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    DRUG:

    darleukin (L19IL2)

    i
    Other names: L19IL2, L19-IL2 fusion protein, anti-EDB-interleukin-2 antibody conjugate, L19-IL-2, L19-IL2, anti-EDB-IL2 antibody conjugate
    Associations

    News

    Trials
    Company:
    Philogen
    Drug class:
    IL-2 stimulant, Fibronectin 1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    24d
    IMMUNOSABR2: IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study (clinicaltrials.gov)
    P2, N=126, Recruiting, Maastricht University Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL2 (Interleukin 2)
    |
    darleukin (L19IL2)
    1m
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
    7ms
    A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1/2, N=6, Terminated, Philogen S.p.A. | Trial completion date: Dec 2022 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Sep 2023; Slow progression due to difficulties in finding eligible patients. Competitive clinical trials with innovative agents and new approved products leaddefinitive stop.
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • IL2 (Interleukin 2)
    |
    CD20 positive
    |
    Rituxan (rituximab) • darleukin (L19IL2)
    2years
    A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P1/2, N=6, Active, not recruiting, Philogen S.p.A. | Recruiting --> Active, not recruiting | N=38 --> 6 | Trial completion date: Dec 2019 --> Dec 2022 | Trial primary completion date: Dec 2019 --> Dec 2022
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • IL2 (Interleukin 2)
    |
    CD20 positive
    |
    Rituxan (rituximab) • darleukin (L19IL2)
    2years
    A Phase I/II Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma (clinicaltrials.gov)
    P1/2, N=96, Active, not recruiting, Philogen S.p.A. | Trial completion date: Jun 2017 --> Jun 2022
    Trial completion date • Combination therapy
    |
    IL2 (Interleukin 2)
    |
    dacarbazine • darleukin (L19IL2)
    2years
    Neoadjuvant L19IL2/L19TNF- Pivotal Study (clinicaltrials.gov)
    P3, N=214, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2018 --> Dec 2023
    Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
    over3years
    Immunocytokines are a promising immunotherapeutic approach against glioblastoma. (PubMed, Sci Transl Med)
    Furthermore, intravenous administration of L19-mIL12 or L19-mTNF cured a proportion of tumor-bearing mice, whereas L19-IL2 did not. Systemic administration of the fully human L19-TNF fusion protein to patients with glioblastoma (NCT03779230) was safe, decreased regional blood perfusion within the tumor, and was associated with increasing tumor necrosis and an increase in tumor-infiltrating CD4 and CD8 T cells. The extensive preclinical characterization and subsequent clinical translation provide a robust basis for future studies with immunocytokines to treat malignant brain tumors.
    Journal
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
    |
    TILs
    |
    Fibromun (onfekafusp alfa) • darleukin (L19IL2)
    4years
    IMMUNOSABR2: IMMUNOtherapy and Stereotactic ABlative Radiotherapy (IMMUNOSABR) a Phase II Study (clinicaltrials.gov)
    P2, N=126, Recruiting, Maastricht University | Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
    Clinical • Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
    |
    IL6 (Interleukin 6) • CEACAM5 (CEA Cell Adhesion Molecule 5) • IL2 (Interleukin 2) • FN1 (Fibronectin 1) • CRP (C-reactive protein)
    |
    darleukin (L19IL2)
    4years
    [VIRTUAL] Targeting glioblastoma with novel immunocytokines. (ASCO 2020)
    The data obtained with the comprehensive preclinical characterization and subsequent clinical translation form the basis for future studies with immunocytokines as novel treatment option for patients with malignant brain tumors. Research Funding: Philogen, Swiss National Sience Foundation
    IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
    |
    darleukin (L19IL2)