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    DRUG:

    Fibromun (onfekafusp alfa)

    i
    Other names: L19-TNF, L19TNF, L19TNFalpha, L19 TNF fusion protein
    Company:
    Philogen, Sun Pharma
    Drug class:
    TNFα inhibitor
    Related drugs:
    2d
    Targeted TNF Potentiates the Activity of Bispecific T-cell Engagers in Solid Tumors by Turning Cold Tumors Hot. (PubMed, Cancer Immunol Res)
    In this study, we report a dual-modality approach to treating colorectal cancer by combining the tumor necrosis factor (TNF)-based fusion protein directed to the extradomain B (EDB) of fibronectin, L19-TNF, which induces localized intratumoral inflammation and facilitates T-cell infiltration, with a CD3-based bispecific T-cell engager (TCE) targeting carcinoembryonic antigen (CEA), which mediates antigen-specific cytotoxicity...Furthermore, mechanistic analyses revealed enhanced TCE extravasation, upregulated intercellular adhesion molecule 1 expression, and increased CD8+ T-cell infiltration, indicating vascular modulation and remodeling of the TME toward an inflamed "hot" phenotype. These findings confirm that targeted delivery of TNF to the TME can effectively enhance the activity of immunotherapeutic agents, such as T cell-redirecting therapies, in challenging tumor settings.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • ICAM1 (Intercellular adhesion molecule 1)
    |
    Fibromun (onfekafusp alfa)
    2d
    GLIOSTELLA: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Philogen S.p.A. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lomustine • Fibromun (onfekafusp alfa)
    8ms
    IMAGLIO: A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Philogen S.p.A.
    New P2 trial
    |
    temozolomide • Fibromun (onfekafusp alfa)
    1year
    FLASH: Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=98, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    dacarbazine • Fibromun (onfekafusp alfa)
    1year
    GLIOSTELLA: A Study with L19TNF in Combination with Lomustine in Patients with Glioblastoma At Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    lomustine • Fibromun (onfekafusp alfa)
    2years
    FLASH: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=98, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Metastases
    |
    dacarbazine • Fibromun (onfekafusp alfa)
    2years
    GLIOASTRA: Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression (clinicaltrials.gov)
    P1, N=0, Withdrawn, Philogen S.p.A. | N=24 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine • Fibromun (onfekafusp alfa)
    2years
    FIBROSARC: A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov)
    P3, N=102, Recruiting, Philogen S.p.A. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
    2years
    DOXO75: Dose Finding Study of L19TNF and Doxorubicin in Patients With STS (clinicaltrials.gov)
    P1, N=2, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
    2years
    GLIOSTAR: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Philogen S.p.A. | Trial primary completion date: Nov 2023 --> Mar 2025
    Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH wild-type
    |
    lomustine • Fibromun (onfekafusp alfa)
    2years
    GLIOSTELLA: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Philogen S.p.A.
    New P2 trial • Combination therapy
    |
    lomustine • Fibromun (onfekafusp alfa)
    over2years
    GLIOSTAR: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Philogen S.p.A.
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH wild-type
    |
    lomustine • Fibromun (onfekafusp alfa)