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IKS04 + isumab04 is an innovative clinical dosing regimen consisting of a novel antibody-drug conjugate (ADC), IKS04, and its unconjugated humanized IgG1 monoclonal antibody component, isumab04. Developed by Iksuda Therapeutics, both components target the carbohydrate antigen CA242 (CanAg), which is highly overexpressed in gastrointestinal cancers such as pancreatic, colorectal, and gastric cancers, with minimal expression in normal tissues. The IKS04 ADC is composed of the isumab04 antibody conjugated to a highly potent pyrrolobenzodiazepine (PBD) dimer prodrug payload via a tumor-selective glucuronide linker. The 'IKS04 Regimen' strategy involves the pre-administration of the naked antibody (isumab04) before the ADC to saturate peripheral sites and improve the penetration and distribution of the ADC within solid tumors. This approach is intended to enhance efficacy and tolerability. The regimen is currently being evaluated in Phase 1 clinical trials for patients with advanced solid tumors expressing CA242.
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