Drug intelligence / Profile preview

db-1311

Development stage
Phase 3
Lead developer
BioNTech
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

DB-1311 is an investigational, next-generation antibody-drug conjugate (ADC) targeting the immune checkpoint protein B7-H3 (CD276), which is overexpressed in a wide range of solid tumors and associated with disease progression and poor prognosis. The ADC consists of an anti-B7-H3 monoclonal antibody linked to P1021, a topoisomerase I inhibitor payload. By binding to B7-H3 on tumor cells, DB-1311 delivers the cytotoxic payload directly to cancer cells, promoting cell death by interrupting DNA replication. Preclinical studies have shown antitumor activity across various solid tumor models. Early clinical data from ongoing Phase 1/2 trials indicate encouraging antitumor activity and a manageable safety profile in patients with advanced or metastatic solid tumors—including small cell lung cancer, non-small cell lung cancer, castration-resistant prostate cancer (CRPC), esophageal squamous cell carcinoma, melanoma, hepatocellular carcinoma (HCC), cervical cancer, and other advanced/metastatic solid tumors[1][2][4][5][6].

Other names
DB 1311DB1311DB-1311BNT 324BNT324BNT-324
02

Targets

B7-H3

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