Date: 2012-09-04
Type of information: Development agreement
Compound: BL-8040
Company: BioLineRx (Israel) Biokine Therapeutics (Israel)
Therapeutic area: Cancer - Oncology
Type agreement: development
licensing
commercialisation
Action mechanism: peptide. BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.
Disease: acute myeloid leukemia and other types of hematological cancers
Details: * On September 4, 2012, BioLineRx has announced that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer. In a Phase I/II, open-label, dose escalation, safety and efficacy clinical trial in 16 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile and was well tolerated at all doses tested. On the basis of data obtained from this study, the FDA has approved an IND application.
BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death).
Financial terms: There are no upfront payments due pursuant to the agreement. BioLineRx is obligated to pay a monthly development fee ranging from $50K to $100K for certain development services that Biokine has committed to provide under the agreement. If the agreed-upon clinical development plan is completed within certain defined timelines, BioLineRx is obligated to pay Biokine a milestone payment of $250K. The agreement does not contain any other milestone payments. Upon any sub-licensing transaction to a third party, BioLineRx is required to pay Biokine a royalty payment on a sliding scale, beginning at 60% of the amounts received as consideration in connection with the sublicensing, and decreasing to 40% of such consideration, based on the aggregate amount of BioLineRx’s investment in the project.
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