BioCryst Pharmaceuticals and Idera Pharmaceuticals to Present at the JMP Securities Life Sciences Conference

On June 13, 2018 BioCryst Pharmaceuticals, Inc. ("BioCryst") (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), reported that they will be presenting at the JMP Securities Life Sciences Conference on Thursday, June 21, 2018 at 10:00 A.M. E.T (Press release, BioCryst Pharmaceuticalsa, JUN 13, 2018, View Source [SID1234527289]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com and in the Investors and Media section of Idera’s website at View Source

BioLineRx to Participate at JMP Securities 2018 Life Sciences Conference

On June 13, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that its Chief Executive Officer, Philip Serlin, will participate in a panel discussion at JMP Securities 2018 Life Sciences Conference on Wednesday, June 20, 2018 at 3:30 p.m. (EDT) (Press release, BioLineRx, JUN 13, 2018, View Source;p=RssLanding&cat=news&id=2354358 [SID1234527290]). The conference will be held at St. Regis New York, NY.

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Details of the panel discussion are as follows:

Title: Combination Strategies in Immuno-Oncology

Description: Recent clinical and commercial success with immune checkpoint blockade and cell-based therapy approaches has resurrected intense scientific interest in cancer immunotherapy. With approaches ranging from immune cell mobilization to epigenetic modulation and metabolic conditioning, panel participants will discuss the opportunities afforded by the field as well as the challenges posed by it, and how their individual development strategies have been designed to maximize the chances of ultimate success in immuno-oncology.

Key topics slated for discussion include: Next-generation immuno-oncology therapeutics, novel targets (e.g., inhibitory checkpoints, co-stimulatory molecules, etc.), biomarker strategies, the future of combination therapies, and challenges associated with drug cost and coverage.

Surface Oncology Announces Initiation of Phase I Clinical Trial of SRF373 / NZV930

On June 12, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of a Phase I trial of SRF373, a fully human antibody targeting CD73. SRF373, also known as NZV930, is the second of Surface’s immunotherapies to advance into the clinic this year (Press release, Surface Oncology, JUN 12, 2018, View Source [SID1234527367]).

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CD73 is an enzyme overexpressed by many tumors that is critical to the production of extracellular adenosine which in turn suppresses immune cell function and the ability of the immune system to recognize and attack tumors. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased activity of immune cells.

The first-in-human study is being led by Novartis, which was granted a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface. Under the collaboration, Surface is eligible to receive development and sales milestone payments for NZV930, as well as tiered royalties.

The Phase I study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NZV930 as a single agent and in combination with other cancer immunotherapies. The initial dose escalation portion of the trial will include patients with triple negative breast cancer, ovarian cancer, microsatellite stable colon cancer, pancreatic cancer, non-small cell lung cancer, and renal cell carcinoma.

"We are very excited that Novartis has advanced our second product program into clinical development" said Rob Ross, M.D., chief medical officer of Surface Oncology. "We believe the profile of NZV930 is compelling and targeting adenosine reduction could play an important role in the treatment of patients suffering with a variety of types of cancer."

ABOUT SRF373 / NZV930

NZV930 is a fully human monoclonal antibody designed to inhibit CD73, an enzyme critical to the production of adenosine—an immunosuppressive metabolite within the tumor microenvironment. CD73 is overexpressed by many tumors making it a potential target with broad applicability. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased T cell activity. Novartis holds a worldwide exclusive license to develop and commercialize NZV930.

Galectin Therapeutics Inc. Announces New CEO

On June 12, 2018 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported that Harold H. Shlevin, Ph.D., currently the Company’s Chief Operating Officer (COO), has been appointed Chief Executive Officer (CEO) and President to succeed Peter G. Traber, M.D., who has tendered his resignation as President, CEO and Chief Medical Officer (Press release, Galectin Therapeutics, JUN 12, 2018, View Source [SID1234527278]). The transition will be effective July 6, 2018.

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Board Chairman, Richard Uihlein commented "As the Company enters this next strategic phase, we are extremely pleased that Dr. Harold Shlevin, who has been Galectin’s COO since 2012, and who has extensive healthcare leadership experience, has agreed to take on the broader role of CEO at this critical juncture. Harold has significant business development experience as an executive and will be responsible for directing and overseeing the potential partnering of our NASH Phase 3 compound. Dr. Shlevin will also oversee future NASH cirrhosis trials and is responsible for the Company’s clinical trials in cancer immunotherapy and any other potential new clinical trials in other indications."

"In conjunction with this transition, the Company has also engaged Back Bay Life Science Advisors, a Boston-based, internationally focused integrated strategy and transaction advisory organization to support the Company, and the management team in its exploration of strategic alternatives. After meeting Dr. Jonathan Gertler and his team, I look forward to my continued involvement in this process. Back Bay, management and the Board have earned and deserve my personal attention and full confidence.", added Mr. Uihlein.

