KB004 (Anti-EphA3) Humaneered®, Recombinant Monoclonal Antibody for the Treatment of Cancers
Currently enrolling patients with myelofibrosis or myelodysplastic syndrome in Phase 2 of Phase 1/2 clinical trial
KB004 is a Humaneered® antibody targeting the receptor tyrosine kinase EphA3. EphA3 is expressed on hematologic and solid tumor cells, but not normal cells. EphA3 is also expressed on tumor stem cells and thus KB004 has the potential to attack tumors at their source by attacking tumor stem cells that are responsible for continued tumor growth.
KaloBios is currently in the expansion portion of its Phase 1/2 clinical trial in hematologic malignances that is currently enrolling patients with myelofibrosis (MF) or myelodysplastic syndrome (MDS) who are prescreened prior to treatment for EphA3 positivity. A biomarker assay has been developed to identify EphA3 expression on bone marrow samples. KB004 Phase 2 clinical trial sites are located in the U.S. and Australia, including at such prestigious medical institutions as Lee Moffitt Cancer Center and Royal Adelaide Hospital.
KaloBios completed the Phase 1 dose-escalating portion of this Phase 1/2 clinical trial in hematologic malignancies at multiple sites in the U.S. and Australia. The data from the Phase 1 portion of this clinical trial showed KB004 is well tolerated and has promising clinical activity. These and other data were presented in a poster presentation at the American Society of Hematology annual conference in December 2014.
- To learn more about this study, including eligibility criteria, please visit www.clinicaltrials.gov
- Please refer to about the KB004 Program page for additional program information.
KB003 (Anti-GM-CSF) Humaneered®, Recombinant Monoclonal Antibody for the Treatment of Cancers
KaloBios intends to commence clinical evaluation of KB003 in patients with chronic myelomonocytic leukemia (CMML)
KB003 is a Humaneered®, recombinant monoclonal antibody (mAb) that neutralizes soluble granulocyte-macrophage colony-stimulating factor (GM-CSF), a critical cytokine for the growth of certain hematologic malignancies and solid tumors. KB003 is a highly potent GM-CSF antagonist with a favorable safety profile that had previously been studied in more than 90 subjects in clinical studies in either healthy adults or adults with autoimmune diseases. Data generated by a collaborator of the company confirm GM-CSF hypersensitivity plays an important role in inappropiate growth and survival of CMML cells, similar to juvenile myelomonocytic leukemia (JMML), in which such hypersensitivity is a hallmark of the disease. These data also strongly suggest a role for KB003 in the treatment of CMML. Because KaloBios is now focused on oncology indications following discussion with clinical experts, the Food and Drug Administration, and the European Medicines Agency, the company intends to initiate a Phase 1 clinical trial in patients with chronic myelomonocytic leukemia, CMML, to assess the safety, pharmacokinetics, and activity of KB003 in this patient population beginning in the second half of 2015.
CMML is a rare, aggressive, clonal hematopoietic stem cell disorder that predominantly affects the elderly, for which there is a significant unmet medical need.
Please refer to the KB003 Program page for additional program information.
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Pipeline
KaloBios' pipeline is comprised of first or best-in-class antibody therapeutic candidates for cancers.