A Multicenter, Open-label, Single-arm, Multiple-dose Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Ianalumab in Chinese Adult Participants With Autoimmune Diseases

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

Start Date25 Nov 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

CTRI/2024/10/075411 / RecruitingPhase 2

A randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis - NIL

Start Date30 Oct 2024

Sponsor / Collaborator

Novartis Healthcare Pvt Ltd.

NCT06470048 / RecruitingPhase 2

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

Start Date09 Oct 2024

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Ianalumab

100 Translational Medicine associated with Ianalumab

100 Patents (Medical) associated with Ianalumab

Literatures (Medical) associated with Ianalumab

01 Sep 2024·Expert Review of Hematology

Novel treatments for immune thrombocytopenia: targeting platelet autoantibodies

Review

Author: Harnett, Brian ; Al-Samkari, Hanny ; Al‐Samkari, Hanny ; Dalmia, Shreyash ; Arnold, Donald ; Arnold, Donald M.

INTRODUCTIONImmune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelets and an increased risk of bleeding. Platelet autoantibodies target major platelet glycoproteins and cause Fc-mediated platelet destruction in the spleen and reticuloendothelial systems. As mechanisms of disease, platelet autoantibodies are important therapeutic targets. Neonatal Fc receptor (FcRn) antagonists are a new class of therapeutics that reduce the half-life of immunoglobulin G including pathogenic platelet autoantibodies. Spleen tyrosine kinase (Syk) inhibitors interfere with Fc-mediated platelet clearance. Bruton's tyrosine kinase (BTK) inhibitors and B-cell activating factor (BAFF) inhibitors reduce antibody production. The efficacy of these targeted therapies provides new support for the role of platelet autoantibodies in pathogenesis of ITP even these antibodies can be difficult to detect.AREAS COVEREDThis review includes an in-depth exploration of the pathophysiologic mechanisms of ITP, focusing on autoantibodies. Treatments outlined in this review include a) FcRn antagonists, b) complement inhibitors, c) B-cell directed therapies such as BTK inhibitors, and anti-BAFF agents, d) Syk inhibitors, e) plasma-cell directed therapies, and f) novel cellular therapeutic products.EXPERT OPINIONPlatelet autoantibodies are often elusive in ITP, yet novel treatments targeting this pathway reinforce their role in the pathogenesis of this autoimmune platelet disorder.

01 Jun 2024·DMW - Deutsche Medizinische Wochenschrift

Das Sjögren-Syndrom im Fokus

Review

Author: Zehrfeld, Nadine ; Witte, Torsten ; Ernst, Diana

01 Apr 2024·International Immunopharmacology

The role of BAFF and BAFF-R inhibitors in the treatment of immune thrombocytopenia; a focused review

Review

Author: Jaffary, Fariba ; Nilforoushzadeh, Mohammad Ali ; Heidari, Nazila ; Najar Nobari, Niloufar ; Lotfi, Zahra ; Ghane, Yekta ; Heidari, Amirhossein ; Najar Nobari, Minou

Immune thrombocytopenia (ITP) is an autoimmune-driven disease characterized by increased destruction and impaired platelet production resulting in an enhanced risk of bleeding. Immunosuppressant agents are the most common treatment strategies for ITP. Despite their efficacy, these medications often cause unpredictable side effects. Recent investigations revealed that patients with ITP exhibit elevated B-cell activating factor (BAFF) levels in both their spleens and serum. Belimumab, a BAFF inhibitor, illustrated a promising therapeutic avenue for managing ITP by interfering with BAFF activity and long-lived plasma cell production. Both clinical and experimental studies have yielded positive outcomes when combining rituximab with an anti-BAFF monoclonal antibody in treating ITP. In addition, ianalumab, a monoclonal antibody with a dual mechanism that targets BAFF-R and deletes peripheral BAFF-R⁺ B cells, is currently being used for ITP treatment [NCT05885555]. The upcoming results from novel BAFF inhibitors, such as ianalumab, could offer clinicians an additional therapeutic option for treating ITP.

