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BioLineRx Ltd.

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BLRX - BioLine RX - Promising Biotech with Big upside - LongBLRX BL-8040 Overview BL-8040 is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which BioLineRx is developing for the treatment of solid tumors, acute myeloid leukemia, or AML, and stem-cell mobilization for bone-marrow transplantation. Solid Tumors: In January 2016, BioLineRx entered into a collaboration with MSD, known as Merck in the U.S. and Canada, in the field of cancer immunotherapy. Based on this collaboration, in September 2016 BioLineRx initiated a Phase 2a study, known as the COMBAT study, focusing on evaluating the safety and efficacy of BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in up to 30 patients with metastatic pancreatic adenocarcinoma. The study is an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity. Partial results will be presented at the 2018 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in January 2018, with top-line results expected in the second half of 2018. September 2016, BioLineRx entered into a collaboration with Genentech , Inc., a member of the Roche Group , in the framework of which both companies would carry out Phase 1b/2 studies investigating BL-8040 in combination with atezolizumab (TECENTRIQ®), Genentech’s anti-PDL1 cancer immunotherapy, in various solid tumors and hematologic malignancies. Genentech commenced a Phase 1b/2 study for the treatment of pancreatic cancer in July 2017, as well as a Phase 1b/2 study in gastric cancer in October 2017. Genentech expects to commence an additional Phase 1b/2 study in lung cancer by early 2018. In September 2017, BioLineRx initiated a Phase 1b/2 study under this collaboration in acute myeloid leukemia (AML). These studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters. n March 2015, BioLineRx reported successful top-line safety and efficacy results from a Phase 1 safety and efficacy trial for the use of BL-8040 as a novel stem-cell mobilization treatment for allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem. In March 2016, BioLineRx initiated a Phase 2 trial for BL-8040 for allogeneic stem-cell transplantation, conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology. Initial results of this study announced in March 2017 show that a single injection of BL-8040 mobilized sufficient amounts of cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care. Topline results of this study are now expected in mid-2018, as a result of certain delays in study recruitment in connection with the addition of two sites to the study and the regulatory filings associated therewith. In August 2017, following a successful meeting with the FDA , BioLineRx announced the filing of regulatory submissions required to commence a randomized, controlled Phase 3 registrational trial of BL-8040 for the mobilization of hematopoietic stem cells, or HSCs, for autologous transplantation in patients with multiple myeloma. The trial is expected to commence by the end of 2017. In November 2017, BioLineRx disclosed preclinical data supporting BL-8040 as robust mobilizer of hematopoietic stem cells, or HSCs, associated with long-term engraftment. The data will be presented as an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting and Exhibition in Atlanta, GA, taking place in December 2017. Pre-Clinical Data In vitro and in vivo data show that BL-8040 binds to CXCR4 at the low nanomolar range (1-10nM) and occupies it for prolonged periods of time (>24h). Characterization of the CXCR4 antagonism action of BL-8040 in comparison to other CXCR4 antagonists revealed that, unlike other compounds from the same class, BL-8040 acts as an antagonist as well as an inverse agonist. This activity leads to decreased autonomous signaling of CXCR4 and suggests activity against constitutively active variants. BL-8040 inhibits the growth of various tumor types including multiple myeloma, non-Hodgkin’s lymphoma, leukemia, non-small cell lung carcinoma, neuroblastoma and melanoma. BL-8040 significantly and preferentially stimulated apoptotic cell death of malignant cells (multiple myeloma, non-Hodgkin’s lymphoma and leukemias). Significant synergistic and/or additive tumor cell killing activity has been observed in-vitro and in-vivo when tumor cells were treated with BL-8040 together with Rituximab, Bortezomib, Imatinib, Cytarbine, BCL-2 inhibitor ABT-199 and the FLT-3 inhibitor AC-220 (in NHL, MM, CML, AML, and AML-FLT3-ITD models, respectively). BL-8040 also mobilizes cancer cells as well as neutrophils and progenitor cells from the bone marrow to the peripheral blood. The U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of AML as well as for stem cell mobilization BL-8040 is being developed by BioLineRx under a worldwide, exclusive license from Biokine Therapeutics. 1. Conclusion: The current data demonstrate that BL-8040 induces mobilization of AML blasts from the BM and has sustained receptor occupancy. In addition, a direct effect on AML blast viability has been observed in samples obtained during BL-8040 monotherapy. Importantly, the data suggest a differential effect of BL-8040 monotherapy on AML blasts vs. normal progenitors. BL-8040 was found to be safe and well tolerated at all doses tested to date. The updated results of the dose escalation phase of this ongoing study will be presented. Source: www.bloodjournal.org 2. The FDA approved the first immunotherapy drug recently, but the field dates back to 1891, when William Coley, a physician and cancer researcher, observed that some cancer patients infected by Streptococcus bacteria experienced a dramatic and spontaneous improvement. He began injecting the bacteria into his patients, with mixed results. The treatment was nearly abandoned amid skepticism from Coley’s peers and the advent of radiotherapy and improved surgical techniques. Today, however, new avenues of immunotherapy research are underway, and the field is considered among the most promising new approaches to cancer treatment, according to Jill O’Donnell-Tormey, CEO and director of scientific affairs at CRI. Source: www.jta.org 3. "activated with human interleukin 2, or activated against patients own tumor cells in the laboratory, when such are available – have been extremely successful in killing every last cancer cell in the patients. The theory is the same, in that the cells are trained to act as honing devices." “It’s fantastic because they all were expected to have been dead long ago,” Slavin told ISRAEL21c. “When the laboratory-treated and separated NK cells are infused into a patient, they go immediately to work because they were already trained in the laboratory to become professional killer cells capable of recognizing and destroying foreign cells.” "The new procedure has little or no side effects, is done during fifteen-minute outpatient intravenous infusion and has already showed promising results in high risk patients with metastatic or resistant cancer." "In order for the procedure to be government-approved, a much larger number of patients must successfully undergo treatment." "The reason I am optimistic is because we use mother nature’s tool – immune-system-cells to fight off disease. Normally too, it is the immune system that can recognize cancer cells as undesirable, and under normal circumstances, it will go on an attack until the single abnormal cell, which can grow to a bitter enemy, is gone. In patients with cancer, the patient’s own immune system failed to recognize the enemy and this is why we use the immune system cells from another individual that can easily recognize and destroy such tumor cells escaping the attention of patient’s immune system,” said Slavin." Summary Source: seekingalpha.com In two January ASCO presentations, BL-8040 showed robust infiltration of anti-tumor T-cells into liver metastases in pancreatic cancer and primes the tumor micro-environment to enhance the effectiveness of immunotherapy agents. New oncology asset AGI-134 induced complete tumor regression in 50% and 67% of two mice melanoma preclinical studies. The company plans to start Phase 1/2a clinical trials in 1H 2018. BiolineRx is funded to 2020 with $55M in cash, no debt. However cash balance might be higher since it's likely company was selling against a $30M ATM since November. The company has plans to deliver up to a dozen high-potential catalysts in 2018 following a busy January (4 conferences, and 4 clinical data). Institutional ownership has increased from 20% to almost 60% in a year. Five analysts have a consensus Buy rating with $3.5/share price target. Chart Screenshots: screenshots.firefox.com screenshots.firefox.com screenshots.firefox.com Will update. -AB
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