Tivozanib

– Industry veteran brings extensive clinical development experience to AVEO Oncology leadership team as Chief Medical Officer – – Formation of a Scientific Advisory Committee from world-renowned cancer institutions – BOSTON, March 25, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (also known as AVEO Pharmaceuticals, Inc.) (“AVEO”), an LG Chem company, today announced the appointment of Edgar E. Braendle, MD, PhD as AVEO Oncology’s new Chief Medical Officer. Dr. Braendle is a life sciences executive with experience spanning from early drug discovery to the launch of small molecules, biologics, radiopharmaceuticals, gene and cell therapies, and medical device development. Dr. Braendle brings more than twenty years of clinical research experience to AVEO Oncology, most recently serving as Chief Development Officer of Autolus Therapeutics Plc since July 2021, where he was responsible for all development functions and the conduct of the pivotal program of AUCATZYL™ (a CD-19 directed genetically modified autologous T cell immunotherapy) in adult acute lymphoblastic leukemia, and the respective filing to the U.S. Food & Drug Administration and European Medicines Agency. “We are delighted to have Dr. Braendle join the AVEO Oncology team particularly at this important juncture as we seek to become a global top 20 oncology leader,” said Michael P. Bailey, President and Chief Executive Officer of AVEO Oncology, an LG Chem company. “Dr. Braendle’s significant experience will be instrumental in our efforts to develop and diversify our pipeline.” Prior to his time at Autolus, Dr. Braendle held the role of Executive Vice President, Chief Medical Officer and Global Head of Development at Sumitomo Dainippon Pharma Oncology, where he was responsible for a full range of development functions and progressed several early-stage, first in human programs and late-stage programs. Prior to this, Dr. Braendle served as President and CEO of ARUP Laboratories, a national clinical and anatomic reference laboratory. Dr. Braendle also spent over a decade at Novartis AG, where he served as Senior Vice President and Global Head of Companion Diagnostics and led the company's precision medicine approach. Dr. Braendle received his medical degree at RWTH Aachen University in Germany, followed by specialty training in medical oncology, urology and pharmacology. Dr. Braendle is also an associate professor at the University of Ulm, Germany. Today, AVEO Oncology, an LG Chem company, and LG Chem Life Sciences also announced the formation of its Scientific Advisory Committee (“Committee”). This esteemed group of experts in oncology research and clinical development were selected to advise and bring unique perspectives to AVEO and LG Chem’s clinical strategy and business development initiatives. "We are excited and privileged to have the opportunity to work with this group of top oncology experts to help guide our drug development initiatives from discovery through commercialization. Notably, the Committee represents key areas of interest including gastrointestinal, genitourinary, ovarian, lung and head and neck cancers," said Mr. Bailey. The Scientific Advisory Committee is comprised of several leading cancer experts, including: Al B. Benson III, MD, FACP, FACCC, FASCO Professor of Medicine Associate Director from Cooperative Groups Robert H. Lurie Comprehensive Cancer Center of Northwestern University Scott Kopetz, MD, PhD Professor and Deputy Chair for Translational Research, Department of Gastrointestinal Medical Oncology Division of Cancer Medicine University of Texas MD Anderson Cancer Center D. Ross Camidge, MD, PhD Professor of Medicine/ Oncology Joyce Zeff Chair in Lung Cancer Director, Thoracic Oncology Faculty, Developmental Therapeutics Program University of Colorado Cancer Center, Aurora John L. Marshall, MD Chief, Hematology and Oncology Professor of Medicine and Oncology Director, Otto J Ruesch Center for the Cure of Gastrointestinal Cancers Georgetown Lombardi Comprehensive Cancer Center Edward Chu, MD, MMS Director, Montefiore Einstein Cancer Center Albert Einstein College of Medicine Tony S.K. Mok, BBS, FASCO Chairman, Department of Clinical Oncology LiShu Fan Professor of Clinical Oncology The Chinese University of Hong Kong Ezra Cohen, MD, FRCPSC, FASCO Chief Medical Officer of Oncology Tempus University of California- San Diego Paul G. Richardson, MD Director, Clinical Research Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Kevin J. Cullen, MD Professor of Oncology University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine Joseph Tabernero, MD, PhD Head, Medical Oncology Department Director, Vall d’Hebron Institute of Oncology Professor of Medicine, UVic-UCC Enrique Grande, MD, PhD, Msc Director, Medical Oncology Program and Clinical Research lead MD Anderson Cancer Center Madrid Jan Vermorken, MD, PhD Emeritus Professor of Oncology Department of Medical Oncology Antwerp University Hospital For more information about the Scientific Advisory Committee, please visit About AVEO Pharmaceuticals, Inc. AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immunooncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. For more information, please visit About LG Chem, Ltd. and LG Chem Life Sciences LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit ContactsMedia: John F. Kouten JFK Communications, Inc. jfkouten@jfkhealth.com (908) 227-4714 Source: AVEO Pharmaceuticals, Inc.

TOKYO, Feb. 6, 2024 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the enrollment of the first patient in a Phase 2 clinical trial, multi-center, randomized, double-masked, parallel group study of tivozanib eye drops (KHK4951). This study investigates the efficacy and safety of KHK4951 in patients with diabetic macular edema (DME). Tivozanib, the active ingredient of KHK4951 is a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI) discovered and developed by Kyowa Kirin. KHK4951 is a novel nano-crystalized tivozanib eye drops designed to deliver it efficiently to the posterior ocular tissues and is being developed as a potential treatment option for neovascular (wet) age-related macular degeneration (nAMD) and DME. An oral formulation of tivozanib is currently marketed as FOTIVDAⓇ in the U.S. by AVEO Oncology, an LG Chem Company, and in Europe by EUSA Pharma (UK) Ltd. for another indication. The Phase 2 study will be recruiting 150 patients with DME across the US, Japan, Australia and South Korea. The primary outcome measure is reduction of 15 or more letters from baseline in BCVA (Best Corrected Visual Acuity) as measured by the ETDRS visual acuity chart. "Tivozanib eye drops have the potential to provide a novel non-invasive treatment option for patients with DME", said Takeyoshi Yamashita, Ph.D., Director of the Board, chief medical officer, and senior managing executive officer of Kyowa Kirin. "The current standard of care is intravitreal injection drugs, which causes various burdens for patients, caregivers and doctors. We believe KHK4951 has the potential to address patient needs and preferences for a less invasive mode of administration." A separate Phase 2 study to evaluate KHK4951 in patients with neovascular(wet) age-related macular degeneration(nAMD) is also being initiated. This study is currently recruiting patients. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. About diabetic macular edema (DME) DME remains the most common cause of vision loss among working-age patients with diabetes mellitus and affects about 1.3 million people in the US. DME can occur at any stage of diabetic retinopathy. It is manifested as retinal thickening and swelling of the macula caused by the accumulation of intraretinal fluid, primarily in the inner and outer plexiform layers, and is believed to be a result of leakage of the retinal vasculature. At present, the treatment choices for DME are all invasive pharmacologic therapies are intravitreal anti-VEGF or corticosteroid injections, and surgical therapies are laser photocoagulation or vitrectomy. About Kyowa Kirin Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by a severe or rare disease. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: . SOURCE Kyowa Kirin