News (Medical) associated with Ianalumab

04 Nov 2024

·www.prnewswire.com

Lupus Research Alliance Announces Lupus Research Highlights at ACR Convergence 2024

Sixteen presentations of preclinical studies funded by the Lupus Research Alliance (LRA) to advance understanding of lupus and potential treatment pathways, including four oral presentations Two reports by Lupus Therapeutics, the clinical affiliate of the LRA, and the Lupus Clinical Investigators Network (LuCIN) on promoting equity in lupus clinical trials, and identifying trial barriers and solutions Fifteen industry-sponsored clinical research studies supported by Lupus Therapeutics and LuCIN, including positive results from the late-breaking Phase 3 dapirolizumab pegol trial NEW YORK, Nov. 4, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA), the largest private funder of lupus research worldwide, today announced that a total of 33 studies, funded by the organization or supported by its clinical research affiliate Lupus Therapeutics, will be presented at ACR Convergence 2024. The annual meeting of the American College of Rheumatology takes place November 14-19, at the Walter E. Washington Convention Center in Washington, D.C. The LRA, which seeks to accelerate the discovery and development of patient-centered treatments and diagnostics, pursues strategies to spur advancements from "bench to bedside." LRA-supported studies presented at ACR Convergence 2024 represent the full continuum of lupus research, from foundational research exploring new avenues of knowledge, to clinical trials evaluating potential new treatments. "ACR Convergence 2024 is met with pride and excitement by the Lupus Research Alliance and Lupus Therapeutics – pride in seeing the fruits of our funding and other initiatives to accelerate drug discovery and development, and excitement as we stand on the precipice of some important advancements," said LRA President and CEO Albert T. Roy. "There are more trials in mid-to-late-stage development than ever before, including dapirolizumab pegol in Phase 3 from UCB/Biogen, a Lupus Therapeutics partner. And we are gratified to witness the volume of CAR T cell therapy approaches in clinical development, having invested in 2014 in early research suggesting this approach as a promising intervention to explore for treating lupus," Roy added. Foundational Research Funded by the LRA Sixteen studies of LRA-funded research (four oral presentations and 12 posters) will be presented. Several focus on Childhood-Onset Systemic Lupus Erythematosus (cSLE), including: a detailed characterization of the disease; the effects of fatigue on pediatric patients' mental and physical health; and the discovery of Anti-Mitochondrial Antibodies (AMA), which are linked to higher disease activity. Other studies include: the development of a precision immunotherapy to target harmful B cells in Antiphospholipid Syndrome (APS) patients; the discovery of innate signaling pathways crucial in causing inflammation in lupus patients; and the epidemiology of strokes in children and adults with lupus. ORAL PRESENTATIONS Saturday, Nov. 16 Abstract #0837: Bispecific Autoantigen-T Cell Engagers (BaiTE) to Selectively Target Autoreactive B Cells in Antiphospholipid Syndrome 3:00-3:15 PM, Room 103AB Sunday, Nov. 17 Abstract #1702: Placental Developmental Defects in a Humanized-TLR8 Mouse Model of Spontaneous Anti-Phospholipid Antibody Induced Pregnancy Loss 3:15-3:30 PM , Room 103AB Monday, Nov. 18 Xist and XChromosome Inactivation in Female Biased Autoimmunity 9:00-9:30 AM, Room 145AB Abstract #2625: Brain Injury Markers Correlate with Impaired Executive Function and Disease Activity in Children with Systemic Lupus Erythematosus 3:30-3:45 PM, Room 202AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0091: Targeting Endothelial Dysfunction in Lupus Nephritis: Effect of Sepiapterin, a Drug That Restores Endothelial Nitric Oxide Synthase Function, in a Murine Model of Lupus Nephritis Abstract #0098: Anti-HSP90α as a Protective Natural Antibody Against Secondary Antiphospholipid Syndrome in Systemic Lupus Erythematosus Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM , Poster Hall: Abstract #1266: Anti-Mitochondrial Antibodies Associate with Disease Activity and IFNα Expression in Childhood-onset Systemic Lupus Erythematosus Abstract #1273: An Investigation of Traumatic Events and Mental Health in cSLE Abstract #1274: Comparing Performance-Based Measures and Self-Reported Questionnaires for Assessment of Executive Function for Youth with Childhood-Onset Systemic Lupus Erythematosus Abstract #1278: The Effects of Fatigue on Self-Reported Mental and Physical Health in Childhood-Onset Systemic Lupus Erythematosus: A Cross-Sectional Study Abstract #1279: Cerebrovascular Accidents in Pediatric and Adult Systemic Lupus Erythematosus: A Comparison of Epidemiology and Outcomes Abstract #1280: Abnormal Cortical Gyrification Patterns in Adolescents with Childhood-onset SLE: Early Associations with Perceived Fatigue Abstract #1504: Novel Analytes Associated with Cognitive Impairment in Patients with Systemic Lupus Erythematosus: Serum S100A8/A9, MMP-9 and IL-6 Abstract #1506: Cognitive Impairment Prevalence and Most Affected Domains in Patients with SLE by the ACR Comprehensive Neuropsychological Battery Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #1788: Memory B Cell Activation and Dysregulation in Systemic Lupus Erythematosus Abstract #2380: Characterizing SLE Patients into Type 1 and Type 2 Disease States: Insights from a Single Lupus Cohort Research Conducted by Lupus Therapeutics and the Lupus Clinical Investigators Network (LuCIN) Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, oversees the Lupus Clinical Investigators Network (LuCIN), consisting of 50+ premier, leading medical research institutions in North America, comprised of 200+ providers with expertise in lupus care and clinical trials. The following studies are based on annual surveys of LuCIN investigators and research teams on promoting equity in lupus clinical trials and identifying trial barriers and solutions. POSTERS Saturday, Nov. 16 Abstract 0180: Collaborative Solutions to Lupus Trial Challenges for Underrepresented Participant Recruitment & Engagement: Perspectives from the Lupus Clinical Investigators Network (LuCIN) Poster Session A, 10:30 AM-12:30 PM, Poster Hall Sunday, Nov. 17 Abstract #1039: Through the LuCIN Lens: Defining Barriers and Forging Solutions for Lupus Clinical Trials in North America Poster Session B, 10:30 AM-12:30 PM, Poster Hall Clinical Research Supported by Lupus Therapeutics and LuCIN The primary goal of Lupus Therapeutics and LuCIN is to accelerate and enhance the quality of lupus clinical trials through clinical expertise, advisory services, patient engagement and partnership/collaboration with biopharmaceutical companies and research partners. Lupus Therapeutics and LuCIN are involved in nearly 25% of active lupus clinical trials. Fifteen Lupus Therapeutics/LuCIN-supported programs and collaborations are being presented at ACR Convergence 2024: ORAL PRESENTATIONS Sunday, Nov. 17 Abstract #1773: Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials 3:30-3:45 PM, Room 145AB Monday, Nov. 18 Abstract #2577: Efficacy and Safety of ABBV-599 (Elsubrutinib and Upadacitinib Combination) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: Results Through 104 Weeks in a Long-Term Extension Study 1:30-1:45 PM, Room 146AB Abstract #2580: Safety and Efficacy of Subcutaneous Ianalumab (VAY736) for up to 68 Weeks in Patients with Systemic Lupus Erythematosus: Results from Phase 2 Study 2:15-2:30 PM Room 146AB Tuesday, Nov. 19 ***LATE-BREAKING ABSTRACT*** Abstract #L16: Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial 8:00-9:30 AM, 146AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0087: SYNCAR: An Engineered IL-2/IL-2R-system That Selectively Enhances CD19 CAR T Cells to Deplete B Cells and Provide Therapeutic Benefit in SLE and RA Mouse Models Without Lymphodepletion Abstract #0324: Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials Abstract #0620: Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren's Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated With Deucravacitinib in the Phase 2 PAISLEY Trial Abstract #0659: Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial Abstract #0662: Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial Abstract #0671: Effect of Litifilimab on Cutaneous Lupus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM, Poster Hall: Abstract #1496: Dysregulated Serum Cytokines in Association with Clinical Manifestations in Patients with Systemic Lupus Erythematosus Abstract #1552: Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinib in Patients with Active SLE in the Phase 2 PAISLEY Trial Abstract #1553: Safety, Pharmacokinetics, Clinical Efficacy and Exploratory Biomarker Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Enpatoran in Active Systemic and Cutaneous Lupus Erythematosus (SLE/CLE) Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #2425: Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial Abstract #2430: Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15-45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus and more likely to experience severe lupus symptoms. About the Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. For more information, please visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram. About Lupus Therapeutics Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with premier research institutions, biopharmaceutical partners, and those living with lupus through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in treatment development. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit LupusTherapeutics.org for more information. This information is brought to you by the Lupus Research Alliance and is not sponsored by, nor a part of, the American College of Rheumatology. SOURCE Lupus Research Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultPhase 3Immunotherapy

