The Science Advisory Board

Company to appoint Prof. Arun J. Sanyal as the new Chairman of HistoIndex's Scientific Advisory Board, bringing unparalleled expertise to guide future innovations. Prof. Vlad Ratziu joins the Scientific Advisory Board to strengthen the Company's global scientific leadership in liver disease management. HistoIndex's AI-driven solutions qFibrosis, qSteatosis, and qBallooning can standardize assessments in MASH clinical trials, improving drug efficacy evaluations and patient screening processes. SINGAPORE, July 1, 2024 /PRNewswire/ -- HistoIndex, a global leader in digital pathology solutions for the management of chronic liver disease, is pleased to announce changes to its Scientific Advisory Board (SAB). Established in 2017 under the leadership of the late Dr. Stephen A. Harrison, the SAB has played a crucial role in guiding HistoIndex's research and development efforts. Current members include Prof. Arun J. Sanyal, Prof. Quentin Anstee, Prof. Wei Lai, and Prof. Jacob George. New SAB Appointments Continue Reading Prof. Arun J. Sanyal, a professor of Medicine, Physiology, and Molecular Pathology at Virginia Commonwealth University (VCU) School of Medicine, has been appointed as the new Chairman of HistoIndex's SAB. Also serving as the Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at VCU, Prof. Sanyal's leadership spans multiple prestigious roles as Chair of the NIH NASH Clinical Research Network, the NIMBLE consortium, and the Liver Forum. A continuous NIH grant recipient since 1995, Prof. Sanyal brings well over 500 publications in leading journals to the role, placing him in the top 0.1% of biomedical scientists globally. "I am honored to lead HistoIndex's Scientific Advisory Board," said Prof. Sanyal. "Our collective expertise will drive innovative solutions in chronic liver disease management, pushing the boundaries of scientific discovery to improve patient outcomes." Prof. Vlad Ratziu, a professor of Hepatology at Sorbonne University and the Pitié-Salpêtrière Hospital in Paris, also joined the SAB. With over 400 publications and an H-index of 96, Prof. Ratziu is a prominent researcher in steatotic liver disease and hepatocellular carcinoma. He has played key roles in numerous MASH therapeutic trials and European research consortia, and is the incoming Editor-in-Chief of the Journal of Hepatology, a leading liver disease publication and the European Association for the Study of the Liver (EASL) flagship journal. "HistoIndex's technology has ushered in a new era in quantifying liver injury. The Company's commitment to innovation and collaboration among industry and academic leaders aligns perfectly with my scientific pursuits. I am thrilled to join the scientific board under Prof. Sanyal's leadership and contribute to innovative work benefiting MASH patients." Remembering Dr. Stephen A. Harrison As we embrace these new changes, we also pause to honor and remember the exceptional contributions of our late chairman, Dr. Stephen A. Harrison, a visionary leader in metabolic disease. His foresight to leverage AI for disease assessment in 2014 propelled HistoIndex's digital pathology solutions to the forefront of liver disease management. Dr. Gideon Ho, CEO of HistoIndex, reflected, "Stephen was more than our chairman; he was a true pioneer and mentor whose persistence and guidance brought our technology to maturation for enhanced patient care. His legacy will continue to inspire our work as we expand the applications of our platform technology to other diseases." Innovative AI Tools HistoIndex's pioneering AI-based image quantitative tools, qFibrosis and qSteatosis, have been incorporated in over 25 MASH clinical trials and demonstrated greater sensitivity in drug efficacy evaluations and patient stratification. Building on the same AI foundations, the Company developed qBallooning, which improved concordance among expert pathologists in ballooned hepatocyte evaluations. "Developing qBallooning is a significant step in standardizing and improving the evaluation of liver biopsies in MASH clinical research and practice," said Dr. Dean Tai, Chief Scientific Officer. "With these advancements and our strengthened SAB, HistoIndex is poised to accelerate liver disease drug development and diagnosis breakthroughs." About MASLD and MASH Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), is a condition