CKD says, "New ADC drug enters first clinical trials"

Aiming for best-in-class

c-MET-targeting ADC wins FDA clinical approval...aims to secure solid tumor indications including NSCLC

Changsik Lee, Head of Chong Kun Dang Research Center, "Potential for effectiveness in low-expression patients…combination strategies also under review"

Changsik Lee, Head of Chong Kun Dang Research Center

Chong Kun Dang is accelerating its development of a new c-Met-targeted Antibody-Drug Conjugate (ADC).

 

With its newly entered clinical candidate, 'CKD-703,' the company is aiming to secure a best-in-class ADC and is seeking a differentiated strategy in a globally competitive landscape.

 

On August 29, Samsung Medical Center and Aimed Bio co-hosted the 3rd ADC Conference at Samsung Hospital's main auditorium.

 

Chong Kun Dang's research director, Changsik Lee, introduced the ADC new drug candidate CKD-703, which has entered the clinical stage.

 

Since 2019, Chong Kun Dang has been collaborating with the Dutch company Synaffix on ADC discovery.

 

In February of last year, it acquired non-exclusive rights to Synaffix's ADC platform technology in a deal valued at $132 million.

 

Synaffix is currently partnering with several key domestic bio-companies on its platform technology.

 

Using this technology, Chong Kun Dang successfully developed CKD-703.

 

CKD-703 is a drug that targets the hepatocyte growth factor receptor (c-Met), which is overexpressed in cancer cells, and is being developed for solid tumors, including non-small cell lung cancer (NSCLC).

 

Last month, the U.S.

 

Food and Drug Administration (FDA) approved Chong Kun Dang's Investigational New Drug (IND) application for a Phase 1/2a clinical trial of CKD-703.

 

This is the first time Chong Kun Dang has entered a global clinical trial for an ADC.

 

c-Met targeted by CKD-703 is a protein expressed by the epithelial-mesenchymal transition (MET) gene.

 

As a key signaling protein, c-Met is a well-known oncogene linked to the development of various solid tumors, including NSCLC, colorectal, gastric, and liver cancers.

 

It is known that the c-Met mutation occurs in 6% of NSCLC patients.

 

Currently, AbbVie's Emrelis (telisotuzumab vedotin) is the only commercially available ADC that targets the c-Met mutation.

 

Emrelis received accelerated approval in the U.S.

 

in May for NSCLC.

 

In its Phase 2 clinical trial involving 84 patients with c-Met overexpression, the objective response rate (ORR) was 35%, and the duration of response (DoR) was 7.2 months.

 

Lee noted, "In clinical trials, Emrelis's efficacy was primarily observed in patients with c-Met overexpression, with an ORR of 35%.

 

We believed there was a significant unmet need that could be addressed in patients with low expression and in terms of response rates."

Synaffix (Netherlands)

However, competitors continue to emerge.

 

Celltrion is also focusing on c-Met-targeted ADCs, having received approval for its CT-P70 Phase 1 clinical trial in Korea and the U.S.

 

this year.

 

Chong Kun Dang plans to differentiate itself from global competitors in areas such as toxicity management and treatment response rates to prove its commercialization potential.

 

Lee stated, "We have confirmed that CKD-703 has a high yield of over 85%, which poses no issues for its progression to clinical trials," and added, "The payload was the main concern, but there was no reason to change it from the one used in Elahere to achieve a better effect.

 

We used MMAE, a microtubule inhibitor payload, which is also applied in Emrelis." And added, "CKD-703 has the potential for improvement over existing treatments in terms of efficacy and safety." Lee analyzed, "In preclinical monkey models, the incidence of thrombocytopenia, a condition where platelet counts drop below the normal range, was lower for CKD-703 compared to Emrelis." Lee emphasized, "We are dedicating our utmost corporate resources to the development.

 

In this clinical trial, we expect CKD-703 to demonstrate a higher efficacy than existing treatments in patients with c-Met overexpression, and also prove its efficacy in patients with low and intermediate expression.

 

Our goal is to secure a best-in-class treatment, and we are open to the possibility of combination therapy with immunotherapies."