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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
    4d
    Phase I/II clinical trial of a melanoma vaccine targeting shared non-mutated antigens and a shared mutated BRAF neoantigen with an agonistic CD40 antibody (CDX-1140) plus TLR3 agonist (poly-ICLC). (PubMed, J Immunother Cancer)
    The vaccine was safe, well-tolerated, and immunogenic. Optimization of vaccines that include agonistic CD40 antibody is needed to enhance immunogenicity. Induction of a multifunctional CD4+ T cell response to mBRAF supports targeting shared mutated neoantigens with melanoma vaccines.
    P1/2 data • Journal • IO biomarker • First-in-human
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    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • LAMP3 (Lysosomal Associated Membrane Protein 3) • CD40 (CD40 Molecule)
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    BRAF V600E • BRAF mutation • BRAF V600
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    CDX-1140 • Hiltonol (poly-ICLC)
    9d
    Evaluation of Antibodies Induced by Melanoma Helper Peptide Vaccine and Their Modulation by Vaccine Adjuvants. (PubMed, Vaccines (Basel))
    Vaccine-induced Abs may respond to multiple epitopes within the same peptide, warranting further studies into their ability to facilitate antigen uptake and presentation through the formation of large immune complexes. 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
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    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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    cyclophosphamide • Hiltonol (poly-ICLC)
    10d
    A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) (clinicaltrials.gov)
    P1, N=27, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P1 trial
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    DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • sirpiglenastat (DRP-104) • DNAJB1-PRKACA peptide vaccine • Hiltonol (poly-ICLC)
    17d
    A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
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    Hiltonol (poly-ICLC)
    2ms
    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™
    |
    Hiltonol (poly-ICLC)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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
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    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)
    3ms
    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)
    |
    Hiltonol (poly-ICLC)
    3ms
    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
    3ms
    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)