Lupus Vasculitis, Central Nervous System

World-renowned researchers with extensive experience in immunology and autoimmune diseases join AltruBio to support scientific advancements and pipeline developmentSAN FRANCISCO, Dec. 03, 2024 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company developing novel immune checkpoint enhancers to address the unmet need in immunological and inflammatory diseases, with a lead candidate in ulcerative colitis (UC), today announced the formation of its scientific advisory board (SAB), comprising esteemed researchers Vijay Kuchroo, DVM, Ph.D., Bernard Malissen, Ph.D., and Arlene Sharpe, M.D., Ph.D. The SAB will collaborate closely with AltruBio’s leadership team to support the company’s research and development (R&D) initiatives, including advancing its novel immune checkpoint enhancer (ICE) PSGL-1 agonist antibody, ALTB-268, which is currently in Phase 2a trials for ulcerative colitis (UC). The SAB will also offer scientific guidance to shape long-term R&D strategies as AltruBio explores other potential indications where ALTB-268 could benefit patients and expands its pipeline. “We are honored to welcome Dr. Kuchroo, Dr. Malissen, and Dr. Sharpe to our Scientific Advisory Board,” said Dr. Judy Chou, President and Chief Executive Officer of AltruBio. “Their extensive research in Immunology has been instrumental in advancing immunotherapies and deepening the understanding of autoimmune diseases. Having such distinguished scientists on our SAB not only adds significant credibility to AltruBio’s unique scientific mechanism but also validates our approach in developing novel therapies. We look forward to collaborating to further advance our science and pipeline.” Vijay K Kuchroo, DVM, Ph.D., Chair of the Board, added,” AltruBio’s science and approach is highly differentiated, targeting PSGL-1 to downregulate chronically activated late-stage effector T cells. I look forward to contributing my expertise and working with AltruBio to help advance potential groundbreaking therapies forward for the many patients with immunological and inflammatory diseases in need of more effective and safe therapeutics.” AltruBio’s SAB is comprised of the following members: Vijay K Kuchroo, DVM, Ph.D., Chair of the BoardDr. Kuchroo is the Samuel L. Wasserstrom Professor of Neurology at Harvard Medical School and a Senior Scientist at Brigham and Women’s Hospital. He is also the founding Director of The Gene Lay Institute, a Member of the Broad Institute of Harvard and MIT, and an investigator in the Klarman Cell Observatory. His research focuses on autoimmunity, particularly co-stimulation, the genetic basis of experimental autoimmune encephalomyelitis, and multiple sclerosis (MS). His lab was the first to describe the TIM family of genes, identifying TIM3 as an inhibitory receptor on T cells, now targeted in cancer immunotherapy. Dr. Kuchroo’s research has contributed significantly to understanding the immune mechanisms driving MS. His efforts continue to pave the way for improved treatments and potential cures for autoimmune diseases. Dr. Kuchroo has published over 400 research articles, and he has received several prestigious awards, including the National Institutes of Health Javits Investigator Award, the Dr. William E. Paul Distinguished Innovator Award from the Lupus Research Alliance, and the Dystel Prize for MS Research from the National Multiple Sclerosis Society. In 2021, he was named a Distinguished Fellow by the American Association of Immunologists, recognizing his pioneering work in T cell biology and CNS autoimmunity. Dr. Kuchroo earned his Ph.D. from the University of Queensland, Australia. Bernard Malissen, Ph.D.Dr. Malissen, founder and director of the Centre for Immunophenomics (CIPHE, INSERM-CNRS) and ex- Director of the Center for Immunology at Marseille-Luminy (CIML), is a pioneering immunologist renowned for his groundbreaking work in T cell receptor (TCR) biology and immune system signaling. He was the first to use gene transfer approaches to dissect the function of major histocompatibility complex (MHC) molecules and successfully reconstructed the TCR complex, providing key insights into its evolution and signalling mechanisms. Dr. Malissen also made significant contributions to understanding transplant rejection by elucidating the atomic structure of an alloreactive TCR complexed with its peptide-MHC ligand. Recently, he has applied "omic" approaches to map TCR signaling networks and better understand the fine-tuning of immune responses. With over 400 publications, Dr. Malissen is one of the most highly cited researchers in immunology. He has been awarded the INSERM Grand Prize and the Behring-Metchnikoff Immunology Prize, among other honors, and is a member of the French Academy of Sciences. Dr. Malissen holds a Doctor of Science degree from the University of Aix-Marseille. Arlene Sharpe, M.D., Ph.D.Dr. Arlene Sharpe is the Kolokotrones University Professor at Harvard University, Chair of the Department of Immunology at Harvard Medical School, and Vice Director of the Gene Lay Institute. She is a leader in cancer immunology, and an authority on T cell co-stimulation. Her groundbreaking research helped uncover the functions of key immunoinhibitory pathways, including PD-1 and CTLA-4, laying the foundation for immune checkpoint blockade therapies. Her discoveries enabled the development of therapies like pembrolizumab and nivolumab. In addition to her role at Harvard, Dr. Sharpe serves as a Member of the Department of Pathology at Brigham and Women’s Hospital and the Broad Institute of MIT and Harvard, as well as the Leader of the Cancer Immunology Program at Dana-Farber/Harvard Cancer Center. She has published over 400 papers and is consistently ranked among the one of the most highly cited researchers in immunology. Her numerous awards include the William B. Coley Award, Warren