CKD aims at developing next-generation·new anti-cancer drug

Positive Data from clinical trials of in-licensed new drug candidates

Has secured in-house technology…Chong Kun Dang's new ADC drug enters U.S. Phase 2 trial

Chong Kun Dang is speeding up investment in the new anti-cancer drug sector.

 

The company aims to commercialize anti-cancer drugs by advancing its in-house pipelines for Antibody-Drug Conjugates (ADCs) and Cell and Gene Therapies (CGTs).

 

Additionally, Chong Kun Dang is securing domestic rights for new drugs, including Chimeric Antigen Receptor T-cell (CAR-T) therapies, cancer vaccines, and targeted therapies.

 

Accelerating Commercialization of New Anti-cancer Drugs...In-licensing New Drugs enters into Late-Stage Clinical Trials According to industry sources on August 26, patient enrollment in the Phase 2 clinical trial of namodenoson, a targeted therapy for which Chong Kun Dang holds domestic rights in Korea, has recently exceeded half of its target.

 

In 2016, Chong Kun Dang signed an exclusive domestic supply and sales agreement for namodenoson with Israel's Can-Fite BioPharma.

 

Namodenoson is a selective A3 adenosine receptor (A3AR) agonist with a mechanism that suppresses the progression of fibrosis.

 

This new drug candidate has demonstrated safety and anti-tumor activity in preclinical models of pancreatic cancer.

 

The current Phase 2a trial is a multi-center, open-label study evaluating the safety and pharmacokinetic (PK) activity of namodenoson in patients with advanced pancreatic adenocarcinoma whose disease has progressed after previous treatment.

 

Patients are administered 25mg of namodenoson orally twice a day in 28-day cycles, and favorable safety results have been observed.

 

Currently, namodenoson is being investigated in a Phase 3 clinical trial for hepatocellular carcinoma, a Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH), and the Phase 2a trial for pancreatic cancer.

 

It has received Orphan Drug Designation in the U.S.

 

and Europe.

 

It has also been granted Fast Track designation by the U.S.

 

Food and Drug Administration (FDA) as a second-line treatment for hepatocellular carcinoma.

 

Its potential has also been confirmed for various other cancers, including colon cancer, prostate cancer, and melanoma.

 

Chong Kun Dang has also secured the rights for a new CAR-T drug candidate.

 

In June, Chong Kun Dang invested KRW 12.2 billion in the biotech company AbClon in Korea, becoming its second-largest shareholder with a 7.33% stake through a third-party share allocation capital increase.

 

It was the first time in Chong Kun Dang's history that it has made an external investment of over KRW 10 billion.

 

AbClon is a new drug development company co-founded by Korean and Swedish researchers in 2010 and was listed on the KOSDAQ in 2017.

 

It has a diverse pipeline of drugs targeting various cancers, including gastric, colorectal, prostate, and hematological cancers, with products such as the HER2-targeted antibody therapy (AC101), bispecific antibody-based immunotherapy (AM105), and the CAR-T therapy (AT101).

 

Chong Kun Dang has secured the priority right for the domestic sales of AbClon's hematological cancer CAR-T therapy, 'AT101,' which is under development.

 

The company plans to expand its collaboration in the co-development and commercialization of CAR-T and bispecific antibody new drugs in the future.

 

AT101 has entered a Phase 2 clinical trial, with the goal of submitting an expedited approval application in 2025.

 

The two companies also plan to co-develop new drugs targeting HER2-targeted CAR-T (AT501), PSMA, CD30, and 4-1BB.

 

Chong Kun Dang also has high hopes for the cancer vaccine sector.

 

A Phase 3 clinical trial for the cancer vaccine 'Tedopi,' for which Chong Kun Dang holds sales rights, is underway in patients with non-small cell lung cancer.

 

Chong Kun Dang in-licensed the domestic rights for Tedopi from OSE Immunotherapeutics, a company based in France, in 2019.

 

Tedopi is a cancer vaccine for patients who have failed immunotherapy.

 

A study in patients with advanced and metastatic lung cancer who failed previous treatments showed that Tedopi reduced the risk of death by 41% compared to chemotherapy.

 

The confirmatory Phase 3 clinical trial is ongoing, and a study in pancreatic cancer patients is also being conducted.

 

Active In-house Anti-Cancer Drug Clinical Trials

In addition to securing new drug rights, Chong Kun Dang expects to see synergies with its own in-house anti-cancer drugs in the medium to long term.

 

The company entered the ADC anti-cancer drug development field last February by signing a technology introduction agreement with Synaffix, a company based in the Netherlands, securing the rights to use three of its platform technologies.

 

Recently, the company's ADC also successfully entered the clinical stage.

 

The FDA approved the Phase 1/2a clinical trial plan (IND) for Chong Kun Dang's ADC new drug candidate, 'CKD-703,' last month.

 

CKD-703 targets the hepatocyte growth factor receptor (c-Met), which is overexpressed in cancer cells, and is being developed for the treatment of solid tumors, such as non-small cell lung cancer.

 

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

 

c-MET is one of the proteins that transmit signals to cells and is considered a key cancer-causing gene, linked to the development of various solid tumors, including non-small cell lung, colorectal, gastric, and liver cancer.

 

It is known that c-MET mutations are found in 6% of non-small cell lung cancer patients.

 

With intense competition among subsequent products, including Daiichi Sankyo's 'Enhertu,' Astellas' 'Padcev,' and Gilead's 'Trodelvy,' Korean companies are also finally entering the clinical stage and are now at the point of verifying their commercialization potential as latecomers.

 

Along with securing opportunities for global co-development through technology exports, some companies are also demonstrating their competitiveness by initiating clinical trials directly in global markets, such as the U.S.

 

To date, there are no approved ADC new drugs that target c-Met, with AbbVie's 'Teliso-V' being the closest to commercialization.

 

AbbVie achieved positive results in a Phase 2 trial announced last year and has since applied for accelerated approval to the FDA based on these findings.

 

Amid the global competitive landscape, Chong Kun Dang plans to prove its commercialization potential by differentiating itself in areas such as toxicity management and treatment response rates.

 

In April of last year, the company also signed a license-in agreement with Curigin, an RNAi-based gene therapy development company, for its candidate compound 'CA102,' which carries a bispecific shRNA.

 

Chong Kun Dang has secured the global rights for Curigin's anti-cancer candidate 'CA102' and plans to proceed with exclusive R&D and commercialization, with superficial bladder cancer as its first indication.