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    DRUG CLASS:

    TLR agonist

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    Associations

    News

    Trials
    18d
    transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=188, Terminated, Ascendis Pharma Oncology Division A/S | Active, not recruiting --> Terminated; The Sponsor made the decision to close enrollment to prioritize our efforts on TransCon IL-2 ß/g.
    Trial termination
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    25d
    INDP-D101: Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=120, Active, not recruiting, Indaptus Therapeutics, Inc | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    MSI-H/dMMR
    |
    Tevimbra (tislelizumab-jsgr)
    4ms
    Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=28, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Yervoy (ipilimumab) • lefitolimod (MGN1703)
    4ms
    PERIO-01: Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (clinicaltrials.gov)
    P1, N=67, Terminated, TriSalus Life Sciences, Inc. | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.
    Trial termination • Checkpoint inhibition
    |
    Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • nelitolimod (SD-101) • relatlimab (BMS-986016)
    6ms
    TLR2 Agonism Suppresses Myeloid Leukemogenesis by Reprogramming Leukemia Stem Cells. (PubMed, Blood Adv)
    We find that the co-expression of TLR2 and MHCII genes is associated with better overall survival in AML patients, which is consistent with our observations of activated TLR2 signaling in mice. These data reveal functional TLR2 signaling critically antagonizes leukemogenesis and emphasizes a role for TLR2 agonism in AML.
    Journal
    |
    TLR2 (Toll Like Receptor 2)
    6ms
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Terminated, Ascendis Pharma A/S | Trial primary completion date: Dec 2024 --> Mar 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    6ms
    Adjuvantation of Kyasanur Forest Disease vaccine with TLR9 agonist CpG adjuvant enhances immunological efficacy and potency of the vaccine. (PubMed, PLoS One)
    The potency test showed that CpG adjuvanted vaccine has higher protective efficacy with better protective index compared with the non-adjuvanted KFD vaccine. Taken together these findings, the study recommends CpG as an adjuvant in the formalin inactivated KFD vaccine since the adjuvantation was safe and enhanced KFD specific immunogenicity and protective efficacy in mice.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha)
    7ms
    Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: May 2027 --> Apr 2026 | Trial primary completion date: Nov 2026 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    7ms
    Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Suspended --> Active, not recruiting | N=48 --> 29
    Enrollment closed • Enrollment change
    |
    CD4 (CD4 Molecule)
    7ms
    BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=27, Terminated, Ascendis Pharma A/S | Completed --> Terminated; The Sponsor made the decision to close enrollment as part of a strategic portfolio review.
    Trial termination
    |
    Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
    8ms
    transcendIT-101: A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=188, Active, not recruiting, Ascendis Pharma Oncology Division A/S | Trial primary completion date: May 2025 --> Jan 2026
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • resiquimod SR (TransCon TLR7/8 Agonist)
    9ms
    Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV (clinicaltrials.gov)
    P1, N=60, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting --> Completed | N=46 --> 60 | Trial completion date: Aug 2025 --> Apr 2025
    Trial completion • Enrollment change • Trial completion date