Minghui Pharma Reports Positive Phase I Results for MHB039A in Refractory Solid Tumors

SHANGHAI, Nov. 6, 2024 /PRNewswire/ -- Minghui Pharmaceutical, Inc., a prominent biopharmaceutical company specializing in immunology and oncology, has disclosed preliminary findings from its Phase I clinical trial involving MHB039A. This innovative PD-1 x VEGF bispecific antibody is being tested on patients with relapsed or refractory solid tumors. The main goals of the trial are to assess safety and identify the recommended Phase 2 dosage (RP2D). Additional aims include understanding pharmacokinetics, pharmacodynamics, and initial antitumor activity.

The trial focused on a group of patients who had already undergone extensive treatment, with a median of three previous therapies. Across all dosage levels, notable PD-1 receptor occupancy and VEGF biomarker responses in the bloodstream were evident. Particularly, the 20 mg/kg Q3W dosage displayed strong and lasting inhibition of both PD-1 and VEGF. Significant tumor reduction was seen in patients with sqNSCLC and non-sq NSCLC without actionable genomic alterations who had previously been treated with PD-1 inhibitors and chemotherapy. This reduction was also observed in NSCLC patients with EGFR mutations who had relapsed after third-generation TKI therapy.

MHB039A was found to be well tolerated at doses up to 20 mg/kg. The maximum tolerated dose (MTD) was not identified, and no dose-limiting toxicities were reported. The safety profile aligned with results from earlier clinical studies on the PD-1 x VEGF bispecific antibody.

"We are very encouraged by the initial clinical results from this Phase I study," stated Guoqing Cao, Ph.D., Chief Executive Officer at Minghui Pharmaceutical. "MHB039A has shown a favorable safety profile and promising antitumor activity in heavily pretreated patients with relapsed/refractory solid tumors. As a PD-1 x VEGF bispecific antibody, it combines two broad-spectrum anti-tumor mechanisms in a single agent. This bispecific antibody offers more than just an additive effect, with enhanced antitumor activity and significantly improved safety profile observed in recent clinical studies, indicating its potential as a next-generation immunotherapy backbone."

"The Phase I dose escalation study has been concluded," Dr. Cao added. "Considering the overall profile of MHB039A, it is well-suited for development in combination with other therapies, such as chemotherapy, ADCs, small molecule inhibitors, vaccines, and T cell engagers. We are eager to explore strategic partnerships to advance this development."

About MHB039A:
MHB039A, created by Minghui Pharmaceutical, is a novel bispecific antibody aimed at PD-1 and VEGF. It has shown complete blocking activities against both PD-1 and VEGF, outperforming competitor antibodies in terms of PD-1 activity. Its unique molecular design improves druggability and physicochemical properties, offering high protein yield and stability. As a next-generation immunotherapy backbone, MHB039A can be paired with various treatment methods—including immuno-oncology agents, small molecule inhibitors, antibody-drug conjugates, vaccines, and T cell engagers—expanding its potential in solid tumor treatment.

About Minghui Pharmaceutical Inc.:
Founded in 2018, Minghui Pharmaceutical is a late-stage biopharmaceutical company dedicated to developing groundbreaking therapies for unmet medical needs in oncology and autoimmune diseases. Utilizing expertise in medical science and proprietary technology platforms, the company is progressing a strong clinical-stage pipeline that includes a range of first-in-class or best-in-class product candidates.

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