EBV viremia

WORLD LEADERS IN SCIENCE, HEALTHCARE, ACADEMIA, BUSINESS AND GOVERNMENT DISCUSS ISSUES AND RAMIFICATIONS OF LONG COVID BALTIMORE, July 22, 2022 /PRNewswire/ -- The Global Virus Network (GVN), a coalition of world leading medical virology research centers, yesterday concluded a two-day gathering on the 'Science of Long COVID.' The first-of-its-kind conference reviewed the wealth of cohort data on long COVID, constructed a framework to characterize and define the conditions, and identified the most critical and urgent areas of research needed to better understand, diagnose, and treat this developing public health crisis. "There is no doubt that long COVID has proven to be as nightmarish as we feared, but what we heard over the past two days reassured us that our colleagues from the global scientific community are ready to come together to rise to the challenge. To do that effectively, the scientists of the GVN and those who participated in the conference call upon governments, foundations, and other institutions worldwide to commit the billions of research dollars required to address the catastrophe of long COVID," said Prof. Christian Bréchot, M.D., Ph.D., GVN President and Associate Vice President for International Partnerships and Innovation at the University of South Florida. Across the globe, nearly half of COVID-19 survivors struggle with persistent symptoms four months or more after diagnosis and are colloquially referred to as long COVID or long haulers. Conference speakers from around the world focused on the vast public health implications of this highly prevalent condition. During the proceedings, they outlined approaches to and research of this complex phenomenon that has already cost Americans alone an estimated $50 billion annually in lost income, a data point that could translate to $200 billion or more of lost income around the globe. "The prevalence of long COVID is staggering," said Robert Gallo, M.D., Co-founder and Scientific Chair of the GVN and Director of the Institute of Human Virology at the University of Maryland School of Medicine. "Two years into the pandemic, we have concrete and irrefutable proof from cohort studies following individuals as they experience a litany of symptoms—memory problems, relentless fatigue, difficulty breathing, cardiac concerns, insomnia and more. What we lacked, and what this conference achieved, is a data-driven and scientific baseline that helps scientific, policymaking and healthcare stakeholders to understand and approach the underlying aspects of long COVID and consequently arrive at a global research framework." As part of the process to establish a global research framework, the conference presented key scientific and clinical evidence on long COVID's far-ranging global impact: 243 million long COVID cases worldwide with a disproportionate burden affecting females (49% versus 37% for men); continental differences (Asia 51% of COVID cases becoming long COVID, Europe 44%, U.S. 31%); and lasting elevated risk levels among long COVID survivors for cardiovascular disease and diabetes. Striking clinical parallels exist between "COVID-fog" and "chemo-fog," with the whole-body inflammation in both causing changes to brain circuitry and cognitive impairment. Different cytokines—immune hormones that affect immune and other cells—may be promising biomarkers, and even therapeutic targets, to measure long COVID's effects in the body and ameliorate long COVID disease. 30-50% of long haulers report breathlessness and 10-20% report cough. More severe lingering effects of long COVID on the respiratory system include damage and scarring of lung tissue. These changes are not necessarily predicted by the severity of the disease or whether a patient was hospitalized. Vaccination has reduced the numbers of individuals with long COVID respiratory disease, while new COVID variants show milder effects. Risk factors for long COVID include Type 2 Diabetes, SARS-CoV-2 RNAemia, Epstein-Barr virus viremia, microclots, protein misfolding, and both pre-existing and disease-specific autoimmunity. These associations are most detectable at the time of diagnosis, emphasizing the need for early disease measurements to advance understanding. "Despite the fact that enormous numbers of people are suffering from persistent symptoms after recovering from Covid, it's been very difficult to define a syndrome to even start to consider how to make a difference. The conference was a great chance to bring together scientists and clinicians to brainstorm about the best future approaches, "said Eric Rubin, M.D., Ph.D., Editor in Chief, New England Journal of Medicine and Adjunct Professor of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health. The GVN is committed to fostering true collaboration among virologists, medical specialists, governments, and non-governmental organizations alike to combat long COVID's critical threat to international health. The conference wrapped up with a call to action for governments and funding agencies to allocate resources to strengthen scientific training and response mechanisms across these priority focus areas: Conduct large scale data analysis on existing cohort studies. Bring the scientific community together to share insights and use artificial intelligence to advance understanding. Acknowledge the effect of time. Research cannot be relegated to studying the effects of ancestral strains of the virus prior to the availability of vaccines. We need diverse samples from patients infected by all subvariants, segmented by whether or not they were vaccinated and whether or not they had prior infection. Transition to interventional clinical trials. A substantial amount of observational data exists on long COVID, documenting an effect on different organ systems in varying degrees of severity for a range of times. We now must move to understand the risks and benefits of treatment within those ranges of time and the best biomarkers to track them. We will need innovative trial designs to move swiftly from early phase studies to large scale clinical trials. Linkage of people living with Long COVID to research activities. We recognize the desperation and frustration of people living with Long COVID and echo their calls for urgent investment in scientific and clinical research so that we can inform the design of much-needed clinical services, identify better diagnostic tests as well as optimal models of care, and discover treatment options for Long COVID. The GVN and the leads of its long COVID Task Force agree that long COVID is an opportunity to create a cohesive, global public health response unlike any other historical effort. To better arm policymakers and decision-makers in prioritizing funding for research and interventions, we've mapped out in a clinical framework assessing how the virus preys on pre-existing conditions and interacts with our biological mechanisms, resulting in clinical manifestations. More than 243 million people worldwide have or had long COVID. The scientific pursuit of solutions will require adequate funding and a continued