LG Chem is accelerating its global anticancer drug development after receiving approval from the U.S. Food and Drug Administration (FDA) for clinical trials of its solid tumor drug candidate. This strategy targets the rare mutation cancer market, which has limited treatment options.
On June 30, LG Chem announced that it has received FDA approval for the Investigational New Drug (IND) application for its anticancer drug candidate, LG00313112. This candidate was acquired from the U.S. biotech company Frontier Medicines in April.
LG00313112 targets the 'TP53 Y220C' mutation, found in approximately 1-3% of all cancer patients. This mutation is known to cause structural instability in the p53 protein, a tumor suppressor, thereby promoting cancer development. LG Chem is developing the drug to stabilize this protein and restore its original tumor-suppressing function.
Notably, this candidate is the first in its class to utilize a covalent-based design, enhancing its binding affinity to the target protein and prolonging its efficacy. Preclinical trials have shown excellent anticancer effects and sustained drug response even at low doses, maintaining anticancer activity in tumor models with KRAS mutations.
Cancers with TP53 mutations are known to have poor prognoses. According to the National Cancer Institute's genomic data (TCGA), the average survival for patients with TP53 mutations is 29 months, compared to 63 months for those without the mutation. Currently, there are no commercially available treatments that directly target this mutation.
To expedite development, LG Chem has adopted a clinical design that combines Phase 1 and Phase 2 trials. This strategy aims to confirm the appropriate dosage and efficacy simultaneously in the early stages, thereby shortening the overall development timeline.
In Phase 1, the trials will evaluate safety, tolerability, recommended dosage, and initial efficacy in patients with advanced solid tumors harboring the TP53 Y220C mutation, including those with ovarian, lung, and breast cancers. Phase 2 will follow to conduct a more comprehensive efficacy validation based on these findings.
Kim Hye-jin, head of LG Chem's Clinical Development Group, stated, "We will identify patients expected to respond to treatment through a clear biomarker-based precision medicine approach and accelerate development to provide new alternatives for cancer patients with limited treatment options."
Meanwhile, the global anticancer drug market was valued at $250 billion as of last year and is projected to grow at an annual rate of 6-12%. It is expected to reach approximately $668 billion by 2034.
On June 30, LG Chem announced that it has received FDA approval for the Investigational New Drug (IND) application for its anticancer drug candidate, LG00313112. This candidate was acquired from the U.S. biotech company Frontier Medicines in April.
LG00313112 targets the 'TP53 Y220C' mutation, found in approximately 1-3% of all cancer patients. This mutation is known to cause structural instability in the p53 protein, a tumor suppressor, thereby promoting cancer development. LG Chem is developing the drug to stabilize this protein and restore its original tumor-suppressing function.
Notably, this candidate is the first in its class to utilize a covalent-based design, enhancing its binding affinity to the target protein and prolonging its efficacy. Preclinical trials have shown excellent anticancer effects and sustained drug response even at low doses, maintaining anticancer activity in tumor models with KRAS mutations.
Cancers with TP53 mutations are known to have poor prognoses. According to the National Cancer Institute's genomic data (TCGA), the average survival for patients with TP53 mutations is 29 months, compared to 63 months for those without the mutation. Currently, there are no commercially available treatments that directly target this mutation.
To expedite development, LG Chem has adopted a clinical design that combines Phase 1 and Phase 2 trials. This strategy aims to confirm the appropriate dosage and efficacy simultaneously in the early stages, thereby shortening the overall development timeline.
In Phase 1, the trials will evaluate safety, tolerability, recommended dosage, and initial efficacy in patients with advanced solid tumors harboring the TP53 Y220C mutation, including those with ovarian, lung, and breast cancers. Phase 2 will follow to conduct a more comprehensive efficacy validation based on these findings.
Kim Hye-jin, head of LG Chem's Clinical Development Group, stated, "We will identify patients expected to respond to treatment through a clear biomarker-based precision medicine approach and accelerate development to provide new alternatives for cancer patients with limited treatment options."
Meanwhile, the global anticancer drug market was valued at $250 billion as of last year and is projected to grow at an annual rate of 6-12%. It is expected to reach approximately $668 billion by 2034.
* This article has been translated by AI.
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