The Chinese University of Hong Kong

Highlights from the Data Presentation Initial safety data presented on the first 10 chronically HBV-infected patients representing 674 patient days of treatment VRON-0200 was well tolerated, with no serious adverse events (SAEs) observed: no patients discontinued treatment one treatment related adverse event was reported (flu-like symptoms which resolved without treatment) No other clinically relevant abnormalities in laboratory tests, including liver function tests, electrocardiograms (ECG), or vital signs were reported Immunologic assessments are ongoing, data expected to be submitted to an upcoming meeting PHILADELPHIA, March 27, 2024 /PRNewswire/ -- Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies, today announced promising safety results from the first-ever human data from its novel, first-in-class, checkpoint modifier immunotherapy, VRON-0200, for HBV functional cure, presented by Professor Grace Wong, M.D., from the Chinese University of Hong Kong, as a late breaker oral presentation at the 33rd Annual Meeting of APASL (The Asian Pacific Association for the Study of the Liver) in Kyoto, Japan. These initial Phase 1B safety results, on the first 10 chronically infected hepatitis B patients on nucleos(t)ide antiviral therapy, all of whom received a single, low dose, intramuscular injection of VRON-0200, demonstrated that it was safe and well-tolerated, with no significant adverse events reported and no other clinically relevant abnormalities in laboratory tests, electrocardiograms (ECGs), or vital signs. Professor Wong commented, "With almost 300 million persons living with chronic hepatitis B in the world, there is a high – and critical - unmet medical need for a functional cure that is not only effective, but also safe. These first clinical data suggest that VRON-0200 is safe and well tolerated, after a single injection into the arm muscle. I look forward to additional safety and other clinical data being available soon." "Finding a treatment for chronic HBV-infected patients will almost assuredly require an immune-based component to help control the infection. To date, the best responses have been observed with regimens that contain pegylated interferon, which requires weekly injections and is often accompanied by high rates of adverse events. These VRON-0200 data - the first ever for a checkpoint modifier containing T cell vaccine of any kind - represent a critical first step in Virion's mission to bring a safe, well tolerated, and easy to administer interferon-sparing functional cure immunotherapy to HBV-infected patients worldwide", said Dr. Sue Currie, COO of Virion, and one of the study authors. "We look forward to sharing additional safety, and the first-ever immunogenicity data, from this trial later this year." Ocean Biomedical co-founder and Executive Chairman Dr. Chirinjeev Kathuria, commented: "We congratulate our Joint Venture Partner, Virion, for the first-ever clinical data presented for their checkpoint modifier immunotherapy and these initial results showing it can be administered simply, and safely, to chronically HBV-infected patients." Summary of clinical trial design VRON-0200 is a Phase 1B, multi-center, open-label, dose escalation, prime only, and prime plus boost therapeutic vaccination study to evaluate the safety, tolerability, immunology, and other clinical measures: Inclusion criteria: Non-cirrhotic, HBeAg positive or negative, chronic hepatitis B patients currently taking nucleos(t)ide antiviral therapy with HBV DNA < 40 IU/mL and HBsAg < 500 IU/mL Dose escalation: Study consists of 2 cohorts: Cohort 1, low dose of VRON-0200; Cohort 2, receive a high dose Prime or Prime-Boost: In each cohort, patients are randomized to receive an intramuscular injection as a prime vaccination only or as a prime and boost regimen More details of the study can be found at ClinicalTrials.gov (Identifier: NCT06070051). About Chronic Hepatitis B Despite a preventative vaccine, cases of chronic hepatitis B (HBV) continue to rise, with an estimated 296 million persons infected worldwide and 820,000 deaths per year from HBV-related liver complications. This includes almost 100 million persons in China who are affected by this disease. Chronic HBV remains a global health issue with a high unmet medical need since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus. About VRON-0200 VRON-0200 is a therapeutic immunotherapy, administered by intramuscular injection, designed with the goal of providing a functional cure for chronic HBV infection. While the virus itself stimulates HBV-specific CD8+ T cells, for those patients that can't clear the initial infection, their T cells soon become exhausted, placing limits on their ability to proliferate and control the virus. Preclinical data support the hypothesis that VRON-0200, through checkpoint modification, can amplify, broaden, and enhance T cell responses that may include T cells that are not normally activated during a chronic HBV infection, which results in improved viral control. About Virion Therapeutics (Virion) Virion Therapeutics, LLC is a clinical-stage company developing novel T cell-based immunotherapies to cure cancer and chronic infectious diseases that utilize proprietary genetically encoded checkpoint modifiers to enhance and broaden CD8+ T cell responses to a tumor or chronic infection. Founded in early 2018, Virion has since developed a robust pipeline, including its lead VRON-0200 clinical program, and several additional IND-enabling programs, including its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies. In early Fall 2023, Virion and Ocean Biomedical entered a joint venture to accelerate and expand Virion's pipeline of novel immunotherapies. To learn more, visit Contacts: Virion Therapeutics, LLC Dr. Sue Currie Chief Operating Officer [email protected] SOURCE Virion Therapeutics, LLC

– 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.

For some leukemia patients, their only treatment option carries a risk of heart failure. For some leukemia patients, the only potential chemotherapy option is a drug that also carries a high risk of heart failure. This means that some patients who recover from their cancer will end up dying of heart disease brought on by the cure. In a new study, researchers from the University of Illinois Chicago and other universities have identified mechanisms that cause the drug, ponatinib, to harm the heart. They also identified a promising treatment that could reverse this process. The paper, with senior author Sang Ging Ong, assistant professor of pharmacology and medicine at UIC, is published in Circulation Research. The study is part of a growing field called cardio-oncology that investigates drugs that shrink tumors but can also cause heart problems. While there are three options of drugs for treating chronic myeloid leukemia, many patients are resistant to the other two, leaving ponatinib as their only choice. "These patients have no other options for treatment," Ong said, despite the concerns about the drug's side effects. In fact, ponatinib was pulled from the market for a few months after its introduction in 2012 because of concerns about heart problems. The researchers were interested in understanding the interaction between ponatinib and the heart cells responsible for contraction. They discovered that ponatinib damages these cells by activating a process known as the integrated stress response. The mechanism for this is related to the functioning of a kinase -- an enzyme involved in energy transfer -- called GCN2. The researchers found that ponatinib, despite being a kinase inhibitor, actually activates GCN2, which in turn switches on the integrated stress response. While this response isn't always a bad thing -- its purpose is to protect cells -- it can also lead to their death under prolonged stress. To see if this response was harming the cells, the researchers studied what would happen if they used a small molecule to block the integrated stress response in both cells and in mice during ponatinib treatment. They found that the treatment helped protect heart cells from the damaging side effects of the drug yet did not diminish ponatinib's tumor-fighting efficacy. "It protects the heart but at the same time, it still allows us to kill cancer cells," Ong said. More research is needed to know if this protective measure would work well in humans, Ong said. The mechanisms they identified are important in other cardiac diseases, as well, which could lead to future research on how to protect cells against different conditions. Ong's co-senior authors on the study are Won Hee Lee at the University of Arizona and Sang-Bing Ong at the Chinese University of Hong Kong. Other UIC authors at the College of Medicine or University of Illinois Cancer Center are Gege Yan, Zhenbo Han, Youjeong Kwon, Jordan Jousma, Sarath Babu Nukala, Xiaoping Du and Sandra Pinho, as well as Benjamin Prosser from the University of Pennsylvania.