Drug intelligence / Profile preview

DB-1305

Development stage
Phase 2
Lead developer
Duality Biotherapeutics
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

DB-1305 is a novel antibody-drug conjugate (ADC) targeting Trop-2, a cell surface glycoprotein overexpressed in various solid tumors. The drug consists of a humanized anti-Trop-2 IgG1 monoclonal antibody linked via a cleavable maleimide tetrapeptide linker to P1021, a DNA topoisomerase I inhibitor payload. Upon binding to Trop-2 on tumor cells, the ADC is internalized and the cytotoxic payload is released intracellularly, leading to DNA damage and tumor cell death. Preclinical studies have shown significant antitumor activity in models of triple-negative breast cancer (TNBC), colorectal cancer, and lung cancer. Clinically, DB-1305 has demonstrated durable activity in patients with previously treated ovarian cancer and is being evaluated for multiple advanced solid tumors including non-small cell lung cancer (NSCLC), head and neck neoplasms, metastatic castration-resistant prostate cancer (mCRPC), and other solid tumors. The drug was initially developed by Duality Biologics (DualityBio) and has received FDA Fast Track designation for platinum-resistant ovarian cancer[1][3][4][5][6].

Other names
anti-TROP-2 antibody-drug conjugate DB-1305anti-TROP2 antibody-drug conjugate DB-1305anti-TROP 2 antibody-drug conjugate DB-1305
02

Targets

TACSTD2 (Tumor-associated calcium signal transducer 2)TOP1 (DNA Topoisomerase I)

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