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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
    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)
    1m
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    Chemokine receptor type-5: a key regulator of immunity, disease pathogenesis, and emerging therapeutic target. (PubMed, Inflammopharmacology)
    With therapeutic inhibition of CCR5 gaining attention, Maraviroc is approved for HIV treatment, while monoclonal antibodies such as leronlimab, genetic strategies (CRISPR), and dual CCR2/CCR5 antagonists such as cenicriviroc are under investigation for broader applications. Blocking CCR5 has shown efficacy in reducing metastasis and improving chemotherapy outcomes, reinforcing its therapeutic potential. Along with CCR5's role in disease pathogenesis, emphasizing its involvement in immune regulation and inflammatory processes, this review explores the multifaceted role of CCR5 in immunity, its contribution to disease pathogenesis, and innovative therapeutic interventions targeting CCR5 to modulate immune responses and treat diseases.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCR5 (C-C Motif Chemokine Receptor 5) • CCL3 (C-C Motif Chemokine Ligand 3) • CCR2 (C-C Motif Chemokine Receptor 2)
    |
    Selzentry (maraviroc) • Vyrologix (leronlimab)
    4ms
    A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC (clinicaltrials.gov)
    P2, N=60, Recruiting, CytoDyn, Inc. | Trial completion date: Aug 2028 --> Mar 2028 | Trial primary completion date: Jun 2028 --> Jan 2028
    Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Vyrologix (leronlimab)
    7ms
    A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC (clinicaltrials.gov)
    P2, N=60, Recruiting, CytoDyn, Inc. | Not yet recruiting --> Recruiting | Initiation date: Feb 2025 --> May 2025
    Enrollment open • Trial initiation date
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Vyrologix (leronlimab)
    9ms
    Study of PRO 140 SC As Single Agent Maintenance Therapy in Virally Suppressed Subjects with CCR5-tropic HIV-1 Infection (clinicaltrials.gov)
    P2/3, N=556, Completed, CytoDyn, Inc. | Active, not recruiting --> Completed | Phase classification: P2b --> P2/3
    Trial completion • Phase classification
    |
    CD4 (CD4 Molecule)
    |
    Vyrologix (leronlimab)
    1year
    A Phase 2 Study of Leronlimab in Combination with TAS-102 + Bevacizumab in Previously Treated Participants with MCRC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, CytoDyn, Inc.
    New P2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Vyrologix (leronlimab)
    over1year
    Biphenylsulfonamides as effective MMP-2 inhibitors with promising antileukemic efficacy: Synthesis, in vitro biological evaluation, molecular docking, and MD simulation analysis. (PubMed, Drug Dev Res)
    Apart from that, the MD simulation study also disclosed stable binding interactions of DH-18 and MMP-2 along with crucial interactions with active site amino acid residues namely His120, Glu121, His124, His130, Pro140, and Tyr142. In a nutshell, this study highlighted the importance of biphenylsulfonamide-based novel and promising MMP-2 inhibitors to open up a new avenue for potential therapy against CML.
    Preclinical • Journal
    |
    MMP2 (Matrix metallopeptidase 2)
    |
    Vyrologix (leronlimab)