Date: 2014-08-14
Type of information: Publication of results in a medical journal
phase: preclinical
Announcement:
Company: KaloBios Pharmaceuticals (USA -CA)
Product: KB004 (Humaneered® anti-EphA3 monoclonal antibody)
Action
mechanism: KB004 is an anti-EphA3 mAb with potential in treating hematologic malignancies and solid tumors. KaloBios is running an ongoing Phase 1/2 study evaluating KB004 in hematologic malignancies. The Phase 1 dose escalation portion of that study in subjects with hematologic malignancies is fully enrolled with dosing ongoing. KaloBios initiated the Phase 2 expansion portion of the study focused on patients with certain EphA3 positive hematologic malignancies in 2014.
Disease:
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 14, 2014, KaloBios Pharmaceuticals announced the publication of preclinical findings describing EphA3 as a novel target expressed by a broad range of human tumors, and whose activation can lead to the selective disruption of the tumor microenvironment and newly formed tumor blood vessels. The expression and function of EphA3 in the tumor microenvironment but not in adult normal tissues together with the favorable safety profile as observed thus far in a Phase 1-2 clinical study, where infusion reactions have been the most common adverse event, supports the development of KB004 (KaloBios\' Humaneered® anti-EphA3 monoclonal antibody) as a potential treatment for both hematologic and solid tumors. The new research findings, published online by the journal of the American Association for Cancer Research, are described by scientists from Monash University School of Biomedical Sciences and Ludwig Institute for Cancer Research in Melbourne, Australia, and KaloBios. \"Eph receptors constitute the largest family of receptor tyrosine kinases, and EphA3 is important in human fetal development. EphA3 is also found in the mesenchymal tissues of various developing organs but is virtually undetectable in normal adult tissues,\" said Professor Andrew Scott, from the Ludwig Institute for Cancer Research. \"However, EphA3 is over-expressed in many solid and hematologic tumors where it is implicated in cell positioning and possible tumor stem cell survival.\" \"In this publication, we show that EphA3 is prominently expressed and functional in the tumor microenvironment, where it contributes to the formation of new blood vessels, and is also found on stromal tissue. We have also demonstrated that treatment of human tumor xenografts with a highly specific anti-EphA3 monoclonal antibody can effectively kill tumor-resident mesenchymal/stromal stem cells and inhibit tumor growth by disrupting the architecture and function of the tumor microenvironment.\" KaloBios is currently conducting a Phase 1/2 clinical trial of KB004 in hematologic malignancies, with the Phase 2 expansion portion of that trial focused on acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myelofibrosis (MF) patients with EphA3-positive malignancies.ontinued development of this compound in severe asthma, and is continuing to analyze the Phase 2 data to review with thought leaders. KaloBios is currently evaluating other possible indications in order to determine next steps, if any, in the development of KB003. Source: \"Targeting EphA3 Inhibits Cancer Growth by Disrupting the Tumor Stromal Microenvironment\". Mary E. Vail et al. Cancer Res , 74(16) August 15, 2014 ; 4470-4481.
All of the company\'s antibodies were generated using its proprietary Humaneered®technology, a method that converts nonhuman antibodies (typically mouse) into recombinant antibodies that have a high binding affinity to their target and are designed for chronic therapeutic use. The company believes that antibodies produced using its Humaneered® technology offer important clinical and economic advantages over antibodies generated by other methods in terms of high binding affinity, high manufacturing yields, and minimal to no immunogenicity (inappropriate immune response) upon repeat administration in humans.
