Minghui Pharmaceutical has announced positive initial results from its Phase I clinical trial of MHB039A in patients with relapsed or refractory solid tumors. The study, which included patients who had undergone an average of three prior lines of treatment, aimed to assess the safety, pharmacodynamics, and preliminary anti-tumor efficacy of MHB039A, as well as to establish the recommended Phase II dose (RP2D).
Key Findings from the Phase I Trial
All doses of MHB039A demonstrated significant programmed cell death protein 1 (PD-1) receptor occupancy and biomarker responses related to circulating vascular endothelial growth factor (VEGF). Notably, a dose of 20 mg/kg administered once every three weeks resulted in sustained inhibition of both PD-1 and VEGF.
This dosage led to a reduction in tumor volume in patients with various types of non-small cell lung cancer (NSCLC), including those without actionable genomic alterations previously treated with PD-1 inhibitors and chemotherapy, and in subjects with epidermal growth factor receptor (EGFR) mutations following third-generation tyrosine kinase inhibitor therapy.
The antibody was well-tolerated at the tested dosage, with no maximum tolerated dose reached and no dose-limiting toxicities reported. The safety profile was consistent with previous studies of PD-1 x VEGF bispecific antibodies.
MHB039A: A Potential Combination Therapy
Minghui Pharmaceutical CEO Guoqing Cao stated, "We are highly encouraged by the initial clinical results from this phase I study. MHB039A has demonstrated a favorable safety profile and promising anti-tumor activity in heavily pretreated patients with relapsed/refractory solid tumors."
Cao added, "The phase I dose escalation study has been completed. Given the overall profile of MHB039A, it is well-suited for development in combination with other therapies, such as chemotherapy, ADCs, small molecules, vaccines, and T cell engagers. We are looking forward to exploring strategic partnerships to facilitate this development."
Minghui's Broader Pipeline
In August of the previous year, Minghui Pharmaceutical initiated a Phase III clinical trial for MH004 Cream, which targets mild to moderate atopic dermatitis, to further evaluate the cream’s safety and efficacy in a larger patient population.
