Drug intelligence / Profile preview

IBI354

Development stage
Phase 3
Lead developer
Innovent Biologics
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
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Overview

IBI354 is an innovative HER2-targeted antibody-drug conjugate (ADC) developed by Innovent Biologics using the proprietary SoloTx® platform. It consists of a humanized anti-HER2 monoclonal antibody (trastuzumab) conjugated to a potent topoisomerase I inhibitor (a camptothecin derivative) with a high drug-to-antibody ratio (DAR) of 8. This design allows for targeted delivery of the cytotoxic payload to HER2-expressing tumor cells, inducing DNA damage and cell death. IBI354 is currently being evaluated in Phase 3 clinical trials for platinum-resistant ovarian cancer and first-line HER2-positive breast cancer, demonstrating a favorable safety profile with reduced incidence of interstitial lung disease and peripheral neuropathy compared to other HER2 ADCs.

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