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KNOXVILLE, Tenn.--( BUSINESS WIRE )--Enigma Biomedical USA ( EB USA ) today announced formation of its Scientific Advisory Board ( SAB ), comprised of top tier physicians and scientists from around the globe, spanning areas of expertise from chemistry, biology to medicine associated with the assessment and ultimate treatment of neurodegenerative diseases, such as Alzheimer’s Disease. Professor Serge Gauthier of McGill University, Montreal, Quebec, Canada will serve as Chairperson of the EB USA SAB, and will be joined by: Richard Hargreaves Ph.D., Senior Vice President Head of Neuroscience TRC, Bristol Myers Squibb, NJ, Kenji Ishii M.D. , Leader, Team for Neuroimaging Research Tokyo Metropolitan Institute of Gerontology, Japan, Keith Johnson M.D., Ph.D., Director, Molecular Neuroimaging, Department of Radiology Massachusetts General Hospital; Neurologist, Memory Disorders Unit, Department of Neurology, Brigham and Women's Hospital; and Professor of Radiology and Neurology, Harvard Medical School, MA, Sterling Johnson Ph.D., Jean R. Finley Professor of Geriatrics and Dementia, Department of Medicine Division of Geriatrics and Gerontology and Principal Investigator, Wisconsin Registry for Alzheimer’s Prevention (WRAP), The University of Wisconsin, WI, Eric M Reiman MD , Executive Director, Banner Alzheimer’s Institute and Chief Executive Officer, Banner Research; Professor of Psychiatry, University of Arizona; University Professor of Neuroscience, Arizona State University; Senior Scientist, Translational Genomics Research Institute; and Director, Arizona Alzheimer’s Consortium, Christopher Rowe FRACP M.D., Director of Molecular Imaging Research and a consultant neurologist to the Memory Disorders Clinic at the Austin Hospital, Australia, Koen Van Laere M.D., Ph.D., D.Sc., Head, Nuclear Medicine and Molecular Imaging, PET-MR Unit, Full Professor, Department of Imaging and Pathology, University Hospital Leuven-KU Leuven, Belgium, and Henrik Zetterberg M.D., Ph.D., Professor/ Chief Physician, Institute for neuroscience and Physiology, University of Gothenburg, Sweden; Group Leader, UK Dementia research Institute, University College London, UK; and Visiting Professor, The University of Wisconsin, WI “We are thrilled to assemble such a remarkably accomplished advisory board, and I am honored to serve as its chairperson. We have a unique mix of complementary expertise from basic sciences to clinical practice that will accelerate knowledge transfer and help persons living with neurodegenerative conditions and their care partners,” said Serge Gauthier, CM, C.Q., M.D., FRCPC, past Director of the McGill University Research Center for Studies in Aging and currently Professor Emeritus in Neurology and Psychiatry and co-lead of the Dementia Education Program at McGill University. “EBG USA greatly appreciates the commitment of these world-class researchers to work with us to advance our mission. We expect this collaboration to yield major strides toward addressing the unmet needs in neurodegenerative disease as well as providing future tools and technologies to support the development of disease modifying therapies,” said Rick Hiatt, President and CEO of EB USA. About Enigma Biomedical – USA Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB’s neuroimaging biomarkers provide Pharma and Academic researchers with state-of-the-art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In pursuit of this vision, subsidiaries of EB have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. Both tracers have recently been acquired by a third party for further development. EB also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers.

