ROCKVILLE, Md., Sept. 5, 2019 /PRNewswire/ -- 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, announces it will host a key opinion leader (KOL) symposium addressing innovations in cancer immunotherapy and recent regulatory reforms impacting the China biopharmaceutical market. The event will be held in New York City on September 10, 2019 at 11:00AM EST.
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.
About CASI Pharmaceuticals
CASI Pharmaceuticals is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world. CASI's product pipeline features (i) an autologous anti-CD19 T-cell therapy investigative product (CNCT19) being developed for the treatment of B-ALL and NHL; (ii) CID-103, an anti-CD38 monoclonal antibody being developed for the treatment of hematological malignancies; (iii) three U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs in-licensed from Acrotech Biopharma L.L.C. and its affiliates for which CASI has exclusive rights to the greater China market, consisting of EVOMELA® (Melphalan for Injection), ZEVALIN® (Ibritumomab Tiuxetan) and MARQIBO® (Vincristine Sulfate Liposome Injection); and (iv) a portfolio of FDA-approved and pending abbreviated new drug applications (ANDAs), including entecavir and tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus. CASI has offices in Rockville, Maryland and a wholly owned subsidiary in Beijing, China through which our China operations are conducted. More information on CASI is available at www.casipharmaceuticals.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including: the difficulty of executing our business strategy in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the FDA, NMPA, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the volatility in the market price of our common stock; risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; risks associated with CID-103, CNCT19, and our product candidates; risks associated with CID-103, CNCT19, and our other early-stage products under development; risks that results in preclinical and early clinical models are not necessarily indicative of later clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; the lack of success in the clinical development of any of our products; and our dependence on third parties. Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition. We caution readers not to place undue reliance on any forward-looking statements, which only speak as of the date made. Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
EVOMELA®, Zevalin® and Marqibo® are proprietary to Acrotech Biopharma LLC and its affiliates.
SOURCE CASI Pharmaceuticals, Inc.