characterized by the buildup of fat in the liver in the absence of harmful alcohol intake. MASLD is closely associated with obesity, type 2 diabetes, and other metabolic disorders. It represents a spectrum of liver disorders ranging from simple steatosis (steatotic liver disease) to a more severe form known as metabolic dysfunction-associated steatohepatitis (MASH), formerly referred to as non-alcoholic steatohepatitis (NASH). MASH is a progressive form of MASLD characterized by liver inflammation and damage, which can lead to fibrosis (scarring), cirrhosis, liver failure, and an increased risk of liver cancer. The presence of ballooned hepatocytes (enlarged and damaged liver cells) is a key feature distinguishing MASH from simple steatosis. Pathologist assessments of liver biopsy remains the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in clinical trials. These endpoints are limited in capturing the complex and heterogeneous nature of the disease. As a result, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH. About qFibrosis®, qSteatosis®, and qBallooning® Current semi-quantitative histologic assessments of MASH are limited in precision for detecting subtle changes and introduce intra- and inter-observer variability. This impacts clinical trial recruitment and evaluation of drug efficacy. qFibrosis®, qSteatosis®, and qBallooning® are advanced tools that provide quantitative, continuous measures of key MASH features. Developed using the NASH-CRN scoring system as the reference standard, these tools quantitatively assess architectural parameters of collagen fibers, fat vacuoles, and hepatocytes to evaluate each histological feature optimally. As automated solutions, they offer enhanced reproducibility, precision, and sensitivity in determining disease severity and treatment responses, making them invaluable in clinical trials and research settings. About HistoIndex Founded in 2010, HistoIndex is a pioneer in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in tissue biopsies. By combining cutting-edge biophotonic technology with AI-based analysis, HistoIndex provides innovative tools that transform research, expedite pharmaceutical drug development, and set new medical standards. SOURCE HistoIndex

The newly formed Scientific Advisory Board chaired by Dr. Marco Taglietti will provide technical and strategic guidance to support AUROBAC’s R&D strategy. Lyon (France), June 20, 2024 AUROBAC THERAPEUTICS, a biopharmaceutical company founded by Boehringer Ingelheim, bioMérieux and Evotec, today announced the creation of its Scientific Advisory Board (SAB) and the appointment of its members. Comprised of distinguished experts in preclinical and clinical drug development, diagnostics, and infectious diseases, the SAB will provide scientific and medical expertise as well as strategic guidance to support AUROBAC’s R&D strategy and to help advance its first products to clinical trials. The SAB duties will also include program execution considerations in the framework of innovation, clinical and market dynamics. “We are thrilled to welcome such a qualified and experienced group of experts to our Scientific Advisory Board”, said Florence Séjourné, CEO of AUROBAC THERAPEUTICS. “Their collective expertise and insights will be invaluable as we navigate the complexities of developing innovative products targeting bacterial infections, antimicrobial resistance and their consequences in acute hospital settings. The creation of the SAB is a significant milestone for AUROBAC, underscoring our commitment to scientific excellence and innovation.” The newly formed SAB will be chaired by Dr. Marco Taglietti, who is also an Independent Member of AUROBAC’s Board, and consists of: Sujata M. Bhavnani, PharmD, M.S., is a distinguished pharmacokinetics-pharmacodynamics expert for antimicrobial agents. Her work has supported decisions for dose selection and interpretive criteria for the in vitro susceptibility testing for numerous new drug applications. She is the Executive Vice-President of Translational Medicine for ICPD (Institute for Clinical Pharmacodynamics). She received her Pharm.D. from the Albany College of Pharmacy, completed a two-year post doctorial fellowship in infectious diseases and pharmacokinetics at Millard Fillmore Hospital, and her M.S. in biometry from the University at Buffalo.Mark Miller, MD, is a renowned medical