Tucotuzumab celmoleukin

Summary

Tucotuzumab celmoleukin (also known as EMD 273066 or huKS-IL2) is an immunocytokine consisting of a humanized anti-EpCAM IgG1 antibody fused to IL-2. It was investigated in clinical trials for EpCAM-positive solid tumors, particularly ovarian cancer, small-cell lung cancer, and other carcinomas, with the goal of concentrating IL-2 activity at the tumor site to reduce systemic toxicity while enhancing local anti-tumor immunity.

Mechanism of Action

Tucotuzumab celmoleukin is a fusion protein combining an anti-EpCAM humanized monoclonal antibody (tucotuzumab) with interleukin-2 (celmoleukin/IL-2). It targets EpCAM-expressing tumor cells, delivering IL-2 to the tumor microenvironment to stimulate local T-cell and NK-cell proliferation and cytotoxic activity, thereby enhancing anti-tumor immune responses.

Routes of Administration

Goals & Uses

• Ovarian cancer treatmentOncologyModerate
• EpCAM-positive solid tumor treatmentOncologyLow
• Small-cell lung cancer treatmentOncologyLow
• Tumor-targeted IL-2 immunotherapyImmunotherapyModerate

Contraindications

• Severe cardiac diseaseCardiovascularHigh
• Hypersensitivity to IL-2 or anti-EpCAM antibody componentsAllergy/HypersensitivityHigh
• Severe pulmonary dysfunctionPulmonaryHigh
• Active autoimmune diseaseAutoimmunityHigh

Adverse Effects

• Capillary leak syndromeVascularUncommonLeakage of fluid from blood vessels into tissues
• HypotensionCardiovascularUncommonLow blood pressure
• Nausea/vomitingGastrointestinalCommon
• Fever and chillsConstitutionalCommon
• FatigueGeneralCommonLow energy or tiredness
• Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

• CorticosteroidsModerate
• Other immunosuppressantsModerate

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant womenReproductiveRelative
• Patients with organ transplantsImmunologicalRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval; investigated in European clinical trials under development by Merck KGaA.
• United StatesInvestigationalStudied under IND; never approved by FDA. Development largely discontinued.

Never received regulatory approval from FDA, EMA, or other major agencies. Investigated under IND in Phase I/II clinical trials. Development largely discontinued or stalled.

Evidence & Sources

No sources recorded yet.