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.

Start Date03 Aug 2021

Sponsor / Collaborator

Institut de Recherches Intern Servier

[+1]

NCT04882007

/ CompletedPhase 2

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.

Start Date02 Oct 2020

Sponsor / Collaborator

OSE Immunotherapeutics SA

NCT03980080

/ CompletedPhase 1

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.

Start Date19 Dec 2018

Sponsor / Collaborator

OSE Immunotherapeutics SA

[+1]

100 Clinical Results associated with Lusvertikimab

100 Translational Medicine associated with Lusvertikimab

100 Patents (Medical) associated with Lusvertikimab

Literatures (Medical) associated with Lusvertikimab

27 Jun 2024·Blood

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

Article

Author: 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 ; Taurelle, Julien ; Escherich, Gabriele ; Raffel, Simon ; Déramé, Mylène ; Bourquin, Jean-Pierre ; Laqua, Anna ; Bornhauser, Beat ; Schrappe, Martin ; Schewe, Denis M. ; Reimer, Claas ; Mary, Caroline ; Vogiatzi, Fotini ; 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.

15 Mar 2023·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

Author: Costantini, Dominique ; Conduzorgues, Jean-Pascal ; Poirier, Nicolas ; Abès, Riad ; Teppaz, Géraldine ; Volckaert, Bram ; 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.

News (Medical) associated with Lusvertikimab

03 Mar 2026

·firstwordpharma.com

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.

VaccineLicense out/inPhase 2Phase 1

03 Mar 2026

·www.biospace.com

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

Phase 2Phase 3ImmunotherapyPhase 1

03 Mar 2026

·www.biospace.com

Boehringer Ingelheim Axes MASH Pact With OSE After Disappointing Mid-Stage Data

iStock, Polinmr OSE Immunotherapeutics has kicked off a strategic realignment initiative that involves deprioritizing the AbbVie-partnered OSE-230 and focusing its resources on the late-stage development of its ulcerative colitis candidate lusvertikimab. Boehringer Ingelheim is abandoning its metabolic dysfunction-associated steatohepatitis program with OSE Immunotherapeutics after a mid-stage study fell short of its primary endpoint. Specifically, results from an exploratory Phase 2 study “did not demonstrate efficacy to support further development in this indication,” OSE said in a Monday release . The French biotech did not reveal specific data from this trial. OSE and Boehringer first partnered up in April 2018 . The German pharma at the time paid €15 million ($17.5 million) upfront and promised an additional €15 million ($17.5 million) in near-term commitments and up to €1.1 billion ($1.28 billion) in development, commercialization and sales milestones. In May 2024, the companies deepened their engagement . The MASH candidate, called BI 770371, was part of this expanded agreement. It is unclear if the alliance will remain, but on its website , OSE lists BI 770371 as its only Boehringer Ingelheim–partnered asset. The discontinuation of the MASH program does not affect BI 770371’s development in cancer, for which the molecule has a distinct mechanism of action, OSE said. There are “multiple” early-stage oncology studies running, which are “progressing as planned.” Boehringer’s pullback on Monday seems to have triggered a strategic restructuring initiative. OSE is suspending the development of its investigational antibody OSE-230, which it was proposing for chronic and severe inflammation, in order to funnel more of its resources into “late-stage, high-potential assets,” the company said. In particular, OSE will concentrate on advancing the CD127 blocker lusvertikimab, which recently wrapped up Phase 2 development for moderate to active ulcerative colitis. According to a strategic roadmap released Monday, OSE is currently working on a subcutaneous formulation of lusvertikimab, which it expects to be ready by the first half of 2027. A Phase 2b/3 trial in ulcerative colitis could start later that same year. OSE will also develop lusvertikimab for chronic pouchitis and hidradenitis suppurativa, with initial Phase 2 data expected in 2028. OSE-230, the deprioritized asset, is partnered with AbbVie and has also been a source of headache for the biotech. AbbVie and OSE first partnered in February 2025 , with the pharma paying $48 million upfront for the exclusive right to advance and commercialize the asset. In December 2025, however, AbbVie amended the agreement and asked OSE to assume responsibility over preclinical and Phase 1 development. While AbbVie still retains the right to take charge of future clinical studies, OSE will now have to shoulder ABBV-230’s early-stage development.

Phase 2License out/inPhase 1PROTACs

100 Deals associated with Lusvertikimab

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sjogren's Syndrome	Phase 2	France	OSE Immunotherapeutics SA	30 Jan 2022
Primary Sjögren's syndrome	Phase 2	United States	Institut Servier de Medecine Translationnelle SARL	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	United States	Institut de Recherches Intern Servier	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	Australia	Institut Servier de Medecine Translationnelle SARL	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	Australia	Institut de Recherches Intern Servier	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	France	Institut de Recherches Intern Servier	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	France	Institut Servier de Medecine Translationnelle SARL	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	Germany	Institut Servier de Medecine Translationnelle SARL	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	Germany	Institut de Recherches Intern Servier	03 Aug 2021
Primary Sjögren's syndrome	Phase 2	Hungary	Institut de Recherches Intern Servier	03 Aug 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04882007 (CoTikiS, GlobeNewswire) Manual	Phase 2	Colitis, Ulcerative	136	Lusvertikimab	-	Positive	04 Nov 2024
				Lusvertikimab (850mg)	ufeqonrbrc(etzmivhfsc) = mcasnpqzrg qkovozdjkp (zqxxbdxljv ) Met View more
NCT04882007 (CoTikiS, PipelineReview) Manual	Phase 2	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe	136	Lusvertikimab	zqegefmfcl(hgdetrudur) = 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. qmllcyzqgd (pluecscoyt )	Positive	24 Jul 2024
				Lusvertikimab (850 mg group)
NCT04605978 (EULAR 12024 \| EULAR 22024) Manual	Phase 2	Primary Sjögren's syndrome	48	S95011	wwmyhucgix(moqmfmhonh) = liemwgotid cagpjqpaox (wnakkahubu, 6.5) View more	Negative	14 Jun 2024
				Placebo	wwmyhucgix(moqmfmhonh) = jgnmtsbyfo cagpjqpaox (wnakkahubu, 4.4) View more
NCT04605978 (CTgov)	Phase 2	Primary Sjögren's syndrome	48	S95011 concentrate for solution for infusion (S95011 Concentrate for Solution for Infusion)	rdxpynkldu(zfapzntocd) = dqrfuyripx fxfzdldjip (nuhyhqtojr, 4.55) View more	-	23 Apr 2024
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	rdxpynkldu(zfapzntocd) = eqadvzmsza fxfzdldjip (nuhyhqtojr, 4.89) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis