Company Update (NASDAQ:BLRX): Bioline RX Ltd Discloses Positive Correlative Data from Phase 2a AML Study and Mechanism-of-Action Data for BL-8040 Oncology Platform at ASH 2016

BLRXBioline RX Ltd (NASDAQ:BLRX) disclosed positive Phase 2a correlative data, as well as detailed mechanism-of-action data, for BL-8040, the Company’s leading oncology platform, that will be presented at the 58th American Society of Hematology (ASH) Annual Meeting and Exhibition in San Diego, California, taking place December 3-6, 2016.

In a poster titled, “The Selective Anti Leukemic Effect of BL-8040, a Peptidic CXCR4 Antagonist, is Mediated by Induction of Leukemic Blast Mobilization, Differentiation and Apoptosis: Results of Correlative Studies from a Ph2a Trial in Acute Myeloid Leukemia”, BioLineRx reports the final correlative results from its Phase 2a trial in acute myeloid leukemia (AML). The trial consisted of 45 AML patients receiving BL-8040 monotherapy on days 1-2, followed by the same dose of BL-8040 plus chemotherapy (Cytarabine) on days 3-7. All patients had poor-risk disease and had been heavily pretreated, with 19% having relapsed after a short first remission (≤12 months), 17% having 2 or more relapses, while 45% were refractory to 1-2 induction treatments.

As previously reported, the composite complete remission rate, including both complete remission (CR) and complete remission with incomplete blood count recovery (CRi), was 38% in subjects receiving BL-8040 dose ≥1.0 mg/kg (n=39). In the 1.5 mg/kg dose selected for the expansion phase of the study (n=22), the composite complete remission rate was 41%. These response rates are superior to the historical response rate of approximately 20% reported for high-risk AML patients treated with Cytarabine alone. The ongoing follow-up of responding patients (n=19) showed median Event Free Survival of 9.3 months (range of 4.3-12.8 months).

Results further show that BL-8040 monotherapy had a substantial therapeutic effect. Treatment with BL-8040 as a single agent triggered robust mobilization of AML blasts from the bone marrow to the peripheral blood stream, and the extent of mobilization was correlated with a positive response to treatment. The preferential mobilization of AML blasts over normal cells (4.7-fold vs. 1.4-fold, respectively) was further confirmed by FISH analysis in a subset of patients. In addition, BL-8040 monotherapy resulted in a 40% increase in AML blast apoptosis.

In an oral presentation at ASH, entitled “The High Affinity CXCR4 Inhibitor, BL-8040, Induces Apoptosis of AML Blasts and their Terminal Differentiation by Blocking AKT/ERK Survival Signals and Downregulating BCL-2, MCL-1 and Cyclin-D1 through Regulation of miR-15a/16-1 Expression”, delivered by Prof. Amnon Peled from the Hadassah Medical Centerand Biokine Therapeutics, BioLineRx reports detailed data on the mechanism-of-action by which BL-8040 directly induces apoptosis of AML cells. The data presented are from in vitrostudies using human AML cell lines and human primary AML samples, as well as in vivostudies using human primary AML cells engrafted in NOD scid gamma (NSG) mice.

The results of the pre-clinical studies show that BL-8040 treatment in vivo triggered mobilization of AML blasts from their protective bone marrow microenvironment and induced their terminal differentiation, further supporting the data presented by BioLineRx at theAmerican Association for Cancer Research annual conference earlier this year.

In addition, the studies illustrate how BL-8040 increases the expression and activity of a special class of microRNA precursors termed miR-15a/16-1. These microRNA molecules have been previously linked to cancer, and shown to suppress the activity of several tumor-related pro-survival proteins. Therefore, by increasing the expression of miR-15a/16-1 microRNA molecules, BL-8040 decreases the expression of tumor-survival proteins and promotes tumor cell death. Importantly, in both in vitro and in vivo experiments, BL-8040 was found to synergize with a selective Bcl-2 inhibitor (Venetoclax) and an FLT3 inhibitor (Quizartinib, also known as AC220) in inducing AML cell death, pointing at potential drug combination treatments.

Philip Serlin, CEO of BioLineRx, commented, “We are pleased to be presenting additional positive results about BL-8040, our lead oncology platform. In particular, clinical studies show that BL-8040 acts selectively on chemotherapy-resistant cells, which may be beneficial in reduction of residual disease and supports the incorporation of BL-8040 in front-line treatment settings such as AML consolidation. Such studies are currently ongoing. We are also encouraged to see, in pre-clinical models, a synergistic effect between BL-8040 and Venetoclax, and between BL-8040 and Quizartinib, drugs which are also being investigated as AML treatments. Given the high percentage of patients experiencing a relapse or that are refractory to available treatments, we anticipate that BL-8040, in combination with a growing repertoire of drugs, will be able to offer hope to AML patients around the world.” (Original Source)

Shares of Biolinerx are currently trading flat at $1.02. BLRX has a 1-year high of $1.73 and a 1-year low of $0.71. The stock’s 50-day moving average is $1.08 and its 200-day moving average is $0.92.

On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on September 23, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on BLRX, with a price target of $7.00, which implies an upside of 586% from current levels. Separately, on September 7, Maxim’s Jason Kolbert reiterated a Hold rating on the stock and has a price target of $1.00.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a yearly average loss of 14.8% and 17.9% respectively. Pantginis has a success rate of 30% and is ranked #4017 out of 4165 analysts, while Kolbert has a success rate of 24% and is ranked #4022.

BioLineRx Ltd. is a clinical-stage biopharmaceutical company. Its activities include indentifying, in-licensing, and developing therapeutic candidates. It in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, and develops them through pre-clinical stages, and then partners with pharmaceutical companies clinical development and commercialization. 

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