On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA) a clinical-stage biopharmaceutical company focused on oncology and immunology, reported the publication of data showing that BL-8040, its lead oncology platform, augments the ability of the immune system to fight cancer by increasing the infiltration of anti-tumor-specific T-cells into the tumor microenvironment (TME), resulting in decreased tumor growth and prolonged survival in a murine model of cancer (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327885 [SID1234523482]). Results of the study will be presented as a poster titled "CXCR4 Antagonist (BL-8040) Enhances Antitumor Effects by Increasing Tumor Infiltration of Antigen-specific Effector T-cells" (Abstract 73) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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In the preclinical study, a murine model of cancer was used to assess the effects of BL-8040 in combination with a cancer vaccine that primes the immune system against the tumor. The results of the study show that combining BL-8040 with the cancer vaccine leads to a significantly enhanced anti-tumor immune response, which attenuates tumor growth and prolongs mouse survival better than either agent administered alone. The results go on to demonstrate that BL-8040 significantly increases the abundance of tumor-specific T-cells in the TME, suggesting an explanation for the enhanced efficacy of the combination over either agent when administered alone.

"I am highly encouraged by the data generated in this preclinical study, which further demonstrates the therapeutic potential of BL-8040," commented Dr. Samir Khleif, Professor of Oncology and Director of the Loop Immunology-Oncology Laboratory at Georgetown Lombardi Comprehensive Cancer Center. "The results provide further evidence that BL-8040 promotes the infiltration of cytotoxic T-cells into tumors, which is seen as a key objective to improve responsiveness to checkpoint therapy. I look forward to seeing the results from the clinical studies in which BL-8040 is being combined with checkpoint blockade."

"We have shown in numerous preclinical and clinical studies that BL-8040 has various anti-tumor effects, including direct and indirect effects, influencing T-cell location and activity as well as tumor cell survival," commented Philip Serlin, Chief Executive Officer of BioLineRx. "The results of the current study suggest that BL-8040 enhances anti-tumor immune response by increasing the number of anti-tumor T-cells in the TME. These results also suggest that BL-8040, a CXCR4 antagonist, is a promising immune-modulatory agent with potent anti-tumor effects, and we remain on track with our eight ongoing clinical trials for this product in various indications, both in blood cancers as well as in solid tumors."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in 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. In a number of clinical and preclinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On January 23, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) (TASE: BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that AGI-134, an immunotherapy compound in development for the treatment of multiple solid tumors, demonstrated successful results in two pre-clinical melanoma studies (Press release, BioLineRx, JAN 23, 2018, View Source;p=RssLanding&cat=news&id=2327860 [SID1234523483]). Results of these studies will be presented as a poster titled "Intratumoral Administration of the Alpha-Gal Glycolipid AGI-134 to Induce Tumor Regression in a Mouse Model of Melanoma" (Abstract 68) on January 25, 2018 at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, being held January 25-27, 2018, in San Francisco, CA.

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The ability of intratumorally injected AGI-134 to induce regression of established primary tumors was assessed in two murine melanoma models. In the two models, there was complete tumor regression in 50% and 67%, respectively, of mice treated with AGI-134. Moreover, treatment with AGI-134 showed a beneficial effect on survival, compared to the control group. In addition, the results show that injection of AGI-134 into the tumors induces activation of the complement system, an important component of the innate immune system. Activation of the complement system within tumors by AGI-134 is predicted to destroy tumor cells and create a pro-inflammatory tumor microenvironment that attracts and activates other immune cells, ultimately resulting in adaptive anti-tumor immunity. Previous studies with intratumoral administration of AGI-134 to primary tumors had shown that AGI-134 protects mice from the development of distant, untreated tumors.

"We are pleased to report these encouraging results for our second lead oncology project at the upcoming ASCO (Free ASCO Whitepaper)-SITC conference," said Philip Serlin, Chief Executive Officer of BioLineRx. "Previous studies have demonstrated that intratumoral administration of AGI-134 induces a systemic anti-tumor response that protects mice from the development of distant tumors. These new studies now show direct regression of established primary tumors after injection with AGI-134, and that this regression is associated with activation of the innate immune system. These compelling pre-clinical data support investigating this approach in a Phase 1/2a study, and we are excited and on track to commence a first-in-man study with this promising novel oncology asset in patients with solid tumors in the first half of 2018."

About AGI-134

AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On January 23, 2018 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported completion of a pre-planned interim futility analysis of the Phase 3 SOPHIA trial (Press release, MacroGenics, JAN 23, 2018, View Source [SID1234523490]). This randomized, multi-center clinical study compares margetuximab plus chemotherapy to trastuzumab plus chemotherapy in subjects with metastatic breast cancer. Based on results from the futility analysis, an independent data safety monitoring committee (DSMC) has recommended that the SOPHIA study continue as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival (PFS) as determined by independent central review. The futility analysis did not allow for early stopping due to efficacy.

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MacroGenics also announced today that the U.S. FDA has granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. Fast Track designation is designed to facilitate the development and expedite the review of new therapies for serious conditions and unmet medical needs. With Fast Track designation, early and frequent communications between the FDA and the sponsor are encouraged to help enable rapid development of the candidate molecule.

"We are encouraged with the DSMC’s determination that there were no safety concerns and that the analysis of PFS data support continuation of the Phase 3 SOPHIA trial. Recruitment of patients into the SOPHIA study is progressing well. We remain on track to complete enrollment by the end of 2018 and we look forward to sharing top-line results after the trial has read out in 2019," commented Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Also, we are very pleased to receive Fast Track designation for margetuximab, as this may potentially expedite future regulatory interactions on this product candidate. Furthermore, the gastric cancer data recently presented at ASCO (Free ASCO Whitepaper) GI for margetuximab in combination with anti-PD-1 may provide additional opportunities to address unmet medical needs in other HER2+ indications."

About the SOPHIA Study

MacroGenics continues to enroll patients in the pivotal Phase 3 SOPHIA clinical study of margetuximab at approximately 200 trial sites across North America, Europe and Asia. The 530-patient study is designed to evaluate the efficacy of margetuximab plus chemotherapy compared to that of trastuzumab plus chemotherapy in relapsed/refractory HER2-positive metastatic breast cancer patients. This registration study has sequential primary endpoints, which include PFS and overall survival. For additional information on the ongoing SOPHIA trial, visit www.clinicaltrials.gov.

About Margetuximab

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, oncoprotein. HER2 is expressed by tumor cells in breast, gastric, and other forms of solid tumor cancers, making it a key marker for biologic therapy. In addition to being studied in metastatic breast cancer, margetuximab is also being studied in combination with an anti-PD-1 agent in a Phase 1b/2 clinical trial in gastric cancer, for which data was recently presented at the recent ASCO (Free ASCO Whitepaper) Gastrointestinal Symposium.

On January 22, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that Bill Enright, President and Chief Executive Officer, will provide a corporate overview at NobleCon14 – Noble Capital Markets’ Fourteenth Annual Investor Conference, being held January 29-30, 2018 at the W Hotel, Fort Lauderdale, Florida (Press release, Altimmune, JAN 22, 2018, View Source [SID1234523403]).

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14th Annual Investor Conference Presentation Details
Date: Tuesday, January 30, 2018
Time: 2:30pm Eastern Time
Location: W Hotel, Ft. Lauderdale, Florida, Studio 2
Webcast: View Source
A high-definition, video webcast of the presentation will be available the following day on the Company’s web site www.altimmune.com and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will be archived on the company’s website and on the Noble websites for 90 days following the event.

On January 22, 2018 Celgene reported Acquisition of Juno Therapeutics (Press release, Juno, JAN 22, 2018, View Source [SID1234524085]).

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