Chong Kun Dang Receives FDA Approval for Phase 1/2a Clinical Trial of ADC-Based Anticancer Drug

Chong Kun Dang receives FDA approval for Phase 1/2a clinical trial of 'CKD-703', an independently developed ADC-based anticancer drug
Plans to confirm safety, maximum tolerated dose, and optimal dose in U.S. patients with non-small cell lung cancer and solid tumors
CKD-703 selectively targets cancer cells using next-generation ADC platform technology
Global clinical expansion planned following U.S. trial approval

On July 25, Chong Kun Dang announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial of its independently developed antibody-drug conjugate (ADC)-based anticancer new drug, 'CKD-703.'

With this clinical trial approval, Chong Kun Dang plans to confirm the safety and maximum tolerated dose of CKD-703 in patients with non-small cell lung cancer and solid tumors in the United States through a stepwise dose escalation. The company also aims to determine the optimal dose through proof-of-concept (POC) studies. In addition, comprehensive evaluations will be conducted on pharmacokinetics, immunogenicity, and preliminary efficacy.

CKD-703 is a drug currently being developed by Chong Kun Dang by combining a monoclonal antibody targeting the hepatocyte growth factor receptor (c-Met), which was independently developed by the company, with next-generation ADC platform technology. It is an innovative anticancer drug candidate with a mechanism that selectively destroys only cancer cells.

This drug inhibits downstream signaling of c-Met and simultaneously delivers cytotoxic agents selectively into cancer cells to induce cell death. As a result, it is expected to improve safety by preventing the drug from being indiscriminately released into the bloodstream. Preclinical studies conducted in Korea have confirmed excellent cell death induction effects, and research is currently underway to expand indications to various solid tumors.

A Chong Kun Dang representative stated, "CKD-703 is Chong Kun Dang's first ADC anticancer new drug, developed through the integration of our proprietary technology and global ADC platform technology. Starting with this FDA approval for Phase 1/2a clinical trials, we plan to expand clinical trial participation to Korea, Asia, and Europe, and focus our global research capabilities."

Last year, CKD-703 was selected as a supported project in the 'Support for Excellent New Drug Development for Global Expansion and Partnering Promotion' program led by the National New Drug Development Project Team, in recognition of its innovation and differentiation. The drug is currently receiving research support for preclinical and Phase 1 clinical trial approval to enter global clinical studies.

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