An Open Label Study to Investigate the Long-term Safety and Efficacy of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

This is an open label extension (OLE) study of an ongoing randomized controlled clinical study 218224 (Parent Study). The OLE study will describe how well tolerated belimumab will be long term, and whether it might continue to slow progression of lung function decline, slow overall disease progression and improve quality of life.

Start Date12 Dec 2024

Sponsor / Collaborator

GSK Plc

[+1]

NCT06381453

/ RecruitingPhase 2IIT

Belimumab in the Management of Autoimmune Hepatitis: a Multi-centre, Open-label Trial of Add-on Belimumab Therapy to Standard of Care

Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic & environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability & safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT<2x ULN & corticosteroids at a dose of

Start Date11 Dec 2024

Sponsor / Collaborator

University Health Network

[+1]

CTR20243677

/ RecruitingPhase 3

一项在结缔组织病（CTD）相关间质性肺疾病（ILD）成人患者中评价贝利尤单抗皮下给药的有效性和安全性的III期、随机、双盲、安慰剂对照、平行组研究

[Translation] A Phase III, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of subcutaneous belimumab in adult patients with connective tissue disease (CTD)-related interstitial lung disease (ILD)

主要目的：评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降方面的有效性。关键次要目的：评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者肺容量下降%预测值方面的有效性。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减缓CTD-ILD受试者ILD进展方面的有效性。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比对CTD-ILD受试者疲劳的作用。评价贝利尤单抗+标准治疗与安慰剂+标准治疗相比在减轻CTD-ILD受试者症状严重程度方面的作用

[Translation]

Primary objectives: To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the decline in lung volume in CTD-ILD subjects. Key secondary objectives: To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the % predicted decline in lung volume in CTD-ILD subjects. To evaluate the effectiveness of belimumab + standard therapy compared with placebo + standard therapy in slowing the progression of ILD in CTD-ILD subjects. To evaluate the effect of belimumab + standard therapy compared with placebo + standard therapy on fatigue in CTD-ILD subjects. To evaluate the effect of belimumab + standard therapy compared with placebo + standard therapy in reducing the severity of symptoms in CTD-ILD subjects.

Start Date18 Nov 2024

Sponsor / Collaborator

GlaxoSmithKline (Ireland) Ltd.

[+2]

100 Clinical Results associated with Belimumab

100 Translational Medicine associated with Belimumab

100 Patents (Medical) associated with Belimumab

1,261

Literatures (Medical) associated with Belimumab

01 Apr 2025·Immunology Letters

Early decrease of T-bet+ B cells during subcutaneous belimumab predicts response to therapy in systemic lupus erythematosus patients

Article

Author: Casato, Milvia ; Conti, Fabrizio ; Visentini, Marcella ; Ceccarelli, Fulvia ; Petriti, Begi ; Stefanini, Lucia ; Sciannamea, Maddalena ; Basili, Stefania ; Spinelli, Francesca Romana ; Picciariello, Licia ; Basile, Umberto ; La Gualana, Francesca ; Natalucci, Francesco ; Olivieri, Giulio ; Gragnani, Laura

Systemic lupus erythematosus (SLE) is characterized by B cell dysregulation and expansion of atypical B cells that may correlate with disease manifestations and activity. This study investigated the impact of subcutaneous (sc) Belimumab (BLM) on the peripheral B cell compartment and on the functional properties of CD21^low, T-bet⁺ and CD11c⁺ atypical B cells, in 21 active SLE patients over a 12-month period. At baseline, active SLE patients displayed reduced unswitched IgM memory B cells and expansion of atypical B cells, compared to healthy donors and to SLE patients in remission. sc BLM therapy promptly restored B cell homeostasis with a reduction of T-bet⁺ B cells, observed early in patients responsive to therapy. These findings highlight the pathogenic role of T-bet⁺ B cells in SLE disease and suggest their potential utility as biomarker of clinical response.

08 Jan 2025·Japanese Journal of Clinical Oncology

Phase II study of carboplatin plus weekly paclitaxel with bevacizumab for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia (Hanshin Cancer Group IP002)

Article

Author: Tokito, Takaaki ; Nakakura, Akiyoshi ; Morita, Satoshi ; Tamiya, Motohiro ; Kaneda, Toshihiko ; Watanabe, Kana ; Okamoto, Tadashi ; Oki, Masahide ; Katakami, Nobuyuki ; Nagata, Kazuma ; Hatachi, Yukimasa ; Amano, Yoshihiro

