Iksuda receives US FDA IND clearance for IKS04
CA242-directed ADC approved for assessment in Phase 1 trials in patients with GI cancers
The ‘IKS04 Regimen’ is an innovative dosing approach for an ADC which is employed to overcome the challenge of solid tumour penetration for high-potency payloads
Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS04, a CA242-directed ADC, enabling assessment in a Phase 1 trial in patients with gastrointestinal (GI) cancers.
CA242 is a tumour-specific glycotope which is strongly expressed in a variety of GI cancers including the majority of colorectal (CRC), gastric, pancreatic and biliary tract cancers, and around half of bladder, endometrial and lung cancers, with limited expression in normal tissue.






