Drug intelligence / Profile preview

IBI3009

Development stage
Phase 1
Lead developer
Roche
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
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Overview

IBI3009 is a novel antibody-drug conjugate (ADC) targeting delta-like ligand 3 (DLL3), developed by Innovent Biologics using its proprietary topoisomerase 1 inhibitor (TOPO1i) platform. DLL3 is a protein that is highly expressed in small-cell lung cancer (SCLC) and other neuroendocrine tumors but has minimal expression in normal tissues, making it a promising therapeutic target. IBI3009 consists of a DLL3-specific monoclonal antibody conjugated to a TOPO1i payload. In preclinical studies, it demonstrated potent anti-tumor activity, including in chemo-resistant models, and a favorable safety profile. In January 2025, Innovent entered into a global collaboration agreement with Roche for the development and commercialization of IBI3009. The drug is currently undergoing Phase I clinical evaluation.

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