On October 3, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has entered into an agreement with Biokine Therapeutics to increase BioLineRx’s stake in its lead oncology platform, BL-8040, a CXCR4 antagonist currently in late stage clinical development in both solid tumor and hematological indications, including stem cell mobilization (SCM), acute myeloid leukemia (AML) and immunotherapy for multiple types of solid tumors (Press release, BioLineRx, OCT 3, 2018, View Source;p=RssLanding&cat=news&id=2370009 [SID1234529860]). As a result of the transaction, BioLineRx will increase its economic stake in the program to 80% from the previous level of 60%. BioLineRx licensed the exclusive worldwide rights to BL-8040 from Biokine Therapeutics in 2012.
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"We are very pleased to execute this transaction with Biokine Therapeutics, which provides us with a significantly greater share of the economics in our lead program, BL-8040, as we continue to advance this promising candidate through late-stage clinical development," stated Philip Serlin, Chief Executive Officer of BioLineRx. "In multiple clinical studies to date in a number of indications, BL-8040’s unique mechanism of action has demonstrated robust mobilization of target cells, a direct apoptotic effect, as well as the ability to induce infiltration of T cells into the core and periphery of solid tumors, while maintaining a favorable safety profile. Looking forward, we are approaching multiple important milestones over the next 6-9 months, most notably topline results from our ongoing Phase 2a pancreatic cancer study in combination with KEYTRUDA under our collaboration with Merck, which we expect later this quarter. As we work to bring novel cancer treatments to patients in need, we believe this transaction reflects our strong commitment to this program and better positions us to create significant long-term value for our shareholders."
Under the terms of the agreement, upon closing of the transaction, BioLineRx will pay Biokine Therapeutics an upfront payment of $10 million in cash plus $5 million in restricted BioLineRx shares. Biokine is also eligible to receive up to a total of $5 million in future milestone payments. The $10 million upfront payment is being financed in full via the receipt of $10 million in debt financing from Kreos Capital. See the Company’s Form 6-K filed this morning for additional details about the transaction. The transaction is expected to close within the next 10 days.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, October 3, 2018 at 10:00 a.m. EDT to discuss this transaction in more detail, as well as to preview upcoming pipeline catalysts and milestones. To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0610 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until October 6, 2018; please dial +1-888-326-9310 from the U.S. or +972-3-925-5901 internationally.
About BL-8040
BL-8040 is a short synthetic peptide for stem cell mobilization and for treatment of hematological malignancies and solid tumors. It functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor that is directly involved in the retention of stems cells in the bone marrow, as well as tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity.
HSCs express CXCR4 and are retained in the protective bone marrow niche via binding to CXCL12 (also known as SDF-1). Blocking of the CXCR4-SDF1 interaction by BL-8040 leads to the mobilization of HSCs into the peripheral blood. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of HSCs.
Furthermore, BL-8040 induce mobilization of leukemic cells and immune-cells from the bone marrow, thereby sensitizing leukemic cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis). BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.