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    DRUG:

    igrelimogene litadenorepvec (TILT-123)

    i
    Other names: TILT-123, Ad5/3-E2F-d24-hTNFa-IRES-hIL2, TNFalpha and IL-2 coding oncolytic adenovirus, PM1016
    Associations

    News

    Trials
    Company:
    Tilt Biotherap
    Drug class:
    IL-2 stimulant, TNFα stimulant
    Related drugs:
    Associations

    News

    Trials
    1m
    PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. (clinicaltrials.gov)
    P1/2, N=29, Recruiting, TILT Biotherapeutics Ltd. | N=76 --> 29
    Enrollment change • Platinum resistant
    |
    Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
    4ms
    AVENTIL: Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1 (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, TILT Biotherapeutics Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Dec 2026
    Enrollment closed • Trial primary completion date
    |
    Bavencio (avelumab) • igrelimogene litadenorepvec (TILT-123)
    4ms
    TUNINTIL: TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma (clinicaltrials.gov)
    P1, N=17, Completed, TILT Biotherapeutics Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    7ms
    TUNINTIL-2: TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma (clinicaltrials.gov)
    P1, N=9, Recruiting, TILT Biotherapeutics Ltd.
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • igrelimogene litadenorepvec (TILT-123)
    7ms
    PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a and 2) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. (clinicaltrials.gov)
    P1/2, N=76, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Jun 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027 | Phase classification: P1 --> P1/2 | N=29 --> 76
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Platinum resistant
    |
    Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
    8ms
    PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (clinicaltrials.gov)
    P1, N=29, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Jan 2027 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Mar 2026
    Trial completion date • Trial primary completion date • Platinum resistant
    |
    Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
    9ms
    Safety and efficacy of combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus TILT-123 in metastatic melanoma. (PubMed, Cell Rep Med)
    In the initial TILT-123 monotherapy phase of the trial, disease control is observed in 6/17 (35%) and 10/16 (63%) in CT and PET, respectively. The study demonstrates good tolerability and preliminary efficacy.
    Journal • Tumor-infiltrating lymphocyte
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    10ms
    The oncolytic adenovirus TILT-123 with pembrolizumab in platinum resistant or refractory ovarian cancer: the phase 1a PROTA trial. (PubMed, Nat Commun)
    Clinical responses were associated with higher serum anti-adenovirus neutralizing antibody titer at baseline and post-treatment. The phase 1b investigating TILT-123, pembrolizumab and PEGylated liposomal doxorubicin in a similar patient population is underway.
    P1 data • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
    10ms
    Transient lymphocyte count decrease correlates with oncolytic adenovirus efficacy in humans: mechanistic and biomarker findings from TUNIMO phase I trial. (PubMed, J Immunother Cancer)
    TILT-123 therapy induced accumulation of effector lymphocytes in tumors. Peripheral lymphocyte count decrease is a promising biomarker for assessing oncolytic adenovirus therapy response.
    P1 data • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    11ms
    Durable complete response after combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus (TILT-123) in a patient with metastatic mucosal melanoma. (PubMed, Immunooncol Technol)
    Immunohistochemical analysis and single-cell sequencing revealed interesting alterations in injected and noninjected tumors as well as in peripheral blood, during the treatment course, suggesting that TILT-123 facilitated TIL engraftment into the tumor, ultimately leading to a complete response. This case underscores the potential of combined immunotherapeutic approaches as a promising strategy for patients with metastatic mucosal melanoma.
    Journal • Tumor-infiltrating lymphocyte
    |
    IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)
    1year
    KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2024 --> Jan 2026
    Trial completion date • Trial primary completion date • Combination therapy • Oncolytic virus • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • igrelimogene litadenorepvec (TILT-123)
    1year
    Single intravenous administration of oncolytic adenovirus TILT-123 results in systemic tumor transduction and immune response in patients with advanced solid tumors. (PubMed, J Exp Clin Cancer Res)
    TILT-123 demonstrated safety and significant intratumoral immunomodulation following a single i.v. administration, warranting further investigation.
    Journal • Oncolytic virus • IO biomarker • Metastases
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    igrelimogene litadenorepvec (TILT-123)