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 ; 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.

News (Medical) associated with Lusvertikimab

29 Jan 2026

·www.biospace.com

OSE Immunotherapeutics Selects Chronic Pouchitis and Hidradenitis Suppurativa as New Key Indications for Lusvertikimab

OSE Immunotherapeutics Selects Chronic Pouchitis and Hidradenitis Suppurativa as New Key Indications for Lusvertikimab Development built on strong IL-7R biological rationale Chronic Pouchitis offers a capital-efficient rare-disease path with fast route to market Hidradenitis Suppurativa enables rapid proof-of-concept in a large dermatology market First Phase 2 clinical trial expected to start in H2 2026, subject to financing Ulcerative Colitis remains a key indication to be partnered Nantes, France, January 29, 2026 – 7:30am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced the selection of two new clinical indications for lusvertikimab (OSE-127): chronic pouchitis and hidradenitis suppurativa (HS). These indications were chosen based on strong, IL-7R-driven biology and are fully aligned with the Company’s 2026–2028 strategic plan to expand lusvertikimab into targeted, high value immune-mediated diseases. Development of one or both indications will proceed subject to financing, with the first Phase 2 clinical trial planned to initiate in H2 2026. A Science-Led Selection of Two High-Value Indications with Significant Unmet Medical Need Chronic pouchitis and HS both exhibit robust translational alignment with IL-7R biology, including T cell-driven inflammation and dysregulation of IL-7/IL-7R pathway and overexpression in diseased tissues. This mechanism mirrors ulcerative colitis, where lusvertikimab has demonstrated statistically significant Phase 2 efficacy and favorable safety profile. Together, the data support lusvertikimab’s potential as a differentiated immunology platform across multiple immune-driven diseases. Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics commented: “We selected pouchitis and hidradenitis suppurativa because both indications present compelling scientific rationale for lusvertikimab, which could become the first-in-class IL-7R antagonist to reach the market. Pouchitis is a natural extension of our ulcerative colitis work and, due to its well-defined population, represents a rare-disease opportunity we can advance independently at a reasonable cost. HS, by contrast, is a much larger dermatology indication where we can move quickly toward a proof-of-concept readout with a highly differentiated asset. Our goal is to initiate a first Phase 2 study in the second half of 2026, subject to financing. Together, these indications reinforce our strategy and strengthen the long-term potential of lusvertikimab as a differentiated immunology platform with multi-billion peak sales potential.” Chronic Pouchitis: Rare, High-Need and Capital-Efficient Approximately 30% of patients with ulcerative colitis are refractory to available therapies and require proctocolectomy with ileal pouch-anal anastomosis (IPAA), an artificial rectum surgically created 1 . Approximately 70% of these patients undergoing surgery will develop pouchitis. 3 Pouchitis is an inflammatory condition of the ileal pouch. Symptoms include increased stool frequency, urgency, and abdominal discomfort, significantly affecting patients’ quality of life. Traditionally the mainstay treatment of acute pouchitis involves the use of antibiotics, but approximately 15% of patients, or an estimated 45,000 patients across the European Union, North America and Japan 2 , 3 , develop chronic pouchitis, which poses significant challenges in terms of management and is an area of significant unmet medical need (only one EMA-approved therapy to date and no FDA-approved options). With a clearly identifiable population, pathogenetic continuity with ulcerative colitis, and limited competition, chronic pouchitis is a high-value, capital-efficient opportunity for OSE to pursue independently. Hidradenitis Suppurativa: Large Dermatological Indication with Fast Proof-of-Concept Potential HS is an inflammatory disorder characterized by recurrent suppurative and painful nodules, abscesses and draining sinus tracts primarily in intertriginous areas of the skin. While not a rare disease, affecting approximately 1% of the general population 4 or an estimated 9.5M individuals across Europe, North America and Japan2, HS is a condition rarely talked about, with patients waiting an average of up to 10 years to receive a proper diagnosis. HS is associated with tremendous impact on quality of life: visible skin lesions associated with intense pain, an unpleasant smell and scarring can cause patients to experience social stigma and depression. An estimated 0.5-0.6M moderate-to-severe patients may be eligible for biologic therapy. 2, 5 Despite several approved biologics, many patients remain inadequately controlled over the long term. HS shows intense Th1/Th17 activation and increased IL-7R expression, offering a strong biological rationale for IL-7R blockade. The indication enables rapid clinical readouts, supporting a fast, data-driven proof-of-concept strategy in a large, high-value immune-dermatology market. Next Steps and Timelines: First Phase 2 study initiation: H2 2026 (either Chronic pouchitis or HS), subject to financing. Second Phase 2 study initiation: H1 2027, contingent on financing. These studies complement the subcutaneous Ulcerative Colitis program, support a balanced late-stage diversification strategy across near-term rare disease and mid-term dermatology, and enhance partnering optionality by demonstrating the breadth and therapeutic relevance of IL-7R biology. Both studies are designed to be capital-efficient and to deliver clear evidence of differentiated clinical efficacy and safety. In parallel of developing these two new indications, OSE will advance the Ulcerative Colitis indication through developing a subcutaneous formulation of lusvertikimab and aims to partner this asset once bioequivalence data have been generated. Additional scientific evidence will be generated to further validate the biomarker signature potentially predictive of a strong clinical response identified in the Lusvertikimab Phase 2 CoTikiS study. Confirming these early findings with a subcutaneous formulation would position Lusvertikimab in Ulcerative Colitis as a game changer in the treatment of this disease, and significantly enhance the attractiveness of this asset for potential partners. 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: Fiona Olivier: fiona.olivier@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 Sriranganathan D, Kilic Y, Nabil Quraishi M, et al. Colorectal Dis 2022;24:27–39 2 Company estimates based on available literature and third-party sources 3 Inflammatory Bowel Diseases, Volume 31, Issue 2, February 2025, Pages 597–600 4 JAMA Dermatol. 2025 Aug 27;161(10):1022-1028. doi: 10.1001/jamadermatol.2025.2373. 5 Attachment EN_260129_OSE Immunotherapeutics - New Indication 127_vdef

