Biokine Therapeutics Ltd. (Biokine) is a clinical-stage biopharmaceutical company developing novel drugs to treat cancer. Biokine is devoted to identifying novel molecular and cellular mechanisms that regulate tumor development and metastasis. Founded in 2000 by Prof. Amnon Peled, a leading cancer and stem cell biologist at Hadassah University Hospital, Biokine has completed more than 18 years of R&D and clinical research.
Biokine focuses its drug research specifically on targeting the tumor microenvironment. The tumor microenvironment (TME) is an integral part of cancer. Cancer cells can communicate with other cells and components of the TME through via molecules such as cytokines and chemokines. The collective work of researchers has highlighted the role of cytokines and chemokines in the mechanisms of cancer drug resistance, as well as in cancer cell progression.
Biokine has a unique knowhow, technologies, and a pipeline for the development of therapeutics targeting cancer. Biokine intends to advance the development of its pipeline into the clinic by establishing collaborations with other companies and conducting fundraising activities from private and public agencies.
Evidence suggests that the CXC–chemokine receptor-4 (CXCR4) pathway plays a major role in cancer cell homing and metastasis and in shaping the tumor microenvironment (TME), and thus represents a potential target for cancer therapy. Under normal conditions the CXCR4 pathway regulates the hematopoietic stem cell niche in the bone marrow (BM)—a property that has led to the approval of the CXCR4 antagonist plerixafor together with G-CSF (AMD3100, Mozobil) for mobilization from the BM and collection of hematopoietic precursors from the blood for transplantation of myeloma and lymphoma patients.
BKT140/BL8040 is in advance Phase II/III studies for multiple indications in cancer and stem cell mobilization
Biokine leading product, BKT140/BL-8040: best-in-class CXCR4 antagonist is a bio-stable 14-residue cyclic peptide with high affinity (1- 2 nM, compare to 84nM of plerixafor) and a slow off-rate of the receptor. We have recently demonstrated in a Phase I study in healthy volunteers that single dose of the CXCR4 antagonist BL-8040 induces a rapid and robust mobilization and mega dose collection of human CD34+ stem and progenitor cells. Mobilization human CD34+ cells for the purpose of donor (allogeneic) transplantation after high-dose chemotherapy is currently performed using a 4-5-day treatment cycle with G-CSF and a 1-2 day apheresis procedure. In a Phase II study single-agent treatment with BL-8040 showed similar efficacy and non-inferiority in recipient engraftment, with all transplanted recipients successfully engrafting with BL-8040-mobilized grafts. A Phase 3, randomized, double-blind, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of BL-8040 in combination with G-CSF, compared to placebo and G-CSF, for the mobilization of CD34 cells for autologous transplantation in multiple myeloma patients have already initiated. The placebo-controlled part is designed to include 177 patients in more than 25 centers. Treatment will include 5 days of G-CSF, with a single dose of BL-8040 or placebo on day 4 with the option to expand treatment to up to 8 days of G-CSF and up to 2 days of BL-8040. Apheresis for collection of CD34 cells will be performed on day 5. An additional 3 apheresis sessions may be conducted if needed in order to reach the goal of ≥ 6×106 mobilized CD34 cells/kg.
BL8040 which as the ability to reshape the microenvironment of tumors is now in Phase IIb clinical trials for the treatment of Acute Myeloid Leukemia (AML), and is tested in multiple cancer indication together with immune check point inhibitors such as Pembrolizumab (Keytruda, Merck) and Atezolizumab (Tecentriq, Genentech/Roche). BL8040 was licensed to BiolineRx on September 2012 and is being developed in the clinic together with BiolineRx Ltd. (NASDAQ:BLRX).
BKT300 is a novel anti-cancer metastasis synthetic small molecule for the oncology market.
Aberrant migration and proliferation of cancer cells are the hallmark of metastatic tumors. A unique screening system developed by Biokine has identified a novel synthetic small molecule (400d, a 5 steps production process) which selectively inhibits the migration and survival of hematological as well as solid cancer cells.
BKT300 selectively induces the arrest of leukemic, ovarian, pancreatic, lung, and prostate cancer cells at G2M and induces their rapid apoptotic cell death in vitro and in vivo. BKT300 had no apparent toxicity in mice injected IV with 40 mg/Kg for up to two weeks.
Preliminary data indicate that BKT300 regulates key component of the cell cycle pathway which is expressed only in tumor cells. In normal cells as well as in some tumor cells that do not response to BKT300, this pathway is absent.