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]

EUCTR2020-001398-59-BG / 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)

开始日期2020-10-13

申办/合作机构

OSE Immunotherapeutics SA

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

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）

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 ; Baccelli, Irène ; Fromond, Claudia

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.

2022-06-01·ACR open rheumatology

Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval

作者: Loncharich, Michael F. ; Anderson, Caleb W.

Journal Club:

Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, et al. Anifrolumab, an anti‐interferon‐α receptor monoclonal antibody, in moderate‐to‐severe systemic lupus erythematosus. Arthritis Rheumatol 2017;69:376‐86.

Objective:

To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase IIb, randomized, double‐blind, placebo‐controlled study of adults with moderate‐to‐severe systemic lupus erythematosus (SLE).

Methods:

We randomly assigned patients in a 1:1 ratio to receive intravenous anifrolumab (300 mg) or placebo every 4 weeks for 48 weeks. The primary end point of this trial was a response at week 52 defined with the use of the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA). A BICLA response requires reduction in any moderate‐to‐severe baseline disease activity and no worsening in any of nine organ systems in the BILAG index, no worsening on the Systemic Lupus Erythematosus Disease Activity Index, no increase of 0.3 points or more in the score on the Physician Global Assessment of disease activity (on a scale from 0 [no disease activity] to 3 [severe disease]), no discontinuation of the trial intervention, and no use of medications restricted by the protocol. Secondary end points included a BICLA response in patients with a high interferon gene signature at baseline; reductions in the glucocorticoid dose, in the severity of skin disease, and in counts of swollen and tender joints; and the annualized flare rate.

Results:

A total of 362 patients received the randomized intervention: 180 received anifrolumab and 182 received placebo. The percentage of patients who had a BICLA response was 47.8% in the anifrolumab group and 31.5% in the placebo group (difference, 16.3 percentage points; 95% confidence interval, 6.3 to 26.3; P = 0.001). Among patients with a high interferon gene signature, the percentage with a response was 48.0% in the anifrolumab group and 30.7% in the placebo group; among patients with a low interferon gene signature, the percentage was 46.7% and 35.5%, respectively. Secondary end points with respect to the glucocorticoid dose and the severity of skin disease, but not counts of swollen and tender joints and the annualized flare rate, also showed a significant benefit with anifrolumab. Herpes zoster and bronchitis occurred in 7.2% and 12.2% of the patients, respectively, who received anifrolumab. There was one death from pneumonia in the anifrolumab group.

Conclusion:

Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate‐to‐severe SLE.https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/10.1002/art.39962Furie RA, Morand EF, Bruce IN, Manzi S, Kalunian KC, Vital EM, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP‐1): a randomised, controlled, phase 3 trial. Lancet Rheumatol 2019;1:E208‐19.

Background:

Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1 investigated for the treatment of systemic lupus erythematosus (SLE), did not have a significant effect on the primary end point in a previous phase 3 trial. The current phase 3 trial used a secondary end point from that trial as the primary end point.

Findings:

Between June 9, 2015, and June 16, 2017, 457 patients were randomly assigned to the anifrolumab 300 mg group (n = 180), the anifrolumab 150 mg group (n = 93), or the placebo group (n = 184). The proportion of patients at week 52 with an SRI‐4 response was similar between anifrolumab 300 mg (65 [36%] of 180) and placebo (74 [40%] of 184; difference − 4·2 [95% CI −14·2 to 5·8], p = 0·41). Similarly, proportions of patients with an SRI‐4 response at week 24, and at week 52 in patients in the interferon gene signature test—high subgroup, did not differ between the anifrolumab and placebo groups. In patients with baseline oral corticosteroids of at least 10 mg/day, sustained dose reduction to 7·5 mg/day or less was achieved by 42 (41%) of 103 patients in the anifrolumab 300 mg group and 33 (32%) of 102 patients in the placebo group (difference 8·9 [95% CI −4·1 to 21·9]). In patients with CLASI activity score of at least 10 at baseline, at least 50% reduction by week 12 was achieved by 24 (42%) of 58 patients in the anifrolumab 300 mg group and 14 (25%) of 54 in the placebo group (difference 17·0 [95% CI −0·3 to 34·3]). Annualised flare rates were 0·60 for anifrolumab and 0·72 for placebo (rate ratio 0·83 [95% CI 0·60 to 1·14]). BICLA response was achieved by 67 (37%) of 180 patients receiving anifrolumab 300 mg versus 49 (27%) of 184 receiving placebo (difference 10·1 [95% CI 0·6 to 19·7]). Anifrolumab's safety profile was similar to that observed in phase 2, with similar proportions of patients having a serious adverse event between groups (25 [14%] of 180 for anifrolumab 300 mg, ten [11%] of 93 for anifrolumab 150 mg, and 30 [16%] of 184 for placebo).