clinician, microbiologist and clinical researcher with expertise in infectious disease and epidemiology. Until recently, he was Chief Medical Officer, Executive Vice-President and was on the Executive Management Committee at bioMérieux for 11 years (2012 – 2024). Prior to bioMérieux, he was Head of Infectious Diseases, Chief of Clinical Microbiology, and Chair of Infection Prevention and Control at the Jewish General Hospital (Montreal, Canada) for over 25 years, until 2012. He received his MD with further specialization in Internal Medicine, Infectious Diseases and Medical Microbiology and his M.Sc. in Epidemiology and Biostatistics from McGill University (Montreal, Canada) where he was appointed a Full Professor of Medicine in 2012.Manu Shankar-Hari, MD, Ph.D., M.Sc., is a clinician scientist with an outstanding expertise in translational research and immunology of sepsis. Currently, he holds the Personal Chair of Translational Critical Care Medicine at the Institute for Regeneration and Repair (University of Edinburgh). He leads a globally unique precision medicine program for critically ill adults to enable targeted immunomodulation (The TRAITS programme). For additional details of Prof Shankar-Hari’s research, please see academic webpage.Ruben Tommasi, Ph.D., has extensive expertise in preclinical development with almost 30 years’ of industry and biotech experience. He is currently Chief Scientific Officer of Dunad Therapeutics since 2022. Prior to Dunad, he was a founding leader and Chief Scientific Officer at Entasis Therapeutics (2015 – 2022). He also spent 4 years at AstraZeneca as Executive Director, Chemistry, of the Infection Innovative Medicines unit, after having been at Novartis for 17 years where he led several medicinal chemistry efforts, most recently the Infectious Disease Therapy unit. He received a Ph.D. in organic chemistry from the State University of New York at Albany.Richard G. Wunderink, MD, is a highly-experienced clinician scientist, active in pulmonary infections and sepsis. He is a professor of medicine in the Pulmonary and Critical Care Division of Northwestern University’s Feinberg School of Medicine and formerly medical director of the MICU, Northwestern Memorial Hospital. He co-chaired the 2007 IDSA (Infectious Diseases Society of America) / ATS (American Thoracic Society) Consensus Guidelines Committee on the management of community-acquired pneumonia. He was a member of previous ATS/IDSA guidelines committee on HAP/VAP and the ERS/ESCIM/ESCMID/ALAT International Guidelines for the Management of HAP/VAP and the recently published ERS/ESCIM/ESCMID/ALAT guidelines for management of Severe CAP. He received his MD from the Indiana University School of Medicine. “I am honoured to take on the role of Chairman of AUROBAC's SAB and look forward to working together with these esteemed scientists to support the development of products addressing antimicrobial resistance, one of the biggest public health threats of our time”, said Dr. Marco Taglietti, Chairman of the SAB. Leveraging the invaluable expertise of the SAB, the AUROBAC team is well prepared to advance its product pipeline and provide effective treatments for patients with severe bacterial infections. About AUROBAC THERAPEUTICS: AUROBAC THERAPEUTICS is a biopharmaceutical company founded in 2022 by three highly renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux. Dedicated to addressing high unmet medical needs associated with infections in acute hospital settings, amidst the growing antimicrobial resistance (AMR) epidemic, AUROBAC is advancing a robust pipeline. This includes ATX101, a potential first-in-class therapeutic targeting the loss of vascular integrity in septic shock, developed in collaboration with Boehringer Ingelheim, and ATX401, an engineered lysin with potent activity against multiple clinically relevant Gram-negative bacteria. Additionally, the company’s unique drug discovery engine aims to identify new precision antimicrobials, as showcased through a collaboration with GENERARE Bioscience. Contact: Julie Cervesi, Head of Business Development - Mail: contact@aurobac-tx.comWebsite: aurobac-tx.comLinkedin: https://linkedin.com/company/aurobac-tx/X: https://x.com/AurobacTX