AbstractBackgroundThere is an increased risk of acute exacerbation of idiopathic interstitial pneumonia when treating patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. There is no standard optimal treatment regimen for patients with lung cancer complicated with idiopathic interstitial pneumonia. We aimed to evaluate the efficacy and safety of carboplatin (CBDCA), bevacizumab (Bmab) and weekly paclitaxel (PXT) in patients with idiopathic interstitial pneumonia.MethodsThis phase 2 study involved chemotherapy-naïve patients with advanced non-small cell lung cancer with idiopathic interstitial pneumonia. Patients received CBDCA (area under the curve: 5 on day 1), PXT (70 mg/m2 on days 1, 8 and 15) and Bmab (15 mg/kg on day 1) every 4 weeks. The primary endpoint was the overall response rate.ResultsTwenty-one patients were enrolled between January 2013 and October 2018 and received at least one course of the protocol treatment. The study was terminated before enrolling the planned number of patients because of poor accrual. The median patient age was 69 (range: 62–79) years, and 19 (90.5%) patients were men. The overall response rate was 61.9% (95% confidence interval [CI], 38.4–81.9), meeting the primary endpoint. The median progression-free survival, time to treatment failure, and overall survival were 9.69 (95% CI, 5.78–11.63), 8.21 (95% CI, 3.75–11.63) and 20.93 (95% CI, 13.17–29.83) months, respectively. There was no acute exacerbation or treatment-related death during protocol treatment.ConclusionThe results indicate that patients with advanced non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonia could be effectively and safely treated using a combination of CBDCA, PXT and Bmab.

01 Jan 2025·Nature Immunology

Disease-associated B cells and immune endotypes shape adaptive immune responses to SARS-CoV-2 mRNA vaccination in human SLE

Article

Author: Runnstrom, Martin C ; Ghimire, Midushi ; Neish, Andrew S ; Ahmed, Hasan ; Williams, M. Elliott ; Kraker, Geoff ; Chen, Weirong ; Scharer, Christopher D ; Anam, Fabliha A ; Hom, Jennifer ; Runnstrom, Martin C. ; Van, Trinh T P ; Anam, Fabliha A. ; Lee, F. Eun-Hyung ; Cheedarla, Suneethamma ; Sanz, Ignacio ; Roback, John D. ; Khurana, Surender ; Williams, M Elliott ; Faliti, Caterina E. ; Mishra, Ashish Kumar ; Haddad, Natalie S ; Tipton, Christopher M. ; Neish, Andrew S. ; Khosroshahi, Arezou ; Faliti, Caterina E ; Lindner, John M ; Woodruff, Matthew C ; Usman, Sabeena Y. ; Scharer, Christopher D. ; Quehl, Hannah ; Kyu, Shuya ; Morrison-Porter, Andrea ; Woodruff, Matthew C. ; Tipton, Christopher M ; Usman, Sabeena Y ; Roback, John D ; Ghosn, Eliver ; Van, Trinh T. P. ; Cheedarla, Narayanaiah ; Haddad, Natalie S. ; Lindner, John M. ; Lee, F Eun-Hyung ; Sanz, Daniel ; Antia, Rustom

Severe acute respiratory syndrome coronavirus 2 mRNA vaccination has reduced effectiveness in certain immunocompromised individuals. However, the cellular mechanisms underlying these defects, as well as the contribution of disease-induced cellular abnormalities, remain largely unexplored. In this study, we conducted a comprehensive serological and cellular analysis of patients with autoimmune systemic lupus erythematosus (SLE) who received the Wuhan-Hu-1 monovalent mRNA coronavirus disease 2019 vaccine. Our findings revealed that patients with SLE exhibited reduced avidity of anti-receptor-binding domain antibodies, leading to decreased neutralization potency and breadth. We also observed a sustained anti-spike response in IgD^-CD27^- 'double-negative (DN)' DN2/DN3 B cell populations persisting during memory responses and with greater representation in the SLE cohort. Additionally, patients with SLE displayed compromised anti-spike T cell immunity. Notably, low vaccine efficacy strongly correlated with higher values of a newly developed extrafollicular B and T cell score, supporting the importance of distinct B cell endotypes. Finally, we found that anti-BAFF blockade through belimumab treatment was associated with poor vaccine immunogenicity due to inhibition of naive B cell priming and an unexpected impact on circulating T follicular helper cells.

News (Medical) associated with Belimumab

13 Jan 2025

·www.accesswire.com

IgA Nephropathy Market to Reach USD 99,655.4 Million by 2035, Growing at a 7.6% CAGR from 2025 to 2035, Driven by Advances in Targeted Therapies and New Treatment Developments