07 Oct 2024

·www.prnewswire.com

The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol Brings a Ray of Hope in Systemic Lupus Erythematosus Therapeutic Space | DelveInsight

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug Approval

16 May 2024

·www.globenewswire.com

Novartis meets all tender offer conditions to acquire MorphoSys AG for EUR 68 per share in cash

Novartis secured 79.6 percent acceptance by MorphoSys shareholders during the initial acceptance period, reaching the minimum 65% acceptance thresholdSettlement of the shares tendered during the initial acceptance period is expected to occur on 23 May 2024Additional statutory acceptance period is expected to end on 30 May 2024 at 24:00 hours CESTTransaction strengthens the Novartis pipeline in oncology, adding pelabresib, a late-stage BET inhibitor for myelofibrosis and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomas Basel, 16 May 2024 – Today, Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, announced the result of its voluntary public takeover offer (the “Offer”) for the shares of MorphoSys AG (“MorphoSys”), including all shares represented by MorphoSys American Depositary Shares (“ADS”). As of the expiry of the acceptance period at 24:00 hours CEST on 13 May 2024, the Offer has been accepted by approximately 79.6 percent of the total share capital of MorphoSys, including purchases by Novartis BidCo AG outside the Offer for approximately 11.6 percent of the share capital. All conditions of the Offer, including the minimum acceptance threshold of 65%, were fulfilled by the end of the acceptance period. The settlement of the shares tendered during the initial acceptance period is scheduled for 23 May 2024. The statutory two-week additional acceptance period for the Offer will commence on 17 May 2024 and end on 30 May 2024 at 24:00 hours CEST and 18:00 hours EDT (also on 30 May 2024). During this time, shareholders who have not tendered their MorphoSys shares, including shares represented by MorphoSys ADS, can still accept the Offer.With all offer conditions fulfilled, Novartis can now begin the necessary steps to progress the integration of MorphoSys, including full access to pelabresib (CPI-0610), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis. The integration also allows full access to tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of EZH1 and EZH2 currently being tested in patients with solid tumors or lymphomas, as well as a broad portfolio of partnered assets, some of which are in partnership with Novartis, including ianalumab (VAY736). In the context of the integration Novartis continues to progress the workstreams for implementation of both a delisting of MorphoSys and a domination and profit and loss transfer agreement with MorphoSys. Georgeson is acting as information agent for Novartis for the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer. The offer document for the Offer and additional information are available at www.novartis.com/investors/morphosys-acquisition. A takeover offer hotline for retail shareholders is available between 9:00-18:00 hours CEST from Monday through Friday at +49 89 38038187 (for German callers) and +44 203 005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 hours EDT from Monday through Friday and 12:00-18:00 hours EDT on Saturdays at +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S.). Additional Information and Where to Find it This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the “Bidder”). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The solicitation and offer to buy shares of MorphoSys is only being made pursuant the offer document. In connection with the Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the “Offer Documents”), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the “Recommendation Statements”). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944. In addition to the Offer to Purchase, including the means to tender and certain other Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov. In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Offer in the manner described in the offer document. Acceptance of the Offer by stockholders residing outside Germany and the U.S. may be subject to further legal requirements. With respect to the acceptance of the Offer outside Germany and the U.S., no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction. DisclaimerThis press release contains forward-looking statements concerning Novartis AG, the Bidder, MorphoSys and the Offer that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this communication, forward-looking statements include statements about the parties’ ability to satisfy the conditions to the consummation of the Offer; statements about the expected timetable for the consummation of the Offer; the plans, objectives, expectations and intentions of Novartis AG and the Bidder; and the financial condition, results of operations and business of MorphoSys and Novartis AG. The forward-looking statements contained in this communication represent the judgment of the Bidder and Novartis AG as at the date of this communication and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of Novartis AG, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if the results, performance, financial condition and liquidity of Novartis AG, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the timing of the Offer; uncertainties as to how many of the MorphoSys stockholders will tender their stock in the Offer; the possibility that competing offers will be made; the possibility that various conditions for the Offer may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Offer; the effects of the Offer on relationships with employees, other business partners or governmental entities; that the Bidder and Novartis AG may not realize the potential benefits of the Offer; transaction costs associated with the Offer; that expectations may be incorrect; 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, as well as the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by MorphoSys and the Tender Offer Statement on Schedule TO and related Offer Documents to be filed by the Bidder and Novartis AG. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this communication. The Bidder, Novartis AG and MorphoSys expressly disclaim any obligation to update any such forward-looking statements in this communication to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation. About Novartis Novartis 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. 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 Marlena Abdinoor +1 617 335 9525 SwitzerlandSatoshi 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

Acquisition

100 Deals associated with Ianalumab

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KEGG	Wiki	ATC	Drug Bank
-	Ianalumab	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis, Autoimmune	Phase 3	BE	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	ES	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	CZ	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	CA	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	CH	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	DE	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	US	Novartis Pharmaceuticals Corp.	15 Feb 2018
Hepatitis, Autoimmune	Phase 3	AR	Novartis Pharmaceuticals Corp.	15 Feb 2018
Autoimmune Haemolytic Anaemias	Phase 3	US	Novartis AG	-
Purpura, Thrombocytopenic, Idiopathic	Phase 3	US	Novartis AG	-

