On November 20, 2018 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that Professor Josep Llovet, an experienced leader with deep background in liver cancer research and development, has been commissioned by the Company to assist in the analysis of the Phase II data that is anticipated during the first quarter of 2019 (Press release, Can-Fite BioPharma, NOV 20, 2018, View Source [SID1234531488]).

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Professor Llovet is Founder and Director of the Liver Cancer Program and Full Professor of Medicine at the Mount Sinai School of Medicine, New York University (USA), and Professor of Research-ICREA in the BCLC Group, Liver Unit, IDIBAPS-Hospital Clínic, University of Barcelona. Professor Llovet has been President, Secretary and Founder of the International Liver Cancer Association (ILCA) and Chairman of the European Clinical Practice Guidelines of management of liver cancer (EASL-EORTC). A renowned key opinion leader, Dr. Llovet has published more than 240 articles in peer-reviewed journals, more than 50 chapters of books, and has delivered more than 500 lectures. He has devoted the past 20 years of his career studying the pathogenesis and treatment of liver cancer.

"We are proud and honored to have the expertise of Prof. Llovet, who is one of the most distinguished Key Opinion Leaders in the field of liver diseases, on our team. We look forward to the insights he will contribute in the analysis of data of our Phase II advanced liver cancer study when the results are unblinded sometime during the first quarter of 2019. We believe his depth of experience both as researcher and as medical practitioner in treatment of liver cancer will be beneficial to Can-Fite. His insight and commitment to this field will be quite helpful as we create a new approach for liver cancer therapy," stated Can-Fite CEO Dr. Pnina Fishman.

Due to patient survival, top line efficacy results are expected during the first quarter of 2019 for Can-Fite’s Phase II clinical trial of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in patients with a Child Pugh B score whose disease has progressed on sorafenib therapy. Enrollment of 78 patients was completed in August 2017 and the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo). Namodenoson has received Fast Track Status in the U.S. and Orphan Drug Designation in Europe and the U.S.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On November 20, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that its Chief Executive Officer, Ron Squarer, will speak at the 30th Annual Piper Jaffray Healthcare Conference in New York (Press release, Array BioPharma, NOV 20, 2018, View Source [SID1234531485]). The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

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Event:

30th Annual Piper Jaffray Healthcare Conference

Presenter:

Ron Squarer, Chief Executive Officer, Array BioPharma

Date:

Tuesday, November 27, 2018

Time:

9:00 a.m. Eastern Time

Webcast:

View Source;tp_key=8e5fb74efb

On November 20, 2018 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, reported that Chairman and CEO Brent Saunders will participate in a fireside chat at the 2018 Citi Global Healthcare Conference in New York City (Press release, Allergan, NOV 20, 2018, View Source [SID1234531484]). The presentation will begin at 11:00 a.m. Eastern Time on Thursday, December 6, 2018.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://www.veracast.com/webca…

An archived version will be available within approximately one hour of the live presentation and can be accessed at the same location for 90 days

On November 20, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will participate in a fireside chat at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 10:30 a.m. ET in New York, NY (Press release, Xencor, NOV 20, 2018, View Source [SID1234531483]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website located at View Source A replay of the presentation will be posted on the Xencor website approximately one hour after the live event and will be available for 90 days following the presentation.

On November 20, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the U.S. Food and Drug Administration (FDA) has granted the Biological Product Designation for AGI-134, the Company’s novel immunotherapy compound (Press release, BioLineRx, NOV 20, 2018, View Source;p=RssLanding&cat=news&id=2377772 [SID1234531480]). This designation provides the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. This regulatory market exclusivity adds an incremental layer of protection in addition to that afforded by existing patents granted in the United States and Europe, and pending in other countries, covering the use of AGI-134 for the treatment of solid cancer tumors. These patents are valid until May 2035, with a possible term extension of up to five additional years.

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"We are extremely pleased to receive the FDA’s Biological Product Designation for AGI-134, our second lead oncology asset. This classification as a biological product is very significant, since it provides us with additional valuable exclusivity and confirms the FDA’s acceptance of AGI-134’s main mechanism of action as a vaccine," said Philip Serlin, Chief Executive Officer of BioLineRx. "Pre-clinical studies have demonstrated that treatment with AGI-134 leads to complete regression of primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, in prior studies, the combination of AGI-134 with an anti-PD-1 immune checkpoint inhibitor demonstrated a synergistic effect in protection from secondary tumor growth. We recently initiated a Phase 1/2a study of this promising product in solid tumors, as both monotherapy and in combination with checkpoint inhibitors, and we anticipate initial top-line results from this important study by the end of 2020."

About AGI-134

AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intratumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-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.