Phase 2Immunotherapy

09 Dec 2025

·www.fiercebiotech.com

Ose narrows focus to conserve cash at expense of wider pipeline

Ose Immunotherapeutics CEO Marc Le Bozec said the strategy is “ambitious yet realistic for a company our size.” \n Ose Immunotherapeutics is prioritizing its lung cancer med Tedopi and shifting the strategy for its ulcerative colitis (UC) therapy lusvertikimab as the French biotech maps out a financially sustainable path forward.In October, the biopharma warned that the 25.4 million euros ($29.5 million) it ended the second half of the year with could run dry in the fourth quarter of 2026. “In the absence of additional short-term funding, the company is not able to finance all of its activities on a 12-month horizon,” Ose pointed out at the time.To address this looming financial cliff-face, this morning Ose unveiled a three-year strategy that focuses squarely on two of Ose’s most advanced assets. One of these is Tedopi, an “off-the-shelf” neo-epitope-based vaccine that the company has previously touted as having “pipeline in a product” potential.Ose read out phase 2 data earlier this year linking Tedopi to a 12-month overall survival rate of 65% among patients with advanced or metastatic pancreatic ductal adenocarcinoma. The company has been running five clinical trials of Tedopi in various oncology indications, including a phase 3 study in non-small cell lung cancer (NSCLC), while phase 2 readouts in NSCLC and ovarian cancer had both been expected next year.Today, Ose name-checked the phase 3 NSCLC study as one of four “value-creating opportunities” the company has identified. The late-stage study will “require limited additional financial resources from OSE and ongoing investigator-led phase 2 studies could also add additional proof-of-concept data at minimal cost,” the company noted.The other asset at the center of Ose’s new priorities is lusvertikimab, an IL-7 antibody that is being investigated in both intravenous and subcutaneous formulations. While Ose said that “great” phase 2 data had been generated for intravenous lusvertikimab as a treatment for UC, the company noted this morning that the “overall UC market is almost entirely focused on more convenient oral and subcutaneous formulations.”“OSE has therefore decided to pivot the UC indication to a subcutaneous formulation of lusvertikimab and aims to partner this asset once bioequivalence data have been generated,” the biopharma explained.Work on intravenous lusvertikimab will now be focused on targeting “one or two new rare or specialty diseases with high unmet medical needs.”“These clinical developments will require more modest financial investment than further development in UC and will expand the asset’s potential to treat multiple immune-mediated conditions, with a faster route to market,” explained Ose. “Indications and clinical development plans are being refined and will be disclosed in early 2026.”The future of the rest of Ose’s pipeline is less clear, with the company stating that “beyond these priorities, other proprietary assets will advance in preclinical development at limited cost to maximize partnership opportunities.”This portfolio includes the anti-PD1 monoclonal antibody OSE-279, which was undergoing a phase 1/2 study in solid tumors, as well as the CD28 antagonist pegrizeprument. There’s also the Boehringer Ingelheim-partnered SIRPa antagonist BI 770371 that is being developed for metabolic dysfunction-associated steatohepatitis. A potential 17.5 million euro ($20.4 million) milestone payment from Boehringer “would significantly reduce financing needs” if it arrives, Ose pointed out.Then there’s the AbbVie-partnered chronic inflammation drug ABBV-230. Only yesterday, AbbVie handed back phase 1 development duties for ABBV-230 to AbbVie, with Ose noting that taking the drug into the clinic would be “contingent upon securing adequate funding.”Ose CEO Marc Le Bozec said the strategy outlined this morning “positions OSE for success by concentrating resources where they can create the most value for all our stakeholders over the next three years.”“It’s ambitious yet realistic for a company our size,” Le Bozec continued.“We’ve reached an inflection point where we focus on programs with the greatest potential for near-term catalysts and return, while preparing to partner assets that require larger scale once they are phase 3-ready,” the CEO added. “Our plan strikes the right balance between clinical risk and financial opportunity, prioritizing late-stage assets and keeping our research engine strong.”

