Handok (Chairman & CEO Young-jin Kim, Vice President Jin-ki Paik), in collaboration with CMG Pharmaceutical and the National OncoVenture (NOV), will announce a poster on Phase I clinical trials for NOV1601 (CHC2014), which selectively inhibits pan-TRK, at the ESMO Virtual Congress 2020 to be held online for three days from September 19, 2020.

The poster will include information on Phase I FIH (first-in-human), which is the first administration to humans of the TRK inhibitor NOV1601 (CHC2014), a genetic cancer-targeting therapy jointly developed by Handok, CMG Pharmaceutical, and NOV. The TRK inhibitor NOV1601 (CHC2014) won approval (IND) from the Ministry of Food and Drug Safety in May 2019, and Phase I trials are being carried out domestically.

The clinical trial for the TRK inhibitor NOV1601 (CHC2014) will evaluate the safety, tolerability, and pharmacokinetics of the subject drug in Korean adult patients with solid malignant tumors in their organs. Four medical institutions (National Cancer Center, CHA University Bundang Medical Center, Severance Hospital, and Seoul National University Hospital) are soliciting patients, and the drug has currently been administered to 14 patients in 4 different dose groups.

The TRK inhibitor NOV1601 (CHC2014) is a selective TRK Tyrosine kinase inhibitor (TKI) with a unique dynamic structure for solvent-front mutations of the Tropomyosin receptor kinase (TRK) protein. TKI is a targeted drug therapy that interferes with signaling pathways that can trigger abnormal growth of cancer cells.

The TRK inhibitor NOV1601 (CHC2014) demonstrated strong and selective antitumor activity in tumor cells and animal model-based tests, and it was also confirmed to be effectively tolerated in previous TRK inhibitors. Drugs with similar mechanisms are Bayer’s Vitrakvi and Roche’s Rozlytrek Capsules that received Korean approval this year.