Drug Profile

Pumitamig - BioNTech

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

Latest Information Update: 30 Oct 2025

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At a glance

Originator Biotheus
Developer BioNTech; Biotheus; 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 Small cell lung cancer; Triple negative breast cancer
Phase II/III Non-small cell lung cancer
Phase II Liver cancer; Malignant-mesothelioma; Neuroendocrine tumours; Solid tumours
Phase I/II Colorectal cancer; HER2 positive breast cancer; Lung cancer

27 Oct 2025 Bristol-Myers Squibb plans a phase II/III ROSETTA GI-204 trial for Stomach cancer and Adenocarcinoma (Second-line therapy or greater, Metastatic disease, late-stage disease) in the US, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, India, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, Turkey and United Kingdom (IV) in March 2026 (NCT07221149)
27 Oct 2025 Bristol-Myers Squibb plans the phase II/III ROSETTA CRC-203 trial for Colorectal cancer (Combination therapy, Inoperable/unresectable, First-line therapy, Metastatic disease) in USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, India, Italy, Japan, the Netherlands, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey, the UK (IV), in March 2026 (NCT07221357)
15 Sep 2025 BioNTech SE plans a phase III trial for HER2-negative breast cancer (First-line therapy, Metastatic diseases, Combination therapy,Inoperable/unresectable) and Triple-negative breast cancer (First-line therapy, Metastatic diseases, Combination therapy,Inoperable/unresectable) in October 2025 (IV) (NCT07173751)

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