CASI Pharmaceuticals, Inc. to Host Key Opinion Leader Symposium on September 10, 2019 in New York City

On September 5, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products in China, U.S., and throughout the world, reported it will host a key opinion leader (KOL) symposium addressing innovations in cancer immunotherapy and recent regulatory reforms impacting the China biopharmaceutical market (Press release, CASI Pharmaceuticals, SEP 5, 2019, View Source [SID1234539326]). The event will be held in New York City on September 10, 2019 at 11:00AM EST.

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The meeting will feature presentations by Dr. James P. Allison, Ph.D., American Immunologist, Nobel laureate, Professor & Chair of Immunology and Executive Director of Immunotherapy at the MD Anderson Cancer Center, and Dr. Ruyi He, M.D., Adjunct Professor, Director of Academic Committee, Center for Regulatory Science, School of Medicine, Tsinghua University, and Former Chief Scientist at the Center for Drug Evaluation at the Chinese National Medical Product Administration (NMPA).

A live webcast and replay of the event will be accessible at www.casipharmaceuticals.com.

About the Speakers

James P. Allison, Ph.D.

Dr. James Allison is the Chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, Director of the Parker Institute for Cancer Research, and the Executive Director of the Immunotherapy Platform at MD Anderson Cancer Center. He has spent a distinguished career studying the regulation of T-cell responses and developing strategies for cancer immunotherapy. He earned the 2018 Nobel Prize in Physiology or Medicine, which he shared with Dr. Tasuku Honjo, "for their discovery of cancer therapy by inhibition of negative immune regulation." Among his most notable discoveries are the determination of the T-cell receptor structure and that CD28 is the major costimulatory molecule that allows full activation of naïve T-cells and prevents anergy in T-cell clones. His lab resolved a major controversy by demonstrating that CTLA-4 inhibits T-cell activation by opposing CD28-mediated costimulation and that blockade of CTLA-4 could enhance T-cell responses, leading to tumor rejection in animal models. This finding paved the wave for the emerging field of immune checkpoint blockade therapy for cancer. Work in his lab led to the development of ipilimumab, an antibody to human CTLA-4 and the first immune checkpoint blockade therapy approved by the FDA. Among many honors, he is a member of the National Academies of Science and Medicine and received the Lasker-Debakey Clinical Medical Research award in 2015. His current work seeks to improve immune checkpoint blockade therapies currently used by our clinicians and identify new targets to unleash the immune system in order to eradicate cancer.

Ruyi He, M.D.

Dr. Ruyi He is Adjunct Professor, Director of Academic Committee, Center for Regulatory Science, School of Medicine, Tsinghua University and former Chief Scientist at the Center for Drug Evaluation at the National Medical Products Administration (NMPA) Dr. He joined NMPA in July 2016, after having worked at the US Food and Drug Administration (FDA) for more than 17 years. Dr. He was the first overseas expert hired by NMPA as the Chief Scientist. He organized and led many recent Chinese FDA reforms on the drug evaluation system. He established numerous technique guidance for drug evaluation and approval un China. He also introduced multiple international polices into NMPA including conditional approval and accepting clinical data from abroad. Quality and speed of drug evaluation in NMPA has significantly improved since Dr. He joined NMPA. Dr. He joined the US Center for Drug Evaluation and Research (CDER) at the US FDA in 1999 as a Medical Officer in the Division of Gastrointestinal and Coagulation Drug Products. He became a Medical Team Leader in 2003 and served as the Acting Deputy Director for 2 years. He chaired several working groups that were tasked with drafting and finalizing guidelines for industry, and was also involved in FDA guidance development in multiple therapeutic areas. He was responsible for approving numerous applications for investigational new drugs (INDs) and new drug applications (NDAs). Dr. He has received many awards since he joined the FDA, including the FDA Excellence in Review Science Award, CDER Leadership Excellence Award, CDER Excellence in Mentoring Award, FDA Award of Merit, and the Department of Health and Human Services Secretary’s Award for Distinguished Service. Dr. He received his medical degree from China Medical University. He completed his intern and residency training in Internal Medicine at Howard University Hospital in Washington, DC and received his clinical and research training at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH) in Bethesda, Maryland. He is a licensed, board-certified physician in Internal Medicine.

Lynda Chin, M.D.

An elected member of the National Academy of Medicine, Dr. Chin is a recognized cancer genomic scientist and a leader in application of technologies, AI/ML and big data in medicine. She conducted research in cancer genomics and cancer biology at Dana Farber Cancer Institute and Harvard Medical School, served on the executive subcommittee of The Cancer Genome Atlas (TCGA) and co-led development of the Firehose pipeline at the Broad Institute. As founding chair of the Department of Genomic Medicine at MD Anderson Cancer Center, she launched initiatives to develop cross-cutting platform capabilities with technologies, data and analytics. Later, as Chief Innovation Officer of the University of Texas System, Dr. Chin created the Institute for Health Transformation to explore public-private partnerships and business strategies for establishing a health data ecosystem and integrating data and technologies in care delivery, especially for the underserved. More recently, Dr. Chin co-founded Apricity Health to develop prescription digital therapeutics to bring real-time data and subspecialty expertise to points-of-care, enabling precision and personalization in management of patients undergoing treatment for serious diseases, starting with cancer immunotherapy (IO).

