Drug intelligence / Profile preview

BIO-201

Development stage
Unknown
Lead developer
BiOneCure Therapeutics
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
Administration
Parenteral
01

Overview

BIO-201 is a novel bispecific antibody-drug conjugate (ADC) developed by BiOneCure Therapeutics for the treatment of solid tumors and other neoplasms. It consists of a bispecific antibody targeting both HER2 (Receptor tyrosine-protein kinase erbB-2) and Trop-2 (Tumor-associated calcium signal transducer 2), conjugated via a cleavable linker to a proprietary DNA topoisomerase I inhibitor payload. The design enables simultaneous targeting of two clinically validated tumor antigens, potentially enhancing specificity, efficacy, and reducing resistance compared to monospecific ADCs. Preclinical studies have demonstrated potent in vitro cytotoxicity against cancer cells co-expressing HER2 and Trop-2 as well as significant tumor regression in xenograft models expressing either or both targets. The payload exhibits similar characteristics to DXd, the cytotoxic component used in some approved ADCs[4][5].

Other names
HER2/TROP2 bispecific ADCanti-HER2 x anti-TROP2 ADCanti-HER-2 x anti-TROP2 ADCanti-HER 2 x anti-TROP2 ADCHER2 x TROP2 BsADCHER-2 x TROP2 BsADCHER 2 x TROP2 BsADC
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)TACSTD2 (Tumor-associated calcium signal transducer 2)TOP1 (DNA Topoisomerase I)

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