Minghui Pharma's MHB039A Shows Promise in Phase I Trial for Solid Tumors

• Minghui Pharmaceutical's MHB039A, a novel PD-1 x VEGF bispecific antibody, demonstrates a favorable safety profile in a Phase I trial for relapsed/refractory solid tumors.
• The study observed robust PD-1 receptor occupancy and circulating VEGF biomarker responses across all dose levels, with the 20 mg/kg Q3W regimen showing substantial inhibition.
• Tumor volume reduction was noted in heavily pretreated NSCLC patients, including those with prior PD-1 inhibitor and chemotherapy or EGFR mutations post-TKI therapy.
• MHB039A's safety profile was consistent with previous studies, with no dose-limiting toxicities observed, supporting its potential as a next-generation immunotherapy backbone.

Minghui Pharmaceutical has announced promising 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, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of MHB039A.

The Phase I study included patients with a median of three prior lines of therapy. The results showed robust PD-1 receptor occupancy and circulating VEGF biomarker responses across all dose levels. Specifically, the 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF.

Clinical Efficacy

Tumor volume reduction was observed in patients with squamous and non-squamous NSCLC without actionable genomic alterations who had previously received PD-1 inhibitors and chemotherapy. Additionally, NSCLC patients with EGFR mutations who had relapsed following third-generation TKI therapy also showed tumor volume reduction.

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 PD-1 x VEGF bispecific antibodies.

Expert Commentary

"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... 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."

Future Development

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."

Minghui Pharmaceutical is actively seeking strategic partnerships to further explore the potential of MHB039A in combination with other cancer therapies.