Minghui Pharmaceutical Inc. Announces First-in-Human Dose of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody in Phase 1a Healthy Volunteer Study

SHANGHAI and HANGZHOU, China and WILMINGTON, Del., May 23, 2023 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a clinical-stage biopharmaceutical company focusing on oncology and autoimmune diseases, today announced that the phase 1a trial of MHB018A has commenced with the dosing of its first subject. The phase 1a, randomized, double-blinded, vehicle-controlled first-in-human study aims to evaluate the safety, tolerability and pharmacokinetics of MHB018A in healthy volunteers.

MHB018A is a novel fusion protein of humanized single domain IGF-1R antibody and human Fc, which showed 3~5 times greater ligand blocking activities than other known IGF-1R antibodies for both IGF-1 and IGF-2. In addition, the molecule has a solubility of 150 mg/ml that makes it suitable for subcutaneous formulation/administration. The preclinical GLP-tox study of MHB018A in cynomolgus monkey also showed excellent safety profile with NOAEL determined at 150 mg/kg.

"The initiation of the first-in-human dose of MHB018A marks a significant milestone in our commitment to developing improved therapeutic options for patients suffering from thyroid eye disease (TED)," stated Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "The superior biological activity, druggability and excellent safety of MHB018A demonstrated in preclinical studies suggest potential better clinical benefits for TED patients. With its highly concentrated formulation of 150 mg/mL and remarkable stability, MHB018A enables convenient subcutaneous administration. These exceptional attributes underscore the potential of MHB018A as a leading therapy for the treatment of TED. We look forward to the results of the phase Ia study, as well as the subsequent phase Ib study involving TED patients, which is expected to conclude in early 2024."

About Thyroid Eye Disease

Thyroid eye disease (TED) is an autoimmune disease caused by the activation of orbital fibroblasts by autoantibodies directed against thyroid receptors. TED is a rare disease, which has an incidence rate of approximately 19 in 100,000 people per year¹. The insulin-like growth factor 1 receptor (IGF-1R) plays an essential role in the pathogenesis of TED^2-4 and is a proven drug target for treatment of TED.

About MHB018A

MHB018A is a novel single domain Fc fusion protein formulated in subcutaneous form targeting human IGF-1R that is developed by Minghui Pharmaceutical Inc. for treatment of patients with TED.

About Minghui Pharmaceutical Inc.

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 of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or circumstances, except as required by law.

Reference:

1. Smith TJ, Hegedüs L. Graves' disease. N Engl J Med 2016.
2. Pritchard J, Han R, Horst N, Cruikshank WW, Smith TJ. Immunoglobulin activation of T cell chemoattractant expression in fibroblasts from patients with Graves' disease is mediated through the insulin-like growth factor I receptor pathway. J Immunol 2003.
3. Douglas RS, Gianoukakis AG, Kamat S, Smith TJ. Aberrant expression of the insulin-like growth factor-1 receptor by T cells from patients with Graves' disease may carry functional consequences for disease pathogenesis. J Immunol 2007.
4. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves' disease aberrantly express the IGF-1 receptor: implications for disease pathogenesis. J Immunol 2008.