Drug intelligence / Profile preview

MHB036C

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

Overview

MHB036C is an investigational antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody targeting TROP2 (trophoblast cell surface protein 2), conjugated to a highly potent DNA topoisomerase I inhibitor via a stable cleavable linker. The ADC is engineered to minimize non-specific uptake and associated toxicities. Preclinical studies have shown that MHB036C has superior tumor-killing activity—5 to 10 times more potent than DS-1062a analogs—and a favorable safety profile with no unique toxicities or interstitial lung disease compared to other TROP2-targeting ADCs. It is being developed for the treatment of various advanced or metastatic solid tumors, including small-cell lung cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, urothelial carcinoma, ovarian cancer, breast cancer (including triple-negative and HER2-positive/negative subtypes), gastric cancer, castration-resistant prostate cancer and others. The drug is currently in phase 1/2 clinical trials. It uses the SuperTopoi ADC platform technology from Minghui Pharmaceutical. Its payload is described as a DNA topoisomerase I inhibitor that is significantly more potent than DXd-based payloads used in other TROP2-targeted ADCs such as DS-1062a. The drug has demonstrated promising efficacy and safety in early-phase clinical trials for multiple solid tumor types. It is developed by Minghui Pharmaceutical.

02

Targets

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

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