A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

开始日期2021-08-03

申办/合作机构

Institut de Recherches Intern Servier

[+1]

NCT04882007

/ Unknown status临床2期

Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s)

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

开始日期2020-10-02

申办/合作机构

OSE Immunotherapeutics SA

NCT03980080

/ Completed临床1期

Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.

开始日期2018-12-19

申办/合作机构

OSE Immunotherapeutics SA

[+1]

100 项与 Lusvertikimab 相关的临床结果

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100 项与 Lusvertikimab 相关的转化医学

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100 项与 Lusvertikimab 相关的专利（医药）

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项与 Lusvertikimab 相关的文献（医药）

2024-06-27·Blood

The IL-7R antagonist lusvertikimab reduces leukemic burden in xenograft ALL via antibody-dependent cellular phagocytosis

Article

作者: Pengam, Sabrina ; Winterberg, Dorothee ; Bergmann, Anke K. ; Poirier, Nicolas ; Dietterle, Anna ; Alten, Julia ; Cario, Gunnar ; Narbeburu, Emma ; Neyton, Stéphanie ; Dovhan, Vladyslava ; Antić, Željko ; Lenk, Lennart ; Corallo, Frédérique ; Heymann, Julia ; Wessels, Wiebke ; Brüggemann, Monika ; den Boer, Monique L. ; Baccelli, Irène ; Escherich, Gabriele ; Raffel, Simon ; Taurelle, Julien ; Déramé, Mylène ; Bourquin, Jean-Pierre ; Laqua, Anna ; Bornhauser, Beat ; Schrappe, Martin ; Schewe, Denis M. ; Reimer, Claas ; Vogiatzi, Fotini ; Mary, Caroline ; Peipp, Matthias ; Boer, Judith M. ; Schüler, Thomas

Abstract:

Acute lymphoblastic leukemia (ALL) arises from the uncontrolled proliferation of B-cell precursors (BCP-ALL) or T cells (T-ALL). Current treatment protocols obtain high cure rates in children but are based on toxic polychemotherapy. Novel therapies are urgently needed, especially in relapsed/refractory (R/R) disease, high-risk (HR) leukemias and T-ALL, in which immunotherapy approaches remain scarce. Although the interleukin-7 receptor (IL-7R) plays a pivotal role in ALL development, no IL-7R–targeting immunotherapy has yet reached clinical application in ALL. The IL-7Rα chain (CD127)–targeting IgG4 antibody lusvertikimab (LUSV; formerly OSE-127) is a full antagonist of the IL-7R pathway, showing a good safety profile in healthy volunteers. Here, we show that ∼85% of ALL cases express surface CD127. We demonstrate significant in vivo efficacy of LUSV immunotherapy in a heterogeneous cohort of BCP- and T-ALL patient-derived xenografts (PDX) in minimal residual disease (MRD) and overt leukemia models, including R/R and HR leukemias. Importantly, LUSV was particularly effective when combined with polychemotherapy in a phase 2-like PDX study with CD127high samples leading to MRD-negativity in >50% of mice treated with combination therapy. Mechanistically, LUSV targeted ALL cells via a dual mode of action comprising direct IL-7R antagonistic activity and induction of macrophage-mediated antibody-dependent cellular phagocytosis (ADCP). LUSV–mediated in vitro ADCP levels significantly correlated with CD127 expression levels and the reduction of leukemia burden upon treatment of PDX animals in vivo. Altogether, through its dual mode of action and good safety profile, LUSV may represent a novel immunotherapy option for any CD127+ ALL, particularly in combination with standard-of-care polychemotherapy.

2023-03-15·Journal of immunology (Baltimore, Md. : 1950)

First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7Rα

Article

作者: Costantini, Dominique ; Conduzorgues, Jean-Pascal ; Poirier, Nicolas ; Abès, Riad ; Volckaert, Bram ; Teppaz, Géraldine ; De Sa, Fanny ; Girault, Isabelle ; Corallo, Frédérique ; Belarif, Lyssia ; Poli, Sonia ; Mary, Caroline ; Pengam, Sabrina ; Braudeau, Cécile ; Josien, Regis ; Soma, Emilienne ; Fromond, Claudia ; Baccelli, Irène

Abstract:

