Minghui Pharmaceutical has announced encouraging 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 trial aimed to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of MHB039A, while also assessing its pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
The study included patients who had undergone a median of three prior lines of therapy. The results indicated robust PD-1 receptor occupancy and circulating VEGF biomarker responses across all dose levels. Notably, the 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF. Tumor volume reduction was observed 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.
Safety and Tolerability
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.
Mechanism of Action and Potential
MHB039A, developed by Minghui Pharmaceutical, is designed to fully block both PD-1 and VEGF. According to Minghui, it has demonstrated superior PD-1 activity compared to competitor antibodies. The company believes that the unique molecular design enhances druggability and physicochemical properties, offering high protein yield and great stability. Minghui envisions MHB039A as a next-generation immunotherapy backbone that 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.
Executive Perspective
"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...indicating its potential to serve as a next-generation immunotherapy backbone."
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."
