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Research Report
An In-Depth Analysis of PM-8002 (BNT327): A Novel PD-L1 x VEGF-A Bispecific Antibody for the Treatment of Solid Tumors
Executive Summary
PM-8002, also known as BNT327, is an investigational, first-in-class bispecific antibody poised to represent a significant advancement in the field of immuno-oncology. Engineered to simultaneously inhibit two critical and synergistic pathways in cancer progression—Programmed death-ligand 1 (PD-L1) and Vascular endothelial growth factor A (VEGF-A)—PM-8002 embodies a sophisticated, second-generation approach to combination immunotherapy within a single molecule. Its unique molecular design, featuring an Fc-silenced anti-VEGF-A antibody fused to anti-PD-L1 VHH domains, is intended to co-localize therapeutic action within the tumor microenvironment, thereby maximizing antitumor activity while potentially mitigating systemic toxicities.
Originally developed by Biotheus Inc., the asset's promising early-phase data prompted a strategic acquisition by BioNTech SE, which has now positioned PM-8002 as a cornerstone of its oncology pipeline. BioNTech is pursuing an ambitious and aggressive global development strategy, initiating registrational Phase 3 trials that directly challenge the current standards of care—pembrolizumab and atezolizumab—in first-line settings for non-small cell and small cell lung cancer, respectively.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2025/08/29 | Not Applicable | Not yet recruiting | |||
2025/08/21 | Not Applicable | Not yet recruiting | |||
2025/08/08 | Not Applicable | Not yet recruiting | |||
2025/07/23 | Not Applicable | Recruiting | |||
2025/07/17 | Not Applicable | Recruiting | |||
2025/05/01 | Phase 2 | Not yet recruiting | |||
2025/03/24 | Phase 1 | Recruiting | |||
2025/02/24 | Phase 2 | Recruiting | |||
2025/02/20 | Phase 2 | Not yet recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2025/02/14 | Phase 1 | Recruiting |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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