Interpretation:

The primary endpoint was not reached. However, several secondary endpoints, including reduction in oral corticosteroid dose, CLASI responses, and BICLA responses, suggest clinical benefit of anifrolumab compared with placebo. Conclusive evidence for the efficacy of anifrolumab awaits further phase 3 trial data. Despite the inherent limitations of a 1‐year phase 3 study, such as incomplete knowledge of applicability to the general population and scarce detection of rare safety signals, in addition to complications from prespecified restricted medication rules, our results suggest that anifrolumab might have the potential to provide a treatment option for patients who have active SLE while receiving standard therapy.

Funding:

AstraZeneca.https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lanrhe/article/PIIS2665-9913(19)30076‐1/fulltextMorand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, et al. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med 2020;382:211‐21.

Conclusions:

Monthly administration of anifrolumab resulted in a higher percentage of patients with a response (as defined by a composite end point) at week 52 than did placebo, in contrast to the findings of a similar phase 3 trial involving patients with SLE that had a different primary end point. The frequency of herpes zoster was higher with anifrolumab than with placebo. (Funded by AstraZeneca; ClinicalTrials.gov number, NCT02446899.)https://www-nejm-org.libproxy1.nus.edu.sg/doi/full/10.1056/nejmoa1912196

2022-04-29·Biochemical Society Transactions2区 · 生物学

MMP-7 marks severe pancreatic cancer and alters tumor cell signaling by proteolytic release of ectodomains

2区 · 生物学

Review

作者: Van Doren, Steven R.

Pancreatic cancer incurs the worst survival rate of the major cancers. High levels of the protease matrix metalloproteinase-7 (MMP-7) in circulation correlate with poor prognosis and limited survival of patients. MMP-7 is required for a key path of pancreatic tumorigenesis in mice and is present throughout tumor progression. Enhancements to chemotherapies are needed for increasing the number of pancreatic tumors that can be removed and for preventing relapses after surgery. With these ends in mind, selective inhibition of MMP-7 may be worth investigation. An anti-MMP-7 monoclonal antibody was recently shown to increase the susceptibility of several pancreatic cancer cell lines to chemotherapeutics, increase their apoptosis, and decrease their migration. MMP-7 activities are most apparent at the surfaces of innate immune, epithelial, and tumor cells. Proteolytic shedding of multiple protein ectodomains by MMP-7 from such cell surfaces influence apoptosis, proliferation, migration, and invasion. These activities warrant targeting of MMP-7 selectively in pancreatic cancer and other tumors of mucosal epithelia. Competitive and non-competitive modes of MMP-7 inhibition are discussed.

项与 Lusvertikimab 相关的新闻（医药）

2024-07-01

·BioSpace

OSE Immunotherapeutics Announces Publication of Preclinical Efficacy Results with Lusvertikimab in Acute Lymphoblastic Leukemia in the Journal ‘Blood’

