lusvertikimab (OSE-127) / OSE Immunotherapeutics - LARVOL DELTA

LUSVERTIKIMAB, A FIRST IN CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICCENTER RANDOMIZEDPLACEBO-CONTROLLED PHASE II STUDY (DDW 2025) - P2 | No abstract available

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL7

OSE Immunotherapeutics Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab (GlobeNewswire) - P2 | N=150 | CoTikiS (NCT04882007) | Sponsor: OSE Immunotherapeutics | "These findings from the open-label extension (OLE) of the Phase 2 CoTikiS study of the anti-IL-7 receptor monoclonal antibody Lusvertikimab in UC, were presented at Digestive Disease Week in San Diego (May 3 – 6, 2025)...89% of participants entered the OLE period and 87% of them completed the study; Rates of symptomatic remission improved for all dose groups in the OLE period, suggesting a deepening of efficacy. For participants who had received the 850 mg dose from the beginning of the study, rates plateaued already after Week 14; rates of symptomatic remission continued to improve through week 26 for the 450 mg induction group (10 weeks of 450 mg, 16 weeks of 850 mg dosing) and through week 34 for the group receiving placebo in the induction phase (10 weeks of placebo, 14 weeks of 850 mg Lusvertikimab)...82% of participants achieved remission of rectal bleeding by the end of the OLE."

P2 data • Ulcerative Colitis

REG-OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025 (TradingView) - "OSE Immunotherapeutics SA...announced that the Company will present further efficacy and safety data1 from the 24-week Open Label Extension (OLE) period from CoTikiS Phase 2 clinical study of Lusvertikimab in ulcerative colitis at the Digestive Disease Week conference in San Diego (May 3 – 6, 2025)...this oral presentation will unveil new clinical data from the 24-week Open Label Extension (OLE) period (Week 10 to Week 34) of the randomized, double-blind, placebo-controlled Phase 2 study evaluating the anti-IL-7 receptor monoclonal antibody Lusvertikimab in moderate to severe ulcerative colitis."

P2 data • Ulcerative Colitis

OSE Immunotherapeutics Hosts KOL Webinar Post-ECCO on Lusvertikimab and the Future of IBD (GlobeNewswire) - "OSE Immunotherapeutics recently hosted a webinar featuring key opinion leaders (KOLs) to discuss the latest clinical trial results and scientific data on Lusvertikimab, particularly its positive outcomes in treating ulcerative colitis (UC)....These experts highlighted the significance of Lusvertikimab’s clinical trial results within the current research and therapeutic landscape. They also discussed how these advancements address unmet patient needs and their potential impact on patient care. Additionally, the webinar provided an overview of the current therapeutic landscape in Inflammatory Bowel Diseases (IBD), with a focus on UC."

Clinical data • Ulcerative Colitis

OSE Immunotherapeutics Reports Full Phase 2 Induction Results for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO (GlobeNewswire) - P2 | N=150 | CoTikiS (NCT04882007) | Sponosr: OSE Immunotherapeutics | "OSE Immunotherapeutics...presented full efficacy and safety data from the induction period of the randomized, double-blind, placebo-controlled, Phase 2 CoTikiS study of Lusvertikimab (OSE-127) in the Oral and Poster presentations at the 20th Congress of ECCO (European Crohn’s and Colitis Organisation), demonstrating meaningful efficacy and a favorable safety profile in moderate to severe active UC patients....CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450 mg or 850 mg) of Lusvertikimab against placebo, a 24-week open-label extension period (OLE) during which subjects received Lusvertikimab 850 mg infusions every four weeks and a 16-week safety follow-up period free of treatment."

