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    DRUG:

    Vyrologix (leronlimab)

    i
    Other names: PRO 140, PRO-140, PA-14, PA14
    Company:
    CytoDyn, Lantheus, Vyera Pharma, amfAR
    Drug class:
    CCR5 receptor antagonist, Viral entry inhibitor
    Related drugs:
    24d
    The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Trial (CLOVER) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, CytoDyn, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    RAS wild-type
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Vyrologix (leronlimab)
    29d
    SALIENT-AD: Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease (clinicaltrials.gov)
    P2, N=20, Recruiting, Weill Medical College of Cornell University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Vyrologix (leronlimab)
    1m
    SALIENT-AD: Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Weill Medical College of Cornell University
    New P2 trial
    |
    Vyrologix (leronlimab)
    2ms
    An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC) (clinicaltrials.gov)
    P=N/A, N=0, Available, CytoDyn, Inc.
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Vyrologix (leronlimab)
    4ms
    CCR-CCL axes as key upstream influencers of pancreatic ductal adenocarcinoma: CCR2-CCL2, CCR5-CCL5, CCR4-CCL17/22, CCR6-CCL20, CCR7-CCL19/21. (PubMed, Front Immunol)
    We further detail past and ongoing therapeutic efforts and trials addressing these axes in both PDAC and relevant non-PDAC settings via several small-molecule antagonists and monoclonal antibodies: BMS-813160, Maraviroc, Leronlimab, FLX475, PF-07054894, IDOR- 1117-2520, and CAP-100. Despite continuous advances in the field, the current body of evidence remains limited and presents significant research gaps in areas such as spatial profiling, stage-specific analyses, and general mechanistic validation in PDAC-specific settings. Addressing these shortcomings will be key to developing a more comprehensive knowledge of the field and improving future therapeutic strategies to overcome PDAC.
    Review • Journal • IO biomarker
    |
    CCR4 (C-C Motif Chemokine Receptor 4) • CCL20 (C-C Motif Chemokine Ligand 20) • CCL19 (C-C Motif Chemokine Ligand 19) • CCR7 (Chemokine (C-C motif) receptor 7) • CCL2 (Chemokine (C-C motif) ligand 2) • CCR2 (C-C Motif Chemokine Receptor 2) • CCR6 (C-C Motif Chemokine Receptor 6)
    |
    tivumecirnon (FLX475) • Selzentry (maraviroc) • Vyrologix (leronlimab) • BMS-813160
    5ms
    Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=16, Completed, CytoDyn, Inc. | N=30 --> 16 | Trial completion date: Jul 2022 --> Jan 2025 | Active, not recruiting --> Completed
    Trial completion • Enrollment change • Trial completion date • Pan tumor
    |
    Vyrologix (leronlimab)
    7ms
    An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study (clinicaltrials.gov)
    P2/3, N=43, Terminated, CytoDyn, Inc. | Active, not recruiting --> Terminated; FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.
    Trial termination
    |
    CXCR4 (Chemokine (C-X-C motif) receptor 4)
    |
    Vyrologix (leronlimab)
    7ms
    PRO 140_CD03 Extension: An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study (clinicaltrials.gov)
    P2/3, N=56, Terminated, CytoDyn, Inc. | Active, not recruiting --> Terminated; FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.
    Trial termination
    |
    Vyrologix (leronlimab)
    8ms
    An Extension of Protocol PRO 140_CD01 Study (clinicaltrials.gov)
    P2, N=20, Terminated, CytoDyn, Inc. | Active, not recruiting --> Terminated; FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.
    Trial termination
    |
    Vyrologix (leronlimab)
    9ms
    PRO 140 in Treatment-Experienced HIV-1 Subjects (clinicaltrials.gov)
    P2/3, N=6, Completed, CytoDyn, Inc. | Active, not recruiting --> Completed | N=25 --> 6
    Trial completion • Enrollment change
    |
    Vyrologix (leronlimab)
    9ms
    Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC (clinicaltrials.gov)
    P1/2, N=10, Terminated, CytoDyn, Inc. | N=48 --> 10 | Active, not recruiting --> Terminated; Study terminated prematurely due to business reasons. Participants are no longer examined or receiving intervention.
    Enrollment change • Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    carboplatin • Vyrologix (leronlimab)
    10ms
    Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 (clinicaltrials.gov)
    P2, N=484, Completed, CytoDyn, Inc. | Active, not recruiting --> Completed | Phase classification: P2b --> P2
    Trial completion • Phase classification
    |
    Vyrologix (leronlimab)