Nantes, France – July 1st, 2024 – 7:30 am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the publication of an article on latest preclinical efficacy data on the use of its anti-IL-7 receptor (IL-7R A&io) antagonist Lusvertikimab (OSE-127) for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) in ‘Blood’, a peer-reviewed medical journal published by the American Society of Hematology. The preclinical data on Lusvertikimab published in ‘Blood’ was generated from a collaborative research program between OSE Immunotherapeutics and the University Medical Center Schleswig-Holstein in Kiel (Germany). This collaboration is using patient-derived samples and in-vivo xenograft models to evaluate the therapeutic potential of anti-IL-7R antagonist Lusvertikimab in targeting and blocking the high and dysregulated IL-7R-expression observed in nearly 85% of B- or T-Acute Lymphoblastic Leukemia (ALL) patients. Pr. Denis Schewe (newly appointed Head of Pediatric Hematology/Oncology, University Hospital Dresden and National Center for Tumor Diseases, Partner Site Dresden, and formerly from the University Medical Center Schleswig-Holstein of Kiel) and Dr. Lennart Lenk (Department of Pediatrics I, Christian-Albrechts University Kiel and University Medical Center Schleswig-Holstein, Kiel), leading the research program in collaboration with OSE Immunotherapeutics, comment: “Treatment options for T-ALL remain very limited and there is an urgent need for novel immunotherapy approaches to reduce toxicity and to target relapsed or refractory disease in ALL patients. Through its dual mode of action comprising both IL-7R signaling blockade and antibody-dependent cellular phagocytosis induction, Lusvertikimab may represent a promising novel immunotherapy option for CD127 positive ALL patients, particularly in combination with polychemotherapy standard of care. When translated into the clinic, Lusvertikimab could significantly improve ALL-therapy and the outcome of relapsed/refractory disease.” Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: “We are very pleased with this publication on Lusvertikimab in ‘Blood’, a high-level journal within the field of hematology whose manuscripts are reviewed by prominent specialists. Novel targeted immunotherapy options are urgently needed for B-ALL and T-ALL patients and we are happy to collaborate with the research leaders in hematology from the University of Kiel to face this clinical challenge.” The abstract, titled: “The IL-7R antagonist Lusvertikimab reduces leukemic burden in xenograft-ALL via antibody-dependent cellular phagocytosis” reported that IL-7R immunotherapy with Lusvertikimab shows significant in vivo efficacy in preclinical models using samples from B-ALL and T-ALL. Mechanistically, Lusvertikimab targeted ALL cells via a dual mode: On one hand it blocks IL-7 receptor signaling and hence block proliferative and pro-survival signals induced by Interleukin-7. In parallel, it induces leukemic cells elimination by macrophages (antibody-dependent phagocytosis), in particular with strong correlation with the level of IL-7R surface expression on leukemic cells. About Acute Lymphoblastic Leukemia (ALL) Acute lymphoblastic leukemia (ALL) is a heterogeneous group of lymphoid disorders resulting from clonal proliferation of immature lymphocytes of B-cell (85%) or T-cell (15%) lineages (3) in the blood, bone marrow, and other lymphoid organs. Although it is one of the most common cancers in children, accounting for approximately 25% of all childhood cancer diagnoses among children under 15 years of age (4), adults can also develop ALL. About 40% cases of ALL diagnosed are in adults and among them about 50% present refractory disease or undergo relapse under current conventional therapies (4). The American Cancer Society estimates that almost 6,660 new cases of ALL will be diagnosed in the United States in 2022(5). In Europe, 7,000 cases of ALL are diagnosed each year (6). The number of patients in Japan was reported to be about 5,000 in a survey by the Japanese MHLW in 2017. The number of diagnosed incident cases of acute lymphocytic leukemia (ALL) in Europe, US, Japan and China is estimated to achieve 26,482 cases in 2029(7). (1) ASH Publication – Blood (2022) 140 (Supplement 1): 1045 - 1047 (2) Lennart Lenk, PhD, Irène Baccelli, PhD, Dorothee Winterberg, PhD, Anna Dietterle, Frédérique Corallo, MD, Julien Taurelle, Emma Narbeburu*, Anna Laqua, PhD, Beat Bornhauser, PhD, Jean-Pierre Bourquin, MD, PhD, Fotini Vogiatzi, PhD, Martin Schrappe, MD, Gunnar Cario, Monika Brüggemann, MD, Nicolas Poirier, PhD and Denis Martin Schewe, MD (3)DeVita, Jr. VT, Hellman S, Rosenberg SA, eds.; Cancer: Principles and Practice of Oncology, 10th ed.; Lippincott-Raven, Philadelphia, PA; 2014. (4) Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version, accessed October 2022 (5) American Cancer Society. Key 2022 Statistics for Acute Lymphocytic Leukemia (ALL). Available at: ., accessed October 2022 (6) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are not so rare: The rare cancer burden in Europe. Eur. J. Cancer. 2011; 47: 2493-2511. (7) Global Data 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). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.). Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic diseases (CRM); positive Phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases planned to be initiated end of 2024. ABBV-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. ABBV-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs. Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs. BiCKI® Platform is a bifunctional fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy by “cis-potentiating” tumor-specific T cells. A first program has been acquired by Boehringer Ingelheim. mRNA Therapeutic platform allows local delivery into the inflammatory site of innovative immunotherapies encoded by RNA to locally controls and/or suppress immune responses and inflammation. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: Follow us on Twitter and LinkedIn Contacts OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 U.S. Media Contact RooneyPartners LLC Kate Barrette kbarrette@rooneypartners.com +1 212 223 0561 Forward-looking statements This 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 in light of 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_240701_OSE-127 Blood

