correction.KBIO "As of June 30, 2015, KaloBios had cash, cash equivalents and investments totaling $23.2 million" (NOT $16M). market cap is only $8.7m, and there are only 4m outstanding. 87% ownership!!,float is about $700k.
Development Program Updates
KB004 Immuno-oncology Program
KB004, the company's monoclonal antibody (mAb) targeting EphA3, is currently in clinical development in the phase 2 expansion portion of an open-label Phase 1/2 study in hematologic malignancies. The Phase 2 portion of the study is currently enrolling two cohorts of up to 20 patients each at the 250mg dose level selected as a result of the Phase 1 dose escalation portion of the study. One cohort consists of patients with myelodysplastic syndrome (MDS), and a second cohort consists of patients with myelofibrosis (MF). Patients in both cohorts must be relapsed-refractory to standard-of-care treatment, and pre-screened to ensure tumor EphA3 expression. As of August 1, 2015, the phase 2 expansion portion of the study has enrolled a total of 8 patients in the MDS cohort and 6 patients in the MF cohort. Based on current enrollment rates, and with several additional clinical sites expected to commence enrollment in the coming months, the company expects enrollment to continue to accelerate. The drug continues to be well tolerated with the most commonly reported side effects being infusion reactions.
KB003 Oncology Program
In July, KaloBios announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for KB003, an anti-GM-CSF mAb, testing in patients with chronic myelomonocytic leukemia (CMML), an orphan oncology indication. As a result, KaloBios is initiating an open-label Phase I study designed to evaluate the safety, pharmacokinetics and clinical activity of KB003 in previously treated CMML patients. The study will consist of an accelerated dose-escalation component starting at 200 mg and escalating up to 600 mg, followed by a cohort expansion of up to 13 additional patients to explore clinical activity at the selected dose level. Site initiation activities are underway, and the company anticipates that enrollment will begin later this year.
"We have made excellent progress in 2015 in strengthening our oncology focus at KaloBios," said Herb Cross, KaloBios' Chief Financial Officer and Interim Chief Executive Officer. "We continue to work to expand our portfolio of oncology programs in clinical development, most notably with the addition of a third oncology indication as a result of the July FDA clearance of our IND for KB003 in CMML. We continue to enroll patients in the KB004 Phase 2 program in MDS and MF, as well as evaluating additional potential oncology indications for KB004 including solid tumors where EphA3 is expressed. With several oncology indications either in development or moving into the clinic, and other potential indications under evaluation, we continue to be excited about the potential of our assets."
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