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    DRUG:

    vidutolimod (CMP-001)

    i
    Other names: CMP-001, CYT003-QbG10, QbG10, CYT 003 QbG10, CYT003, QbG10, allergy vaccine, ARB-1598, Immunodrug CYT003-QbG10, ARB 1598, CMP 001, CYT-003, CYT003 PolQb, CYT003 PolQbeta, virus-like particle-based cancer vaccine
    Company:
    Kuros, Regeneron, Xoma
    Drug class:
    Immunomodulator, TLR9 agonist
    Related drugs:
    18d
    In vitro characterization of cellular responses elicited by endosomal TLR agonists encapsulated in Qβ virus-like particles. (PubMed, BMC Immunol)
    In summary, endosomal TLRa VLPs all have the ability to activate pDCs, however, combined TLR7/8 activation using TLR7/8a VLPs was significantly more effective than the other VLPs at activating T cells and was dependent on direct contact with pDCs. Therefore, TLR7/8a VLPs may potentially induce a robust anti-tumor immune response and warrant further investigation for cancer therapy.
    Preclinical • Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • TLR8 (Toll Like Receptor 8) • IFNA1 (Interferon Alpha 1)
    |
    vidutolimod (CMP-001)
    3ms
    Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=10, Suspended, Emory University | Trial completion date: Jun 2027 --> Jun 2028
    Trial completion date
    |
    Opdivo (nivolumab) • vidutolimod (CMP-001)
    4ms
    Intratumoral vidutolimod as monotherapy or in combination with pembrolizumab in patients with programmed cell death 1 blockade-resistant melanoma: Final analysis from a phase 1b study. (PubMed, Cancer)
    Vidutolimod PS20-A alone or in combination with pembrolizumab had an acceptable safety profile and promising clinical activity in patients with PD-1 blockade-resistant melanoma.
    P1 data • Journal
    |
    PD-1 (Programmed cell death 1)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    5ms
    Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy (clinicaltrials.gov)
    P1, N=199, Completed, Regeneron Pharmaceuticals | Phase classification: P1b --> P1
    Phase classification
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    7ms
    In situ treatment with a TLR9 agonist virus-like particle to promote immune responses against oral epithelial dysplasia progression. (PubMed, Cancer Immunol Immunother)
    ELISA revealed significantly elevated levels of IFN-γ, IL-12, and TNF-α in the sera of mice after 24 h of one treatment with vidutolimod + ICB as well as increased levels of proliferating T cells and pDCs in draining lymph nodes 72 h after the third and final treatment, thus indicating the immune-boosting effect of this therapy. Vidutolimod + ICB caused a significant decrease in Ki-67 expression by epithelial cells in the lesion area compared to untreated mice, implicating that this treatment regime may prevent lesion progression.
    Journal • IO biomarker
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • TLR9 (Toll Like Receptor 9)
    |
    vidutolimod (CMP-001)
    8ms
    A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    9ms
    CMP-001 and Pre-operative Stereotactic Body Radiation Therapy (SBRT) in Early Stage Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Centre Hospitalier Universitaire Vaudois | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Sep 2023 --> Dec 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    vidutolimod (CMP-001)
    10ms
    A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1year
    CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=39, Active, not recruiting, Umar Farooq | Trial primary completion date: Apr 2025 --> Aug 2024
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1year
    CMP-001 for Relapsed and Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=39, Active, not recruiting, Umar Farooq | Suspended --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)
    1year
    A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (clinicaltrials.gov)
    P2, N=77, Terminated, Regeneron Pharmaceuticals | Active, not recruiting --> Terminated; Sponsor Decision related to study drug supply
    Trial termination • Combination therapy • Metastases
    |
    Libtayo (cemiplimab-rwlc) • vidutolimod (CMP-001)
    1year
    A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma (clinicaltrials.gov)
    P2, N=60, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • vidutolimod (CMP-001)