The increasing number of clinical trials and subsequent approvals are expected to drive substantial market growth. Projections indicate that the IgAN treatment market by registering a CAGR of 6.2% in the forecast period 2025 to 2035 in the United States NEWARK, DE / ACCESSWIRE / January 13, 2025 / The IgA Nephropathy Market is poised for significant growth over the forecast period from 2025 to 2035, driven by advancements in diagnostics, therapeutic innovations, and an increasing prevalence of chronic kidney disease (CKD). In 2025, the market is valued at USD 46,821.70 million, with projections estimating a substantial increase to USD 99,655.4 million by 2035, reflecting a robust CAGR of 7.6%.Key factors fueling this growth include the rising adoption of biologics and biosimilar, an uptick in government funding for research and treatment programs, and improved accessibility to healthcare in emerging markets. The growing awareness among healthcare professionals and patients about IgA nephropathy, also known as Berger\'s disease, further strengthens market momentum.The emergence of targeted therapies, such as corticosteroids, immunosuppressant, and advanced monoclonal antibodies, has revolutionized treatment regimens. These therapies effectively manage proteinuria and inflammation, improving patient outcomes. Meanwhile, innovations in molecular diagnostics ensure early and precise disease detection, playing a pivotal role in reducing disease progression.North America currently dominates the market, owing to strong healthcare infrastructure, high awareness levels, and the availability of advanced treatment options. However, Asia-Pacific is anticipated to exhibit the fastest growth rate due to increasing patient populations and government investments in healthcare infrastructure.IgAN is an autoimmune disease that attacks the kidneys. It affects blood filtration in the small blood vessels of the kidneys. It occurs when an abnormal protein damages the filtering unit (glomerulus) inside the kidneys. This, in turn, causes pain leading to patients undertaking different forms of treatments. Which are Some Prominent Drivers of IgA Nephropathy Market?Conventional treatments and approval of medication favoring the growth of the marketConventional major treatments to manage IgAN include ACE inhibitors (angiotensin-converting enzyme inhibitors) and ARBs (angiotensin II receptor blockers), to manage symptoms like high blood pressure, etc. Other treatments include corticosteroids, to slow the progression of the disease, and other immunosuppressants like MMF, cyclophosphamide, etc.TARPEYO (budesonide) delayed-release capsules are the first and only FDA-approved drug for the treatment of IgAN. It is indicated for IgAN patients, who are at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. It was approved by the US FDA in December 2021, under an accelerated approval pathway, recognizing the urgent need for safe and efficacious therapies.The availability of therapeutic treatments creates lucrative opportunities for the IgA nephropathy marketTarpeyo: Calliditas Therapeutics ABTarpeyo (developed under the project name Nefecon) is a patented oral formulation of a potent and well-known active substance- budesonide for targeted release. The formulation is designed to deliver the drug to the Peyer\'s patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Tarpeyo is derived from the TARGIT technology, which allows the substance to pass through the stomach and intestine without being absorbed and released in a pulse-like fashion only when it reaches the lower small intestine.In addition to its potent local effect, another advantage of using this active substance is its very low bioavailability, i.e., around 90% of it is inactivated in the liver before it reaches systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.Sparsentan: Travere Therapeutics, IncSpartan is a first-in-class, orally active, single-molecule that functions as a high-affinity dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors which are associated with kidney disease progression.Endothelin I and angiotensin II lead to a decline in kidney function by contributing to inflammation and fibrosis in the kidney, changes to the shape of podocytes, podocyte loss, and increased permeability of the glomerular filtration barrier. Endothelin I and angiotensin II are also vasoconstrictive, meaning they cause a narrowing of blood vessels and an increase in pressure in the glomeruli.Reimbursement of treatments propelling the growth of the IgA nephropathy marketProactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select markets with better market access can be a critical business and price strategy.To assist patients and their healthcare providers who prescribe Tarpeyo, Calliditas has launched a comprehensive patient support program - Tarpeyo Touchpoints. It is a full-service patient and provider support program designed to accelerate and streamline access to Tarpeyo. It utilizes biologics by McKesson\'s Pharmacy Elite model integrated hub and exclusive specialty pharmacy under one roof and is staffed by care navigators and a designated rare pod team (nurses, pharmacists, fulfillment, and distribution team).Key Takeaways from Market StudyThe global IgA Nephropathy Market size will grow from USD 46,821.70 million in 2025 to USD 99,655.4 million by 2035, with a CAGR of 7.6%.Biologics and biosimilars are projected to dominate the therapeutic segment, offering enhanced efficacy and fewer side effects.North America leads the market, accounting for over 40% of revenue share in 2025. Asia-Pacific is expected to witness the fastest CAGR during 2025-2035.Increased healthcare expenditure and favorable government initiatives are boosting market dynamics globally.Innovative technologies in diagnostics and the adoption of digital health platforms will further drive market growth.