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

/ Completed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）

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 ; Braudeau, Cécile ; Pengam, Sabrina ; 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.

项与 Lusvertikimab 相关的新闻（医药）

2026-03-03

·Firstwordpharma

OSE reshuffles pipeline amidst setbacks on Boehringer, AbbVie partnered programmes

After AbbVie handed early-stage development rights for a mAb back to OSE Immunotherapeutics, the immunology-focused drug developer is pausing the programme's development. AbbVie paid $48 million upfront in 2024 for an exclusive global license to OSE-230 and is on the hook for up to $665 million in milestones. The mAb, designed to activate the GPCR target ChemR23 and modulate both macrophages and neutrophils, was in development for chronic and inflammatory diseases. However, OSE disclosed in December that, under an amendment to the licensing deal, it will be responsible for preclinical and Phase I development of OSE-230, noting that such development is "contingent upon securing adequate funding." If OSE successfully completes Phase I testing, AbbVie, which still holds an exclusive license to the asset, would resume full development and commercialisation rights.Now it's looking like OSE doesn't have the capital to commit towards OSE-230's early development right now. The company said Monday it will pause development of the programme and instead focus on a pair of late-stage assets: Tedopi, a T-cell epitope-based cancer vaccine in Phase III testing for non–small-cell lung cancer (NSCLC) and lusvertikimab (OSE-127), a mAb directed against CD127 being explored for chronic pouchitis and hidradenitis suppurativa. Another asset affected by the reprioritisation is OSE's CLEC‑1 programme in oncology, for which the company will discontinue all exploratory research activities. While OSE called the programme "scientifically promising," it noted that the early myeloid checkpoint target "does not fall within…immediate clinical or partnership priorities.""By stepping away from selected early‑stage programmes which were not expected to generate meaningful value inflection points over our three-year strategic programme, we are concentrating our resources where OSE can create the greatest value in the near term," said CEO Marc Le Bozec. "This strengthened focus enhances our ability to deliver late‑stage clinical progress, secure meaningful partnerships, and accelerate Tedopi and lusvertikimab."Boehringer mAb's MASH dudAlong with the pipeline reshuffle, OSE also shared that another partnered programme has hit a bump in the road.The biotech first linked up with Boehringer Ingelheim in 2018 to jointly develop an anti-SIRPα antibody for cancer; in 2024, the German pharma elected to expand the development programme for BI 770371 to include cardiovascular-renal-metabolic (CRM) diseases, paying a one-time "partial royalty buy-out" of €25.3 million ($27.4 million).However, the play doesn't seem to have paid off. OSE said that Boehringer has discontinued development of BI 770371 in metabolic dysfunction-associated steatohepatitis (MASH) after it "did not demonstrate efficacy" in an exploratory Phase II study. OSE emphasised that the candidate's development in oncology is unaffected, with multiple Phase I studies underway.

