SHANGHAI, Nov. 6, 2024 /PRNewswire/ — Minghui Pharmaceutical, Inc., a late-stage biopharmaceutical company focused on developing transformative medicines in immunology and oncology, today announced initial results from its Phase I clinical trial of MHB039A, a novel PD-1 x VEGF bispecific antibody, in patients with relapsed/refractory solid tumors. The primary objectives of the trial are to evaluate safety and determine the recommended Phase 2 dose (RP2D). Secondary objectives include characterizing pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
The study included a heavily pretreated patient population, with a median of three prior lines of therapy. Robust PD-1 receptor occupancy and circulating VEGF biomarker responses were observed across all dose levels. The 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF. Tumor volume reduction was noted in patients with sqNSCLC and non-sq NSCLC without actionable genomic alterations (AGA) who had previously received PD-1 inhibitors and chemotherapy, as well as in NSCLC patients with EGFR mutations who had relapsed following third-generation TKI therapy.
MHB039A was well tolerated at doses up to 20 mg/kg. The maximum tolerated dose (MTD) was not reached, and no dose-limiting toxicities were observed. The overall safety profile was consistent with findings from previously reported clinical studies on the PD-1 x VEGF bispecific antibody.
“We are highly encouraged by the initial clinical results from this phase I study,” said Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. “MHB039A has demonstrated a favorable safety profile and promising anti-tumor activity in heavily pretreated patients with relapsed/refractory solid tumors. As a PD-1 x VEGF bispecific antibody, it integrates two broad-spectrum anti-tumor mechanisms within a single agent. Importantly, this bispecific antibody offers more than an additive effect, with enhanced anti-tumor activity and significantly improved safety reported in recent clinical studies, indicating its potential to serve as a next-generation immunotherapy backbone.”
“The phase I dose escalation study has been completed.” Dr. Cao added, “Given the overall profile of MHB039A, it is well-suited for development in combination with other therapies, such as chemotherapy, ADCs, small molecule, vaccines, and T cell engagers. We are looking forward to exploring strategic partnerships to facilitate this development.”
About MHB039A
MHB039A, developed by Minghui Pharmaceutical, is a novel bispecific antibody targeting PD-1 and VEGF. It demonstrated full blocking activities against both PD-1 and VEGF with superior PD-1 activity compared to competitor antibodies. The unique molecular design enhances druggability and physicochemical properties, offering high protein yield and great stability. As a next-generation immunotherapy backbone, MHB039A can be combined with various treatment modalities—including immuno-oncology agents, small molecule inhibitors, antibody-drug conjugates, vaccines, and T cell engagers—broadening its potential in solid tumor treatment.
About Minghui Pharmaceutical Inc.
Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range 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.
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