Wei-Wu He, Ph.D.

Dr. He is Chairman and CEO of CASI Pharmaceuticals. Prior to joining CASI, Dr. He was the CEO of OriGene Technologies, Inc. and remains Chairman of their Board of Directors. He also is the founder and General Partner of Emerging Technology Partners, LLC (ETP), a life sciences focused venture fund established since 2000. Dr. He has been involved in founding or funding over 60 biotech companies throughout his career, some of which went on to be acquired by significantly larger firms. In the earlier part of his career, Dr. He was one of the first few scientists at Human Genome Sciences, and prior to that, was a research fellow at Massachusetts General Hospital and Mayo Clinic. Dr. He is an author to more than 30 research publications and inventor of over 32 issued patents. Dr. He received his Ph.D. in Molecular Biology from Baylor College of Medicine and received an M.B.A. degree from the Wharton School.

Accuray to Set ASTRO 2019 in Motion with Patient-first Cancer Treatment Innovations

On September 5, 2019 Accuray Incorporated (NASDAQ: ARAY) reported that it will showcase its industry-leading motion-synchronization cancer treatment technologies at the upcoming American Society for Radiation Oncology (ASTRO) Annual Meeting taking place September 15 – 18, 2019 in Chicago, Illinois (Press release, Accuray, SEP 5, 2019, View Source [SID1234539325]). The company will provide multiple opportunities for attendees to explore its new innovations in patient-first cancer treatments, including booth presentations and demonstrations at its Innovation Pavilion (booth #3405) and presentations at the Accuray Symposium.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Synchrony Motion Tracking and Correction Technology¹ for the Radixact System to be Unveiled
Accuray has brought Synchrony, its exclusive motion synchronization technology, from the CyberKnife System to the Radixact System. During the meeting, attendees will have the chance to learn how Synchrony for Radixact synchronizes the treatment delivery beam with the movement of the tumor, accurately delivering high doses of radiation directly to the tumor and minimizing dose to healthy tissue, all while the patient breathes naturally. Clinicians attending the ASTRO meeting are invited to the unveiling of Synchrony for Radixact on Sunday, September 15 at 11:00 am CT at the Accuray booth.

Faster Radiation Treatments with the CyberKnife System
Meeting attendees can also hear more about the CyberKnife VOLO Optimizer, a next-generation optimizer that enables physicians to significantly improve operational efficiency by reducing both the time to create high quality treatment plans and the time it takes to deliver patient treatments. Clinicians now have an option for delivering the same highly precise radiosurgery and stereotactic body radiation therapy treatments they have come to expect with the CyberKnife System, more quickly and for a wider range of patient cases.

Accuray Symposium: Clinicians to Share Treatment Perspectives
At Accuray’s Symposium event on Monday, September 16, 2019 from 12:15pm CT – 1:15pm CT, ASTRO meeting attendees will hear how 15 years’ of dynamic tracking and motion synchronization leadership has translated into improved patient outcomes. The symposium panelists will discuss their perspectives and share best practices on how they have used Accuray’s motion synchronization technologies to transform the way cancer treatments are delivered.

Symposium panelists will include:

Symposium Chairman & Introduction: Iris C. Gibbs, M.D., FACR, FASTRO, Stanford University Medical Center, Stanford (CA)
Clinical Value of Motion Synchronization for Prostate SBRT: Ronald C. Chen, M.D. M.P.H., University of North Carolina, Chapel Hill (NC)
Clinical Value of Motion Synchronization for Lung SBRT: Jonathan W. Lischalk, M.D., Medstar Georgetown University Hospital, Washington (DC)
First Site Experience on Real-time Motion Synchronization on the Radixact System: X. Allen Li, Ph.D., DABMP, FAAPM, Medical College of Wisconsin, Milwaukee (WI)
AERO Academy Program Presentations
Live in the Accuray booth, ongoing interactive discussions with industry experts on topics designed to help improve clinical practice, including:

Synchrony Motion Synchronization for the Radixact System
The CyberKnife VOLO Experience
CyberKnife for Prostate SBRT, Liver and Brain Metastases
TomoTherapy for Breast and Advanced Rectal Cancers
Medicare Radiation Oncology Alternative Payment Model, What it Means to Your Practice
The full AERO Academy talk schedule can be found here. Attendees can also book a personalized demonstration with an Accuray expert here.

