Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced a phase I/II clinical study of KRAS G12C inhibitor IBI351 in Chinese patients with solid tumors (ClinicalTrials.gov, NCT05005234) completed dosing of the first subject.
This study is an open-label, multi-center Phase I/II clinical study in Chinese patients with advanced solid tumors (non-small cell lung cancer (NSCLC) and gastrointestinal cancer) harboring KRAS G12C mutation, with the primary objective to assess the safety/tolerability, pharmacokinetics and efficacy of IBI351.
Professor Yilong Wu, principal investigator of the study, tenured director of Guangdong Provincial People's Hospital and honorary director of Guangdong Lung Cancer Institute, stated: "KRAS is the most common RAS protein subtype, with a high mutation rate in non-small cell lung cancer, pancreatic cancer, colorectal cancer and other cancer cells. Preclinical data showed that IBI351 is sufficiently differentiated from competitors already or about to enter the clinic, and we look forward to positive results in the safety/tolerability and efficacy data of IBI351. We will also continue to explore the application of precision therapy and potential combination therapy to benefit more cancer patients with KRAS G12C mutations."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "KRAS G12C is one of the most commonly mutated oncogenes in human cancer and was well known as a non-druggable target. At present, there are limited clinical treatments for this mutation, and there is a great unmet clinical need. We are pleased that the first patient has already received the first dose of IBI351 and this is an important milestone for the clinical development of IBI351 in China. Based on preclinical data, we hope that the development of IBI351 in China will benefit more patients with lung cancer and solid tumors carrying KRAS G12C mutation and bring more treatment options to clinicians."
Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet Therapeutics, stated, "Current data demonstrates the higher response to selective KRAS G12C inhibitors in population of lung cancer patients with KRAS G12C mutation. The first patient with KRAS G12C mutation administrated after precision screening is a key milestone in the clinical development of GFH925 (Innovent R&D code: IBI351). Thanks to our joint efforts with investigators from our sites, we have completed program initiation and began patient screening in a very short amount of time. We are also confident that our collaboration with Innovent, with its successful track records of developing and commercializing novel therapies, will speed up the study process in order to bring this life-saving treatment to patients across the globe."
About IBI351 (KRAS G12C Inhibitor)
IBI351 (GenFleet's R&D code: GFH925) is a highly effective oral new molecular, independently developed by GenFleet Therapeutics Inc. and has complete intellectual property rights. By covalently and irreversibly modifying the cysteine residue of KRAS G12C mutant, it effectively inhibits the protein-mediated GTP/GDP exchange and thus down-regulates the KRAS protein activation level. Preclinical cysteine selectivity test also shows the highly selective inhibitory potency of IBI351 on this mutation point. In addition, inhibition of KRAS protein by IBI351 inhibited downstream signaling pathways, profoundly induced tumor cell apoptosis and cell cycle arrest, and achieved anti-tumor effect.
In September 2021，Innovent and GenFleet Therapeutics (Shanghai) Inc. ("GenFleet"), entered into an exclusive license agreement in which Innovent will be responsible for clinical development and commercialization of IBI351 in China including mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China with additional option-in rights for global development and commercialization.
About Innovent
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