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

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