[Edaily Reporter NA EUN-KYUNG ] LGCHEM,LTD(051910)is set to begin full-scale development of a treatment for solid tumors with specific genetic mutations for which no commercially available therapy currently exists.

LGCHEM,LTD announced on the 30th that it has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for Phase 1 and 2 clinical trials of its new anticancer drug candidate, LG00313112.

LG00313112 is a candidate drug for which LGCHEM,LTD acquired global exclusive development and commercialization rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from U.S.-based Frontier Medicines last April.

This candidate targets the TP53 Y220C gene mutation, which is found in approximately 1–3% of all cancer patients. TP53 is the gene that encodes p53, a protein that normally suppresses the proliferation of cancer cells; however, when the Y220C mutation occurs, the structure of p53 becomes unstable, impairing its tumor-suppressing function. LG Corp. is developing LG00313112 with a mechanism that stabilizes the p53 protein rendered unstable by the mutation, thereby restoring its original function.

LGCHEM,LTD aims to enhance binding affinity to the target protein and prolong the duration of therapeutic effect by applying the first covalent-binding-based drug design in this class.

LGCHEM,LTD explained that preclinical studies confirmed anticancer efficacy and sustained drug effect even at low doses, and that anticancer activity was maintained even in tumor models carrying KRAS mutations, which frequently co-occur with various solid tumors.

According to the National Cancer Institute’s (NCI) Cancer Genome Atlas (TCGA), the average survival period after treatment for cancer patients with TP53 mutations is 29 months—less than half that of patients without the mutation (63 months). To date, there are no commercially available therapies targeting the TP53 Y220C mutation.

To shorten the development timeline, LGCHEM,LTD is conducting a combined Phase 1/2 clinical trial that integrates Phase 1 and Phase 2 under a single protocol. This strategy involves confirming the appropriate dose and initial efficacy in the early stages, followed immediately by an evaluation of efficacy.

In the Phase 1 trial, the company will evaluate safety, tolerability, the recommended Phase 2 dose (RP2D), and preliminary efficacy in patients with advanced solid tumors—including ovarian, lung, and breast cancers—that harbor the TP53 Y220C mutation. Subsequently, in the Phase 2 trial, the company plans to fully verify the treatment’s efficacy based on the Phase 1 results.

Kim Hye-jin, Head of the Clinical Development Group at LGCHEM,LTD, stated, “Through a clear biomarker-based precision medicine approach, we will efficiently identify patients expected to respond to treatment, thereby increasing the likelihood of success in new drug development.” She added, “We will accelerate the development of LG00313112 so that cancer patients with limited treatment options can lead healthier lives for longer.”