PM 8002
Alternative Names: BNT-327; PM-8002Latest Information Update: 19 Sep 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- 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
Most Recent Events
- 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)
- 31 Aug 2025 Biotheus plans a phase II trial for Colorectal cancer (Combination therapy, First-line therapy, Metastatic disease, Inoperable/Unresectable) in China (IV, Infusion) in August 2025 (NCT07133750)
- 08 Aug 2025 BioNTech SE plans to initiate a phase Ib/II trial for Non-small Cell Lung Cancer (Late-stage disease, In combination therapy, Metastatic disease, Recurrent, Second-line therapy or greater) (IV) (NCT07111520)