疫苗引进/卖出临床2期临床1期

2026-03-03

·抗体圈

勃林格叫停合作项目，这家 biotech 管线大瘦身

摘要：法国生物科技公司 OSE 继去年 12 月与艾伯维的炎症药物合作终止后，今年 3 月又因一款 SIRPα 拮抗剂在 MASH 二期临床未显效，失去与勃林格殷格翰的相关合作。OSE 随即再次精简研发管线，暂停多款早期项目，将全部研发资源聚焦于两款核心后期资产，试图在资金与研发效率间找到平衡。合作黄了，MASH 项目折戟就在 3 月初，OSE 又一次站在了管线调整的路口。这次的原因，是和勃林格殷格翰联手开发的 BI 770371，在针对 MASH 相关肝硬化的二期临床里，没看到预期的治疗效果。这款 SIRPα 拮抗剂本是双方的重要布局，它能阻断肿瘤的 “别吃我” 信号，原本在肿瘤领域的研发走得挺顺，后来双方才把合作范围扩到代谢疾病。有意思的是，OSE 透露这款药在 MASH 研究里的安全性还不错，只是疗效没跟上，勃林格也没完全放弃它，只是把研发重心拉回了最初的肿瘤领域。其实这已经是 OSE 半年内第二次因合作方退出调整管线了。去年 12 月，艾伯维放弃了其炎症药物 OSE-230 的开发权，当时 OSE 就已经开始收缩战线，没想到才过三个月，又要因合作告吹重新规划。管线大瘦身，砍停多个早期项目面对接连的合作变故，OSE 选择了快刀斩乱麻，直接把研发管线里的 “非核心项” 清了一遍。首先是去年刚从艾伯维手里拿回的 OSE-230，这款慢性炎症药物的研发直接按下暂停键。这款抗 ChemR23 单克隆抗体，原本还在临床前和一期临床阶段，如今也暂时退出了 OSE 的研发清单。还有肿瘤领域的 CLEC-1 项目，也因为不在公司近期的优先级里，彻底终止了研究。 OSE 自己倒也看得开，说这些受影响的项目，未来三年都没什么里程碑付款的可能，所以这次调整并不会影响公司的现金流。坦白讲，这种果断砍停的操作，在烧钱的生物科技领域，其实也算常规操作了。押宝两款核心，赌后期临床突围砍了这么多项目，OSE 的研发重心也彻底明确了 —— 把所有鸡蛋都放进两个篮子里，就是两款最成熟的后期资产。第一个是 lusvertikimab，一款 IL-7 抗体，分静脉和皮下两种给药形式，目前主要在研究治疗溃疡性结肠炎，还有望用于慢性袋炎和化脓性汗腺炎。这款药的临床数据其实还不错，之前的试验里，九成以上的患者能维持症状缓解，算是 OSE 手里的一张好牌。另一款是 Tedopi，一款现成的新表位肿瘤疫苗，主攻非小细胞肺癌、卵巢癌和胰腺癌。今年二季度，这款疫苗的卵巢癌二期临床顶线数据就要公布了，还有两项非小细胞肺癌的临床数据也会在今年出炉，这几个数据节点，大概率会成为 OSE 接下来的关键看点。 OSE 的 CEO 说，这次调整就是为了把资源集中在能快速创造价值的项目上。只是生物科技的研发本就充满未知，押宝两款核心资产，能不能让公司在后续的临床和市场里站稳脚跟，现在还真不好说。目前公司也在积极找融资，想为这两款药的后期临床铺路，后续的进展，只能慢慢看了。参考来源：https://www.fiercebiotech.com/biotech/boehringer-axes-mash-deal-ose-biotech-continues-whittle-down-pipeline 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

临床2期疫苗引进/卖出

2026-03-03

·BioSpace

OSE Immunotherapeutics Accelerates Strategic Refocusing to Advance Late Stage Value Drivers Lusvertikimab and Tedopi®

Streamlining of selected non‑strategic early-stage programs completed, consistent with previously announced three-year 2026-2028 strategic plan No impact on cash runway or financing strategy as no milestone associated with these programs was expected within this three-year timeframe Focused investment on high‑value late‑stage assets Lusvertikimab and Tedopi® Multiple clinical catalysts expected from 2026 to 2028 Nantes, France, March 2, 2026 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced a targeted realignment of its R&D portfolio to reinforce execution of its previously announced 2026-2028 strategic plan. The Company will pause development of OSE‑230, allowing OSE to focus its resources on late‑stage, high‑potential assets lusvertikimab (OSE‑127) and Tedopi®. These two assets are expected to generate multiple clinical catalysts over the next three years. At the same time, Boehringer Ingelheim has decided to discontinue BI 770371 in MASH following completion of an exploratory Phase 2 study that did not demonstrate efficacy in this indication. The treatment was well tolerated with a manageable safety profile, and this indication‑specific decision does not affect the molecule’s ongoing oncology development, where multiple Phase 1 studies continue as planned. Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics, commented: “These decisions mark a disciplined evolution of our portfolio. By stepping away from selected early‑stage programs which were not expected to generate meaningful value inflection points over our three-year strategic program, we are concentrating our resources where OSE can create the greatest value in the near term. This strengthened focus enhances our ability to deliver late‑stage clinical progress, secure meaningful partnerships, and accelerate Tedopi® and lusvertikimab, the cornerstone assets of our 2026–2028 roadmap. In parallel, the Company continues to actively assess financing options to fully support the progression of its late‑stage clinical portfolio.” OSE‑230: Strategic Focus on Near‑Term Value OSE Immunotherapeutics has decided to pause OSE‑230 as part of its ongoing portfolio prioritization and disciplined capital allocation strategy. This decision, following an amendment to the collaboration agreement with the development partner in December 2025, reflects the Company’s focus on advancing its most mature clinical programs and near‑term value drivers. OSE Immunotherapeutics will continue to assess opportunities to maximize value across its broader pipeline. BI 770371: Partner‑Led Realignment, Focus on Oncology Although BI 770371 was well tolerated with a manageable safety profile, Boehringer Ingelheim has decided to discontinue development of BI 770371 for people with liver cirrhosis caused by MASH after an exploratory Phase 2 study (NCT06675929) did not demonstrate efficacy to support further development in this indication. This MASH decision does not impact BI 770371’s ongoing oncology development, which was the initial and lead program of the OSE and Boehringer Ingelheim collaboration, where the mechanism of action is distinct and multiple Phase 1 programs remain active and progressing as planned. Additional Pipeline Prioritization As part of the Company’s ongoing portfolio streamlining, OSE will also discontinue exploratory research activities related to the CLEC‑1 programme in oncology, an early myeloid checkpoint target still at preclinical stage. While scientifically promising, CLEC‑1 in oncology does not fall within the Company’s immediate clinical or partnership priorities. This decision further aligns OSE’s portfolio with its late‑stage value creation strategy. Expected Value Inflection Points over OSE’s three-year strategic plan (2026-2028) On January 29, 2026 1 , OSE announced the selection of chronic pouchitis and hidradenitis suppurativa (HS) as the next potential targeted indications for lusvertikimab (OSE‑127), based on strong IL‑7R‑driven biological rationale. In parallel, the Company is developing a subcutaneous formulation to advance lusvertikimab in ulcerative colitis (UC) and completing the Tedopi® Phase 3 in NSCLC. This 2026-2028 strategic plan comes with significant expected value inflection points, including 2 : Q2 2026: Tedopi® Ovarian Cancer Investigator Sponsored Trial Phase 2 read-out Q3 2026: Tedopi® NSCLC Pivotal Phase 3 interim futility analysis H2 2026: Tedopi® 2L NSCLC combo Investigator Sponsored Trial Phase 2 read-out H1 2027: Lusvertikimab sub-cutaneous formulation readiness H2 2027: Possible start of Ulcerative Colitis Phase 2b/3 Q1 2028: Tedopi® NSCLC Pivotal Phase 3 read-out 2028: Lusvertikimab 1st Phase 2 read-out in pouchitis or hidradenitis suppurativa. 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 listed on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: . Follow us on LinkedIn . Contacts OSE Immunotherapeutics: investors@ose-immuno.com FP2Com: Florence Portejoie: fportejoie@fp2com.fr I +33 6 07 768 283 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 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, 2025, including the annual financial report for the fiscal year 2024, 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 EN_260129_OSE-Immunotherapeutics-New-Indication-127_vdef.pdf 2 Timeline dependent on financial capabilities Attachment EN_260302_OSE Immunotherapeutics_PipelineUpdates_FINAL

