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    DRUG CLASS:

    IL-7R antagonist

    Related drugs:
    1m
    Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) (clinicaltrials.gov)
    P2, N=102, Active, not recruiting, Q32 Bio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    6ms
    SIGNAL-AA: Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Q32 Bio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    7ms
    Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients (clinicaltrials.gov)
    P2, N=48, Completed, Institut de Recherches Internationales Servier | Phase classification: P2a --> P2
    Phase classification
    |
    lusvertikimab (OSE-127)
    8ms
    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.
    Journal • IO biomarker
    |
    IL7R (Interleukin 7 Receptor) • IL7 (Interleukin 7)
    |
    IL7R expression
    |
    lusvertikimab (OSE-127)
    9ms
    Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) (clinicaltrials.gov)
    P2, N=102, Recruiting, Q32 Bio Inc. | Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Feb 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    9ms
    SIGNAL-AA: Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata (clinicaltrials.gov)
    P2, N=40, Recruiting, Q32 Bio Inc. | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    11ms
    SIGNAL-AA: Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata (clinicaltrials.gov)
    P2, N=40, Recruiting, Q32 Bio Inc.
    Trial completion date • Trial primary completion date
    12ms
    SIGNAL-AA: Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 Phase 2a Trial for the Treatment of Severe Alopecia Areata (clinicaltrials.gov)
    P2, N=40, Recruiting, Q32 Bio Inc. | Phase classification: P2a --> P2
    Phase classification
    12ms
    Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) (clinicaltrials.gov)
    P2, N=102, Recruiting, Q32 Bio Inc. | Phase classification: P2a --> P2
    Phase classification
    over1year
    CD127 is expressed by acute lymphoblastic leukemias and is efficiently targeted by the IL7R-antagonist OSE-127 through macrophage-mediated antibody dependent phagocytosis (AACR 2023)
    In fact, ADCP levels induced by OSE-127 treatment in vitro correlated with its capacity to reduce ALL blasts in the blood of PDX mice in vivo. Altogether, through its dual mode of action, OSE-127 may represent a powerful novel immunotherapy option for ALL patients, including cases with dysregulated IL7R signaling, particularly in combination with standard of care polychemotherapy.
    IO biomarker
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IL7R (Interleukin 7 Receptor) • PBX1 (PBX Homeobox 1) • IL7 (Interleukin 7)
    |
    IL7R mutation • IL7R expression
    |
    lusvertikimab (OSE-127)
    2years
    The IL7R-Antagonist OSE-127 Blocks Acute Lymphoblastic Leukemia Development Via a Dual Mode of Action (ASH 2022)
    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
    IO biomarker
    |
    IL7R (Interleukin 7 Receptor) • IL7 (Interleukin 7)
    |
    IL7R expression
    |
    vincristine • lusvertikimab (OSE-127)
    3years
    IL7R Targeting Using OSE-127 Shows Robust Anti-Leukemic Activity in B-Cell Precursor Acute Lymphoblastic Leukemia Xenografts (ASH 2021)
    Antibody-based immunotherapies like Blinatumomab have improved BCP-ALL outcome, yet these can quickly turn ineffective due to CD19 antigen escape. 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.
    IO biomarker
    |
    NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • CD19 (CD19 Molecule) • ETV6 (ETS Variant Transcription Factor 6) • IL7R (Interleukin 7 Receptor) • PBX1 (PBX Homeobox 1)
    |
    MLL rearrangement • IL7R expression
    |
    Blincyto (blinatumomab) • lusvertikimab (OSE-127)
    over3years
    [VIRTUAL] Optimized antagonist anti-PD-1/IL-7 bispecific antibody to sustain exhausted T cell function and to disarm Treg suppressive activity (AACR 2021)
    Taken together, our data validate the therapeutic potential of providing IL-7 signal to strengthen PD1 therapy and prevent immunoresistance by sustaining T cell response and overcoming Treg suppression. The bispecific BiCKI®IL-7 mutein can preferentially deliver and activate IL-7 into PD1+ tumor-specific T cells limiting the risk of I-O/I-O immunotoxicity.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL2 (Interleukin 2) • IL7R (Interleukin 7 Receptor) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    CD8 expression
    |
    BiCKI IL-7