Phase 2Phase 1VaccinePhase 3Immunotherapy

29 Aug 2025

·www.globenewswire.com

OSE Immunotherapeutics Reaffirms its Strategic Priorities and Publishes Shareholder Q&A to Restore Information Ahead of AGM

OSE Immunotherapeutics Reaffirms its Strategic Priorities and Publishes Shareholder Q&A to Restore Information Ahead of AGM Nantes, August 29, 2025, 8:00 a.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today published a comprehensive Questions and Answers document in advance of its Annual General Meeting (AGM) convened on September 30, 2025. The document provides clear, factual information about financing, governance, scientific development and the Company’s strategy. OSE Immunotherapeutics’ strategy is to capitalize on its two flagship programs, Tedopi® and Lusvertikimab, expected to advance through a combination of strategic partnerships and appropriate financing mechanisms, while continuing to progress its productive Research activities. The Company’s late-stage programs are designed to create significant value and position OSE as a leading European biotech in the field of immunotherapy in oncology and inflammation. However, OSE Immunotherapeutics has been the target of intense shareholder activism, characterized by an unprecedented public misinformation campaign led by a group of minority shareholders. These tactics have generated confusion and distorted facts in the lead-up to the Annual General Meeting (AGM). Didier Hoch, Chairman of OSE Immunotherapeutics, commented: “The AGM on September 30 is a decisive moment for OSE. Shareholders are being asked to choose between a credible, value-creating strategy, grounded in advancing Tedopi® and Lusvertikimab and securing the right partnerships when pivotal data are available, or the uncertainty of entrusting the Company to a small group of minority private interests whose proposals lack industrial coherence, financial credibility, and a viable roadmap for sustainable development.” Clear Strategy, Focused on Value Creation OSE’s strategy is to preserve strategic optionality in the advancement of its two lead assets Tedopi® and Lusvertikimab, ensuring the right balance between near-term financing and value creation, while avoiding premature dilution of shareholder potential upside. The Company engages actively with potential pharmaceutical partners and feedback has been consistently strong: the industry is seeking derisked late-stage assets and is closely monitoring OSE’s programs. Entering a partnership too early, particularly for Lusvertikimab, could crystallize value prematurely and significantly reduce the shareholder potential upside. OSE remains focused on disciplined execution toward these pivotal value-defining milestones, which are likely to unlock greater value on more favourable terms Tedopi® is currently in a pivotal phase 3 clinical trial for non-small cell lung cancer. Enrollment is expected to be completed in the second half of 2026, with the first readout – based on overall patient survival – anticipated by the end of 2027. Additional clinical data are expected in 2026 from the TEDOPaM Phase 2 combination study in pancreatic cancer (survival follow-up), the Tedova Phase 2 combination study in ovarian cancer (readout expected in the first half of 2026), and the Combi-TED Phase 2 combination study in lung cancer (readout expected in the second half of 2026). In parallel, the Company will continue preparing for market access and scaling up industrial manufacturing.Lusvertimab’s development plan includes a Phase 2b clinical trial in ulcerative colitis to validate dosing, biomarker strategy, and sustained efficacy. Subject to financing, the study is expected to be initiated in 2026, with readouts in 2027 and 2028. In parallel, the Company will advance the development of a commercial subcutaneous formulation – now standard of care - through bridging studies in 2026, followed by early clinical validation in ulcerative colitis patients in 2027.Internal research programs in oncology and inflammation are progressing well. These innovative projects will continue to mature through 2026-2027, reaching key inflexion points for early development and potential integration into OSE Immunotherapeutics’ proprietary pipeline or those of future strategic partners. New Q&A to Restore Information To support shareholders ahead of the AGM and to counter misinformation, the Company has published a Shareholder Q&A document. This resource provides clear, accessible, and fact-based information on OSE’s strategy, governance, financial trajectory, and scientific programs. The Q&A document outlines OSE’s financing model and clarifies recent misconceptions: The Lusvertikimab Phase 2b trial is expected to cost in the tens of millions of euros, far below the €500 million figure recently circulated as part of misleading statements from the concertist shareholders.The Board has no current strategic plan to pursue large convertible debt financing contrary to assertions by the concertist shareholders. The resolutions for the June AGM included a technical adjustment to align financing tools with existing equity ceilings and market standards, not a signal of intended use. It has since been revised to €30 million ceiling to reaffirm the Company’s prudent and transparent financial strategy.Industrial preparation for Tedopi® is critical to ensure launch success; scale-up and market access planning must begin at least 18–24 months prior to potential commercialization.Governance at OSE is guided by a structured nomination process and aligned with best practices, ensuring that the Board represents all shareholders fairly. Legal Actions to Protect All Shareholders and Ensure a Fair Shareholder DebateThe activist campaign led by a group of minority shareholders seeking de facto control of the Company, contradicts both principles of sound governance and their own public declarations. In May 2025, this group publicly disclosed an “action de concert” without prior notice, abruptly ending the dialogue previously underway with the Board. The Board of Directors decided to postpone the AGM to September 30, 2025, to ensure that all shareholders can vote under fair and transparent conditions, based on accurate information regarding the true nature and intentions behind this concerted action. OSE Immunotherapeutics has initiated legal proceedings before the Commercial Court of Nantes, as several elements in its possession suggest that this concerted action may have been in place much earlier and involve a broader group of shareholders than declared. An internal audit also revealed unauthorized access by some of the minority shareholders to sensitive, confidential Company information. These findings raise serious concerns about the timing, scope, and true nature of the concerted action. The Court agreed to postpone the AGM to September 30, 2025, to allow a ruling on the merits. A hearing is scheduled for September 8, 2025. If the irregularities are confirmed, the Court may neutralize or limit the voting rights of the minority shareholders involved, an essential step to preserve fairness and protect the interests of all other shareholders. In parallel, OSE Immunotherapeutics has taken appropriate measures to correct the imbalance in the shareholder communication environment caused by misleading and unofficial external statements. The Company will continue to act with transparency, professionalism and determination, and reserves all rights, including pursuing additional legal and regulatory actions should future conduct threaten its governance, integrity, reputation, or the collective interest of its shareholders. Next Steps & Shareholder Engagement OSE reiterates its commitment to open and constructive dialogue and encourages all shareholders to: Review the full Q&A, available https://www.ose-immuno.com/en/question-answer/.Register for the upcoming shareholder webinar on September 18, 2025, at 6:00 p.m. [https://ose-immunotherapeutics.engagestream.companywebcast.com/2025-09-18-event-en].Make their voice count at the Annual General Meeting on September 30. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotechnology company developing first-in-class products in immuno-oncology (IO) and immuno-inflammation (I&I) to address the unmet needs of today's and tomorrow's patients. We partner with leading academic institutions and biopharmaceutical companies to combine our efforts to develop and bring to market transformative medicines for people suffering from serious diseases. OSE Immunotherapeutics is based in Nantes and Paris and is listed on Euronext. More information on OSE Immunotherapeutics' assets is available on the Company's website: http://www.ose-immuno.com Follow us on Linkedln. ContactsOSE ImmunotherapeuticsFiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comContact Media France: FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283Contact Media US:RooneyPartners 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, 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. Attachment EN_250828_PressRelease_QA_vf