Amarna Therapeutics announces formation of Scientific Advisory Board to support advancement of groundbreaking Nimvec™ AM510 gene therapy against Type 1 Diabetes Members: Prof. Dr. Colin Dayan, Prof. Dr. Desmond Schatz, Prof. Dr. Didac Mauricio, Dr. Luiza Caramori, Dr. Kei Kishimoto, Prof. Dr. Roberto Mallone, Dr. Sylvaine You. Leiden, The Netherlands, 17 June 2024 – Amarna Therapeutics, (“Amarna” or “the Company”) a privately-held biotechnology company focused on developing transformative gene therapies for a range of rare and prevalent genetic diseases, including Type 1 Diabetes Mellitus (T1DM), is pleased to announce the formation of its new Scientific Advisory Board (SAB).The newly established SAB consists of seven distinguished international scientific opinion leaders. These experts bring extensive experience and knowledge in the fields of pre-clinical and clinical development, gene therapy, immunology, endocrinology, and regulatory affairs. The SAB will leverage its extensive expertise to ensure that Amarna’s groundbreaking Nimvec™ AM510 program meets the highest scientific and regulatory standards. This initiative underscores the company's commitment to pioneering treatments for T1DM and enhancing patient outcomes. The SAB's insights will be pivotal in navigating the complex landscape of clinical trials and regulatory approvals, ultimately accelerating the path to market for this groundbreaking therapy. “The formation of this Scientific Advisory Board marks a major development step for Amarna as we continue our evolution in becoming a clinical stage gene therapy development company,” said Henk Streefkerk, CEO of Amarna. “We are proud and excited to bring together leading clinicians and scientists from across the world who are dedicated to, and have decades of experience in, the clinical development of novel therapeutics for genetic diseases. We believe their collective expertise will be instrumental in guiding Amarna advancing its lead drug candidate, Nimvec™ AM510, as we work to optimize its potential to transform the treatment of Type 1 Diabetes Mellitus and a range of other prevalent debilitating genetic disorders.” The members of the Scientific Advisory Board (SAB) are as follows: Colin Dayan, MA MBBS, FRCP, PhD, is Professor of Clinical Diabetes and Metabolism at Cardiff University School of Medicine, in Cardiff (UK), Senior Clinical Researcher at the University of Oxford and Director at the Cardiff Joint Research Office. His focus lies mainly on translational research in immunopathology of Type 1 Diabetes Mellitus, clinical trials on peptide immunotherapy and nanoparticles in T1DM. Desmond Schatz, MD, PhD, is Professor of Pediatrics, Medical Director of the Diabetes Institute, and Medical Director of the Clinical Research Center, at the University of Florida, and served as President of Science and Medicine of the American Diabetes Association (2016). Dr. Schatz has been involved in Type 1 diabetes research since the mid 1980’s and has published over 400 manuscripts, the majority related to the prediction, natural history, genetics, immunopathogenesis and prevention of the disease, as well as the management of children and adolescents with Type 1 diabetes. Didac Mauricio, MD, PhD, is Director of the Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau in Barcelona, and Professor with the Faculty of Medicine, University of Vic & Central University of Catalonia (UVic/UCC). He is leading the Diabetes Research Group at his current institution and has recently been appointed Scientific Director of the CIBER of Diabetes and Associated Metabolic diseases (CIBERDEM), Instituto de Salud Carlos III (Ministry of Science and Innovation), in Spain. Luiza Caramori, MD, MSc, PhD, is a Staff Physician at the Institute of Endocrinology and Metabolism at Cleveland Clinic Foundation and at the Department of Cardiovascular and Metabolic Sciences, Lerner Research Institute, Cleveland, Ohio (USA) and an Adjunct Associate Professor at the University of Minnesota, Minneapolis, MN (USA). Dr. Caramori’s is a physician-scientist with 25+ years research experience, whose main research interests include studies on the relationships between kidney structure and function in type 1 diabetes, early molecular and structural predictors of diabetic kidney disease (DKD) in patients with type 1 diabetes, and clinical trials studying repurposed and new drugs for the prevention and treatment of DKD both in patients with type 1 and type 2 diabetes. Kei Kishimoto, PhD, is a highly accomplished