P2 data • Ulcerative Colitis

OSE Immunotherapeutics Presents Positive Preclinical Data on Combination of Anti-IL-7 Receptor Lusvertikimab in Chronic Colitis In Oral Presentation at 20th Congress of ECCO (GlobeNewswire) - "Interleukin-7 (IL-7) drives not only the survival but also the differentiation of human T lymphocytes subsets, such as Th17 (IL-17-secreting pathogenic T lymphocytes). IL-23 is the primary driver of Th17 differentiation, and IL-23 antagonists (currently one of the standards of care in Inflammatory Bowel Diseases [IBD]) inhibit the generation of Th17 cells. However, in the presence of IL-7, IL-23 antagonists lose their inhibitory activity in vitro. Combining Lusvertikimab with an anti-IL-23 monoclonal antibody (eg. Guselkumab) restores the inhibition of human Th17 cells in the presence of both IL-7 and IL-23....Using a well-validated preclinical chronic colitis model, OSE Immunotherapeutics’ R&D team reported that while the IL-12/23 antagonist mAb is efficient, it is not sufficient in monotherapy to achieve complete remission at both macroscopic and histological levels."

Preclinical • Crohn's disease • Ulcerative Colitis

Lusvertikimab is efficacious in severe ulcerative colitis (UC) patients with high fecal calprotectin (FCP): results from the CoTikiS study (ECCO-IBD 2025) - P2 | "Conclusion Lusvertikimab, a pure IL-7 receptor antagonist, significantly decreased FCP after 10 weeks of treatment and achieved improvements in clinical and endoscopic outcomes in UC patients with active inflammation per FCP > 250 µg/g at baseline. These data strengthen the overall results of the primary and key secondary endpoints from the CoTikiS study."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL7

Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe Ulcerative Colitis: results of a multicenter, randomized, placebo-controlled phase II study (ECCO-IBD 2025) - P2 | "Conclusion Lusvertikimab, a pure IL-7 receptor antagonist, demonstrated its clinical and endoscopic efficacy in moderate to severe UC compared to placebo at week 10 with no clinically relevant safety signal. These positive findings support the further clinical development for treatment of UC to elaborate its potential place in the therapeutic armentarium of UC."

Clinical • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL7 • IL7R

Anti-IL-7 receptor plus anti-IL12/23 combination induces complete histological normalization in chronic colitis (ECCO-IBD 2025) - P2 | "We developed a humanized anti-IL7R lusvertikimab with a good PK/PD and tolerance profile in healthy volunteers 3 and recently announced positive phase 2 efficacy results in ulcerative colitis after a 10 week-induction treatment period (randomized placebo-controlled CoTikiS study: NCT04882007)...In vitro, we confirmed that IL-7 drives human Th17 differentiation despite IL23 blockade and that combining IL7R and IL23 blockade was efficient to prevent Th17 generation in the presence of both IL7 and IL23. Conclusion Our findings show that anti-IL-7R is well tolerated in combination with anti-IL12/23 mAb in mice and act in synergy to achieve a profound control of chronic colitis and complete histological normalization compared to monotherapy."

Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A • IL7 • IL7R

OSE Immunotherapeutics Presents Three Abstracts for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO (GlobeNewswire) - "OSE Immunotherapeutics SA...shares details of the three scientific abstracts on its anti-IL-Receptor (IL-7R) Lusvertikimab, which is in clinical development for ulcerative colitis. These abstracts will be presented in Oral Presentation, Digital Oral Presentation and Poster Presentation at the upcoming 20th Congress of ECCO (European Crohn’s and Colitis Organization) to be held February 19-22, 2025, in Berlin (Germany)."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

OSE Immunotherapeutics to Present Anti-IL-7R Lusvertikimab Phase 2 Induction Results in Ulcerative Colitis at 20th Congress of ECCO (GlobeNewswire) - "OSE Immunotherapeutics SA...announced that an abstract related to its first in class anti-IL-7 Receptor (IL-7R) Lusvertikimab, has been accepted for Oral Presentation at the 20th congress of the European Crohn’s and Colitis Organization (ECCO) being held February 19-22, 2025, in Berlin (Germany)."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CD127-Directed Immunotherapy with Lusvertikimab Outperforms Imatinib in Preclinical ABL-Class-Fusion-Positive BCP-ALL (ASH 2024) - P2 | "Animals treated with the combination showed no signs of enhanced toxicity as compared to the monotherapy groups. Overall, our data suggest LUSV as a potential immunotherapeutic agent for the treatment of ABL-class fusion+ BCP-ALL, warranting clinical investigation in pediatric and adult patients."