OSE-127 is a humanized mAb targeting the IL-7Rα-chain (CD127), under development for inflammatory and autoimmune disease treatment. It is a strict antagonist of the IL-7R pathway, is not internalized by target cells, and is noncytotoxic. In this work, a first-in-human, phase I, randomized, double-blind, placebo-controlled, single-center study was carried out to determine the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of OSE-127 administration. Sixty-three healthy subjects were randomly assigned to nine groups: six single ascending dose groups with i.v. administration (0.002–10 mg/kg), a single s.c. treatment group (1 mg/kg), and two double i.v. injection groups (6 or 10 mg/kg). Subjects were followed during <146 d. OSE-127’s pharmacokinetic half-life after a single dose increased from 4.6 (1 mg/kg) to 11.7 d (10 mg/kg) and, after a second dose, from 12.5 (6 mg/kg) to 16.25 d (10 mg/kg). Receptor occupancy was ≥95% at doses ≥0.02 mg/kg, and this saturation level was maintained >100 d after two i.v. infusions at 10 mg/kg. IL-7 consumption was inhibited by OSE-127 administration, as demonstrated by a decreased IL-7 pathway gene signature in peripheral blood cells and by ex vivo T lymphocyte restimulation experiments. OSE-127 was well tolerated, with no evidence of cytokine-release syndrome and no significant alteration of blood lymphocyte counts or subset populations. Altogether, the observed lack of significant lymphopenia or serious adverse events, concomitant with the dose-dependent inhibition of IL-7 consumption by target cells, highlights that OSE-127 may show clinical activity in IL-7R pathway–involved diseases.

2020-07-01·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology2区 · 医学

Targeting the interleukin‐7 receptor alpha by an anti‐CD127 monoclonal antibody improves allergic airway inflammation in mice

2区 · 医学

Article

作者: Bouchaud, Grégory ; Brouard, Sophie ; Henrio, Kelly ; Cheminant, Marie‐Aude ; Mai, Hoa Le ; Nguyen, Thi Van Ha ; Magnan, Antoine

Abstract:

Background:

Interleukin‐7 (IL‐7) is the most important cytokine for T‐cell homeostasis. IL‐7 signals through the IL‐7 receptor (IL‐7R) which is composed of an alpha chain (IL‐7Rα), also called CD127 and a common gamma chain. T lymphocytes, especially T helper type 2, play a crucial role in the pathobiology of allergic asthma.

Objective:

To study the effects of an anti‐CD127 monoclonal antibody (mAb) in a murine model of allergic airway inflammation induced by house dust mite (HDM).

Methods:

Allergic airway inflammation was induced in mice using a protocol comprising 4 weekly percutaneous sensitizations followed by 2 weekly intranasal challenges with total HDM extracts and treated by intraperitoneal injections of an anti‐CD127 mAb. Because CD127 is shared by both IL‐7R and the receptor for thymic stromal lymphopoietin (TSLP), a group of mice was also treated with an anti‐IL‐7 mAb to block only the IL‐7 signalling pathway.

Results:

Anti‐CD127 mAb‐treated mice showed significantly lower airway resistance in response to methacholine and improvement in lung histology compared with isotype mAb‐treated animals. Anti‐CD127 mAb treatment significantly decreased the mRNA expression of Th2 cytokines (IL‐4, IL‐5, and IL‐13) and chemokines (CCL5/RANTES) in lung tissue, decreased the secretion of Th2 cytokines (IL‐4, IL‐5, and IL‐13) and chemokines (CXCL1 and CCL11/eotaxin) in bronchoalveolar lavage fluid (BALF), decreased serum HDM‐specific IgE, and reduced the number of total leucocytes and leucocyte subpopulations such as eosinophils, macrophages, lymphocytes, T lymphocytes, and ILC2 in BALF and lung tissue. Mice treated with anti‐IL‐7 mAb also showed less allergic airway inflammation as evidenced by significantly lower airway resistance and fewer leucocytes in BALF and lung tissue compared to mice treated with the corresponding isotype control mAb.

Conclusion and Clinical Relevance:

Targeting the IL‐7Rα by an anti‐CD127 mAb improves allergic airway inflammation in mice and presents as a potential therapeutic approach for allergic asthma.

