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 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 22, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.

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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."

"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: View Source

About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.

On January 22 2018 AskAt reported Ningbo NewBay Medical Technology Co., Ltd. (Headquarters in Ningbo, China, CEO: Zhenhai Shen, NewBay), a subsidiary company of Ningbo Tai Kang Medical Technology Co., Ltd ("Ningbo Tai Kang"), which licensed AskAt Inc.’s EP4 antagonist AAT-007 (generic name: grapiprant) for oncology in China, has filed an IND application with the China Food and Drug Administration (Press release, AskAt, JAN 22, 2018, View Source [SID1234535057]).

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AskAt Inc. will receive a milestone payment according to the terms of the License Agreement executed between Ningbo Tai Kang and AskAt as a result of achieving this filing.

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

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