Hyundai Bioscience is advancing its niclosamide-based cancer candidate into Phase I/IIa trials for several hard-to-treat cancers following a successful preclinical study in combination with chemotherapy.
The candidate, jointly developed with CNPharm, was investigated in combination with the chemotherapy drug docetaxel. In the preclinical study, animals were implanted with triple-negative breast cancer cells and given the combination therapy, or docetaxel alone. The combination treatment was found to be more effective, with the anti-cancer efficacy 67% better than the docetaxel-treated group.
The Phase I/IIa trial will be conducted in Korea for various difficult-to-treat cancers, including triple-negative breast cancer, pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and metastatic prostate cancer. The drug project will be carried out by a new subsidiary of Hyundai called ADM Korea, said Hyundai’s CEO Oh Sang-gi in the 22 April announcement.
Niclosamide is an antiparasitic drug that Hyundai and CNPharm previously developed for Covid-19 and other viral infections under the name Xafty. In June 2023, Hyundai filed results of a Phase II clinical study (NCT04521296) of Xafty with the Korea Disease Control and Prevention Agency for emergency use authorisation on Covid-19. Its mechanism involves cellular autophagy, a process where cells identify and eliminate foreign invaders like viruses. The broad-spectrum anti-viral action is seen as a promising avenue for treating various viral diseases.
The drug has also demonstrated efficacy as a cancer treatment by acting on the metabolic processes of cancer cells. Results from Hyundai and CNPharm’s in vitro preclinical test demonstrated efficacy in cancer treatment through multiple mechanisms. The drug disrupts cancer cell metabolism and blocks signalling pathways in tumour cells, preventing drug resistance and impeding cancer recurrence and metastasis.
The progress of niclosamide was long hindered by low bioavailability and a short half-life. Through its drug delivery technology, Hyundai’s formulation claims to have a high enough drug concentration to inhibit the proliferation of cancer cells without being toxic.
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In May 2022, Hyundai announced plans to submit a fast-track processing request for Xafty to the US Food and Drug Administration (FDA) to treat monkeypox. More recently, the company announced that the drug can be used to treat Dengue virus, with plans to get emergency use authorisation (EUA) in areas where dengue fever is an endemic disease.
In the announcement accompanying the preclinical data, Hyundai’s R&D lead Jin Geun-Woo said: “This is the first case that is statistically proven in vivo that the oral niclosamide-based anticancer treatment has a remarkable effect on triple-negative breast cancer, a type of cancer that is challenging to treat.”
