Minghui Pharmaceutical has dosed the first patient in its two Phase I clinical trials of MHB036C and MHB088C antibody-drug conjugates (ADCs) to treat selected types of advanced or metastatic solid tumours.
The study will evaluate the preliminary efficacy and pharmacokinetics of both ADCs and determine the recommended Phase II dose (RP2D) and maximum tolerated dose (MTD).
Both ADCs utilise the SuperTopoi ADC platform, which includes a highly potent topoisomerase (TOPO) 1 inhibitor linked through a cleavable linker.
The therapeutic potency of the ADCs is enhanced by the new payload for treating cancer cells with moderate or low tumour-associated antigen expression.
Minghui Pharmaceutical CEO Guoqing Cao said: “MHB036C and MHB088C hold great promise in the fight against various human solid tumours and we look forward to the results from the Phase I studies, anticipated to conclude in early 2024.”
MHB036C and MHB088C have shown efficacy during in vitro and in vivo studies by killing tumour cells three to ten times more potently compared to their DXd counterparts.
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An excellent safety profile with no severe pulmonary toxicities was also observed in preclinical GLP tox studies.
MHB036C and MHB088C target TROP-2 and B7-H3, respectively.
Last Month, Minghui dosed the first healthy volunteer in a Phase Ia trial of MHB018A to treat thyroid eye disease.
In this trial, MHB018A demonstrated three to five times greater ligand-blocking activities compared to other IGF-1R antibodies for IGF-1 and IGF-2.