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    DRUG:

    varlilumab (CDX 1127)

    i
    Other names: CDX 1127, CDX-1127, CD27 mAb, CDX1127
    Company:
    Celldex
    Drug class:
    T-cell stimulant, CD27 agonist
    Related drugs:
    24d
    DIAL: Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas (clinicaltrials.gov)
    P2, N=54, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2025 --> Oct 2026
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IRF4 (Interferon regulatory factor 4)
    |
    Opdivo (nivolumab) • varlilumab (CDX 1127) • ABP 206 (nivolumab biosimilar)
    3ms
    CD27 agonist antibodies mediate clinical responses through intratumoral stimulation in B-cell malignancies: multicenter RiVa trial. (PubMed, Clin Cancer Res)
    Rituximab and varlilumab show modest activity. However, CD27 agonist antibodies may elicit meaningful anti-tumor responses when tumors express sufficient intratumoral targets and exhibit existing immune priming.
    Journal
    |
    CD4 (CD4 Molecule) • CD27 (CD27 Molecule)
    |
    Rituxan (rituximab) • varlilumab (CDX 1127)
    4ms
    Reversibility of Immune Dysfunction Following Pediatric Thermal Injury. (PubMed, J Burn Care Res)
    Our hypothesis was immune suppression after pediatric thermal injury is reversible ex-vivo using immunomodulators recombinant human granulocyte macrophage-colony stimulating factor (GM-CSF) and varlilumab (CD27-agonist)...Samples co-incubated with GM-CSF significantly increased ex-vivo LPS-induced TNFα while samples containing CD27 increased PHA-induced IL-10 production capacity, in the first 72 h, compared to samples that did not receive immunomodulators. The results of our study identified key markers to discover those most at risk for development of NI and provided early evidence of immunomodulators that may enhance immune function early after pediatric burn injury.
    Journal • IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10) • CD14 (CD14 Molecule) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2)
    |
    varlilumab (CDX 1127)
    8ms
    DERIVe: DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Annick Desjardins, MD | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • CCL3 (C-C Motif Chemokine Ligand 3)
    |
    temozolomide • varlilumab (CDX 1127)
    1year
    RiVa: A Combination of Rituximab and Varlilumab Immunotherapy in Patients with B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=26, Completed, University Hospital Southampton NHS Foundation Trust | Active, not recruiting --> Completed | Phase classification: P2a --> P1/2 | Trial completion date: Mar 2024 --> Aug 2024
    Trial completion • Phase classification • Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Rituxan (rituximab) • varlilumab (CDX 1127)
    1year
    DIAL: Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas (clinicaltrials.gov)
    P2, N=54, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> Oct 2025
    Trial completion date • Combination therapy • Tumor mutational burden • IO biomarker
    |
    ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CD27 (CD27 Molecule) • IRF4 (Interferon regulatory factor 4)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    Opdivo (nivolumab) • varlilumab (CDX 1127) • ABP 206 (nivolumab biosimilar)
    over1year
    A Phase I Trial of Atezolizumab and Varlilumab in Combination With Radiation in Patients With Metastatic NSCLC. (PubMed, JTO Clin Res Rep)
    Varlilumab in combination with atezolizumab and RT was safe and well tolerated; no additional signal was identified for toxicity. Clinical activity for the combination was modest with 25% of patients with stable disease as the best response.
    P1 data • Journal • Combination therapy • Metastases
    |
    CD27 (CD27 Molecule)
    |
    Tecentriq (atezolizumab) • varlilumab (CDX 1127)
    over1year
    A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG) (clinicaltrials.gov)
    P1, N=14, Terminated, Nicholas Butowski | Active, not recruiting --> Terminated; Industry sponsor decision
    Trial termination
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    varlilumab (CDX 1127) • Hiltonol (poly-ICLC) • IMA950
    almost2years
    Mel-65: Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma (clinicaltrials.gov)
    P1/2, N=33, Completed, Craig L Slingluff, Jr | Recruiting --> Completed
    Trial completion
    |
    CD4 (CD4 Molecule)
    |
    varlilumab (CDX 1127) • Hiltonol (poly-ICLC)
    2years
    DIAL: Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, National Cancer Institute (NCI) | N=106 --> 52 | Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> May 2023
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IRF4 (Interferon regulatory factor 4)
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    Opdivo (nivolumab) • varlilumab (CDX 1127) • ABP 206 (nivolumab biosimilar)
    2years
    RiVa: A Combination of Rituximab and Varlilumab Immunotherapy in Patients With B-cell Lymphoma (clinicaltrials.gov)
    P2a, N=26, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Jan 2023 --> Mar 2024
    Trial completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Rituxan (rituximab) • varlilumab (CDX 1127)
    2years
    A combinatory vaccine with IMA950 plus varlilumab promotes effector memory T-cell differentiation in the peripheral blood of patients with low-grade gliomas. (PubMed, Neuro Oncol)
    The combinational immunotherapy, including varlilumab, was well-tolerated and induced vaccine-reactive T-cell expansion in the peripheral blood but without a detectable response in the tumor. Further developments of strategies to overcome the blood-tumor barrier are warranted to improve the efficacy of immunotherapy for LGG patients.
    Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • CD27 (CD27 Molecule)
    |
    varlilumab (CDX 1127) • Hiltonol (poly-ICLC) • IMA950