Alpert Foundation Prize, FASEB Excellence in Science Lifetime Achievement Award, AAI Lifetime Achievement Award the Harrington Prize for Innovation in Medicine, and the David and Beatrix Hamburg Award for Advances in Biomedical Research and Clinical Medicine from the National Academy of Medicine. Dr. Sharpe is an elected member of the National Academy of Sciences, National Academy of Medicine, and American Academy of Arts and Sciences. She earned her M.D. and Ph.D. from Harvard Medical School and completed her residency in Pathology at Brigham and Women’s Hospital. About AltruBio Inc.AltruBio is a clinical-stage biotechnology company developing novel therapies leveraging immune checkpoint agonism to address unmet medical needs in immunological and inflammatory diseases. The Company’s lead candidate, ALTB-268, acts as an immune checkpoint enhancer (ICE), designed to activate natural pathways that downregulate a chronically overactivated immune system to restore balance. ALTB-268 operates through a unique mechanism of action, targeting PSGL-1, a key immune checkpoint regulator. It preferentially targets and downregulates chronically activated late-stage effector T cells, leading to their exhaustion and apoptosis. Currently being evaluated in a Phase 2 trial in ulcerative colitis, ALTB-268 holds the potential to be a pipeline in a product to address a range of inflammatory diseases, which AltruBio plans to explore in upcoming Phase 2 trials. Led by an expert team with successful track records in drug development and commercialization in immunology, AltruBio is dedicated to delivering safer, more effective, and durable biologic treatments to improve the lives of patients. Contacts AltruBio Inc: +1-415-655-6603 info@altrubio.com Media Contact:LifeSci CommunicationsLuke Shiplolshiplo@lifescicomms.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5c68c17e-64d1-49ab-880e-105258e40558

Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1 More than 80% of patients receiving first-line Kesimpta were progression-free for up to six years, reinforcing the value of introducing Kesimpta early1 Patients switching to Kesimpta from IV anti-CD20 therapy showed no new active lesions (Gd+ T1) 12 months after switch in separate US single-arm, open-label, Phase IIIb OLIKOS study2 Basel, September 18, 2024 – Novartis today announced new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta® (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide1. A separate US-based single-arm OLIKOS Phase IIIb study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline2. These data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting in Copenhagen, Denmark on September 18-20. “We continue to study the efficacy and safety of Kesimpta in different populations of people living with relapsing multiple sclerosis as part of our mission to advance care,” said Norman Putzki, M.D., Ph.D., Global Development Unit Head, Neuroscience & Gene Therapy, Novartis International AG. “Novartis is committed to understanding and solving some of the most burdensome neurological conditions to improve the quality of life for patients and their caregivers, and to make a positive impact on society.” Kesimpta benefits in first-line patients Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer 6-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide1. These benefits appeared more pronounced in the RDTN subgroup, defined as starting treatment within three years of diagnosis1. RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW compared to those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%)1. RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%)1. “These data showed that people recently diagnosed with relapsing multiple sclerosis who received first-line Kesimpta had fewer disability worsening events and greater likelihood of being progression-free,” said lead investigator Amit Bar-Or, M.D., Director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania. “The reduction of disability accumulation observed early in the disease course supports earlier adoption of Kesimpta.” Limitations of the results include a potential for attrition bias and the open-label nature of the extension study1. No new T1 lesions in patients who switched from IV therapy to KesimptaThe US-based OLIKOS study analyzed 102 clinically stable RMS patients who switched from previous IV anti-CD20 therapy (99% from ocrelizumab) to Kesimpta2. For 84 patients with MRI results, no new Gd+ T1 lesions were observed at 12 months, the study’s primary endpoint. Additionally, 98% of patients did not develop new/enlarging T2 (NeT2) lesions at 12 months, an exploratory endpoint in the study2. Treatment-emergent adverse events (TEAEs) occurred at a similar frequency as in the core Phase III ASCLEPIOS clinical trials, with no new safety signals identified2. The most commonly reported (≥10%) TEAEs were COVID-19, headache, fatigue, and urinary tract infection. Mean serum immunoglobulin G (IgG) and IgM levels remained stable up to 12 months2. About Multiple SclerosisMultiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord3. MS, which affects nearly 3 million people worldwide4, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)5. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease3. About Kesimpta® (ofatumumab)Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously6-9. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional6,7. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen10. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 201511. Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 90 countries worldwide with more than 100,000 patients treated as of August 20246,7,12. Novartis in NeuroscienceAt Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, pediatric neurology, neurodegeneration and neuroinflammation and psychiatry. DisclaimerThis media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise. About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Bar-Or A, Hauser SL, Cohen JA, et al. Early Initiation of Ofatumumab Delays Disability Progression in People With Relapsing Multiple Sclerosis: 6-Year Results From ALITHIOS Open-Label Extension Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Hua LH, Brown B, Camacho E, et al. Efficacy and Safety in Patients With Relapsing Multiple Sclerosis Who Switched to Subcutaneous Ofatumumab From Intravenous Anti-CD20 Therapies: Results From the OLIKOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS Accessed September 10, 2024 Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl… Accessed September 11, 2024. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. 2023. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf Accessed June 23, 2024. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27–29, 2020; West Palm Beach, FL, US. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14–17, 2016; London, UK. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d Accessed September 10, 2024. Novartis. Data on file. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Switzerland Satoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck +41 61 324 7188 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 8269 Parag Mahanti +1 973 876 4912

SHANGHAI, NANJING, CHINA, and SAN JOSE, Calif., July 1, 2024 /PRNewswire/ -- IASO biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, presented the clinical data and single-cell analysis of the fully human anti-BCMA CAR T cell therapy (Equecabtagene Autoleucel, Eque-cel) for the treatment of central nervous system autoimmunity in an oral presentation at the 2024 European Academy of Neurology (EAN) Annual Meeting. Presentation Title: Single-cell analysis of anti-BCMA CAR T cell therapy in patients with central nervous system autoimmunity Presentation Type: Oral report Session Date and Time: 1 July 2024, 8:30 - 9:45 (EEST) Location: Helsinki, Finland Publication Number: A-24-12777 Presenter: Professor Chuan Qin, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology This report is based on an investigator-initiated study to evaluate the safety and efficacy of Eque-cel for the treatment of relapsed/refractory antibody-mediated idiopathic inflammatory disorders of the nervous system (NCT04561557). It was conducted by Professor Wei Wang's team at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. The study enrolled 12 subjects with aquaporin-4 (AQP4) antibody-positive relapsed/refractory neuromyelitis optica spectrum disorder (NMOSD), all of whom had been treated with at least one immunosuppressant for over a year but had poor symptom control. The study results preliminarily demonstrated the good tolerability and safety, durable pathogenic antibody clearance, and potential clinical efficacy of Eque-cel in NMOSD. And CAR-T cells with chemotactic properties can cross the blood-brain barrier and enter the central nervous system to directly kill abnormal plasma cells in the central nervous system. The action facilitates the restoration of central immunity as it reduces the secretion of autoantibodies within sheaths and the abnormal activation of immune cells. As a result, the immune disorder in the central nervous system of the NMOSD patients can be rectified and its immune system can be reset. As one of the pioneering research teams that first use BCMA CAR-T therapy for the treatment of immune diseases in the world, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology and IASO Bio have achieved breakthrough research results that validate the clinical value of innovative cell therapy for relapsed and refractory immune diseases, making its application prospects increasingly recognized and valued internationally. Currently, BCMA CAR-T therapy has been rated as one of the most promising treatment strategies by the International Neuromyelitis Optica Study Group (NEMOS) and incorporated into the latest revised treatment recommendations (J Neurol 2024). In addition, Professor Maximilian F. Konig from department of immunology, Johns Hopkins University, stated in Year in review, Immunotherapies in 2023: The rise of precision cellular therapies, published in Nat Rev Rheumatol, that the application of CAR-T therapy has brought groundbreaking advancements in innovative cellular therapies for immune diseases. Professor Wei Wang from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, the principal investigator of this study, stated: "This study was the world's first clinical trial of CAR-T therapy in the field of AQP4-mediated relapsed/refractory NMOSD. It not only demonstrated the encouraging efficacy and controllable safety of Eque-cel in NMOSD but also elucidated the cellular dynamics and immunological characteristics of CAR-T therapy for central nervous system autoimmune diseases. This provides a new therapeutic approach for antibody-mediated autoimmune diseases and also provides scientific insights into refining CAR-T cell therapies for autoimmune diseases. In addition to NMOSD, Eque-cel has shown an excellent clinical efficacy in the treatment of other antibody-mediated autoimmune diseases, including myasthenia gravis and immune-mediated necrotizing myopathy, even with early signs of reversing the disease. We have published several related research papers in leading international academic journals. There is a large patient population with autoimmune diseases, which are prone to relapses, difficult to cure, and require long-term or even lifelong medication, with a huge unmet clinical demand. We will continue to explore the application of Eque-cel in more refractory autoimmune diseases with IASO Bio team, aiming to transform the treatment landscape of autoimmune diseases." About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RRMM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . SOURCE IASO Bio