(LG Chem) LG Chem said Tuesday it has received US Food and Drug Administration clearance for its investigational new drug application to begin a phase 1/2 clinical trial of LG00313112, an anticancer drug candidate.LG00313112, licensed from Frontier Medicines in April last year, targets TP53 Y220C, a mutation found in 1 to 3 percent of cancer patients. The drug is designed to stabilize the structurally unstable p53 protein caused by the mutation and restore its tumor-suppressing function.LG Chem said the candidate could offer a sustained therapeutic effect through its first-in-class covalent-binding design, which enables stable binding to the target.In preclinical studies, anticancer drug showed efficacy at low doses, a sustained drug response and activity in tumor models with co-occurring KRAS mutations.According to the Cancer Genome Atlas compiled by the US National Cancer Institute, cancer patients with TP53 mutations have an average survival period of 29 months after treatment, less than half that of patients without the mutation. No drug targeting the TP53 Y220C mutation has been commercialized to date.To accelerate global development, LG Chem designed the phase 1/2 study under a single protocol.The phase 1 portion will evaluate safety, tolerability, the recommended dose and preliminary efficacy in patients with advanced solid tumors, including ovarian, lung and breast cancers, carrying the TP53 Y220C mutation. The phase 2 portion will further assess efficacy based on phase 1 results."We will select patients with high potential treatment responses and accelerate development of LG00313112 so cancer patients with limited treatment options can live longer, healthier lives," said Kim Hye-jin, head of clinical and regulatory affairs at LG Chem.