Iksuda Receives FDA Clearance to Begin Phase I Trial of IKS04
Friday, July 31, 2026
Iksuda Therapeutics has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for IKS04, allowing the company to begin a Phase I clinical trial in patients with gastrointestinal (GI) cancers.
IKS04 is an antibody-drug conjugate (ADC) that targets CA242, a tumour-specific marker found in several gastrointestinal cancers, including colorectal, gastric, pancreatic and biliary tract cancers. The marker is also present in some bladder, endometrial and lung cancers, while showing limited expression in normal tissues.
The therapy combines a humanised anti-CA242 antibody with a pyrrolobenzodiazepine (PBD) prodrug payload. Unlike conventional ADC approaches, IKS04 will be administered alongside an unconjugated anti-CA242 antibody. The strategy is designed to improve drug penetration into solid tumours, particularly those with high levels of CA242 expression, and may help overcome treatment resistance.
Preclinical studies demonstrated strong anti-tumour activity across a range of gastrointestinal cancers and showed a favourable therapeutic index. The company also reported improved anti-cancer activity in high-expression tumour models when IKS04 was co-administered with the unconjugated antibody, supporting the planned dosing regimen.
IKS04 is based on Iksuda’s ADC platform, which combines tumour-targeting antibodies with prodrug payloads that are selectively activated within tumour tissue through glucuronide-trigger technology. The same platform is being used in the company’s other clinical-stage programmes, including IKS014 for HER2-positive cancers and IKS03 for B-cell malignancies, both of which are currently in Phase I clinical development.
Source: businesswire.com
