By Fineline Cube 
China-based Minghui Pharmaceutical Inc. announced the initiation of a Phase II clinical study to evaluate the safety and efficacy of a combination therapy using MHB039A and MHB036C in patients with advanced non-small cell lung cancer (NSCLC). This marks a significant step in the development of novel treatment options for this challenging condition.
MHB039A: Bispecific Antibody Innovation
MHB039A is a novel bispecific antibody (BsAb) targeting PD-1 and VEGF. It has demonstrated robust blocking activities against both PD-1 and VEGF, with superior PD-1 activity compared to competitor antibodies. In a completed Phase I dose-escalation study, MHB039A showed good tolerability at doses up to 30 mg/kg, with no dose-limiting toxicities (DLTs) observed and the maximum tolerated dose (MTD) not reached. Its safety profile aligns with previously reported PD-1xVEGF bispecific antibodies.
MHB036C: ADC Targeting TROP-2
MHB036C is a novel antibody-drug conjugate (ADC) targeting TROP-2, developed using Minghui’s proprietary SuperTopoi ADC platform. In ongoing Phase I/II studies involving 138 patients with advanced or metastatic solid tumors, MHB036C has demonstrated a favorable safety profile, with no major hematologic adverse events or interstitial lung disease (ILD) reported. Promising anti-tumor activity has been observed, particularly in heavily pre-treated NSCLC and breast cancer patients.
Combination Therapy Potential
The Phase II study aims to further explore the synergistic potential of combining MHB039A and MHB036C. By leveraging the distinct mechanisms of these two investigational drugs, the study seeks to enhance therapeutic outcomes for patients with advanced NSCLC. This combination approach highlights Minghui Pharmaceutical’s commitment to innovation in oncology treatment.-Fineline Info & Tech