Drug intelligence / Profile preview

IKS04 + isumab04

Development stage
Unknown
Lead developer
Iksuda Therapeutics
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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.

Other names
IKS04 RegimenIKS-04 RegimenIKS 04 Regimen
02

Targets

CanAg (CA242/CanAg glycoform of MUC1)DNA

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