Chinese late-stage biopharmaceutical company Minghui Pharmaceutical Inc on Wednesday announced initial results from the company's Phase I clinical trial of MHB039A, a novel PD-1 x VEGF bispecific antibody, in patients with relapsed/refractory solid tumours.

Primary objectives are to assess safety and determine the recommended Phase 2 dose (RP2D), while secondary objectives include characterising pharmacokinetics, pharmacodynamics and preliminary antitumor activity.

The study included a heavily pretreated patient population, with a median of three prior lines of therapy. Robust PD-1 receptor occupancy and circulating VEGF biomarker responses were seen across all dose levels.

The 20 mg/kg Q3W regimen demonstrated substantial and sustained inhibition of both PD-1 and VEGF. Tumour volume reduction was noted 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.

The product 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.