临床结果免疫疗法疫苗临床2期临床1期

2024-06-04

·美通社

勃林格殷格翰与OSE Immunotherapeutics扩大合作，开发肿瘤和心肾代谢疾病同类首创疗法

2024年5月31日 -- 近日，勃林格殷格翰和临床阶段生物技术公司OSE Immunotherapeutics SA (OSE)（ISIN：FR0012127173；Mnemo：OSE）宣布扩大合作。两个开发同类首创疗法的新项目将被添加到正在进行的抗 SIRPα肿瘤免疫项目中。第一个项目涉及扩大对已合作资产的治疗评估以覆盖更多患者，另一个涉及新资产收购：对抗SIRPα肿瘤免疫化合物BI 765063和BI 770371现有合作和许可协议进行了修订，这些化合物正在开展针对晚期实体瘤的I期临床研究，现在还将被用于在心肾代谢疾病中（CRM）进行开发研究。将通过资产收购启动基于OSE的cis靶向抗PD1/细胞因子平台的免疫细胞激活疗法的临床前项目。全球超过10亿人的生命受到CRM疾病影响，每年导致 2000 万人死亡。CRM疾病相互关联、共存，并且可以相互放大，给患者的生活造成重大负担。肿瘤导致近 1000 万人死亡，对于许多肿瘤患者来说，没有或只有有限的治疗选择。新的开发项目加强了勃林格殷格翰的产品管线，并体现了公司坚定不移的承诺，致力于探索和开发新疗法以满足患者的未尽需求，包括 CRM 疾病和肿瘤。cis靶向抗PD1/细胞因子平台资产将进一步丰富勃林格殷格翰一系列新型潜在免疫调节肿瘤疗法。正在进行的抗SIRPα化合物的新适应症开发加强了公司全面的CRM产品管线，并计划在今年晚些时候启动2期临床研究。勃林格殷格翰高级副总裁、全球发现研究负责人 Clive R. Wood 表示："我们非常高兴能够扩大我们潜在的同类首创 CRM 疾病产品管线，以及我们同类首创的基于 T 细胞的抗肿瘤疗法产品管线。与 OSE 扩大合作体现了我们的共同使命，那就是改善受到全球两大最威胁健康疾病患者的预后。" OSE Immunotherapeutics首席执行官 Nicolas Poirier 表示："我们对于将两个高度创新的新开发项目添加到我们与勃林格殷格翰已有的、富有成果的合作中感到兴奋。我们期待与勃林格殷格翰的科学家合作开展新的开发项目，这些项目有可能为 CRM 疾病和肿瘤患者带来新的突破性治疗选择。" OSE Immunotherapeutics将收到 1350万欧元的预付款，以及潜在的1750 万欧元近期里程碑付款，用于购买处于临床前阶段的新型cis靶向抗 PD-1/细胞因子资产。关于两项正在进行的抗 SIRPα项目BI 765063 和 BI 770371，双方达成部分特许权买断协议，勃林格殷格翰同意一次性支付 2530 万欧元。此外，勃林格殷格翰还将获得在进一步开发过程中进行额外收购的选择权，触发一次性付款并增加销售里程碑付款。所有其他约定的开发、监管和销售里程碑支付，最高可达11亿欧元，仍按照双方在初始协议下达成的协议保持不变。勃林格殷格翰是全球领先的生物制药企业，布局人用药品、动物保健两大业务领域。公司研发投入位居行业前列，致力于研究突破性疗法，解决巨大未满足的医疗需求，从而帮助改善或延长生命。自1885年成立以来，勃林格殷格翰一直是独立的家族企业，始终着眼长远发展，将可持续发展理念贯穿全价值链。公司在全球有超过5.35万名员工，服务逾130个市场，致力于打造一个更健康、更可持续、更公平的未来。更多详情，请访问：www.boehringer-ingelheim.com OSE Immunotherapeutics 是一家生物技术公司，致力于开发免疫肿瘤 (IO) 和免疫炎症 (I&I) 领域的同类首创资产。公司当前均衡的同类首创临床管线包括： Tedopi®（激活肿瘤特异性 T 细胞的免疫疗法，即用型，基于新表位）：这种肿瘤疫苗是该公司最先进的产品；在检查点抑制剂治疗失效后出现继发性耐药的非小细胞肺癌患者中开展的 3 期临床试验（Atalante 1）取得了积极结果。由临床肿瘤团队赞助的 Tedopi® 2 期临床试验联合治疗实体瘤正在进行中。 OSE-279（抗PD-1）：正在开展的针对实体瘤的1\/2 期临床试验已取得积极结果。 OSE-127 - lusvertikimab（IL-7 受体的人源化单克隆抗体拮抗剂）；正在开展针对溃疡性结肠炎 2 期临床试验（ OSE Immunotherapeutics赞助）；正在开展针对白血病临床前研究（OSE Immunotherapeutics）。 FR-104\/VEL-101（抗CD28单克隆抗体）：与Veloxis Pharmaceuticals, Inc.合作开发移植治疗；正在开展针对肾移植的1\/2 期临床试验（南特大学医院赞助）；在美国成功完成1期临床试验（ Veloxis Pharmaceuticals, Inc.赞助）。与勃林格殷格翰合作开发 BI 765063 和 BI 770371（CD47\/SIRPα 通路上的抗 SIRPα 单克隆抗体）用于治疗晚期实体瘤；在单药疗法和联合疗法中，特别是与抗PD-1抗体ezabenlimab一起，呈现出积极的第一阶段剂量递增结果。现在正在开展国际 1b 期临床试验，单独连用ezabenlimab 或与其他药物联用治疗复发\/转移性头颈鳞状细胞癌 (HNSCC) 和肝细胞癌 (HCC) 患者。 OSE-230（ChemR23 激动剂单克隆抗体）与 AbbVie 合作开发，用于治疗慢性炎症。 OSE Immunotherapeutics 期望进一步发掘其三个专有药物发现平台的重大价值，这些平台是公司实现提供下一代同类首创免疫疗法宏伟目标的核心： Pro-resolutive mAb平台专注于靶向和促进炎症消退，以及优化 I&I 中靶向中性粒细胞和巨噬细胞的治疗潜力。OSE-230（已授权给 AbbVie）是该平台生成的第一个候选药物，新的pro-resolutive GPCRs发现项目正在进行中。 Myeloid Checkpoint平台专注于通过靶向巨噬细胞和树突状细胞表达的免疫调节受体来优化 IO 中髓系细胞的治疗潜力。BI 765063 和 BI 770371（已授权给勃林格殷格翰）是该平台生成的最先进的候选药物。正在进行的其它研发项目，特别是在新的抗 CLEC-1 mAb 单药疗法中获得了积极的临床前结果。双功能检查点抑制剂\/细胞因子平台专注于利用I-O 和I&I 中细胞因子的顺式传递递送。BiCKI®是一个双功能融合蛋白平台，建立在抗PD1的关键骨架成分上，与新的免疫治疗靶点相结合，以提高抗肿瘤功效。内容来源于网络，如有侵权，请联系删除。

