Minghui Pharmaceutical Inc. Announces First Patient Dosing in Phase 1 Clinical Studies of Both the Antibody-Drug Conjugate Programs Targeting TROP-2 or B7-H3 Respectively, for Treatment of Advanced or Metastatic Solid Tumors

SHANGHAI and HANGZHOU, China and WILMINGTON, Del., June 20, 2023 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a leading clinical-stage biopharmaceutical company, announced today that the first dosing has been completed in two phase 1 clinical studies evaluating MHB036C and MHB088C. 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.

MHB036C and MHB088C, the two antibody-drug conjugates (ADCs) targeting TROP-2 or B7-H3, respectively, are generated through Minghui's cutting-edge proprietary SuperTopoi^TM 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 SuperTopoi^TM 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. 

About Minghui Pharmaceutical

Minghui Pharmaceutical Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for unmet medical needs in oncology and autoimmune diseases. Leveraging the expertise in medical science and the proprietary technology platforms, the company is developing a rich clinical-stage pipeline including a variety of first-in-class or best-in-class product candidates. For more information, please visit www.minghuipharma.com.

Forward-Looking Statements

This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein.

SOURCE Minghui Pharmaceutical, Inc.