\"The IgA Nephropathy Market is entering an era of transformative growth fueled by advancements in targeted therapies and precision medicine. Stakeholders focusing on R&D collaborations, digital health integration, and market expansion in developing economies will be well-positioned to capitalize on this growth trajectory. The integration of AI in diagnostics and a surge in biosimilar approvals further underscore the market\'s evolution,\" Says Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.)A Detailed Full Report - https://www.futuremarketinsights.com/reports/iga-nephropathy-marketCountry-wise Insights:The section below discusses the industry analysis for the IgA nephropathy market in several nations. Market demand analysis for important nations in numerous areas of the world, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe, and Middle East & Africa, is provided.The United States is expected to remain the leader in North America, with a larger market share through 2035. In South Asia and the Pacific, India is expected to grow at a CAGR of 9.1% by 2035.CountriesValue CAGR (2025 to 2035)United States6.2%Germany4.4%China9.0%France2.4%India9.1%Spain5.7%Australia & New Zealand6.5%South Korea6.0%IgA Nephropathy Market Day-by-Day Opportunities:The IgA Nephropathy Market offers opportunities for stakeholders across the value chain, including pharmaceutical companies, diagnostic service providers, and healthcare technology firms. Key opportunities include:R&D in Precision Medicine: Investments in personalized medicine to create patient-specific therapies will likely transform disease management strategies.Expanding Biosimilars Market: Development and commercialization of cost-effective biosimilars will ensure accessibility in cost-sensitive regions.Technological Advancements in Diagnostics: AI-powered diagnostic tools and molecular biomarker research present avenues for early diagnosis.Strategic Collaborations: Partnerships between biotech companies and research institutions are expected to accelerate drug discovery processes.Component Insights:Therapeutics: Biologics are expected to dominate, accounting for more than 50% of market revenue by 2035. Monoclonal antibodies such as belimumab and rituximab show promise in reducing renal inflammation and improving patient prognosis.Diagnostics: Molecular diagnostics are anticipated to grow at a CAGR exceeding 8%, driven by the demand for early and accurate detection of IgA nephropathy.Services: Increased focus on patient-centered care has led to growth in home-based care services and telemedicine adoption.How do biomarkers contribute to the early diagnosis of IgA nephropathy?Biomarkers play a crucial role in the early diagnosis of IgA nephropathy (IgAN), also known as Berger\'s disease, by providing non-invasive and specific indicators of the disease\'s presence and progression. Here are the main ways in which biomarkers contribute to the early diagnosis of IgA nephropathy:Identification of Disease-Specific Biomarkers:Galactose-Deficient IgA1 (Gd-IgA1): Elevated levels of Gd-IgA1 in serum and urine have been identified as significant biomarkers for IgAN. Studies have shown that Gd-IgA1 levels correlate with disease activity, making it a potential marker for early diagnosis and monitoring of the diseaseImmune Complexes: The presence of Gd-IgA1-containing immune complexes is associated with the pathogenesis of IgAN. Measuring these complexes can help in identifying patients at risk for developing the diseaseCorrelation with Disease Activity:Biomarkers such as serum Gd-IgA1 and Gd-IgA1-specific antibodies have been linked to disease activity. Their levels can indicate inflammation and damage within the kidneys, allowing for earlier intervention before significant renal impairment occursNon-Invasive Testing:The use of serum and urinary biomarkers allows for non-invasive testing methods compared to traditional kidney biopsies, which are invasive and carry risks. This non-invasive approach can facilitate earlier diagnosis and monitoring without subjecting patients to unnecessary proceduresDifferentiation from Other Kidney Diseases:Certain biomarkers help differentiate IgAN from other renal diseases. For instance, assessing serum IgA levels and the serum IgA/C3 ratio can aid in distinguishing IgAN from conditions that present similarly, such as minimal change disease or focal segmental glomerulosclerosisMonitoring Progression and Treatment Response:Biomarkers not only assist in diagnosis but also in monitoring disease progression and response to treatment. For example, changes in urinary protein excretion can indicate worsening kidney function or effectiveness of therapeutic interventionsPredictive Models:Recent advancements include the use of machine learning models that incorporate various biomarkers to predict the likelihood of IgAN development or progression. These models analyze multiple factors, including age, serum albumin levels, and urinary findings, providing a comprehensive assessment that enhances diagnostic accuracyRegional Analysis of IgA Nephropathy Market:North America:Leading region with over 40% of revenue share in 2025.Strong focus on R&D and patient access to advanced therapies.Europe:Second-largest market, driven by government funding and adoption of biosimilars.Key focus on collaborative research initiatives.Asia-Pacific:Fastest-growing region, with a CAGR of over 8%.Increasing awareness, expanding healthcare infrastructure, and government support.Latin America & Middle East:Emerging markets with growing adoption of biologics and molecular diagnostics.Competitive Landscape:Key players in the IgA Nephropathy Market are employing a variety of strategies to maintain their competitive edge. Among these, product innovation remains a top priority, with companies focusing on developing unique formulations and advanced treatment options. To ensure effective market penetration, firms are forging strategic alliances with healthcare providers, aiming to streamline distribution networks and enhance accessibility to their products.Additionally, many organizations are actively pursuing partnerships and collaborations to diversify their product portfolios and strengthen their foothold in the global market. These partnerships not only accelerate R&D activities but also open avenues for expansion into emerging markets, boosting their overall market presence.Recent Industry Developments in IgA Nephropathy Market:March 9, 2023: Sandoz announced plans to establish a state-of-the-art biologics manufacturing facility in Lendava, Slovenia, by signing a memorandum of understanding (MOU).February 9, 2023: Takeda completed its acquisition of Nimbus Lakshmi, Inc., a subsidiary of Nimbus Therapeutics, thereby enhancing its pipeline of innovative therapeutics.January 11, 2023: Sanofi Ventures increased its capital commitment to over USD 750 million for its Evergreen Venture Fund, with a focus on scaling its investment capabilities and expanding its global influence.Key Players of IgA Nephropathy Market:Novartis AGSanofi S.A.AstraZenecaTakeda Pharmaceutical Company LimitedPfizer Inc.Validus Pharmaceuticals LLCOrganon Group of CompaniesKey Segments of IgA Nephropathy Market:By Diagnosis & Treatment:In terms of diagnosis & treatment, the industry is divided into- diagnosis and treatment.By Disease Type:In terms of disease type, the industry is segregated into- primary IgA nephropathy and secondary IgA nephropathy.By Indication:In terms of indication, the industry is segregated into- hematuria, proteinuria, hypertension, edema and others.By Population Type:In terms of population type, the industry is segregated into- pediatrics and adults.By Route of Administration:In terms of route of administration, the industry is segregated into- oral and parenteral.By End User:In terms of end user, the industry is segregated into- hospitals, specialty clinics, homecare and others.By Region:Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.AuthorSabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.Explore FMI\'s Extensive Coverage in the Healthcare Domain:The global sales of surgical navigation system is estimated to be worth USD 1,235.7 million in 2025 and anticipated to reach a value of USD 2,255.2 million by 2035.The aortic stents grafts market size is anticipated to be worth USD 2.5 billion in 2023. The market is assumed to surge at a CAGR of 5% during the forecast period and, reach USD 4.2 billion by 2033.The coronary artery bypass graft market is estimated to be valued at USD 17,612.1 million in 2023. The coronary artery bypass graft industry is likely to cross a valuation of USD 22,765.9 million by 2033.In 2023, the adoption of coronary stent in India stands at a valuation of USD 843.8 million. This surge is attributed to the demand for minimally invasive procedures to address the rising cases of cardiovascular diseases.The coronary intravascular lithotripsy market size is projected to be worth USD 324.4 Million in 2023. The market is likely to surpass USD 592.2 Million by 2033 at a CAGR of 6.2% during the forecast periodThe visual electrophysiology market is anticipated to flourish at a steady CAGR of 7.0% between 2023 and 2033.The immunochemistry analyzer market is expected to register a CAGR of 16% during the forecast period, up from USD 14.2 Billion in 2021, to reach a valuation of USD 72.69 Billion by 2032.The immunochemistry products market is anticipated to record a CAGR of 7.25% during the forecast period, up from USD 2.08 Billion in 2021 to reach a valuation of USD 4.5 Billion by 2032.The global birch allergy treatment market garnered a market value of USD 571 Million in 2023 and is expected to accumulate a market value of USD 1123.24 Million by registering a CAGR of 7%The global nasal allergy treatment market enjoys a valuation of USD 6.6 Billion in 2022, and it is further projected to expand at a CAGR of 6.7%About Future Market Insights (FMI)Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai and has delivery centres in the United Kingdom, the United States, and India. FMI\'s latest market research reports and industry analysis helps businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Our customized and syndicated market research reports deliver actionable insights that drive sustainable growth. A team of expert-led analysts at FMI continuously tracks emerging trends and events in a broad range of industries to ensure that our clients prepare for the evolving needs of their consumers.Join us as we commemorate 10 years of delivering trusted market insights. Reflecting on a decade of achievements, we continue to lead with integrity, innovation, and expertise.Contact Us:Future Market Insights Inc.Christiana Corporate, 200 Continental Drive,Suite 401, Newark, Delaware - 19713, USAT: +1-347-918-3531For Sales Enquiries: [email protected]Website: https://www.futuremarketinsights.comLinkedIn | Twitter | Blogs | YouTubeSOURCE: Future Market Insights Inc.

