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    DRUG:

    Hiltonol (poly-ICLC)

    i
    Other names: P.I.C.L.C., poly-ICLC
    Associations

    News

    Trials
    Company:
    Oncovir
    Drug class:
    TLR3 agonist, IFIH1 modulator, RET modulator, RIG-I modulator
    Related drugs:
    Associations

    News

    Trials
    6d
    Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)
    P1, N=32, Recruiting, Washington University School of Medicine | N=16 --> 32
    Enrollment change
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    Signatera™
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    Hiltonol (poly-ICLC)
    13d
    1B-22-2: In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
    Enrollment closed • Trial completion date • Trial primary completion date • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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    Keytruda (pembrolizumab) • CDX-1140 • Hiltonol (poly-ICLC) • Mobista (CDX-301)
    27d
    Peptide Vaccines for Pediatric High-Grade Glioma and Diffuse Midline Glioma: Current Progress and Future Perspectives. (PubMed, Vaccines (Basel))
    However, the unique challenges of the immunosuppressive tumor microenvironment and the detrimental effect of necessary corticosteroids remain paramount barriers. Future success relies on multi-modal combination strategies, the development of next-generation personalized neoantigen vaccines, and the application of advanced neuroimaging to accurately assess treatment response.
    Review • Journal
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    BIRC5 (Baculoviral IAP repeat containing 5)
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    H3.3K27M
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    temozolomide • Hiltonol (poly-ICLC)
    28d
    Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Washington University School of Medicine
    New P1 trial
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    Keytruda (pembrolizumab) • carboplatin • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Hiltonol (poly-ICLC)
    1m
    NCI-2018-01581: Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
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    HER-2 negative • PD-L1 negative
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    carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab-actl) • Trodelvy (sacituzumab govitecan-hziy) • Hiltonol (poly-ICLC)
    1m
    Antibody Responses to Melanoma Helper Peptide Vaccines May Enhance Antigen Opsonization Through Formation of Immune Complexes and are Modulated by Vaccine Adjuvants. (PubMed, bioRxiv)
    The findings also show that adding polyICLC to IFA can significantly enhance Ab responses. Collectively, this work underscores the immunologic potential of peptide-induced Abs and the importance of adjuvant selection in cancer vaccine design.
    Journal
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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    Hiltonol (poly-ICLC)
    2ms
    IRB00210915: Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2025 --> Jun 2027 | Trial primary completion date: Aug 2025 --> Jun 2027
    Trial completion date • Trial primary completion date • Mismatch repair
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    KRAS (KRAS proto-oncogene GTPase)
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    KRAS mutation
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • Hiltonol (poly-ICLC) • KRAS peptide vaccine
    2ms
    KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer (clinicaltrials.gov)
    P1, N=54, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Nov 2028 --> Jul 2029 | Trial primary completion date: Nov 2028 --> Mar 2028
    Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase)
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    balstilimab (AGEN2034) • botensilimab (AGEN1181) • Hiltonol (poly-ICLC)
    3ms
    Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
    P1, N=33, Completed, Washington University School of Medicine | Active, not recruiting --> Completed
    Trial completion
    |
    Hiltonol (poly-ICLC)
    3ms
    Prostate cancer in situ autovaccination with the intratumoral viral mimic poly-ICLC: Modulating the cold tumor microenvironment. (PubMed, Med)
    Intratumoral poly-ICLC immunotherapy for PCa is safe and may modulate the tumor microenvironment, enhancing antitumor responses. These findings support larger, controlled trials to assess effects on long-term clinical outcomes.
    Journal
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
    |
    Hiltonol (poly-ICLC)
    3ms
    A Phase Ib Study of Indirect Immunization with Oregovomab and Toll-like-Receptor-3 Stimulation with Hiltonol® in Patients with Recurrent Platinum-Resistant Ovarian Cancer. (PubMed, Curr Oncol)
    The safety and compatibility of combining oregovomab with Hiltonol® have been demonstrated in this study. The potential to enhance activity of chemotherapy using oregovomab indirect immunization and Hiltonol® stimulation is proposed.
    P1 data • Journal • Platinum resistant
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    MUC16 (Mucin 16, Cell Surface Associated) • TLR3 (Toll Like Receptor 3)
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    Hiltonol (poly-ICLC) • OvaRex (oregovomab)
    3ms
    Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2027 --> Nov 2025
    Trial completion date
    |
    Hiltonol (poly-ICLC)