IO biomarker • Preclinical • Acute Lymphocytic Leukemia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Leukemia • Oncology • Pediatrics • Ulcerative Colitis • ABL1 • ETV6 • IL7R • PDGFRB

OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis (GlobeNewswire) - P2 | N=150 | CoTikiS (NCT04882007) | Sponosr: OSE Immunotherapeutics | "Lusvertikimab (Lusv) met the primary efficacy endpoint defined by the improvement of the Modified Mayo Score (MMS) at week 10 (W10) at the two doses tested and demonstrated statistically significant and clinically meaningful results on key secondary endpoints...Improvement of the global Disease Activity Index of UC (MMS): Lusv 850mg group: difference of -0.9 point versus placebo (p=0.036); Lusv 450mg group: difference of -1.16 point versus placebo (p= 0.019); 450 + 850mg pooled group: difference of -1.00 point versus placebo (p= 0.010)...Lusvertikimab displayed a good safety profile and was well tolerated, with no difference between both dose groups and placebo in the incidence of drug related serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe drug-related AEs, opportunistic infections or infusion reactions during the induction period."

P2 data • Inflammatory Bowel Disease • Ulcerative Colitis

OSE Immunotherapeutics Announces Positive Efficacy Results for Lusvertikimab in the Phase 2 trial for the treatment of Ulcerative Colitis (GlobeNewswire) - P2 | N=150 | CoTikiS (NCT04882007) | Sponosr: OSE Immunotherapeutics | "OSE Immunotherapeutics SA...today reported first positive results from its CoTikiS randomized, double-blind, placebo-controlled, Proof of Concept phase 2 study of Lusvertikimab...A favorable safety profile was observed during both the induction phase and during the 6 months of open-label extension phase trial...The 850 mg group (n=50, Placebo n=49) in the principal analysis obtained significant results at week 10 versus Placebo on the improvement of the MMS with a -0.82 (95%CI: -1.63. -0.01) difference in treatment effect between lusvertikimab and placebo (p=0.047). The 450 mg group (n=35, Placebo n=49) obtained significant results versus placebo...with a differenceµ of -1.17 (95%CI: -2.18; -0.16) between lusvertikimab and placebo (p=0.023)."

P2 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

OSE Immunotherapeutics Announces Publication of Preclinical Efficacy Results with Lusvertikimab in Acute Lymphoblastic Leukemia in the Journal ‘Blood’ (GlobeNewswire) - "OSE Immunotherapeutics...announced the publication of an article on latest preclinical efficacy data on the use of its anti-IL-7 receptor...antagonist Lusvertikimab (OSE-127) for the treatment of B- and T-Cell Acute Lymphoblastic Leukemia (B- and T-ALL) in ‘Blood’....The abstract...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."

Preclinical • Acute Lymphocytic Leukemia

ASSESSMENT OF S95011 (OSE-127, LUSVERTIKIMAB), AN ANTI-INTERLEUKIN 7 RECEPTOR MONOCLONAL ANTIBODY, IN PATIENTS WITH PRIMARY SJÖGREN'S SYNDROME: AN INTERNATIONAL MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2A STUDY (EULAR 2024) - "S95011, an anti-IL-7 receptor monoclonal antibody, did not demonstrate efficacy in patients with pSS, suggesting that inhibition of the IL-7 pathway over 13 weeks may not be sufficient to impact disease progression. The safety profile of S95011 was acceptable."

Clinical • P2a data • Dental Disorders • Dry Eye Disease • Fatigue • Immunology • Infectious Disease • Ophthalmology • Rheumatology • Sjogren's Syndrome • Xerostomia • IL7 • IL7R

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Institut de Recherches Internationales Servier | Phase classification: P2a ➔ P2

Phase classification • Immunology • Sjogren's Syndrome

The IL-7R antagonist Lusvertikimab reduces leukemic burden in xenograft-ALL via antibody-dependent cellular phagocytosis. (PubMed, Blood) - "Lusvertikimab-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, Lusvertikimab may represent a novel immunotherapy option for any CD127-positive ALL, particularly in combination with standard-of-care polychemotherapy."