Drug ApprovalAcquisition

10 Jan 2025

·medcitynews.com

Immunology Startup Ouro Sets Out With $120M for Drugs That Reset the Immune System - MedCity News

Autoimmune disease is an unrelenting attack of the body on itself. Drugs that suppress the immune system quell the attack for a while, but patients need to keep taking these drugs, putting them at risk for complications that come from a chronically suppressed immune system. What if a patient could just start over with immune cells that don’t target bodily tissue? Ouro Medicine aims to achieve that with a drug candidate that works like an immune system reset button. This program is on track to enter the clinic and the startup has more in the pipeline. On Friday, San Francisco-based Ouro emerged from stealth revealing $120 million in funding from backers that include GSK, which helped form the young company. “Fundamentally, we think this could change the practice of medicine if we’re right,” CEO Jaideep Dudani said. “The way these patients are treated currently, they’re always taking drug. We can put them into durable remission without chronic immunosuppression.” presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Ouro’s drugs are part of a class of therapies called T cell engagers, or TCEs. By simultaneously binding to a T cell and a disease-driving cell, these engineered antibodies direct the T cell to kill the pathogenic cell. TCEs first reached patients as cancer treatments. But dysregulated cells that drive certain cancers are also behind certain autoimmune diseases. Research is underway at multiple companies aiming to expand the scope of cancer immunotherapy to autoimmune disease. Ouro was founded by Monograph Capital. Dudani, who is also portfolio principal at Monograph, said the venture capital firm had been tracking the immunology space, watching the data for CAR T-therapies as this class of medicines expands from cancer to autoimmune disease. Monograph also started working with GSK to form the immune reset company that would become Ouro. GSK has a longstanding history in B-cell biology, Dudani explained. The company’s portfolio includes Benlysta, a lupus drug that works by blocking an enzyme B cells need to survive. Two studies published in the New England Journal of Medicine in September turned Ouro on to TCEs. Both studies were tests of Tecvayli, a Johnson & Johnson TCE already approved as a treatment for multiple myeloma. This drug targets BCMA, a protein abundant on the surface of the B cells that drive this blood cancer. B cells also drive certain immune diseases, such as lupus, scleroderma, and rheumatoid arthritis. In the test of Tecvayli in four patients with severe autoimmune disease, results showed a reduction in autoantibodies as well as a clinical response. The other study evaluated Tecvayli in a woman whose aggressive lupus did not respond to other treatments. After a short course of Tecvayli, she had a drug-free complete remission. The sample size of these studies is small, but Dudani characterized the results as “remarkable clinical data.” Ouro found its own candidate in China, licensing OM336, a TCE that Keymed Biosciences is developing for multiple myeloma. After securing exclusive rights to the drug outside of greater China, Ouro closed the Series A round of funding in November, Dudani said. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech TCEs for cancer come with warnings for the risk of severe side effects, but Dudani expects the safety profile in immunological indications will be better. The lower disease burden of autoimmune disease compared to cancer permits lower doses and shorter courses of therapy, which reduces the risk of adverse effects. He also expects the drugs will have a longer-lasting effect. Depleting disease-driving cells erases the memory that these cells targeted the body. The naïve cells that repopulate the immune system are not exposed to a self-antigen that makes them pathogenic, so these new cells could enable long periods of remission. “You’re not repopulating with cells that are autoreactive, you’ve reset the body to not be as reactive to self,” Dudani said. “So the hope is when these cells repopulate, they come back in a more naïve fashion to be less self-toxic.” Interest in bringing dual-targeting antibodies to autoimmune disease is growing. In October, GSK acquired global rights to a TCE from Chimagen, which the pharma giant plans to advance to Phase 1 testing in lupus this year. Candid Therapeutics’ $370 million in funding and two in-licensed TCEs were unveiled days after the September publication of the Tecvayli data. Before that, Merck licensed rights to a bispecific antibody with plans to develop it in cancer and autoimmune disease. And Cullinan Therapeutics last year changed its name from Cullinan Oncology to reflect the expansion of its TCE research to autoimmune disease. Despite the progress of the TCE field, there are stumbles. On Thursday, IGM Biosciences announced it would stop work on two TCEs and restructure its operations after an interim look at clinical data showed lower than expected B cell depletion. Ouro’s Series A round was co-led by TPG Life Sciences Innovations, NEA, and Norwest Venture Partners. Other disclosed investors in the financing include Monograph Capital, GSK, Boyu/Zoo Capital, LongRiver Investments, and UPMC Enterprises. With the funding, Dudani expects Ouro can begin a Phase 1 test of OM336 later this year. The rest of the pipeline consists of discovery-stage assets internally developed by Ouro. All of them target different aspects of B-cell biology to achieve an immune system reset, Dudani said. That aspiration led to the name of the company, which refers to the ouroboros, a circular symbol of a snake devouring itself. “It represents eternal rebirth and recycle,” Dudani said, adding that Ouro’s drugs “give the opportunity for immune reset and rebirth.” Illustration: Thom Leach/Science Photo Library, via Getty Images

ImmunotherapyClinical Result

03 Dec 2024

·www.prnewswire.com

Lupus Nephritis Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 30+ Companies Working in the Domain

