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IKS04
- Development stage
- Phase 1
- Lead developer
- Iksuda Therapeutics
- Modality
- Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
- Administration
- Intravenous
01
Overview
IKS04 is an investigational antibody-drug conjugate (ADC) developed for the treatment of gastrointestinal cancers, particularly solid tumors such as colon adenocarcinomas. It consists of a humanized anti-CA242 (CanAg) monoclonal IgG1 antibody site-specifically conjugated to a highly potent DNA cross-linking payload—a PBD (pyrrolobenzodiazepine) prodrug—via a β-glucuronide linker. This design enables tumor-selective activation and release of the cytotoxic payload by beta-glucuronidase, an enzyme overexpressed in cancer cell lysosomes. The ADC is characterized as "ultra-low DAR" (drug-to-antibody ratio), aiming to maximize therapeutic index and minimize off-target toxicity. Preclinical studies have shown strong efficacy in GI tumor models. The drug is currently in late preclinical development with IND submission anticipated by 2025[1][2][3][7].
- Other names
- CA242-ADCCA-242-ADCCA 242-ADCCanAg-ADC
02
Targets
CanAg (CA242/CanAg glycoform of MUC1)DNA
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