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    DRUG CLASS:

    TLR3 agonist

    Related drugs:
    9d
    KEYNOTE-B77: BO-112 With Pembrolizumab in Unresectable Malignant Melanoma (clinicaltrials.gov)
    P2, N=42, Completed, Highlight Therapeutics | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab) • polyinosinic:polycytidylic acid (BO-112)
    30d
    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)
    1m
    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)
    1m
    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
    |
    MUC16 (Mucin 16, Cell Surface Associated) • TLR3 (Toll Like Receptor 3)
    |
    Hiltonol (poly-ICLC) • OvaRex (oregovomab)
    1m
    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)
    2ms
    Vaccine immunotherapy for glioblastoma: How can previous attempts guide us? (PubMed, Exp Neurol)
    Vaccine immunotherapy for GBM appears to depend on dendritic cells to achieve significant improvements in survival. The incorporation of innate immunity modulators such as GM-CSF and Poly-ICLC, along with stratification by MGMT-methylation, are promising. Although an expressive HR reduction was achieved, there are still primary scientific validity concerns, the residual hazard leads to a reserved prognosis and should be addressed by multimodal treatment approaches.
    Review • Journal
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • CSF2 (Colony stimulating factor 2)
    |
    Hiltonol (poly-ICLC)
    2ms
    Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov)
    P2, N=90, Suspended, AIM ImmunoTech Inc. | Trial completion date: Oct 2028 --> Jan 2030 | Trial primary completion date: Sep 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    Ampligen (rintatolimod)
    3ms
    Synergy between TLR3-ligand and IFN-α in the transient sensitization of "Cold" tumors to PD-1 blockade and the induction of systemic immunity. (PubMed, J Immunother Cancer)
    The ability of systemic CKM to eliminate the PD-1-resistance of cold tumors indicates that intratumoral CTL accumulation, rather than tumor immunogenicity, is the key factor limiting the therapeutic effectiveness of ICI. These data suggest a broad therapeutic potential of TME-reprogramming strategies.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • TLR3 (Toll Like Receptor 3) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • IFNA1 (Interferon Alpha 1) • BATF3 (Basic Leucine Zipper ATF-Like Transcription Factor 3)
    |
    Ampligen (rintatolimod)
    3ms
    Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease (clinicaltrials.gov)
    P1, N=16, Recruiting, Washington University School of Medicine | Trial completion date: Sep 2033 --> Mar 2033
    Trial completion date
    |
    Signatera™
    |
    Hiltonol (poly-ICLC)
    3ms
    Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706 (clinicaltrials.gov)
    P1, N=40, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Hiltonol (poly-ICLC)
    3ms
    NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting | N=30 --> 12 | Trial primary completion date: Nov 2026 --> Jun 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
    4ms
    PANCOV: Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers (clinicaltrials.gov)
    P1/2, N=48, Recruiting, ANRS, Emerging Infectious Diseases
    New P1/2 trial
    |
    Hiltonol (poly-ICLC)