^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    TLR3 agonist

    Related drugs:
    19h
    Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov)
    P2, N=90, Recruiting, AIM ImmunoTech Inc. | Trial completion date: Apr 2028 --> Jul 2028
    Trial completion date
    |
    Ampligen (rintatolimod)
    16d
    Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in the HVTN706/MOSAICO Study and Remain Without HIV (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
    New P1 trial
    |
    CD40 (CD40 Molecule)
    |
    Hiltonol (poly-ICLC)
    1m
    Regulatory T cells modulate monocyte functions in immunocompetent antiretroviral therapy naive HIV-1 infected people. (PubMed, BMC Immunol)
    We observed that Treg cells were able to down modulate autologous monocytes activation as well as interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α) production during stimulation with polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (poly-ICLC)...Compared to immunosuppressed participants (CD4 < 500 cells/µL), immunocompetent participants (CD4 ≥ 500 cells/µL) showed significantly higher levels of transforming growth factor beta (TGF-β) and IL-10 (p < 0.001 and p < 0.05, respectively), key cytokines used by Treg cells to exert their immunosuppressive functions. Our findings suggest the contribution of both TGF-β and IL-10 in the suppressive activity of Treg cells.
    Journal
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    Hiltonol (poly-ICLC)
    2ms
    Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)
    P1, N=11, Recruiting, University of Virginia | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Hiltonol (poly-ICLC)
    2ms
    HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, VA Office of Research and Development | N=16 --> 0 | Trial completion date: Apr 2028 --> Jun 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2026 --> Jun 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Hiltonol (poly-ICLC)
    2ms
    Pirarubicin combined with TLR3 or TLR4 agonists enhances anti-tumor efficiency. (PubMed, Int Immunopharmacol)
    Our results provide new ideas for the combination strategy of THP with TLR agonists which improves prognosis of breast cancer.
    Journal • IO biomarker
    |
    TLR4 (Toll Like Receptor 4) • TLR3 (Toll Like Receptor 3)
    |
    Pinorubin (pirarubicin)
    3ms
    Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)
    P2, N=24, Completed, Jonsson Comprehensive Cancer Center | Active, not recruiting --> Completed | N=60 --> 24 | Trial completion date: Jan 2026 --> Aug 2024 | Trial primary completion date: Jan 2025 --> Aug 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    Hiltonol (poly-ICLC)
    3ms
    Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer (clinicaltrials.gov)
    P1, N=37, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=25 --> 37
    Enrollment change
    |
    KRAS (KRAS proto-oncogene GTPase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • IFNG (Interferon, gamma) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CD4 (CD4 Molecule) • EPCAM (Epithelial cell adhesion molecule) • PMS1 (PMS1 protein homolog 1)
    |
    Hiltonol (poly-ICLC)
    3ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=24, Recruiting, Roswell Park Cancer Institute | Trial completion date: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2025 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    4ms
    Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Washington University School of Medicine
    New P1 trial
    |
    Opdivo (nivolumab) • Hiltonol (poly-ICLC)
    4ms
    Ampligen Compared to No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=90, Recruiting, AIM ImmunoTech Inc. | Trial completion date: Jul 2027 --> Apr 2028 | Trial primary completion date: Jun 2027 --> Mar 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Ampligen (rintatolimod)
    4ms
    Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens Is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1. (PubMed, Vaccines (Basel))
    We also evaluated whether combination vaccines incorporating anti-PD-L1 checkpoint blockade and/or a chemokine-modulating (CKM; IFNα + TLR3-L [rintatolimod] + Celecoxib) regimen would improve T cell infiltration/functionality in tumors yielding enhanced treatment benefits. Peptide-based vaccines that selectively target either melanoma antigens or TBVAs elicited a CD8+ T cell repertoire recognizing both tumor cells and tumor-associated VECs and pericytes in vitro, consistent with a treatment-induced epitope spreading mechanism. Notably, combination vaccines including anti-PD-L1 + CKM yielded superior therapeutic effects on tumor growth and animal survival, in association with the potentiation of polyfunctional CD8+ T cell reactivity against both tumor cells and tumor-associated vascular cells and a pro-inflammatory TME.
    Journal
    |
    CD8 (cluster of differentiation 8) • TLR3 (Toll Like Receptor 3) • IFNA1 (Interferon Alpha 1)
    |
    Ampligen (rintatolimod) • celecoxib oral
    4ms
    Mel66: Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) (clinicaltrials.gov)
    P1/2, N=22, Completed, Craig L Slingluff, Jr | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Mar 2024 | Trial primary completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    CDX-1140 • Hiltonol (poly-ICLC)
    4ms
    NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
    P2, N=30, Suspended, Roswell Park Cancer Institute | Trial completion date: May 2024 --> May 2026 | Trial primary completion date: May 2024 --> May 2026
    Trial completion date • Trial primary completion date • Surgery
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
    5ms
    Mel 70: FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma (clinicaltrials.gov)
    P1, N=11, Not yet recruiting, University of Virginia
    New P1 trial • Metastases
    |
    Hiltonol (poly-ICLC)
    5ms
    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
    5ms
    Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
    P1, N=30, Recruiting, Washington University School of Medicine | Active, not recruiting --> Recruiting
    Enrollment open • Surgery
    |
    Hiltonol (poly-ICLC)
    5ms
    GCC-16047: Pembrolizumab + Poly-ICLC in MRP Colon Cancer (clinicaltrials.gov)
    P1/2, N=42, Completed, Asha Nayak | N=31 --> 42
    Enrollment change • Mismatch repair • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Hiltonol (poly-ICLC)
    5ms
    Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=45, Recruiting, Robert Edwards | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition • Checkpoint block
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • cisplatin • Ampligen (rintatolimod)
    6ms
    SPOTLIGHT204: Clinical Trial to Evaluate BO-112 in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
    P2, N=60, Recruiting, Highlight Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    polyinosinic:polycytidylic acid (BO-112)
    6ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=24, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2025 --> Aug 2025
    Trial completion date • Combination therapy • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    6ms
    A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center | Initiation date: May 2024 --> Dec 2024
    Trial initiation date
    |
    Hiltonol (poly-ICLC)
    6ms
    Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=12, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Dec 2025 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
    6ms
    SPOTLIGHT204: Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of BO-112 in Patients With BCC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Highlight Therapeutics
    New P2 trial
    |
    polyinosinic:polycytidylic acid (BO-112)
    6ms
    TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial. (PubMed, Nat Commun)
    Patients that exhibit higher interferon response gene expression demonstrate prolonged survival and delayed disease progression. These findings suggest that combining ATL-DC with poly-ICLC can induce a polarized interferon response in circulating monocytes and CD8+ T cells, which may represent an important blood biomarker for immunotherapy in this patient population.Trial Registration: ClinicalTrials.gov Identifier: NCT01204684.
