Dendritic cells (DC) can be obtained from peripheral blood mononuclear cells (PBMC) by in vitro culture with IL-4 and granulocyte-macrophage colony-stimulating factor (GM-CSF). IL-13 shares properties with IL-4 but its receptor does not involve the common gamma chain present in the receptor complex of IL-4 and other cytokines. The present study was aimed to elucidate whether IL-13 can substitute for IL-4 in DC cultures and to compare the phenotypic and functional characteristics of cells obtained using these two cytokines. Monocyte-enriched PBMC were cultured with GM-CSF and IL-4 or GM-CSF and IL-13. Cell yields and DClike morphology were similar. The cells showed a membrane phenotype typical of DC (MHC II+; CD1a+; CD14-; CD3-; CD20-). IL-13-derived and IL-4-derived DC were similar in terms of macropinocytosis, stimulatory capacity of cord blood lymphocytes in mixed leukocyte reaction (MLR), and responsiveness to chemotactic signals. It is concluded that IL-13 is as effective as IL-4, combined with GM-CSF in sustaining DC differentiation from PBMC and that activation of the common gamma chain-driven transduction pathways is dispensable for DC differentiation and function.

项与 IL-13(Scinai) 相关的新闻（医药）

2024-09-27

·Pharmaceutical Technology

FDA greenlights Regeneron’s Dupixent for the treatment of COPD

COPD is the sixth approved indication for the interleukin-4 receptor alpha antagonist monoclonal antibody. Credits: Wildflower_macro/Shutterstock.com With the latest nod from the US Food and Drug Administration (FDA), Regeneron Pharmaceuticals and Sanofi have expanded the US label of Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD). The approval makes COPD the sixth indication for the blockbuster treatment and makes Dupixent the first available biologic for the condition. As per a 27 September press announcement, Dupixent will be used as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. Current treatment options for COPD include bronchodilators such as beta2-agonists and anticholinergics, standalone or combination inhaled corticosteroids (ICS), and other combination medications. While these therapies are tolerated by patients, GlobalData’s analysts note that the progressive nature of COPD necessitates the development of maintenance therapies in addition to standard of care. Dupixent’s approval in COPD comes after GSK ’s anti-IL-5 antibody Nucala (mepolizumab) failed to pass muster with the regulator . AstraZeneca ’s anti-IL-5 antibody Fasenra (benralizumab) also had a high-profile failure when its Phase III study did not meet its primary endpoints . Both companies are pursuing the COPD label for their respective biologics with ongoing late-stage studies. Alongside the opportunity to present patients with a new treatment option that may improve quality of life, the approval of Dupixent indicates a step towards closing the gap marked by the absence of biologics in the US COPD treatment market, said GlobalData Pharma analyst Asiyah Nawab. See Also: BMS wins approval for schizophrenia drug acquired from Karuna Phare Bio receives ARPA-H funds for AI drug discovery platform The approval of Dupixent was granted based on positive data from two pivotal Phase III studies dubbed BOREAS (NCT03930732) and NOTUS (NCT04456673). Both studies evaluated the safety, efficacy, and tolerability of Dupixent against placebo in adult patients with moderate to severe COPD with type 2 inflammation. Treatment with Dupixent was shown to reduce COPD exacerbations by 30% in the BOREAS trial and by 34% in the NOTUS trial over 52 weeks. Additionally, the biologic was associated with improvements in lung function at 12 weeks, which were sustained through 52 weeks. While the safety of Dupixent across both trials was consistent with the known safety profile of the therapy, NOTUS reported that commonly observed adverse events were Covid-19, nasopharyngitis and headache. The approval of Dupixent, an interleukin-4 receptor alpha antagonist that inhibits both IL-4 and IL-13, is hot on the heels of similar approvals for the biologic in the EU and China. The European Medicines Agency (EMA) approved Dupixent for this indication in July while China’s National Medical Products Administration (NMPA) granted an approval earlier today (27 September). Dupixent is also approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic oesophagitis, and prurigo nodularis. In 2023, Duxpient generated global sales of $11.6bn, with the US market driving sales of $8.8bn. According to GlobalData’s consensus forecasts, Dupixent is anticipated to generate global sales of $23.6bn in 2030. GlobalData is the parent company of Pharmaceutical Technology .

