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GenFleet, Innovent Launch First-in-Human Trial of KRAS G12C Inhibitor

NEW YORK – Biotechnology companies GenFleet Therapeutics and Innovent Biologics on Thursday said the first cancer patient with a KRAS G12C mutation had received the firms' investigational therapy GFH925 in a Phase I/II clinical trial in China.

The first-in-human trial of GFH925 will involve more than 100 patients with late-stage non-small cell lung and gastrointestinal cancers with KRAS G12C mutations. Researchers led by Yilong Wu at Guangdong Provincial People's Hospital will evaluate the oral KRAS inhibitor's safety, tolerability, efficacy, and pharmacokinetics. They will also look for biomarkers and explore combination therapies that might allow patients to receive more personalized treatment.

"KRAS G12C is one of the most frequently mutated oncogenes in human cancer cells, and RAS used to be an undruggable target over decades," Hui Zhou, senior VP of clinical development at Innovent, said in a statement. "So far there have been few treatments for patients with this mutation, and we can see huge unmet medical needs."

Earlier this month, Hong Kong-based Innovent paid Shanghai-headquartered GenFleet $22 million upfront to develop and commercialize GFH925 in China, including the Chinese mainland, Hong Kong, Macau, and Taiwan. Innovent also has the option to garner global development and commercialization rights for the drug.