    Clinical • P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • CD38 (CD38 Molecule) • CD4 (CD4 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
    |
    PD-1 expression • CD8 expression • ENTPD1 expression
    |
    Hiltonol (poly-ICLC)
    7ms
    HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial primary completion date: Mar 2026 --> Jun 2026
    Trial primary completion date • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Hiltonol (poly-ICLC)
    7ms
    Dendritic Cell Vaccine for Patients With Brain Tumors (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    Hiltonol (poly-ICLC)
    7ms
    Efficacy of LCMV-based cancer immunotherapies is unleashed by intratumoral injections of polyI:C. (PubMed, J Immunother Cancer)
    Intratumoral injection of poly(I:C) sensitizes MHClow tumors to the antitumor effects of artLCMV-E7E6, resulting in a potent therapeutic synergy.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CCL3 (C-C Motif Chemokine Ligand 3) • IFNA1 (Interferon Alpha 1) • BATF3 (Basic Leucine Zipper ATF-Like Transcription Factor 3)
    |
    polyinosinic:polycytidylic acid (BO-112)
    8ms
    A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P1 trial
    |
    Hiltonol (poly-ICLC)
    8ms
    Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery (clinicaltrials.gov)
    P1, N=25, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting
    Enrollment closed • Surgery
    |
    Hiltonol (poly-ICLC)
    8ms
    Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses. (PubMed, Clin Cancer Res)
    This study presents compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through rintatolimod. Rintatolimod may break immunological tolerance by enhancing anti-tumor immunity through DC-mediated Th-cell responses. Furthermore, our findings lay the groundwork for investigating the potential synergy between TLR-3 activation and immune checkpoint inhibitor therapy to improve therapeutic outcomes.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD4 (CD4 Molecule) • BTLA (B And T Lymphocyte Associated) • TLR3 (Toll Like Receptor 3)
    |
    PD-L2 expression
    |
    Ampligen (rintatolimod)
    8ms
    NF111: A Phase II Trial of Poly-ICLC for Low-Grade Gliomas (clinicaltrials.gov)
    P2, N=20, Recruiting, University of Alabama at Birmingham | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    Hiltonol (poly-ICLC)
    8ms
    Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, Albert Einstein College of Medicine | Trial completion date: May 2024 --> May 2025
    Trial completion date
    |
    Hiltonol (poly-ICLC)
    8ms
    Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ (clinicaltrials.gov)
    P1, N=50, Recruiting, Finn, Olivera, PhD | Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Aug 2028
    Enrollment open • Trial completion date
    |
    MUC1 (Mucin 1)
    |
    letrozole • anastrozole • exemestane • Hiltonol (poly-ICLC)
    9ms
    NCI-2019-08556: Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date • Surgery
    |
    Opdivo (nivolumab) • polyinosinic:polycytidylic acid (BO-112)
    9ms
    NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
    P2, N=30, Suspended, Roswell Park Cancer Institute | Trial completion date: Nov 2024 --> May 2024 | Trial primary completion date: Nov 2023 --> May 2024
    Trial completion date • Trial primary completion date • Surgery
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
    9ms
    H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas (clinicaltrials.gov)
    P1/2, N=50, Completed, Sabine Mueller, MD, PhD | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> Dec 2023 | Trial primary completion date: Nov 2024 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02:01 • H3.3K27M • HLA-A*02 • HLA-A2 positive
    |
    Opdivo (nivolumab) • Hiltonol (poly-ICLC)
    9ms
    HAITEN-ICI: Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC (clinicaltrials.gov)
    P1/2, N=16, Not yet recruiting, VA Office of Research and Development | Trial completion date: Dec 2028 --> Apr 2028 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Hiltonol (poly-ICLC)
    10ms
    Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=12, Recruiting, Roswell Park Cancer Institute | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
    10ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=24, Recruiting, Roswell Park Cancer Institute | Suspended --> Recruiting
    Enrollment open
    |
    CD8 (cluster of differentiation 8)
    |
    CD8 positive
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    10ms
    KEYNOTE-B77: BO-112 With Pembrolizumab in Unresectable Malignant Melanoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Highlight Therapeutics | Trial completion date: Dec 2023 --> Aug 2024
    Trial completion date • Combination therapy
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • polyinosinic:polycytidylic acid (BO-112)
    10ms
    Exploratory Study of BO-112 in Adult Patients With Aggressive Solid Tumors (clinicaltrials.gov)
    P1, N=44, Completed, Highlight Therapeutics | Terminated --> Completed
    Trial completion • Combination therapy
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • polyinosinic:polycytidylic acid (BO-112)