149)
25 Mar 2026 Bristol-Myers Squibb plans a phase-II MountainTAP-5 trial for Solid tumours (Late-stage disease, Metastatic disease, Combination therapy, First-line therapy, Second-line therapy or greater, Inoperable/Unresectable) in USA, Belgium, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Norway, South Korea and Spain in July 2026 (NCT07492680)
16 Mar 2026 Phase-III clinical trials in Non-small cell lung cancer (Monotherapy, Late-stage disease, Inoperable/Unresectable, Second-line therapy or greater) in USA (IV) (NCT07361497)

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