上市批准临床3期临床结果

2024-09-16

·FiercePharma

Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss

With an FDA approval in atopic dermatitis for Ebglyss, Eli Lilly hopes to challenge Regeneron and Sanofi's Dupixent, which is dominant in the indication. Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss to treat atopic dermatitis (AD).The endorsement covers adults and patients between the ages of 12 and 18 who weigh at least 88 pounds. It is for those who have a moderate-to-severe form of the disease and don't achieve an adequate response with prescription topical treatments. The company said it plans to launch Ebglyss, also known as lebrikizumab, in the coming weeks but is not yet divulging its price in the U.S.The nod comes on top of Lilly expanding its label for JAK inhibitor Olumiant in 2022 as the first systemic medicine to treat alopecia areata and gaining approval in October of last year for IL-23 ulcerative colitis therapy Omvoh. In 2022, Lilly’s then chief of its immunology unit, Patrik Jonsson, said that the company was making a “long-term commitment” to immunology for the “coming decade or decades.”As part of the push in 2020, Lilly acquired lebrikizumab when it bought out California-based Dermira for $1.1 billion.The approval for Ebglyss comes a year late. The FDA rejected it in October, citing findings from an inspection of a third-party manufacturer. The agency’s complete response letter (CRL) did not raise any issues with lebrikizumab’s clinical data package, label or safety.Earlier this year, Japan and Canada signed off on Ebglyss. It was approved last year in Europe, where Spain’s Almirall has licensed the rights to develop and commercialize it for dermatology indications. “Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” Jonathan Silverberg, M.D., Ph.D., professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a release.Ebglyss is dosed monthly with a 250 mg injection after an introductory regimen, which includes 250 mg injections two weeks apart until adequate clinical response is achieved. It can be used along with topical corticosteroids. Three trials, which included more than 1,000 patients, backed the approval of Ebglyss. In the ADvocate 1 and 2 studies, an average of 38% of those who took Ebglyss had clear or almost-clear skin after 16 weeks, versus 12% on placebo. Of those who achieved that standard, 77% retained those results with maintenance dosing for a year. Of those Ebglyss responders who switched to placebo at Week 16, 48% maintained their results for a year.Lilly hopes to challenge Regeneron and Sanofi’s dominant IL-4/IL-13 treatment in the indication, Dupixent. Another IL-13 on the market for AD is Leo Pharma’s Adbry, which was launched in 2022.

上市批准临床结果并购免疫疗法

2024-09-16

·BioSpace

Lilly Secures FDA Nod for Eczema Therapy, Eyes Launch in ‘Coming Weeks’

iStock, jetcityimage Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns. The FDA on Friday signed off on Eli Lilly ’s therapeutic antibody lebrikizumab for the treatment of moderate-to-severe atopic dermatitis. Lilly will market the therapy under the brand name Ebglyss. Ebglyss is administered via a subcutaneous injection that can be given with or without topical corticosteroids, and is indicated for adults or children aged 12 years and above who weigh at least 40 kg. Lilly expects to make Ebglyss available in the U.S. in the “coming weeks,” according to its news release, and will work with insurers and health providers to ensure patient access to the treatment. Lilly also has available support programs, including co-pay assistance, for eligible insured patients. Daniel Skovronsky, CSO and president of Lilly Research Laboratories, said in a statement that Ebgylss’ approval can help patients mitigate some of the unpredictability of symptoms. “Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation,” he said, adding that the treatment provides long-lasting symptom relief with a convenient once-monthly maintenance dose. Designed to selectively target and neutralize IL-13, Ebglyss is a monoclonal antibody that disrupts the type 2 inflammation cascade in the skin, in turn effectively addressing an underlying disease pathway in eczema. Ebglyss has high binding affinity for IL-13 and a slow dissociation rate. Lilly backed Ebglyss’ application with data from the Phase III ADvocate 1 and ADvocate 2 studies, which together showed that around 38% of patients on the drug achieved clear or almost-clear skin at 16 weeks. In the placebo arm, only 12% of patients reached this endpoint. For 10% of responders, treatment effects were apparent as early as four weeks. ADvocate 1 and ADvocate 2 also showed that of patients who had clear or almost-clear skin at 16 weeks, 77% were able to maintain the response at one year with monthly maintenance. Lilly also supported Ebglyss with data from the Phase III ADhere study, which in April 2022 showed that 41% of treated patients achieved clear or almost-clear skin at 16 weeks, versus 22% on placebo. Ebglyss also resulted in at least a 75% improvement in disease severity in 70% of treated patients. For Lilly, Friday’s approval was a long time coming. During the 41st J.P. Morgan Healthcare Conference in January 2023, executives said that they planned to launch lebrikizumab that year. However, in October 2023, the FDA rejected the application , citing problems with a third-party manufacturer. The regulator at the time did not identify issues with the safety and efficacy data of lebrikizumab.

临床3期临床结果上市批准

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适应症	最高研发状态	国家/地区	公司	日期
哮喘	临床前	澳大利亚	The Max Planck Institute	2024-04-03
哮喘	临床前	德国	University Medical Center Göttingen	2024-04-03
哮喘	临床前	以色列	Scinai Immunotherapeutics Ltd.	2024-04-03
特应性皮炎	临床前	澳大利亚	The Max Planck Institute	2024-04-03
特应性皮炎	临床前	德国	University Medical Center Göttingen	2024-04-03
特应性皮炎	临床前	以色列	Scinai Immunotherapeutics Ltd.	2024-04-03