- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Anti-IL-7 receptor plus anti-IL12/23 combination induces complete histological normalization in chronic colitis (A5) - Dec 21, 2024 - Abstract #ECCOIBD2025ECCO_IBD_407;
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.
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
CD127-Directed Immunotherapy with Lusvertikimab Outperforms Imatinib in Preclinical ABL-Class-Fusion-Positive BCP-ALL (Marriott Grand Ballroom 5-6 (Marriott Marquis San Diego Marina)) - Nov 6, 2024 - Abstract #ASH2024ASH_1294;
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.
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Phase classification: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Apr 23, 2024
P2, N=48, Completed,
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. Phase classification: P2a --> P2
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Journal, IO biomarker: The IL-7R antagonist Lusvertikimab reduces leukemic burden in xenograft-ALL via antibody-dependent cellular phagocytosis. (Pubmed Central) - Mar 22, 2024
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.
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial completion: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Jun 5, 2023
P2a, N=48, Completed,
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. Active, not recruiting --> Completed
- |||||||||| lusvertikimab (OSE-127) / Servier
Clinical, P1 data, Journal: First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7R?. (Pubmed Central) - Mar 9, 2023
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.
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial primary completion date: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Mar 2, 2023
P2a, N=48, Active, not recruiting,
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. Trial primary completion date: May 2023 --> Jan 2023
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Enrollment closed: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Jan 17, 2023
P2a, N=45, Active, not recruiting,
OSE-127 is currently being evaluated in a Phase 2b study in UC patients (CoTikiS study: NCT04882007). Recruiting --> Active, not recruiting
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial completion date, Trial primary completion date: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Dec 1, 2022
P2a, N=45, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2022 --> May 2023 | Trial primary completion date: Dec 2022 --> May 2023
- |||||||||| lusvertikimab (OSE-127) / Servier
The IL7R-Antagonist OSE-127 Blocks Acute Lymphoblastic Leukemia Development Via a Dual Mode of Action (ENMCC - Great Hall AD) - Nov 4, 2022 - Abstract #ASH2022ASH_3407;
P1, P2, P2
We previously reported high preclinical efficacy of OSE-127 in BCP-ALL patient derived xenograft (PDX) models of different cytogenetic backgrounds (Lenk and Baccelli et al...Finally, we conducted a phase2-like PDX overt leukemia study testing OSE-127 alone or in combination with Dexamethasone/Vincristine/PEG-Asparaginase chemotherapy employing PDX samples with high CD127 expression (6 BCP-ALL and 3 T-ALL-PDX samples with >50% CD127+ cells in flow cytometry analysis)...and D.M.S. share senior authorship
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial completion date, Trial primary completion date: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Aug 3, 2022
P2a, N=45, Recruiting,
share senior authorship Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Sep 2022 --> Dec 2022
- |||||||||| OSE-127 / Servier
IL7R Targeting Using OSE-127 Shows Robust Anti-Leukemic Activity in B-Cell Precursor Acute Lymphoblastic Leukemia Xenografts (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2878;
Of note, OSE-127 therapy response associated with IL7R expression levels on BCP-ALL cells and no significant downregulation of the IL7R antigen was observed upon OSE-127 treatment. Taken together, our data demonstrate that IL7R-targeting using OSE-127, which has already demonstrated a good safety profile in healthy volunteers, is an efficient approach for BCP-ALL immunotherapy and may be particularly beneficial for patients with high IL7R-expression and/or relapsed/refractory disease after CD19-directed therapy.
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Enrollment open: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Aug 23, 2021
P2a, N=45, Recruiting,
Taken together, our data demonstrate that IL7R-targeting using OSE-127, which has already demonstrated a good safety profile in healthy volunteers, is an efficient approach for BCP-ALL immunotherapy and may be particularly beneficial for patients with high IL7R-expression and/or relapsed/refractory disease after CD19-directed therapy. Not yet recruiting --> Recruiting
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial completion date, Trial initiation date, Trial primary completion date: Efficacy and Safety of S95011 in Primary Sj (clinicaltrials.gov) - Mar 18, 2021
P2a, N=45, Not yet recruiting,
An anti-IL-7R antibody decreased the IFN signature in T cells during pSS and could be of therapeutic interest. Trial completion date: Apr 2022 --> Sep 2022 | Initiation date: Dec 2020 --> Jun 2021 | Trial primary completion date: Apr 2022 --> Sep 2022
- |||||||||| lusvertikimab (OSE-127) / OSE Immunotherapeutics
Trial completion: Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects (clinicaltrials.gov) - Dec 12, 2019
P1, N=63, Completed,
Interestingly, IL7 signaling may participate to the IFN signature observed in different glandular cellular sub-types in pSS, as demonstrated by decreased IFN signature after IL7-R inhibition both in the explant and in the cellular supernatant. Recruiting --> Completed
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