并购免疫疗法

2024-05-30

·GlobeNewswire-Health Care

OSE Immunotherapeutics Provides Business and Corporate Update

OSE Immunotherapeutics Provides Business and Corporate Update Three pharmaceutical agreements signed during the last three months: New strategic partnership with AbbVie for OSE-230, a novel preclinical potential first-in-class program for the treatment of chronic inflammation. Major partnership expansion with Boehringer Ingelheim: Amendment of the collaboration and licensing agreement on first-in-class SIRPα compounds already developed in immuno-oncology, now expected in Phase 2 in cardiovascular-renal-metabolic diseases later this year.New asset acquisition of a preclinical program which will be launched from the OSE’s cis- targeting anti-PD1/cytokine platform. Solid financial position to support implementation of the strategy until 2027, integrating the recent ‘France 2030’ public funding for Tedopi® pivotal clinical Phase 3 in lung cancer.Additional new experienced international executives who will support the next stages of the Company’s growth on the Board of directors will be present at the upcoming General Shareholders’ meeting. NANTES, France, May 30, 2024 – 6:15pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided business and corporate update after reinforcement of the Company’s business-model based on strategic pharmaceutical partnerships following the three recent new agreements concluded with AbbVie and Boehringer Ingelheim. These steps allow strategy implementation relying on both proprietary late-stage immunotherapy assets in oncology (Phase 3 in NSCLC to be launched) and inflammation (Phase 2 in Ulcerative Colitis with other potential indications), and in accelerating and strengthening first-in-class preclinical programs from its innovative discovery platforms. A strategic evolution of the Board of directors will be presented at the next General Shareholders’ meeting with seasoned pharmaceutical and global executives who will reinforce the Company’ international positioning. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We achieved major industrial partnerships from our differentiated immunological pipeline and our sustainable innovation engine. Our business-model, which is based on recurrent and strategic pharmaceutical partnerships, has been reinforced and allows us to develop our first-in-class clinical late-stage multi-products. We look forward to reaching new milestones in 2024, a transformative year for the Company with potential clinical inflection points from our proprietary and partnered assets, the anti-IL-7R monoclonal antibody Lusvertikimab in Phase 2 in Ulcerative Colitis and cancer vaccine Tedopi® in pivotal Phase 3 in Non-Small Cell Lung Cancer. We are preparing the next steps of the Company’s growth via our promising preclinical programs in immuno-inflammation and immuno-oncology.” Dominique Costantini, Chairwoman of OSE Immunotherapeutics, comments: “In just a few years, we have built a fully integrated biotech company with a rich and differentiated drug-candidate portfolio of both proprietary and partnered programs with pharmaceutical companies, highly recognized as experts in their development fields and markets. The OSE team has already delivered significant achievements and is working to discover and develop innovative immunotherapies. All these significant milestones position 2024 to be a transformational year for OSE with the ambition to become one of the key European biotechs in immunotherapy. We propose a strategic evolution of the Board of directors with both highly experienced and international pharmaceutical and financial experts who will be able to support the Company in its future strategic choice growth.” Corporate Evolution Four new independent directors will be proposed to the General Shareholders’ meeting on June 19th: Markus Goebel, MD, PhD, MBA Markus is a seasoned executive with 30+ year experience in the Life Science industry. He has deep understanding and broad hands-on experience across the entire value chain in various Pharma and Bio/Medtech positions including as a board member. Managing Director Novartis Venture Fund (2004-2019) in the United States & Europe with a top quartile track record. He is also founder & CEO of M&G Advisors GmbH (Bio-and Medtech consulting with a focus to fundraising and transactions). He completed his MBA with dissertation on innovation in the pharma industry to characterize blockbuster drugs. He is a certified MD in Oncology/Haematology (plus additional certifications) with more than 10 years in academia. Martine George, MD, M.Sc.Martine has a rich pharma and academic international expertise mainly in the United States. She is a proven leader of large development teams for global Fortune 500 pharmaceutical organizations and small biotechnology companies. She was Principal, Senior Executive consultant, Life Sciences in Global Development Associates, Inc., Skillman, NJ, a key contributor to strategies leading to multiple drug regulatory approvals or licensing/acquisitions and significant M&A. She was Vice President, Global Medical