Chong Kun Dang announced on July 25 that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1/2a clinical trials for its self-developed cancer drug, CKD-703. The drug is an antibody-drug conjugate (ADC)-based therapy, representing an innovative approach to cancer treatment.
The FDA approval allows Chong Kun Dang to evaluate the safety and maximum tolerated dose of CKD-703 in patients with non-small cell lung cancer and solid tumors within the United States. The trial will involve a dose-escalation process to determine optimal dosing, as well as assessments of pharmacokinetics, immunogenicity, and preliminary efficacy through concept proof (POC) studies.
CKD-703 is a proprietary drug developed by Chong Kun Dang, utilizing a next-generation ADC platform technology combined with a monoclonal antibody targeting c-Met, a receptor involved in cancer cell growth. The drug works by selectively inducing cell death in cancer cells through targeted delivery of a cytotoxic payload while inhibiting downstream c-Met signaling. It is designed to enhance safety by reducing nonspecific drug release into the bloodstream.
Preclinical studies have demonstrated strong cell-killing effects, with ongoing research to expand its applicability across various solid tumors. The company highlights CKD-703 as its first ADC anticancer agent created through its own technology integrated with a global ADC platform.
A Chong Kun Dang representative stated, “CKD-703 is our first ADC anticancer drug developed through the convergence of our proprietary technology and a global ADC platform. Starting with FDA approval for clinical trials, we plan to expand this development to other regions including Asia and Europe, ultimately aiming to develop a best-in-class cancer therapy by focusing on global research capabilities.”
Last year, CKD-703 received support from the Korea Drug Development Fund’s initiative to promote global advancement and partnership of innovative new drugs, recognizing its potential and uniqueness, and supporting nonclinical and Phase 1 clinical trial preparation efforts for international expansion.
