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Innovent Begins Phase I Trial of IBI389 in Claudin18.2-Expressing Solid Tumors

NEW YORK – Innovent Biologics on Tuesday said it has dosed the first patient in a Phase Ia/b trial of its Claudin18.2- and CD3-targeted bispecific antibody IBI389 in advanced solid tumors.

The company is evaluating IBI389 in the trial as a monotherapy and in combination with Eli Lilly's PD-1 inhibitor Tyvyt (sintilimab) plus chemotherapy or chemotherapy alone. The trial will involve 320 patients with advanced or metastatic solid tumors and patients will provide archival or fresh tissue samples for CLDN18.2 expression analysis.

In the Phase Ia portion of the trial, Innovent will enroll any solid tumor patient who is out of standard treatment options or who can't tolerate standard therapies. The aim in this phase is to determine the maximum tolerated dose and recommend a Phase II dose for both the single-agent IBI389 and the combination regimen. In the second phase of the study, Innovent will enroll patients with pancreatic cancer, gastric cancer, and solid tumors to evaluate safety and efficacy.

"In recent years, CLDN18.2 has become one of the most topical R&D areas in molecular biology, and preliminary efficacy results in some clinical studies demonstrated encouraging druggability of this target," Feng Bi, principal investigator of the study, said in a statement. "IBI389 bispecific antibody distinguishes itself from traditional monoclonal antibodies by encouraging T-cell infiltration and killing of tumors, thus enhancing the antitumor effect as a single agent."

IBI389 kills tumors by binding to CD3-activated T cells and directing them to CLDN18.2-expressing tumor cells. In preclinical studies, IBI389 showed antitumor effects in cell lines with CLDN18.2 expression including those with low CLDN18.2 expression. Patients with low to moderate CLDN18.2 expression have not responded well to conventional antibodies in previous research, and Suzhou, China-based Innovent believes IBI389 could be a promising treatment for this subset of patients.