Chong Kun Dang announced on the 25th that it has received approval from the U.S. Food and Drug Administration (FDA) for a clinical phase 1·2a trial of its antibody-drug conjugate (ADC) candidate 'CKD-703.'
ADC is a therapeutic technology that attaches a drug to an antibody that binds to cancer cells, delivering the drug precisely to the cancer cells. It is referred to as a guided missile that accurately targets only cancer cells.
With this approval, Chong Kun Dang plans to assess the safety and maximum tolerated dose of CKD-703 by gradually increasing the dosage for patients with non-small cell lung cancer and solid tumors in the U.S., and derive the optimal dose through proof of concept (POC). Evaluations of pharmacokinetics (PK), immunogenicity, and initial efficacy will also be conducted.
CKD-703 is a drug that targets the hepatocyte growth factor receptor (c-Met) with a monoclonal antibody developed by Chong Kun Dang, combined with ADC platform technology. Chong Kun Dang expects this drug to act precisely on cancer cells, delivering toxic drugs into the cancer cells to induce cell death.
CKD-703 was selected last year as part of the 'Excellent New Drug Development Support Project' by the National New Drug Development Project Group and is receiving support for non-clinical and phase 1 research to promote global expansion and partnerships.
Chong Kun Dang confirmed the excellent cell death-inducing effect of CKD-703 in non-clinical studies conducted in Korea and is also conducting research to expand the treatment target diseases for various solid tumors.
A company official said, 'CKD-703 is the first ADC anticancer drug that combines Chong Kun Dang's proprietary technology with a global ADC platform, and after this FDA approval, we will expand the clinical regions to Korea, Asia, and Europe and focus our global capabilities to develop it as a best-in-class drug.'