Results from 15 very advanced patients who were progressing after prior therapies, including irinotecan, were presented at the
"We are encouraged by these early results, which appear to show that IMMU-130 is well tolerated within a clinically effective dosage range, and may be active even after its parent molecule, irinotecan, proved to be ineffective," commented
The maximum tolerated dose for the once-every-2-weeks dosing schedule has been confirmed to be below 24 mg/kg. This study has moved to a dose expansion stage to evaluate lower doses given once or twice weekly. About 10 clinical sites may participate in this new study. No human anti-humanized antibodies have yet been detected. Serum analysis revealed a quicker removal of the intact conjugate compared with the parent antibody, due in part to the intended release of SN-38 from the ADC.
About Labetuzumab-SN-38 (IMMU-130)
Labetuzumab-SN-38 is one of three agents from the Company's robust ADC program that are in clinical development. Labetuzumab is a slowly-internalizing antibody that recognizes the carcinoembryonic antigen (CEA; CEACAM5 or CD66e), which is expressed in many solid cancers, including more than 80% of colorectal cancer. In prior clinical trials, the antibody was shown to be safe when administered unconjugated or bound to the radioisotope, iodine-131, for radioimmunotherapy.
SN-38 is the active metabolite of irinotecan, which is a standard therapy for patients with metastatic colorectal cancer, but has major gastrointestinal and hematologic toxicity. By targeting SN-38 directly to CEA-expressing tumors, delivery of SN-38 may be increased while mitigating systemic toxicity. Preclinical studies have shown that the antibody-drug linkage was susceptible to cleavage in serum, with 50% of SN-38 released in ~1.0 day, leading to a locally enhanced concentration within the tumor site. In animal models of human colorectal cancer, the ADC exhibited high anti-tumor activity.
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