Affairs, Oncology, at Pfizer Inc., New York, NY, driving global medical strategy and worldwide medical affairs and reimbursement activities for oncology drugs. Previously, she served as Senior Vice President, Drug Development and Chief Medical Officer at GPC Biotech Inc., Princeton; Senior Vice President, Head of Oncology at Johnson & Johnson, Raritan, NJ; and Vice President, Medical Affairs at Rhone-Poulenc Rorer (Sanofi-Aventis), Collegeville, PA. She began her carreer at Sandoz Pharmaceuticals Corporation (Novartis), East Hanover, NJ, and previously at American Cyanamid Pearl River, NY. She has a strong expertise in clinical research, medical affairs, and regulatory affairs specializing in oncology and other therapeutic areas. Her extensive Board experiences were also acquired in large and small companies; in public and private (i.e Phaxiam/ Erytech/ GammaMabs/ Cytomics, Inc/ Non-for-profit organizations Breast Cancer Research Foundation, New York, NY/Ressource Center for Women & Their Families, Hillsborough, NJ). Cécile Nguyen-Cluzel:Cécile has extensive experience in financial engineering and healthcare private equity. After nearly 30 years investing in French small cap funds (Initiative & Finance, MBO +), Cécile joined the London-based pan-European fund Apposite Capital in January 2024 as Senior Advisor in healthcare for France and Europe. Over the course of her career, she has acquired specific expertise in the growth and buyout of companies (investments of between €10m and €40m) in a variety of healthcare sectors, such as diagnostics (spin-off of Cerba in 1998), healthcare services (orthoprosthetists, nuclear medicine), CROs and digital health. Cécile has regularly held positions on the strategic committees of her portfolio companies. Cécile holds a Master “Ingéniérie financière” Dauphine and the ‘Leading the digital transformation in healthcare’ certificate from Harvard medical school. Marc Dechamps Marc is a biologist with extensive experience in the pharmaceutical industry dating back more than 35 years. During his career, he has worked for corporate pharma companies including GSK & ViiVHealthcare, building his expertise in market development for new products in infectious diseases, immunological disorders, oncology, CNS disorders and vaccines. In 2016, Marc founded and became Managing Director of XMF consulting, a company which supports biotech and biopharma businesses with strategic advice. He has also served as Managing Director of Delphi Genetics (CDMO) and interim CEO of eTheRNA Immunotherapies (mRNA biotech company). Presently, he is CEO of Bioxodes, a phase 2a clinical stage biotech company (prevention of thrombosis and neuroinflammation in hemorrhagic stroke patients). He also serves also as President of the board of InvestSud Tech (group InvestSud) and board member of HealthTech for Care (HT4C). Marc is co-academic Director for the advanced masters in biotech & medtech ventures at the Solvay Brussels School of Economics & Management. Strategic announcements since early 2024 On February 28th, OSE Immunotherapeutics and AbbVie announced partnership to develop OSE-230, a novel monoclonal antibody for the treatment of chronic inflammation. OSE received a $48 million upfront payment upon signature of this strategic partnership and is eligible to receive up to $665 million potential additional milestones. On April 10th, OSE Immunotherapeutics received €8.4 million in non-dilutive public funding as part of the France 2030 “i-Démo” program to support the Phase 3 registration clinical trial of cancer vaccine Tedopi® in lung cancer. On May 24th, OSE Immunotherapeutics and Boehringer Ingelheim expanded their collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases. OSE received a total €38.8 million payment after strengthening its partnership with Boehringer Ingelheim for the development of anti-SIRPα programs in oncology and cardio-renal-metabolic diseases, as well as the launch of a new preclinical asset from OSE’s cis-targeting anti-PD1/cytokine platform; and up to €1.1 billion in potential additional milestones. 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). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors.OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics).FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.). Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic diseases (CRM); positive Phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases planned to be initiated end of 2024.OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs.Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs.BiCKI® Platform is a bifunctional fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Sylvie Détrysylvie.detry@ose-immuno.comNicolas PoirierChief Executive Officer nicolas.poirier@ose-immuno.comFrench Media: FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooneyPartners 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 in light of 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, 2023, 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_240530 Business and corporate Updates-vf