项与 Lusvertikimab 相关的新闻（医药）

2025-04-09

·GlobeNewswire-Health Care

OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025

OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025New Clinical Data from Phase 2 Extension Period in Ulcerative Colitis on Long-Term Benefits and Safety of Anti-IL-7R mAb Lusvertikimab NANTES, France – April 9, 2025, 7:30 a.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, today announced that the Company will present further efficacy and safety data1 from the 24-week Open Label Extension (OLE) period from CoTikiS Phase 2 clinical study of Lusvertikimab in ulcerative colitis at the Digestive Disease Week conference in San Diego (May 3 – 6, 2025). Following the excellent efficacy and safety profile from the trial’s induction period presented as a highlight at the 2025 ECCO congress, this oral presentation will unveil new clinical data from the 24-week Open Label Extension (OLE) period (Week 10 to Week 34) of the randomized, double-blind, placebo-controlled Phase 2 study evaluating the anti-IL-7 receptor monoclonal antibody Lusvertikimab in moderate to severe ulcerative colitis. These new findings are expected to provide deeper insights into the long-term benefits and safety of Lusvertikimab, supporting further development in ulcerative colitis, as well as in other chronic autoimmune and inflammatory diseases. Presentation details: Title: “LUSVERTIKIMAB, A FIRST IN CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICCENTER RANDOMIZED PLACEBO-CONTROLLED PHASE II STUDY” Date and Time: Monday, May 05, 2025, from 4:45pm to 5:00pm Pacific TimeSession Presentation: Clinical Trials in IBD: Biologics and Emerging TherapiesSession Number: 0004 ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, or colon, and rectum, in which the lining of the gastrointestinal tract becomes inflamed and develops ulcers. This condition is the result of an overactive immune system. UC affects 3.3 million patients in the US, Europe and Japan2. Despite broad therapeutic options, remission rates are only 25-30%3 leaving most patients without satisfactory treatments. 15% of patients4 fail to respond to all therapies and undergo surgery as a last option. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn. Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 The abstract was submitted before the completion of the 24-week Open Label Extension (OLE) period. The new data to be presented at DDW 2025 includes additional findings not available at the time of submission.2 Evaluate Pharma3 Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.2125724 Scientific Reports volume 10, Article number: 12546 (2020) Attachment EN_250409_DDW_Lusvertikimab_vf

临床2期免疫疗法临床结果

2025-02-01

·GlobeNewswire-Health Care

OSE Immunotherapeutics Presents Three Abstracts for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO

OSE Immunotherapeutics Presents Three Abstracts for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO NANTES, France - January 28 2025, – 7:30am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), shares details of the three scientific abstracts on its anti-IL-Receptor (IL-7R) Lusvertikimab, which is in clinical development for ulcerative colitis. These abstracts will be presented in Oral Presentation, Digital Oral Presentation and Poster Presentation at the upcoming 20th Congress of ECCO (European Crohn’s and Colitis Organization) to be held February 19-22, 2025, in Berlin (Germany). Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “With three abstracts accepted for presentation at ECCO 2025, we look forward to sharing new preclinical and clinical efficacy data on Lusvertikimab with the world’s leading specialists in Inflammatory Bowel Diseases (IBD).” Presentation Details: Oral presentationTitlePresenterSessionDate and timeOP36 - "LUSVERTIKIMAB, A FIRST-IN-CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED PHASE II STUDY " Arnaud BourreilleSession name: Sustainability in IBD and beyond Session 10: Hot topics in IBDSession hall: Plenary Hall / Hall BSession date: February 20, 2025 Session time: 08:30 -10:50Presentation time: 10:10 - 10:20Selected amongst the Top 10 oral abstracts for 20th Congress of European Crohn’s and Colitis Organization (ECCO) Highlights. Digital oral presentationTitlePresenterSessionDate and timeDOP031 - "ANTI-IL-7 RECEPTOR PLUS ANTI-IL12/23 COMBINATION INDUCES COMPLETE HISTOLOGICAL NORMALIZATION IN CHRONIC COLITIS "Nicolas PoirierSession name: DOP Session 4: Novel targets in IBDSession hall: A5Session date: February 20, 2025 Session time: 17:45 - 18:45Presentation time: 18:03 - 18:09 Poster presentationTitlePresenterSession Date and timePO916 – “LUSVERTIKIMAB IS EFFICACIOUS IN SEVERE ULCERATIVE COLITIS (UC) PATIENTS WITH HIGH FECAL CALPROTECTIN (FCP): RESULTS FROM THE COTIKIS STUDY”Walter ReinishPoster sessions: February 20, 2025, 10:30 to 18:00 February 21, 2025, 08:00 to 18:00 February 22, 2025, 09:00 to 13:00 Guided poster session: February 21, 2025, 12:40-13:40 ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Attachment EN_250128_ECCO Lusvertikimab_vf

临床2期免疫疗法临床结果

2024-12-18

·GlobeNewswire-Health Care

OSE Immunotherapeutics to Present Anti-IL-7R Lusvertikimab Phase 2 Induction Results in Ulcerative Colitis at 20th Congress of ECCO