immunologist and drug developer with over 30 years of experience in biopharma. He was most recently Chief Scientific Officer of Selecta Biosciences, where he led development of an immune tolerance technology that was successfully validated in Phase 3 clinical trials. Prior to joining Selecta, he was Vice President of Research at Momenta Pharmaceuticals and Senior Director Inflammation at Millennium Pharmaceuticals. His expertise is focused on immunology, immune tolerance, autoimmune diseases, vaccines, immunogenicity and gene therapy. Kei Roberto Mallone, MD, PhD, is Professor and Hospital Physician in Clinical Immunology and Diabetology at Paris Cité University - Cochin Hospital and Research Director at INSERM U1016 Cochin Institute in Paris, France and at the Indiana Biosciences Research Institute (IBRI) in Indianapolis (USA). His research spans from preclinical studies with human samples and mouse models to clinical trials. It focuses on autoimmune T cells and beta-cell vulnerability and the understanding of type 1 diabetes mechanisms to develop T-cell-based biomarkers and therapeutics aimed at blunting T-cell aggressiveness and enhancing beta-cell resilience. Sylvaine You, MD, PhD, is a distinguished researcher specializing in the immune mechanisms driving type 1 diabetes (T1DM) and the development of therapeutic strategies. She is Research Director at Cochin Institute (INSERM) in Paris, France, focuses on T-cell Tolerance, Biomarkers and Therapies in type 1 Diabetes. Additionally, she co-leads a research team at the Indiana Biosciences Research Institute (IBRI), exploring the mechanisms that fail to keep autoreactive T lymphocytes inoffensive and make the beta cells more visible and vulnerable to an autoimmune attack. === E N D S === About Type 1 Diabetes MellitusType 1 Diabetes is a debilitating disease occurring in millions of patients globally, with rising incidences each year, where despite advancements in therapy the life expectancy remains lower than the general population. Diabetes is an autoimmune disease where self-reactive T lymphocytes selectively attack and destroy insulin-producing β cells lodged within the pancreas, leaving the patient unable to maintain glucose homeostasis. Proinsulin (PI) is the primary self-antigen involved in the autoimmune β cell destruction. To date, Type 1 Diabetes cannot be cured, and the glucose homeostasis can be more or less maintained in patients by daily insulin injections. Although Diabetes is seen as a manageable disease nowadays, secondary complications of the current therapy are considerable and lead to significant morbidity and mortality. Using Nimvec™ AM510 we intend to restore the immune tolerance to proinsulin and potentially cure the patients. About Nimvec™ AM510The development of AM510 is based on our proprietary NimvecTM platform, which has demonstrated exceptional promise in preclinical studies. Unlike other gene therapies that induce a strong immune response, limiting the possibility for repeat dosing and efficacy, NimvecTM does not trigger such responses. Instead, it moderates the immune system to induce tolerance, making it an ideal vehicle for our therapeutic approach. Our preclinical data with Nimvec™ AM510 showcases its protective effects in delaying the onset of hyperglycemia and preventing the development of T1DM in relevant animal models. About AmarnaAmarna Therapeutics has developed a groundbreaking non-immunogenic viral platform NimvecTM to deliver any transgene of choice into humans. This platform shows exceptional promise in preclinical studies for delivering treatments, potential cures, and disease prevention globally. Amarna is advancing a pipeline of transformative gene therapies for a range of rare and prevalent diseases, including monogenetic indications, autoimmune diseases and chronic inflammation. The lead program Nimvec™ AM510 is being developed for the treatment of patients with Type 1 Diabetes Mellitus. Follow up programs include Multiple Sclerosis, Age-related Macular Degeneration, and Hemophilia. More information on www.amarnatherapeutics.com Follow us on LinkedIn https://www.linkedin.com/company/amarna-therapeutics-b.v. For further inquiries please contact: Amarna TherapeuticsHenk Streefkerk, CEOE-mail: info@amarnatherapeutics.com LifeSpring Life Sciences Communication, AmsterdamLéon MelensTel: +31 6 538 16 427E-mail: lmelens@lifespring.nl