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03656562 (CVAY736X2208, EULAR2024) Manual	Phase 2	Systemic Lupus Erythematosus	67	ianalumab 300 mg subcutaneous	(oqyfzsjmnr) = dnpibzgwle nzogumjuuf (xniialbnee )	Positive	14 Jun 2024
				placebo	(oqyfzsjmnr) = jhstewxhsu nzogumjuuf (xniialbnee )
EULAR2023	Not Applicable	Systemic Lupus Erythematosus	67	Ianalumab	vnbgikxjhj(hvatrlhsuk) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) tpyggojfzc (xecmabduqy ) View more	-	31 May 2023
				Placebo
NCT03400176 (AACR2023) Manual	Phase 1	Chronic Lymphocytic Leukemia	39	VAY736+ibrutinib	(yljzpezthw) = vxocmydgeg sxjqjrwghw (meiutjcawg ) View more	Positive	15 Apr 2023
				VAY736+ibrutinib (1L)	(yljzpezthw) = jryhiergkl sxjqjrwghw (meiutjcawg ) View more
NCT03287414 (CTgov)	Phase 2	Idiopathic Pulmonary Fibrosis	30	Standard of Care (SoC)+VAY736 (VAY736)	strjgnmcru(rgtcsddzkw) = zovxdnnkag zxjugadksp (yfyqmryhdg, wffiwqbhjz - adllhozylx) View more	-	10 Mar 2023
				Placebo (Placebo)	strjgnmcru(rgtcsddzkw) = ogedrhttuz zxjugadksp (yfyqmryhdg, lwtyzjptku - spcmazgjri) View more
NCT01930175 (CTgov)	Phase 2	Pemphigus	13	VAY736 (VAY736 3 mg/kg)	xfgmttdeao(ivnkfokygr) = egfammuwop xkvqreipyy (ohxobbezuk, tqyitjzori - hwuplleban) View more	-	19 Oct 2020
				VAY736 (VAY736 10 mg/kg)	xfgmttdeao(ivnkfokygr) = eecuxwdsxi xkvqreipyy (ohxobbezuk, lwkbnghlei - bwhjwwcnib) View more
phase 2b study (EULAR2020)	Phase 2	Primary Sjögren's syndrome anti-Ro/SSA+	190	VAY736 300mg	evibwvqwwf(gkheemfeug) = onvpygydbi dqvvjkkjin (acqbnoohma )	Positive	03 Jun 2020
				Placebo	evibwvqwwf(gkheemfeug) = quwdmhjtwf dqvvjkkjin (acqbnoohma )
NCT02038049 (CTgov)	Phase 2	Multiple Sclerosis, Relapsing-Remitting	8	VAY736 (VAY736)	niqwpoufbe(iatadhgtpq) = nbisoawtfi slzhrqvrfo (gwvscmeymy, dqanowcjit - difyhjnhec) View more	-	30 Oct 2019
				Placebo (Placebo to VAY736)	niqwpoufbe(iatadhgtpq) = ejxfcotldy slzhrqvrfo (gwvscmeymy, lxlqmwrhjx - ohpfvahkjd) View more
NCT02149420 (CVAY736X2201, Pubmed) Manual	Phase 2	Primary Sjögren's syndrome	27	ianalumab	(iywokubuxw) = A similar trend showing positive therapeutic effect by ianalumab was observed across the primary clinical outcome (ESSDAI) and all secondary clinical outcomes (ESSPRI, Multidimensional Fatigue Inventory, Short Form-36, global assessments by physician and patient) versus the placebo-treated group. subguizfmj (wfyfywgpuj ) View more	Positive	01 May 2019
				Placebo
NCT02149420 (Phase IIa Clinical Trial for VAY736 in Primary Sjögren’s Syndrome \| CVAY736X2201, CTgov)	Phase 2	Primary Sjögren's syndrome	27	Placebo (Placebo)	bwuzjefbgr(umlyswdbso) = gufueyrvsi oxsedhpstf (jktfkubstn, nicbayxlia - rebvunfoyr) View more	-	12 Feb 2019
				VAY736 (VAY736 3 mg/kg)	bwuzjefbgr(umlyswdbso) = ozahcbwxlq oxsedhpstf (jktfkubstn, cmoxbismis - mxsynvnibu) View more

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