A clinical abstract on the induction results from the CoTikiS Phase 2 trial of anti-IL-7 Receptor Lusvertikimab in Ulcerative Colitis accepted for Oral Presentation and selected amongst the Top 10 oral abstracts for 20th Congress of European Crohn’s and Colitis Organization (ECCO) Highlights. Research highlights OSE Immunotherapeutics’ continued commitment to advancing the treatment and management of IBD. NANTES, France, December 18, 2024 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that an abstract related to its first in class anti-IL-7 Receptor (IL-7R) Lusvertikimab, has been accepted for Oral Presentation at the 20th congress of the European Crohn’s and Colitis Organization (ECCO) being held February 19-22, 2025, in Berlin (Germany). Details of the presentation: EC25-1892 - "Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe Ulcerative Colitis: results of a multicenter, randomized, placebo-controlled phase II study" has been accepted as an Oral Presentation in the Scientific Program and selected amongst the Top 10 oral abstracts for the Congress Highlights of ECCO’25 video. Presentation number: OP36Session name: Sustainability in IBD and beyond - Session 10: Hot topics in IBDSession date: 22/02/25; Session time: 08:30 - 10:50; Presentation time: 10:10 - 10:20Session hall: Plenary Hall / Hall B Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are excited to present for the first time at a congress the clinical efficacy and safety data from the induction study in ulcerative colitis. This prestigious scientific meeting gathers the world’s leading specialists in Inflammatory Bowel Diseases (IBD). Lusvertikimab, a pure interleukin-7 receptor antagonist mAb that exclusively blocks IL-7 boasts a differentiated mechanism of action and a favorable tolerance profile. We believe Lusvertikimab is uniquely positioned in IBD, with potential also for a broader spectrum of chronic inflammatory and autoimmune diseases.” Interleukin-7 (IL-7) produced locally by epithelial cells is a crucial survival factor for pathogenic T lymphocytes residing in tissues, such as colitogenic memory T cells1. Lusvertikimab is a unique antagonist of IL-7R targeting the CD127 receptor, the alpha chain of the IL-7R, with a differentiated mechanism of action allowing a selective inhibition of the IL-7 biology while sparing TSLP (Thymic Stromal LymphoPoietin) cytokine and growth factor. This allows potent inhibition of pathogenic memory and effector T lymphocytes expressing high level of CD127, while promoting regulatory T cells (Tregs) biology expressing low level of CD127. The protective role of TSLP in intestinal immunity has been reproducibly described, in particular to instruct Treg generation against commensal bacteria2 and TSLP inhibition has been reported to exacerbate mucosal inflammation and colitis3. This biology together with the results of the CoTikiS study supports the continued clinical development of a pure IL-7 antagonist in IBD, and other diseases where Tregs and microbiota cross-talks are implicated in tissular healing. Interleukin-7 Receptor (IL-7R) overexpression has been associated with numerous diseases4 and therapeutic areas, with preclinical efficacy already demonstrated in IBD5, rheumatoid arthritis6, neuroinflammation7, airways inflammation8, dermatology9, type 1 diabetes10 and lupus11. ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. This condition is the result of the immune system’s overactive response. UC affects 3.3 million patients in the US, Europe and Japan (1). Despite broad therapeutic options, remission rates remain only 25-30% (2) leaving most patients without satisfactory treatments. 15% of patients (3) fail to respond to all therapies and undergo surgery as a last option.(1) EvaluatePharma (2) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572(3) Scientific Reports volume 10, Article number: 12546 (2020)ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Markus F. Neurath, Strategies for targeting cytokines in inflammatory bowel disease, Nat Rev Immunol 20242 I Spadoni et al., Dendritic cells produce TSLP that limits the differentiation of Th17 cells, fosters Treg development, and protects against colitis, Mucosal Immunol, 2012 3 Jonathan L Messerschmidt et al., TSLP/dendritic cell axis promotes CD4+ T cell tolerance to the gut microbiome, JCI Insight, 2023 Betsy C Taylor et al., TSLP regulates intestinal immunity and inflammation in mouse models of helminth infection and colitis, J Exp Med, 20094 Barata, J. T., S. K. Durum, and B. Seddon. 2019. Flip the coin: IL-7 and IL-7R in health and disease. Nat. Immunol. 20: 1584_1593.5 Belarif, L., R. Danger, L. Kermarrec, V. Nerri`ere-Daguin, S. Pengam, T. Durand, C. Mary, E. Kerdreux, V. Gauttier, A. Kucik, et al. 2019. IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease. J. Clin. Invest., 2019.Willis, C. R. et al., Interleukin-7 receptor blockade suppresses adaptive and innate inflammatory responses in experimental colitis. J. Inflamm., 2012.6 Sarita A Y Hartgring, Blockade of the interleukin-7 receptor inhibits collagen-induced arthritis and is associated with reduction of T cell activity and proinflammatory mediators, Arthritis Rheum, 2010Zhenlong Chen, The novel role of IL-7 ligation to IL-7 receptor in myeloid cells of rheumatoid arthritis and collagen-induced arthritis, J Immunol, 2013 7 Li-Fen Lee et al., IL-7 promotes T(H)1 development and serum IL-7 predicts clinical response to interferon-β in multiple sclerosis 8 Hoa Le Mai et al., Targeting the interleukin-7 receptor alpha by an anti-CD127 monoclonal antibody improves allergic airway inflammation in mice, Clin Exp Allergy, 2020 9 Lyssia Belarif et al., IL-7 receptor blockade blunts antigen-specific memory T cell responses and chronic inflammation in primates, Nat Commun, 2018Zhenpeng Dai et al., Blockade of IL-7 signaling suppresses inflammatory responses and reverses alopecia areata in C3H/HeJ mice, Sci Adv, 2021 10 Li-Fen Lee et al., Anti-IL-7 receptor-α reverses established type 1 diabetes in nonobese diabetic mice by modulating effector T-cell function, Proc Natl Acad Sci U S A, 2012 Cristina Penaranda, IL-7 receptor blockade reverses autoimmune diabetes by promoting inhibition of effector/memory T cells, Proc Natl Acad Sci U S A, 201211 Rosana Gonzalez-Quintial et al., Systemic autoimmunity and lymphoproliferation are associated with excess IL-7 and inhibited by IL-7Rα blockade PLoS One, 2011 Attachment EN_241218_ECCO Lusvertikimab

