On June 20, 2023 Minghui Pharmaceutical, Inc., a leading clinical-stage biopharmaceutical company, reported that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C (Press release, Minghui Pharmaceutical, JUN 20, 2023, View Source [SID1234632806]). The studies aim to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), as well as assess the pharmacokinetics and preliminary efficacy of the ADCs in patients with selected types of advanced or metastatic solid tumors.
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MHB036C and MHB088C, the two antibody-drug conjugates (ADCs) targeting TROP-2 or B7-H3, respectively, are generated through Minghui’s cutting-edge proprietary SuperTopoiTM ADC platform, which incorporates a highly potent topoisomerase (TOPO) 1 inhibitor linked through a cleavable linker. This novel payload significantly enhances the therapeutic potency of the ADCs, especially against cancer cells with moderate or low tumor-associated antigen expression.
Comprehensive in vitro and in vivo studies across a variety of cancer types demonstrated the exceptional efficacy of MHB036C and MHB088C, exhibiting 3 to 10 times more potent in killing tumor cells compared to their DXd counterparts. Additionally, preclinical GLP tox studies demonstrated an excellent safety profile, with no unique toxicities observed, particularly no severe pulmonary toxicities.
"We are delighted to announce the successful dosing of the first patient in our two ADC programs" stated Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "MHB036C and MHB088C epitomize the tremendous potential of Minghui’s SuperTopoiTM platform. These novel ADCs have undergone extensive research and development, showcasing remarkable efficacy and safety in preclinical studies. MHB036C and MHB088C hold great promise in the fight against various human solid tumors and we look forward to the results from the phase 1 studies, anticipated to conclude in early 2024. "
About MHB036C
MHB036C is an antibody drug conjugate (ADC) composed of a humanized anti-TROP-2 monoclonal antibody conjugated to Minghui’s proprietary DNA topoisomerase I inhibitor via a cleavable linker.
About MHB088C
MHB088C is an antibody drug conjugate (ADC) composed of a humanized anti-B7-H3 monoclonal antibody conjugated to Minghui’s proprietary DNA topoisomerase I inhibitor via a cleavable linker. The antibody has also shown more potent antigen binding and higher endocytosis efficiency.