IO biomarker • Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • IL7 • IL7R

OSE Immunotherapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial Evaluating Lusvertikimab in Patients with Ulcerative Colitis (Businesswire) - "OSE Immunotherapeutics SA...announced today the completion of patient enrollment in the Phase 2b clinical trial evaluating anti-IL-7 receptor monoclonal antibody Lusvertikimab (OSE-127) in patients with moderate to severe active Ulcerative Colitis (UC)....The purpose of the randomized, double-blind Phase 2 clinical trial CoTikiS is to evaluate the efficacy and safety of Lusvertikimab (OSE-127) versus placebo in patients with moderate to severe active UC who are naïve of treatment or who previously failed, lost response, or were intolerant to previous treatment(s)....Top-line efficacy results after the induction phase (primary endpoint at week 10) and the first early assessment after six months of therapy in open-label extension are expected in the next months (mid-2024)."

P2b data • Trial status • Ulcerative Colitis

OSE Immunotherapeutics Highlights Clinical Portfolio Advancements and Provides 2024 Outlook (Businesswire) - "Phase 2 clinical trial ongoing in ulcerative colitis; end of patient enrollment expected in Q1 2024...the trial was redirected towards new clinical centers in countries further west in Europe, concerning patients naive to biological treatments, who are much more numerous in the countries from Eastern Europe. Due to this rebalancing, the end of recruitment is now expected in Q1 2024, and the first results (from induction to week 10 and after 6 months of maintenance) are expected in mid-2024."

Enrollment status • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL) (FDA) - Date Designated: 07/20/2023

Orphan drug • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia

OSE Immunotherapeutics Announces Advances in IL-7 Receptor Antagonist Lusvertikimab (Businesswire) - "OSE Immunotherapeutics...announces that the Independent Expert Committee ( DSMB , Drug Safety Monitoring Board ) of the Phase 2 clinical study of the receptor antagonist IL-7 (IL-7R) Lusvertikimab (OSE-127) in ulcerative colitis, recommended continuation of the trial until completion. In parallel, the European Medicines Agency ( EMA , European Medicines Agency ) issued a favorable opinion on the orphan status designation for Lusvertikimab in the treatment of Acute Lymphoblastic Leukemia (ALL)."

DSMB • European regulatory • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • Ulcerative Colitis

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients (clinicaltrials.gov) - P2a | N=48 | Completed | Sponsor: Institut de Recherches Internationales Servier | Active, not recruiting ➔ Completed

Trial completion • Sjogren's Syndrome

OSE Immunotherapeutics to Continue the Clinical Development in Ulcerative Colitis with Full Rights to Lusvertikimab (Market Screener) - "The ongoing Phase 2 trial sponsored by OSE Immunotherapeutics is evaluating the efficacy and safety of Lusvertikimab (OSE-127) versus placebo in patients with moderate to severe active Ulcerative Colitis who previously failed or lost response or were intolerant to previous treatment(s). A positive interim futility analysis was observed in the prespecified first 50 patients (i.e., 33% of the total patient enrollment in the study) having completed the induction phase. The upcoming major milestone for this Phase 2 clinical trial is expected in December 2023 with the top-line results after the induction phase (primary endpoint at week 10) and in H1 2024 for the first early assessment in maintenance after 6 months of therapy (CoTikiS trial: NCT04882007)."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

OSE Immunotherapeutics to Continue the Clinical Development in Ulcerative Colitis with Full Rights to Lusvertikimab (Businesswire) - "OSE Immunotherapeutics SA...announced that the Company will complete its clinical Phase 2 study in ulcerative colitis on Lusvertikimab (anti-IL7 receptor first-in-class mAb) having earned the full worldwide rights of the asset. OSE Immunotherapeutics and Servier signed a two-step option license agreement in December 2016. The companies decided to mutually terminate this agreement based on OSE Immunotherapeutics’ strategic commitment in Ulcerative Colitis and following Servier’s priority portfolio review after the negative results on their exploratory Phase 2a clinical study in the primary Sjögren Syndrome (sponsored by Servier). OSE Immunotherapeutics is hence actively continuing its sponsored international clinical Phase 2 study in Ulcerative Colitis and is exploring additional strategic opportunities in Acute Lymphoblastic Leukemia (ALL)."

Licensing / partnership • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis