Hyundai Bio "Oral Niclosamide Anticancer Drug Preclinical Success in Triple-Negative Breast Cancer"

Hyundai Bio announced on the 19th that it has proven a 67% superior anticancer effect in the combination therapy group compared to the docetaxel monotherapy group by conducting preclinical trials on triple-negative breast cancer, a representative intractable cancer, using the 'niclosamide-based oral metabolic anticancer agent' jointly developed with C&Pharm in combination with the chemotherapeutic agent docetaxel. The preclinical results are planned to be published through an SCI-level paper.

Hyundai Bio stated that it has succeeded in drug repositioning of niclosamide, which has been found effective in treating various cancers by acting on the metabolic processes of cancer cells through decades of cell experiments, into an oral metabolic anticancer agent.

A metabolic anticancer agent is an anticancer drug that disrupts the unique metabolic mechanisms of cancer cells and blocks neurotransmitter systems to inhibit the growth and survival of cancer cells. When combined with existing anticancer drugs, it is characterized by enhanced anticancer effects.

Niclosamide is a drug identified as a representative metabolic anticancer substance that disrupts cancer cell metabolism to inhibit proliferation and survival, blocks major neurotransmitter systems of cancer cells to prevent the development of resistance to anticancer drugs, and suppresses cancer stem cells to prevent recurrence and metastasis. Among these, the simultaneous resolution of resistance and metastasis issues is known to be achievable only by niclosamide anticancer agents.

Due to these anticancer mechanisms, niclosamide has been found effective against various cancers such as lung cancer, breast cancer, prostate cancer, colon cancer, liver cancer, kidney cancer, and head and neck cancer. In particular, it shows excellent efficacy against intractable cancers such as triple-negative breast cancer, lung cancer, prostate cancer, ovarian cancer, colon cancer, pancreatic cancer, and head and neck cancer, which exhibit resistance to existing anticancer treatments.

Although niclosamide has been shown to have excellent anticancer effects, it has not reached clinical trials in humans for over 60 years due to unresolved issues of 'low absorption rate' and 'short maintenance time of effective drug concentration in blood.'

Hyundai Bio announced that, in collaboration with C&Pharm, it has completed an oral anticancer drug formulation with a drug delivery system patent technology that achieves a drug concentration (IC50) that inhibits cancer cell proliferation within a niclosamide dose that does not cause toxicity.

Hyundai Bio confirmed that niclosamide doubles the anticancer effect in an experiment where triple-negative breast cancer, known as a representative intractable cancer, was transplanted into animals and oral niclosamide anticancer agent was administered in combination with docetaxel.

Regarding the significance of this preclinical result, Jin Geun-woo, head of research at Hyundai Bio, said, "This is the first case to statistically prove in vivo that oral niclosamide anticancer agent has excellent effects on triple-negative breast cancer, an intractable cancer. Niclosamide metabolic anticancer agents can solve the problems of resistance and metastasis that make anticancer treatment impossible." He added, "We plan to conduct clinical phase 1/2a trials in Korea targeting various intractable cancers including triple-negative breast cancer, pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and metastatic prostate cancer."

Osang-gi, CEO of Hyundai Bio, stated, "The oral niclosamide anticancer agent business will be conducted by a new subsidiary," and added, "To this end, Hyundai Bio also plans to transfer the oral niclosamide anticancer agent technology to the new subsidiary."