The lupus nephritis market is poised for growth, driven by rising disease prevalence, advancements in therapeutics such as biologics and targeted therapies, and increased investment in R&D. Heightened awareness and robust support from governments and key industry players further create a dynamic environment for innovation and better patient outcomes. LAS VEGAS, Dec. 3, 2024 /PRNewswire/ -- DelveInsight's ' Lupus Nephritis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline lupus nephritis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the lupus nephritis pipeline domain. Key Takeaways from the Lupus Nephritis Pipeline Report DelveInsight's lupus nephritis pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for lupus nephritis treatment. Key lupus nephritis companies such as AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others are evaluating new lupus nephritis drugs to improve the treatment landscape. Promising lupus nephritis pipeline therapies such as Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others are under different phases of lupus nephritis clinical trials. In November 2024, Adicet Bio announced that the first LN patient had been dosed in the Phase I clinical trial evaluating ADI-001 in autoimmune diseases. In November 2024, Kyverna Therapeutics announced that it would present updated clinical data from LN patients treated with KYV-101 in ongoing Kyverna-sponsored KYSA-1 and KYSA-3 Phase I/II studies and named patient treatments. In October 2024, Kezar Life Sciences suspended subject enrolment and patient dosing in the Phase II PALIZADE trial of zetomipzomib for active lupus nephritis. In June 2024, Nkarta announced the initiation of Ntrust-I, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. In June 2024, Adicet Bio announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. In April 2024, Caribou Biosciences announced that it had received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024. In March 2024, Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN). Request a sample and discover the recent advances in lupus nephritis treatment drugs @ Lupus Nephritis Pipeline Report The lupus nephritis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage lupus nephritis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the lupus nephritis clinical trial landscape. Lupus Nephritis Overview Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE), an autoimmune disease that can affect multiple organ systems. In lupus nephritis, the immune system mistakenly attacks the kidneys, leading to inflammation and damage. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors, including infections and exposure to certain drugs or UV light. Symptoms of lupus nephritis can vary but often include swelling in the legs and feet, high blood pressure, foamy urine, and in severe cases, hematuria. Patients may also experience fatigue, joint pain, and skin rashes, typical of lupus. Diagnosis usually involves a combination of blood tests, urinalysis, and imaging studies. A kidney biopsy may be necessary to evaluate the extent of kidney damage and guide treatment. Treatment for lupus nephritis aims to reduce inflammation and prevent kidney damage. It often involves corticosteroids and immunosuppressive medications such as mycophenolate mofetil or azathioprine. In severe cases, more aggressive treatments, including cyclophosphamide or biologic therapies like belimumab, may be utilized. Regular monitoring of kidney function and overall health is crucial for managing the disease effectively. Find out more about lupus nephritis treatment drugs @ Drugs for Lupus Nephritis Treatment A snapshot of the Lupus Nephritis Pipeline Drugs mentioned in the report: Learn more about the emerging lupus nephritis pipeline therapies @ Lupus Nephritis Clinical Trials Lupus Nephritis Therapeutics Assessment The lupus nephritis pipeline report proffers an integral view of the lupus nephritis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Lupus Nephritis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interferon alpha-beta receptor antagonists, Cell death inhibitors, Cell death stimulants, Antibody-dependent cell cytotoxicity, B-cell activation factor receptor antagonists, Glucokinase stimulants, Dendritic cell inhibitors, Complement factor D inhibitors, Complement C3 inhibitors, Proteasome inhibitors, Natural killer cell replacements, Immunologic cytotoxicity; T lymphocyte replacements Key Lupus Nephritis Companies: AstraZeneca, Hoffmann-La Roche, Novartis, Qilu Pharmaceutical, Vera Therapeutics, Conduit Pharmaceuticals, Amgen, Johnson & Johnson, BeiGene, RemeGen, Argenx, Kyverna Therapeutics, Cabaletta Bio, ImmPACT Bio, Alpine Immune Sciences, AlloSite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, Adicet Bio, Shenzhen Pregene Biopharma Co., Ltd., Resolve Therapeutics, BioAegis Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, and others. Key Lupus Nephritis Pipeline Therapies: Anifrolumab, Obinutuzumab, Ianalumab, QLG1074, Atacicept, AZD1656, Daxdilimab, Nipocalimab, Zanubrutinib, Telitacicept, Efgartigimod alfa, KYV-101, CABA-201, IMPT-514, Povetacicept, ONT01, BCMA-CD19 cCAR T cells, CB-010, ADI-001, PRG-2311, RSLV-621, Recombinant human plasma gelsolin, LN-008, TST 008, and others. Dive deep into rich insights for new drugs for lupus nephritis treatment, visit @ Lupus Nephritis Drugs Table of Contents For further information on the lupus nephritis pipeline therapeutics, reach out @ Lupus Nephritis Treatment Drugs Related Reports Lupus Nephritis Epidemiology Lupus Nephritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted lupus nephritis 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, CABALETTA BIO, among others. Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus 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 SLE companies, including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. 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. 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

