IKS04 Utilizing Ligachem Bio Platform Receives FDA Clinical Trial Approval

CA242-Targeted ADC Enters Phase 1 Clinical Trial for GI Cancers

Third Clinical Candidate Utilizing the Platform Technology

"Co-administration Strategy with Unconjugated Antibody Introduced"

Ligachem Bio announced on July 31 that its partner, Eksuda Therapeutics, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for "IKS04," a CA242-targeted antibody-drug conjugate (ADC) candidate utilizing Ligachem Bio's proprietary ADC platform technology. With this approval, IKS04 will enter a Phase 1 clinical trial for gastrointestinal (GI) cancer patients.

Egsuda Therapeutics company logo image. Egsuda Therapeutics

CA242 is a tumor-specific antigen that is highly expressed in most gastrointestinal cancers, including colorectal, gastric, pancreatic, and biliary cancers. Its limited expression in normal tissues has led to growing attention as an ADC target.

IKS04 is a candidate developed by combining a CA242 humanized antibody with Ligachem Bio's PBD (pyrrolobenzodiazepine) prodrug payload and next-generation ADC platform technology. It is designed to activate selectively within tumors, releasing the drug payload, and aims to improve safety (tolerability) compared to conventional linkers.

Eksuda Therapeutics is currently conducting Phase 1 clinical trials for "IKS014," which targets HER2, and "IKS03," which targets CD19. IKS04 is the third clinical-stage pipeline to utilize Ligachem Bio's platform.

IKS04 features a combination strategy involving the co-administration of the unconjugated antibody along with the ADC. The company explained that preclinical studies have demonstrated anticancer activity across various GI cancer models, and the combination with the unconjugated antibody produced even greater antitumor effects in high-expression models.

Sejin Park, CEO of Ligachem Bio, stated, "The FDA IND approval for IKS04 is another validation of our prodrug platform technology, following IKS014 and IKS03, across various partner pipelines. We will continue to expand collaborations with global partners and strengthen our platform competitiveness."

This content was produced with the assistance of AI translation services.