Actinium Pharmaceuticals to Present at the Rodman & Renshaw 21st Annual Global Investment Conference

On September 5, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium"), reported that it will present at the Rodman & Renshaw 21st Annual Global Investment Conference (Press release, Actinium Pharmaceuticals, SEP 5, 2019, View Source;renshaw-21st-annual-global-investment-conference-300912476.html [SID1234539324]). The conference is being held at the Lotte New York Palace Hotel in New York City on September 8-10, 2019. Details of Actinium’s presentation are as follows:

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Date: Tuesday, September 10, 2019
Time: 4:40 PM ET
Room: Holmes I (4th Floor)
Venue: Lotte New York Palace Hotel

Members of Actinium’s Executive team will be available for 1-on-1 meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer via email at [email protected].

Amgen To Present At The Morgan Stanley Global Healthcare Conference

On September 5, 2019 Amgen (NASDAQ: AMGN) reported that it will present at the Morgan Stanley Global Healthcare Conference at 9:10 a.m. ET on Tuesday, Sept. 10, 2019, in New York City (Press release, Amgen, SEP 5, 2019, View Source [SID1234539323]). Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Sumitomo Dainippon Pharma and Roivant Sciences Enter into a Memorandum of Understanding to Create Broad Strategic Alliance to Deliver Promising New Medicines to Patients

On September 5, 2019 Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading Japanese pharmaceutical company, and Roivant Sciences Ltd., a technology-enabled healthcare company, reported that they have entered into the Memorandum for the creation of a novel and broad Alliance to include the transfer to Sumitomo Dainippon Pharma of Roivant’s ownership interests in 5 of their biopharmaceutical companies ("Vants"), with options to acquire up to 6 additional Vants, and access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation (Press release, Sumitomo Dainippon Pharma, SEP 5, 2019, View Source [SID1234539322]). Roivant will collaborate with Sumitomo Dainippon Pharma with the continued involvement of Roivant’s senior leaders to ensure the success of the Alliance. In addition, Sumitomo Dainippon Pharma will take an equity stake of over 10% of shares outstanding in Roivant.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We respect Roivant’s innovative business model and underlying culture, and we look forward to deepening our relationship with Roivant, which has a rich development pipeline, technology platforms, and distinctive talents," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Dainippon Pharma. "I am hopeful that through this Alliance between the two companies, Sumitomo Dainippon Pharma will not only obtain growth engines after expiry of the U.S. market exclusivity of LATUDA, but also address issues identified in the Mid-term Business Plan 2022 and contribute significantly to establish a position as a ‘Global Specialized Player’ which we aspire to be by 2033 through our transformation into a novel pharmaceutical business model leveraging data and digital technologies."

"We are pleased to enter into this relationship with Sumitomo Dainippon Pharma and we look forward to working closely with them to ensure the success of the Alliance," said Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant. "Sumitomo Dainippon’s expertise in commercializing major products globally, combined with support from our technology-oriented Vants and the central Roivant platform, will enhance the value of the product portfolio included in this Alliance. We view this partnership as a major validation of the Roivant platform and we will continue to launch other innovative Vants in the future."

Structure of the Alliance

Pursuant to the Memorandum, the Sumitomo Dainippon-Roivant Alliance, a new entity to be wholly owned by Sumitomo Dainippon Pharma, is expected to assume Roivant’s ownership interests in Myovant Sciences (women’s health and prostate cancer), Urovant Sciences (urinary diseases), Enzyvant Therapeutics (pediatric rare diseases), Altavant Sciences (respiratory rare diseases), and one additional company to be specified before the execution of the definitive agreement. Sumitomo Dainippon Pharma will also gain options to acquire Roivant’s ownership interests in up to 6 additional biopharmaceutical Vants. These 11 Vants collectively have more than 25 innovative clinical programs, with multiple potential product launches expected from 2020 to 2022.

Sumitomo Dainippon Pharma plans to support the Vants in the Alliance by leveraging the potential benefits of scale and other advantages associated with Sumitomo Dainippon Pharma’s global commercial infrastructure such as market access and drug distribution. Roivant also plans to continue to support the six Vants subject to the option. Sumitomo Dainippon and Roivant will further collaborate with the goal of successfully progressing each of the Vants’ ongoing programs.

Access to Technology Platforms

Sumitomo Dainippon Pharma will gain key elements of Roivant’s proprietary technology platform, including the DrugOme, which assists in accelerating pipeline acquisition and clinical development, and Digital Innovation, which uses technology to improve business processes. These platforms will continue to be used by Roivant under separate contract for other Vants as well as future business activities. Sumitomo Dainippon Pharma also expects to enter contract agreements with Roivant Health technology Vants, including Datavant and Alyvant, to support its own ongoing and future clinical and commercialization activities and maximize the value of its product portfolio, including products in the Sumitomo Dainippon-Roivant Alliance.

Timeline for Definitive Agreement

Roivant and Sumitomo Dainippon Pharma expect to sign the definitive agreement by the end of October 2019. The transaction will be subject to customary closing conditions and any required governmental approvals. Roivant is expected to receive USD $3 billion from Sumitomo Dainippon Pharma as an upfront payment to enter the Alliance, which includes taking a substantial equity ownership interest in Roivant (over 10% of shares outstanding).