commitment to information sharing, which is why the GVN commits to convening regular global conferences to continue this urgent discussion. About the Global Virus Network (GVN) The Global Virus Network (GVN) is essential and critical in the preparedness, defense and first research response to emerging, existing and unidentified viruses that pose a clear and present threat to public health, working in close coordination with established national and international institutions. It is a coalition comprised of eminent human and animal virologists from 69 Centers of Excellence and 11 Affiliates in 37 countries worldwide, working collaboratively to train the next generation, advance knowledge about how to identify and diagnose pandemic viruses, mitigate and control how such viruses spread and make us sick, as well as develop drugs, vaccines, and treatments to combat them. No single institution in the world has expertise in all viral areas other than the GVN, which brings together the finest medical virologists to leverage their individual expertise and coalesce global teams of specialists on the scientific challenges, issues and problems posed by pandemic viruses. The GVN is a non-profit 501(c)(3) organization. For more information, please visit . Follow us on Twitter @GlobalVirusNews SOURCE Global Virus Network

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, today announced the presentation of data supporting the proposed mechanism of action of their lead product candidate, tabelecleucel (tab-cel®), and five additional poster presentations at the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), held virtually February 8-12, 2021. “We are pleased to present key translational data advancing the clinical development of ATA188 and tab-cel®, the most advanced allogeneic T-cell immunotherapy in development. Additional data being presented at TCT also support the further development of tab-cel® in EBV-driven diseases, such as EBV+ acquired and primary immunodeficiency lymphoproliferative diseases (AID-LPD and PID-LPD) for which we’re currently enrolling patients for a clinical study,” said Jakob Dupont, M.D., Head of Global Research & Development at Atara. “These are diseases with few treatment options and poor prognosis, and it is our goal to ultimately bring this potentially transformative therapy to patients in need. We look forward to advancing tab-cel®, remaining on track to complete the Biologics License Application in the third quarter of this year based on very encouraging clinical data from an interim analysis of our pivotal trial.” Results presented at TCT detail new findings from a comprehensive multiomic analysis of modes of activation for tab-cel®. Each component of the assessment contributes to building the overall understanding of therapeutic activity, mechanisms of action and extended characteristics. In this analysis, a subset of tab-cel® lots were used to confirm and establish the consistency of the product’s profile, regardless of donor. These results demonstrated, that upon stimulation, tab-cel® exhibits a consistent activation signature at the level of gene expression, T-cell receptor engagement (TCR), and secretion of factors associated with effective T cell responses. Results further illustrated that the tab-cel® manufacturing process results in complementary clonal expansion and consistent enrichment of TCRs associated with productive engagement of EBV-driven diseases. Atara will also report additional data sets related to tab-cel®, as well as preclinical findings demonstrating the potent anti-tumor activity of the Company’s next-generation CD19-based CAR T, ATA3219. Additionally, the Company is presenting data on an innovative testing solution to detect and quantify non-engineered allogeneic T-cell therapies such as ATA188. As demonstrated in partnership with CareDx, AlloCell is a precise and reproducible method that resolves the analytical barrier for non-engineered allogeneic cell therapies, which do not have transgenes available to support standard quantitative pharmacokinetic (PK) assay development. The novel testing solution offers potential applications in clinical development for determining PK profiles and correlating with response and other clinical endpoints, including the understanding of fundamental aspects of pharmacology such as presence and expansion in the patient’s body. “Together these analyses represent a leading edge for allogeneic cell therapy research, leveraging state-of-the-art profiling technologies and innovating new methodologies in collaboration with CareDx to support development of Atara’s programs,” said Blake Aftab, Head of Preclinical Science and Translational Medicine at Atara. “These methods not only support our novel allogeneic EBV T-cell development programs, but also have potential for wide-ranging applications for patients.” Atara Poster Presentations at TCT 2021: All posters will be available for viewing at the start of the meeting on Monday, February 8, 2021. Title: Comprehensive activation profiling of tabelecleucel, an off-the-shelf, allogeneic EBV-specific T cell therapy Poster #: 206 Title: A sensitive and precise universal surveillance solution for pharmacokinetic monitoring of off-the-shelf cell therapies (in collaboration with CareDx) Poster #: 204 Title: Clinical experience of tabelecleucel in patients with EBV+ primary (PID) or acquired immunodeficiency (AID) associated lymphoproliferative disease (encore from ASH 2020) Poster #: 219 Title: Clinical experience of tabelecleucel in patients with life-threatening complications of Epstein–Barr virus viremia (encore from ASH 2020) Poster #: 223 Title: A multicenter, multicohort, open-label, single arm per cohort, Phase II study to assess the efficacy and safety of tabelecleucel in patients with EBV-associated diseases using an adaptive two-stage study design (encore from ASH 2020) Poster #: 532 Title: ATA3219: A potent next-generation allogeneic off-the-shelf CD19 CAR-T therapy without the need for gene editing (encore from ASH 2020) Poster #: 203 About Atara Biotherapeutics, Inc. Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn. Forward-Looking Statements This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: preclinical results and data for ATA3219; the timing and progress of ATA3219, Atara’s ability to successfully advance the development of its CAR T programs, the potential benefits, safety and efficacy of tab-cel®; the timing and progress of clinical trials of tab-cel®, Atara’s ability to successfully advance the development of tab-cel®; data on an innovative testing solution, and Atara’s ability to advance development of its programs, including ATA188. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara’s cash resources and need for additional capital; and other risks and uncertainties affecting Atara’s and its development programs, including those discussed in Atara Biotherapeutics' filings with the Securities and Exchange Commission (SEC), including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara Biotherapeutics disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.