KaloBios Pharmaceuticals, Inc. (KBIO) announced preliminary results from an ongoing multi-center phase I study of an anti-EphA3 monoclonal antibody (mAb), KB004.
KaloBios is currently conducting a phase I study on KB004, for the treatment of hematologic malignancies.
The primary endpoint of the ongoing phase I study is to determine the maximum tolerated dose, which has not been achieved yet. Secondary endpoints include the evaluation of pharmacokinetics, immunogenicity and clinical activity.
In the dose escalation portion of the study, 44 patients who were suffering from refractory disease or who were unfit for chemotherapy were enrolled. Results showed that KB004 have been well-tolerated at doses up to 190 mg, with mild-to-moderate transient infusion reactions.
KaloBios plans to start a phase II study evaluating the efficacy of KB004 for the treatment of acute myeloid leukemia (:AML) and myelodysplastic syndrome (:MDS) by year end. Initial results from these studies are expected in the second quarter of 2015.
We are encouraged by KaloBios’ pipeline progress. Besides KB004, the company also has another interesting candidate in its pipeline – KB001-A – a second generation, anti-TTSS antibody. The candidate is currently in a phase II study for the treatment of chronic pseudomonas aeruginosa (Pa) infections in cystic fibrosis (CF) patients.
Meanwhile, KaloBios has completed enrolment of 160 patients in a phase II study on another candidate, KB003. KB003 is being studied for the treatment of severe asthma. KaloBios anticipates top-line results in the first quarter of 2014.
The preliminary results were encouraging as KB004 was well-tolerated. KaloBios carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Aeterna Zentaris Inc. (AEZS), Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals plc (JAZZ), each carrying a Zacks Rank #1 (Strong Buy).