临床2期临床结果免疫疗法

100 项与 Lusvertikimab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
干燥综合征	临床2期	法国	OSE Immunotherapeutics SA	2022-01-30
干燥综合征	临床2期	法国	Servier Group	2022-01-30
原发性干燥综合征	临床2期	美国	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	美国	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	澳大利亚	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	澳大利亚	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	法国	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	法国	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	德国	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	德国	Institut de Recherches Intern Servier	2021-08-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04882007 (CoTikiS, GlobeNewswire) 人工标引	临床2期	溃疡性结肠炎	136	Lusvertikimab	-	积极	2024-11-04
				Lusvertikimab (850mg)	夢積範齋膚壓鹹選範積(顧壓齋窪鹽壓願遞鹹醖) = 遞願憲選蓋製糧顧鏇製顧蓋鹽遞遞積夢積觸積 (廠憲獵範網鏇膚齋顧醖 ) 达到更多
NCT04882007 (CoTikiS, PipelineReview) 人工标引	临床2期	活动性中度溃疡性结肠炎 \| 活动性重度溃疡性结肠炎	136	Lusvertikimab	夢簾夢築鬱齋鹽簾鬱齋(遞衊衊壓積淵構繭網醖) = no safety signal was reported by the Data Safety Monitoring Board during the trial. Both doses of lusvertikimab show favorable safety profile in comparison with placebo, with similar rates of adverse events across the 3 treatment groups. 糧醖艱廠蓋繭構鹹鑰糧 (顧憲願壓淵顧襯遞糧鹽 )	积极	2024-07-24
				Lusvertikimab (850 mg group)
NCT04605978 (EULAR 12024 \| EULAR 22024) 人工标引	临床2期	原发性干燥综合征	48	S95011	鑰憲衊觸繭糧顧淵築顧(鬱膚積廠鬱遞壓築繭艱) = 鑰積齋簾製鹽糧襯齋餘艱選鏇鬱廠製醖鏇艱糧 (顧淵夢鬱艱鹹憲積衊網, 6.5) 更多	不佳	2024-06-14
				Placebo	鑰憲衊觸繭糧顧淵築顧(鬱膚積廠鬱遞壓築繭艱) = 壓襯餘範夢艱積積窪範艱選鏇鬱廠製醖鏇艱糧 (顧淵夢鬱艱鹹憲積衊網, 4.4) 更多
NCT04605978 (CTgov)	临床2期	原发性干燥综合征	48	S95011 concentrate for solution for infusion (S95011 Concentrate for Solution for Infusion)	願鑰網範網鬱鏇積艱膚(醖範膚鏇網鹹遞廠鹹蓋) = 膚憲醖範願鬱憲醖齋衊築構遞獵鑰製顧蓋築顧 (觸襯餘淵淵築艱夢顧顧, 4.55) 更多	-	2024-04-23
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	願鑰網範網鬱鏇積艱膚(醖範膚鏇網鹹遞廠鹹蓋) = 齋齋艱衊衊醖構繭顧鹽築構遞獵鑰製顧蓋築顧 (觸襯餘淵淵築艱夢顧顧, 4.89) 更多