The study involved patients who had undergone an average of three previous lines of treatment. Credit: PeopleImages.com – Yuri A/Shutterstock.

Minghui Pharmaceutical has reported promising initial outcomes from its Phase I trial of MHB039A to treat patients with relapsed or refractory solid tumours.

The study involved patients who had undergone an average of three previous lines of treatment. Notably, all doses of MHB039A showed significant programmed cell death protein 1 (PD-1) receptor occupancy and biomarker responses related to circulating vascular endothelial growth factor (VEGF).

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Its primary objectives were to assess the safety and establish the recommended Phase II dose (RP2D). Secondary objectives include evaluating pharmacodynamics, initial antitumour efficacy and pharmacokinetics.

A dose of 20 mg/kg administered once every three weeks demonstrated a sustained inhibition of both PD-1 and VEGF.

This dosage led to decreased tumour volume in patients with various types of non-small cell lung cancer (NSCLC), including those without actionable genomic alterations who were treated priorly with PD-1 inhibitors and chemotherapy, and also in subjects with mutations of epidermal growth factor receptor (EGFR) post third-generation tyrosine kinase inhibitor therapy.

The antibody was well-tolerated at given dosage strength, without reaching the maximum tolerated dose and no dose-limiting toxicities were reported.

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The safety profile aligns with previous studies on PD-1 x VEGF bispecific antibodies.

Minghui Pharmaceutical CEO Guoqing Cao said: “We are highly encouraged by the initial clinical results from this phase I study.

“MHB039A has demonstrated a favourable safety profile and promising anti-tumour activity in heavily pretreated patients with relapsed/refractory solid tumours.”

“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.”

In August last year, Minghui Pharmaceutical began a Phase III clinical trial for MH004 Cream, targeting mild to moderate atopic dermatitis, to further investigate the cream’s safety and efficacy in a broader patient population.