IND

100 Deals associated with Belimumab

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KEGG	Wiki	ATC	Drug Bank
D03068	Belimumab	L04AA26	DB08879

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Nephritis	LI	GlaxoSmithKline (Ireland) Ltd.	13 Jul 2011
Lupus Nephritis	NO	GlaxoSmithKline (Ireland) Ltd.	13 Jul 2011
Lupus Nephritis	IS	GlaxoSmithKline (Ireland) Ltd.	13 Jul 2011
Lupus Nephritis	EU	GlaxoSmithKline (Ireland) Ltd.	13 Jul 2011
Systemic Lupus Erythematosus	US	GlaxoSmithKline LLC	09 Mar 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lupus Nephritis	Phase 2	KR	GSK Plc	12 Jul 2012
Lupus Nephritis	Phase 2	DE	Hospira, Inc.	12 Jul 2012
Lupus Nephritis	Phase 2	TH	GSK Plc	12 Jul 2012
Lupus Nephritis	Phase 2	US	Hospira, Inc.	12 Jul 2012
Lupus Nephritis	Preclinical	MX	GSK Plc	12 Jul 2012
Systemic Lupus Erythematosus	Preclinical	CA	GSK Plc	01 Dec 2006
Systemic Lupus Erythematosus	Preclinical	CR	GSK Plc	01 Dec 2006
Systemic Lupus Erythematosus	Preclinical	MX	GSK Plc	01 Dec 2006
Systemic Lupus Erythematosus	Preclinical	IL	GSK Plc	01 Dec 2006
Systemic Lupus Erythematosus	Preclinical	PR	GSK Plc	01 Dec 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024 Manual	Not Applicable	Systemic Lupus Erythematosus	782	rituximabbelimumab	(wjmyltmzbt) = blklkyqadm oebpudyydd (qqcglnusin, 8.5) View more	Negative	05 Jun 2024
				rituximab or belimumabor SoC (Patients without SI)	(wjmyltmzbt) = gjmtaswcin oebpudyydd (qqcglnusin, 8.4) View more
EULAR2024	Not Applicable	Lupus Nephritis \| Systemic Lupus Erythematosus	106	Subcutaneous Belimumab	iltwtfuzsb(gfdffpkwjh) = PSL reduction ≥5 mg was achievable in active disease and positive C1q-binding immune complex jisngohvzq (vcerdeoydw ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Systemic Lupus Erythematosus	-	Belimumab	kfprglxtzs(ekncynmmrz): HR = 0.72 (95% CI, 0.62 - 0.83), P-Value = <0.0001 View more	-	05 Jun 2024
				Placebo
EULAR2024	Not Applicable	Pregnancy	17	Belimumab	mlcmfyjhhn(eldnilluvl) = jkzhtzjuev dopqconvna (nqxocdogfn ) View more	Positive	05 Jun 2024
				Non-Belimumab	knyjtlioxi(avlzldfjox) = sonohspted dmojrwmcdw (qertrutbvx ) View more
EULAR2024	Not Applicable	Systemic Lupus Erythematosus BAFF cytokine	1,137	Belimumab	ahlgyyicfn(azfygcgrvg) = ccqkhtvzfl blvyizitig (iyeayyosin ) View more	Positive	05 Jun 2024
				Belimumab (Standard of Care)	ahlgyyicfn(azfygcgrvg) = ayqbvoqtda blvyizitig (iyeayyosin ) View more
EULAR2024	Phase 3	Systemic Lupus Erythematosus baseline SLE disease duration \| baseline Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score \| baseline immunosuppressant (IS) use	3,086	Belimumab	lpeiurekrv(lvibuggfbj): OR = 1.7 (95% CI, 1.46 - 1.98), P-Value = <0.0001	Positive	05 Jun 2024
				Placebo
EULAR2024	Not Applicable	Lupus Erythematosus	-	Belimumab	idrlmimktv(pobjrklthb) = bptbhutyzo dmnrltrdow (iyqhwvkxfp, 6.3)	-	05 Jun 2024
				Control (no belimumab exposure)	idrlmimktv(pobjrklthb) = wiknijnjmm dmnrltrdow (iyqhwvkxfp, 6.5)
EULAR2024	Not Applicable	-	54	Belimumab	(dpelyyspib) = hbrflibljn fcmpecrazd (ijuwhbvaje ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Lupus Erythematosus	-	Belimumab	zkvdztqawp(vusachmkki) = bhzfehreex hroarsxlxr (koltbjhymv )	Positive	05 Jun 2024
NCT04179032 (CTgov)	Phase 2	Systemic Lupus Erythematosus	25	Belimumab	zsrdyewaol(spzcpsqnny) = mntiigglzw otbcphskvc (gtmlepursp, kspsvnlvhm - blboavnkky) View more	-	26 Mar 2024

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