Seattle Genetics to Present at the Morgan Stanley Global Healthcare Conference

On September 4, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 2:05 p.m. EDT (Press release, Seattle Genetics, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365825 [SID1234529344]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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Top Line Results of the Namodenoson Phase II Advanced Liver Cancer Trial Expected by End of Year

On September 4, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported its Phase II clinical trial of drug candidate Namodenoson (CF102) for the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy (Press release, Can-Fite BioPharma, SEPT 4, 2018, View Source [SID1234529260]). Top line efficacy results are expected by end of year.

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The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Advanced liver cancer is categorized into 3 subclasses including Child Pugh A, mostly treated with Nexavar, Child Pugh B and Child Pugh C. Although a few drugs for the treatment of advanced liver cancer have recently launched, none are specifically aimed at treating patients who have reached the Child Pugh B stage. This represents a major unmet need and potentially positions Namodenoson as an important drug candidate to treat this patient population.

Enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled, 22 completed at least 12 cycles of treatment (each cycle is 28 days of treatment), of whom 5 completed 24 cycles. The longest-treated subject has been receiving study medication for over 3 years.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

Can-Fite’ CEO, Dr. Pnina Fishman, commented, "We are pleased with the progress so far in our clinical trial for Namodenoson for the treatment of advanced HCC, the third leading cause of cancer deaths worldwide, and look forward to data release. We believe a major advantage of Namodenoson stems from its favorable safety profile demonstrated thus far, in which Namodenoson selectively targets diseased cells while sparing normal cells which express very low levels of the A3 receptor.

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

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.

Mustang Bio Announces Presentations on CAR T Therapies at 4th Annual CAR-TCR Summit 2018

On September 4, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a Fortress Biotech (NASDAQ: FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology and gene therapies for rare diseases, reported oral and poster presentations related to its CAR T therapies at the 4th Annual CAR-TCR Summit 2018, to be held September 4-7,2018, at the Seaport Hotel & World Trade Center in Boston (Press release, Mustang Bio, SEP 4, 2018, View Source [SID1234529307]).

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Details on the oral presentations are as follows:
Title: Confronting Analytical Challenges of Chimeric Antigen Receptor T Cell
Presenter: Junxia Wang, M.D., Ph.D., Director of Analytical Development, Mustang Bio
Track: Manufacturing
Date and Time: Tuesday, September 4, 2018, 3 p.m. EDT

Title: CAR T Cell Therapy for Glioblastoma: Progress, Promises and Challenges
Presenter: Behnam Badie, M.D., Professor and Chief, Division of Neurosurgery & Director, Brain Tumor Program,
City of Hope Medical Center
Track: Focus Day: Overcoming CAR T Toxicity in Solid Tumors
Date and Time: Friday, September 7, 2018, 12 p.m. EDT

Title: CAR T cells and Combination Therapies: The Next Chapter of the Immuno-Oncology Revolution
Panelist: Ekta Patel, Ph.D., Associate Director of Translational Sciences, Mustang Bio
Track: Focus Day: Alternative CAR Strategies
Date and Time: Friday, September 7, 2018, 1 p.m. EDT
Details on the poster presentation are as follows:

Title: Considerations for the Industrialization of a Phase 1 Academic CD20 CAR-T Manufacturing Process
Presenter: Suchit Sahai, Ph.D., Staff Scientist, Process Development, Fred Hutchinson Cancer Research Center
Track: Scientific Poster Session
Date and Time: Thursday, September 6, 2018, 8 a.m. EDT

Dr. Sadik Kassim, Chief Scientific Officer of Mustang Bio, will also present a plenary talk titled "From Academia to
Industry: Lessons Learned in the Development of CAR-T Therapies" during the opening ceremony on Wednesday,
September 5, 2018, at 8:45 a.m. EDT.

Seattle Genetics to Present at the Morgan Stanley Global Healthcare Conference

On September 4, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 2:05 p.m. EDT (Press release, Seattle Genetics, SEPT 4, 2018, View Source;p=irol-newsArticle&ID=2365825 [SID1234529261]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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Agios Announces Chief Executive Officer Succession Plan

On September 4, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that effective February 1, 2019, David Schenkein, M.D., will transition to the role of executive chairman of the board of directors and serve as a member of the board’s Science & Technology Committee, after a successful decade-long tenure as chief executive officer (Press release, Agios Pharmaceuticals, SEP 4, 2018, View Source [SID1234529308]). Jacqualyn ("Jackie") Fouse, Ph.D., a member of the company’s board, has been named as Agios’ next chief executive officer.

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Prior to joining Agios’ board in December 2017, Dr. Fouse served as president and chief operating officer of Celgene Corporation, a global biopharmaceutical company, until April 2017, and as a member of its board through June 2017. Dr. Fouse joined Celgene in 2010 as chief financial officer and was named president of the company’s global hematology and oncology franchise in 2014. Prior to joining Celgene, Dr. Fouse served as chief financial officer of Bunge Limited, a leading agribusiness and food company. Earlier in her career, she held senior roles at Alcon Laboratories and various international companies.

Dr. Schenkein has served as Agios’ chief executive officer since 2009. During this time, he has overseen the evolution of Agios from a pure research organization to a fully integrated biopharmaceutical company with two approved medicines from its discovery engine, three additional molecules in clinical development and a robust research pipeline.

"With the recent approval and launch of our second internally discovered medicine, Agios has demonstrated that it is capable of discovering, developing and commercializing precision medicines. After leading the company for nearly 10 years, the board and I believe now is the right time to begin this transition. Having worked closely with Jackie for several years and as a member of our board, I am confident that she is the right person to build on the strong foundation we’ve established," said Dr. Schenkein. "It has been a privilege to lead Agios from a blank piece of paper to a thriving biopharmaceutical company with a science-focused culture that puts patients at the center of everything we do. I look forward to continuing my engagement with the company as executive chair and working with Jackie and the leadership team over the next several months to ensure a smooth transition."

John Maraganore, Ph.D., chairman of the Agios board of directors, said, "Jackie’s appointment as CEO is the result of a thoughtful succession planning process jointly undertaken by David and the board. Jackie brings extensive global leadership experience, a proven track record and tremendous knowledge of our industry. Throughout her career, Jackie has demonstrated the ability to effectively plan for and successfully execute on clinical and commercialization strategies, which will be essential as the company works to further its transition to a sustainable multi-product company. On behalf of the entire board of directors, I want to thank David for his extraordinary leadership and his unwavering commitment to patients during his tenure. Under David’s leadership, Agios has become a recognized leader in cellular metabolism with demonstrated ability to rapidly translate novel biology into precision medicines in areas of high unmet need. Agios will continue to benefit from David’s scientific and clinical expertise as part of his new role as executive chairman of the board."

"Agios is well positioned to become one of the next great science-focused companies in our industry, and I am honored to succeed David as the company’s next CEO," said Dr. Fouse. "I greatly admire David’s leadership in addition to the high-performance track record and enviable culture that he and the Agios team have built. Together with the leadership team and all of Agios’ employees, I look forward to building on this strong foundation and continuing our pace of innovation and execution. Importantly, I bring a shared commitment to culture, science and patients."

With Dr. Schenkein transitioning to the role of executive chairman effective February 1, 2019, Dr. Maraganore will transition to a director of the Agios board at that time, and Dr. Fouse will remain a member of the board.