Phase 2ImmunotherapyPhase 3

100 Deals associated with Lusvertikimab

R&D Status

10 top R&D records.

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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	Germany	Institut Servier de Medecine Translationnelle SARL	17 Nov 2020
Colitis, Ulcerative	Phase 2	-	OSE Immunotherapeutics SA	15 Sep 2020
Hidradenitis Suppurativa	Preclinical	France	OSE Immunotherapeutics SA	29 Jan 2026
Pouchitis	Preclinical	France	OSE Immunotherapeutics SA	29 Jan 2026
Acute Lymphoblastic Leukemia	Preclinical	France	OSE Immunotherapeutics SA	05 Nov 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)	aoazkrwpvd(zvqhzqyryk) = jbskrfqmqw icntkqybhx (qohkflobww ) Met View more
NCT04882007 (CoTikiS, PipelineReview) Manual	Phase 2	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe	136	Lusvertikimab	tgkagspttq(bdbqolgjxp) = 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. iycvmxvupq (rcjbjnialh )	Positive	24 Jul 2024
				Lusvertikimab (850 mg group)
NCT04605978 (EULAR 12024 \| EULAR 22024) Manual	Phase 2	Primary Sjögren's syndrome	48	S95011	mhchcjdpvc(usuvcwnxur) = vlacprskad orpnwexwex (vjhtoqwurp, 6.5) View more	Negative	14 Jun 2024
				Placebo	mhchcjdpvc(usuvcwnxur) = szxifchmzv orpnwexwex (vjhtoqwurp, 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)	ixdlxzhczn(ikddvyjyrn) = pyxahlhykz aahyjbxqee (ogkjgzwgyr, 4.55) View more	-	23 Apr 2024
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	ixdlxzhczn(ikddvyjyrn) = qpnomffevn aahyjbxqee (ogkjgzwgyr, 4.89) View more

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