Minghui Pharmaceutical to Present the Phase I/II Study of MHB088C (B7-H3 ADC) for the Treatment of Patients with Recurrent or Metastatic Solid Tumors in Late-breaking Oral Presentation at the 2024 ASCO Annual Meeting

2024-05-08

抗体药物偶联物

SHANGHAI, May 8, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company focused on autoimmune diseases and oncology, will feature Dr. Lin Shen from Beijing Cancer Hospital Cancer Hospital at the upcoming ASCO Annual Meeting in Chicago. Dr. Shen will present the results from the Phase I/II clinical study of MHB088C, a well-differentiated B7-H3-targeting antibody-drug conjugate (ADC) for recurrent or metastatic solid tumors, in an oral presentation.

Oral Presentation

Abstract Title: Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT

Presentation Time/Duration: 8:00 AM – 8:06 AM CDT

Presenter: Dr. Lin Shen

Abstract ID: 3012

About MHB088C

MHB088C is a novel B7-H3 ADC generated through Minghui's SuperTopoiTM ADC platform. Minghui's proprietary payload is 5 to 10 times more potent than Dxd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. Conjugated with Minghui's proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor's antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types. It was 3 to 10 times more potent in killing tumor cells than the competitor's compound in xenograft models.

Preclinical GLP tox studies revealed an excellent safety profile, with no unique toxicities, particularly no pulmonary toxicities. The highest non-severely toxic dose (HNSTD) was identified at 30 mg/kg, administered once every two weeks (Q2W) for a total of seven doses. The first patient in the Phase I/II study was enrolled on June 20, 2023. Since then, over 150 patients with different tumor types have been enrolled and received at least one dose of MHB088C, showing promising efficacy and a favorable safety profile. Registrational trials for selected tumor types are expected to start by the end of the year.

About Minghui Pharmaceutical

Minghui Pharmaceutical, Inc. is a late-stage clinical 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.