Regarding Dr. Traber, Board Chair Richard Uihlein stated, "Peter has been tireless in his efforts in guiding Galectin over the past seven years. As a distinguished scientist and hepatologist, Peter has a keen interest in conquering NASH cirrhosis, and we believe our compound, GR-MD-02, has shown tremendous potential in this regard. Peter’s clinical and scientific vision was critical to the company in reaching its current Phase 3 ready development trajectory. His recent leadership in meeting with the FDA and being allowed to proceed to clinical phase 3 has been indispensable and positions the Company for its next stage of growth and development. We thank him for his many contributions to the Company."

Dr. Shlevin said, "I am extremely grateful for the Board’s confidence in our experienced team, many of whom I recruited to Galectin Therapeutics and worked with for many years prior to joining Galectin. It has been a personal and professional pleasure to work with Peter over the last six years, and the Company and I wish him well in his future endeavors."

"We believe our NASH-CX Phase 2 trial was the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in HVPG in NASH cirrhosis patients. With our management team and other core team members and the Board leadership under Dick Uihlein, I am confident in our ability to build value for our shareholders and advance GR-MD-02 to provide patients a treatment option for dealing with their NASH cirrhosis," concluded Dr. Shlevin.

About Dr. Shlevin:

Dr. Shlevin is a 25-year bioscience-industry executive with broad senior management experience in development and commercialization of medical devices, pharmaceuticals, diagnostics and vaccines. As COO of Galectin Therapeutics, he was responsible for all operational aspects of the company, including regulatory affairs & quality assurance, manufacturing, clinical development, business development and commercial development.

Prior to his work at Galectin, Dr. Shlevin served Georgia Institute of Technology’s Advanced Technology Development Center (ATDC) as manager of bioscience partnering and commercialization efforts. He was also previously President and CEO of Solvay Pharmaceuticals US and a member of Solvay’s global pharmaceutical management team. He has also held senior executive positions at Bausch & Lomb Pharmaceuticals, CIBA Vision Ophthalmics (which he co-founded), and CIBA-Geigy Pharmaceuticals, amongst others. Dr. Shlevin earned a B.A. degree from Boston University and M.S. and Ph.D. degrees in physiology from the University of Rochester Medical School and postdoctoral fellowship at Mayo Foundation and Mayo Medical School.

About NASH Cirrhosis

NASH cirrhosis is the final stage in the progression of non-alcoholic steatohepatitis (NASH), a disease of the liver that affects millions of people in the U.S. and worldwide. The liver cell death and inflammation seen in NASH eventually causes progressive scarring of the liver, which eventually can result in liver cirrhosis. While the early stages of NASH can be treated by changes in lifestyle, such as losing weight and exercising, once the disease progresses to NASH cirrhosis there is no treatment available short of a liver transplant. Of the total number of individuals in the world believed to presently have NASH, it is predicted that NASH cirrhosis will eventually kill 20 million of those people.

One of the results of NASH cirrhosis is an increase in blood pressure in the portal vein that brings blood and nutrients from the digestive tract through the liver and then out to the rest of the body. As the scarring effect of cirrhosis on the liver progresses, blood flow through the liver becomes more difficult, increasing the blood pressure in the portal vein, creating varying degrees of portal hypertension. Eventually, this increase in blood pressure causes the veins connected to the liver to dilate and form esophageal varices, which are dilated veins that divert blood through the esophagus, bypassing flow through the liver. These dilated veins in the esophagus are prone to bleeding, which is a major cause of morbidity and mortality in patients with NASH cirrhosis. About half of the patients with well compensated NASH cirrhosis do not have varices, and identification of these patients is determined by endoscopy, which is included in the standard of care for all patients with cirrhosis.

About GR-MD-02

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin-3 proteins and disrupts its function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

Agilent Companion Diagnostic Gains Expanded FDA Approval in Cervical Cancer

On June 12, 2018 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use (Press release, Agilent, JUN 12, 2018, http://www.agilent.com/about/newsroom/presrel/2018/12jun-ca18057.html [SID1234527279]).

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Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with KEYTRUDA, an anti-PD1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada).

PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.

"PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This expansion of use for the Dako PD-L1 IHC 22C3 pharmDx assay gives patients with cervical cancer the possibility of having their tumor sample tested for PD-L1 expression, and determining eligibility for treatment with KEYTRUDA."

Cervical cancer is the third most common gynecologic cancer in the United States, with 13,000 cases expected to be diagnosed this year alone. The overall survival rate has not improved in the past 40 years, despite advancements in prevention and early detection. Cervical cancer patients previously had few treatment options other than highly toxic chemotherapy.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, with their therapeutic value being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co.