AUSTIN, Texas--( BUSINESS WIRE )--Veravas, a leading innovator in clinical diagnostics, today announced the results of an analytical verification study of its VeraBIND™ Tau assay, a next-generation test being co-developed with Phanes Biotech, an early-stage biotech company focused on treatments for neurodegenerative diseases, for the detection of Alzheimer’s disease (AD). The test is designed to detect and measure disease pathology to enable the diagnosis of AD at its earliest, most treatable stages. Unlike first-generation tests that measure biomarkers indicative of potential disease, VeraBIND Tau is designed to detect active disease by studying measurable binding activity occurring in the brain between hyperphosphorylated tau (HPT) and normal tau (nTau), which is a hallmark of AD. 1 The test can also aid in the diagnosis of AD, giving clinicians an accessible, accurate, and affordable alternative to tau PET imaging. AD is the sixth leading cause of death in the United States, afflicting an estimated 6.9 million Americans aged 65 or older. 2,3 It’s critical that clinicians have accessible tools to quickly and accurately diagnose and distinguish AD from other dementias causing cognitive impairment to enable targeted treatment. In AD, lifestyle modifications and emerging tau-directed therapies have shown promise in slowing or delaying cognitive decline. Veravas demonstrated VeraBIND Tau’s ability to accurately measure the pathological activity of hyperphosphorylated tau. In this analytical verification study, the test protocol was performed on 100 retrospectively collected patient samples, including 52 confirmed positive for AD tau pathology via F18 MK6240 tau PET imaging (of which, 19 had normal cognitive function, 21 had mild cognitive impairment, and 12 had dementia), 38 healthy controls, and 10 patients positive for beta amyloid plaques but negative by tau PET. 4 The data showed 94.2% sensitivity and 89.6% specificity resulting in an overall VeraBIND Tau assay agreement of 92.0% against tau PET imaging. “These analytical data show that VeraBIND Tau can measure active tau pathology of AD both among individuals with and without cognitive impairment,” said Bernard Hanseeuw, M.D., Ph.D., Associate Head of the Memory Clinic, Neurology Department, Saint Luc University Hospital in Belgium and Instructor at Mass General Hospital, Boston, MA. “The implementation of such a test could not only one day speed the diagnosis of AD, it could also be used to inform the development and testing of tau-directed therapeutics. It also holds great promise for non-AD tauopathies, as the assay proved positive in 7 out of 8 cases tested with low-amyloid, and positive tau-PET data”. To co-develop the VeraBIND Tau assay, the companies used Veravas’s proprietary VeraBIND technology, a platform that is designed to capture and purify key proteins in blood to enable highly accurate protein detection and characterization. When combined with antibodies, VeraBIND magnetic nanobeads act as a filter for multiple sample types, enabling the removal of interfering substances that can obscure the biomarker of interest and potentially produce false results. This patented technology makes it possible to study low-abundance disease-causing proteins that may otherwise be undetectable by enriching samples pre-analytically to improve the detectability of the analyte. “These results demonstrate the transformative potential of VeraBIND Tau to upend the standard of care for management of patients suspected of potentially having Alzheimer’s disease,” said Josh Soldo, Chief Scientific Officer at Veravas. "Our highly accurate analytical test protocol can be performed quickly and cost-effectively and could potentially eliminate both the uncertainties associated with biomarker detection tests and the high costs and wait times associated with tau PET imaging, thereby helping clinicians get answers to their patients much more rapidly.” “The VeraBIND Tau assay will enable Alzheimer’s disease diagnosis for the first time in geographies where tau PET imaging is not available” said Khalid Iqbal, Chief Scientific Officer of Phanes Biotech. For more information about the VeraBIND Tau assay and other VeraBIND products, visit www.veravas.com . About Veravas Veravas is a leading innovator in clinical diagnostics focused on early-stage detection and prognostic screening for Alzheimer’s disease and other neurological conditions. The company’s proprietary VeraBIND™ technology transforms challenging sample types into measurable biomarkers, enabling earlier disease detection and the development of novel diagnostic tests. Its VeraBIND Tau assay is a first-in-class blood-based test that measures the pathological activity of hyperphosphorylated tau in blood samples of cognitively normal individuals or individuals experiencing cognitive impairment which may be used to aid in the diagnosis of Alzheimer's disease. Learn more at Veravas.com or follow us on LinkedIn . About Phanes Biotech Phanes Biotech is an early-stage biotech company focused on developing breakthrough treatments for neurodegenerative diseases, including Alzheimer’s, macular degeneration, traumatic brain injury, stroke, Down syndrome-associated Alzheimer’s, and cognitive aging. Phanes takes a unique and differentiated approach to Alzheimer’s and other neurodegenerative diseases, setting it apart from existing therapies and drugs currently in development. The company’s pipeline includes innovative drugs: (1) Neuroregenerative small molecule P021 – This promising therapeutic aims to address Alzheimer’s disease by shifting the balance from neurodegeneration toward neural regeneration. (2) Immunotherapy PB43D – A potent, high-affinity antibody designed to target and bind to tau. It is the only antibody shown to reduce both tau and Aβ pathologies. Through a strategic partnership, Phanes leverages its portfolio of tau-targeting antibodies to develop a groundbreaking, first-in-class blood-based assay. This innovative diagnostic tool aims to detect and measure tau pathology activity in the brain, setting a new standard for diagnosing and tracking the progression of Alzheimer’s disease. Learn more at Phanesbiotech.com or follow us on LinkedIn . Thal DR, Tomé SO. The central role of tau in Alzheimer's disease: From neurofibrillary tangle maturation to the induction of cell death. Brain Res Bull. 2022;190:204-217. doi:10.1016/j.brainresbull.2022.10.006 Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5)." Ahmad FB, Cisewski JA, Anderson RN. Mortality in the United States — Provisional Data, 2023. MMWR Morb Mortal Wkly Rep 2024;73:677–681. DOI: http://dx.doi.org/10.15585/mmwr.mm7331a1 . Gérard T, et al. The spatial extent of tauopathy on [18F]MK-6240 tau PET shows stronger association with cognitive performances than the standard uptake value ratio in Alzheimer's disease. Eur J Nucl Med Mol Imaging. 2024 May;51(6):1662-1674.