临床2期高管变更临床3期疫苗临床1期

100 项与 Lusvertikimab 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
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	澳大利亚	Adir SRL	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	匈牙利	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	西班牙	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	英国	Adir SRL	2021-08-03
溃疡性结肠炎	临床2期	白俄罗斯	OSE Immunotherapeutics SA	2020-10-02
溃疡性结肠炎	临床2期	比利时	OSE Immunotherapeutics SA	2020-10-02
溃疡性结肠炎	临床2期	保加利亚	OSE Immunotherapeutics SA	2020-10-02

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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


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)	衊願醖壓鏇鹹獵顧壓積(網遞鹽衊遞夢選鹽齋齋) = 網膚襯淵積簾顧夢鏇觸淵醖蓋鹹構選築顧鬱簾 (衊範觸願繭艱願遞淵簾, 積襯醖壓簾願繭鬱壓網 ~ 獵觸網觸願醖齋夢餘夢) 更多	-	2024-04-23
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	衊願醖壓鏇鹹獵顧壓積(網遞鹽衊遞夢選鹽齋齋) = 範製獵築艱願齋繭遞鑰淵醖蓋鹹構選築顧鬱簾 (衊範觸願繭艱願遞淵簾, 範範觸膚鹽蓋齋範衊鬱 ~ 襯繭壓憲鏇壓衊築廠壓) 更多