临床2期临床3期免疫疗法临床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
干燥综合征	临床2期	法国	OSE Immunotherapeutics SA	2022-01-30
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	美国	Institut Servier de Medecine Translationnelle SARL	2021-08-03
原发性干燥综合征	临床2期	澳大利亚	Institut Servier de Medecine Translationnelle SARL	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	Institut Servier de Medecine Translationnelle SARL	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
原发性干燥综合征	临床2期	德国	Institut Servier de Medecine Translationnelle SARL	2021-08-03
原发性干燥综合征	临床2期	匈牙利	Institut de Recherches Intern Servier	2021-08-03

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临床结果

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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)	觸構襯餘鹽獵廠憲鏇簾(膚鬱遞淵夢醖鏇簾壓夢) = 襯獵夢糧製鹹範窪積構蓋觸壓遞蓋膚顧齋壓鹽 (廠鬱積憲製鏇範簾簾簾 ) 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	遞築構壓範蓋壓網遞壓(繭網鹹選鹽鬱鏇獵製簾) = 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. 選鏇衊窪鹽蓋網餘製齋 (廠醖顧淵顧夢衊艱選壓 )	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	廠壓壓範構鏇糧艱餘網(蓋淵鏇繭衊網壓網鏇網) = 夢製糧製選窪顧選築艱憲齋顧襯觸製製顧鹽願 (選鑰遞網簾製餘獵觸夢, 6.5) 更多	不佳	2024-06-14
				Placebo	廠壓壓範構鏇糧艱餘網(蓋淵鏇繭衊網壓網鏇網) = 糧鹹衊獵簾壓製衊醖網憲齋顧襯觸製製顧鹽願 (選鑰遞網簾製餘獵觸夢, 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)	蓋憲鑰簾鏇艱鹹繭廠鹽(鹹餘網遞鬱淵蓋簾鹽齋) = 遞窪壓鹹窪觸鹽獵範鏇構網觸糧鏇襯醖顧選獵 (窪鬱餘顧顧繭遞衊繭網, 4.55) 更多	-	2024-04-23
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	蓋憲鑰簾鏇艱鹹繭廠鹽(鹹餘網遞鬱淵蓋簾鹽齋) = 壓鏇選壓範糧製製築鏇構網觸糧鏇襯醖顧選獵 (窪鬱餘顧顧繭遞衊繭網, 4.89) 更多