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KaloBios Continues Dose-Escalation Study

Data presented at ASH

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

KaloBios Pharmaceuticals has reported preliminary results of an ongoing multi-center Phase I study of KB004, an anti-EphA3 monoclonal antibody (mAb), which the company is developing as a treatment for hematologic malignancies. The experimental patient-targeted therapeutic has been well tolerated, with initial evidence of clinical activity. Forty-four patients with refractory disease or who were unfit for chemotherapy have been enrolled in the dose escalation portion of the study.

Preliminary results of the study were presented at the 55th American Society of Hematology Annual Meeting and Exhibition (ASH), held this week in New Orleans, LA.

Escalating doses of KB004 were administered as a one- or two-hour infusion on days 1, 8, and 15 of a 21-day cycle at incremental doses of 20, 40, 70, 100, 140, 190 and 250 mg and will thereafter increase at 33% increments, up to a planned maximum of 700 mg. The primary study objective is to determine a maximum tolerated dose, which has not yet been reached. Secondary objectives included evaluation of pharmacokinetics, immunogenicity and clinical activity. The investigators also evaluated EphA3 expression on tumor, stromal and endothelial cells.

The company hopes to determine an optimum high-end dose for the Phase II expansion portion of the study in patients with AML or myelodysplastic syndrome (MDS), which is expected to begin by the end of the year.

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