Hyundai Bio Conducts Clinical Trial Targeting Cancer Patients with p53 Gene Mutation

Hyundai Bio (CEO Oh Sang-gi) announced on the 25th that it has decided to conduct clinical trials of an oral niclosamide repurposed anticancer drug targeting patients with intractable cancers caused by p53 gene mutations.

'p53 gene mutation' is expressed in almost all cancer cells and is a cause of various intractable cancers, especially ovarian cancer, uterine cancer, and esophageal cancer.

The p53 gene detects cell DNA damage and induces cell death, earning it the nickname "guardian of the genome." When the p53 gene mutates, its function is lost, leading to resistance to existing anticancer drugs and rapid metastasis of cancer cells. Until now, attempts have been made to develop anticancer drugs that directly target p53 gene-mutated cancer cells, but they have failed to selectively kill only p53-mutated cancer cells without damaging normal cells.

Research has shown that 'niclosamide' induces cancer cell death by regulating cancer cell metabolic pathways, minimizing side effects while simultaneously addressing drug resistance and cancer cell metastasis. It is known to have superior anticancer effects when used in combination with existing anticancer drugs compared to monotherapy with existing anticancer drugs.

Although niclosamide has been found to have excellent anticancer effects, it has not been developed as an anticancer drug for over 60 years due to unresolved issues of 'low absorption rate' and 'short maintenance time of effective blood drug concentration.' Hyundai Bio overcame these challenges of niclosamide through patented drug delivery technology and successfully repurposed it as an oral anticancer drug with a drug concentration (IC50) required to inhibit the proliferation of most cancer cells at a niclosamide dose without toxicity (NOAEL).

Hyundai Bio recently demonstrated in a triple-negative breast cancer animal model that the 'combination treatment group of oral niclosamide repurposed anticancer drug and the representative chemotherapeutic agent docetaxel' showed 67% superior anticancer effects compared to the 'docetaxel monotherapy group.' Through a long-term (13-week) animal toxicity test, it was confirmed that the blood concentration at the maximum non-toxic dose (NOAEL) of niclosamide was 7,888 ng/mL. Considering that the IC50 of most cancer cells ranges from 65 to 654 ng/mL, this means that niclosamide can inhibit the proliferation of most cancer cells even when administered at less than one-tenth of the NOAEL dose.

Oh Sang-gi, CEO of Hyundai Bio, stated, "Niclosamide repurposed anticancer drug will be the first p53-targeted anticancer drug that selectively kills p53 gene-mutated cancer cells," adding, "We plan to conduct clinical trials targeting patients with intractable cancers caused by p53 mutations as the first step in the niclosamide repurposed anticancer drug business to be carried out through our subsidiary ADM Korea."

Lim Jong-eon, CEO of ADM Korea, said, "We plan to apply for clinical trials designed to compare the combination treatment group of existing anticancer drugs and oral repurposed anticancer drugs with the existing anticancer drug treatment group," and added, "Starting with this clinical trial, we will transform into a specialized pharmaceutical and bio company for oral repurposed anticancer drugs."