Fibromun (L19TNF) is a fully-human immunomodulatory product consisting of the human anti-EDB antibody L19, fused to human TNF, a strong pro-inflammatory cytokine. Recombinant TNF (Beromun®, Boehringer Ingelheim) has so far been approved only for certain clinical applications.
Fibromun has previously been studied in clinical trials as monotherapy for systemic administration in patients with solid tumors and in melanoma patients using the Isolated Limb-Perfusion setting.
In preclinical tumor models, including sarcoma, L19TNF has shown a strongly synergistic anti-tumor effect with chemotherapeutic agents like doxorubicin and dacarbazine and the combination therapy was able to cure all treated animals.
In a phase Ib clinical trial the combination of Fibromun and doxorubicin was shown to be well tolerated and to confer efficacy in heavily pretreated soft tissue sarcoma patients evidenced by (i) induction of wide areas of tumor necrosis, (ii) significant shrinkage of metastatic lesions and (iii) cases with partial and complete response.
In a recently established collaboration with the University Hospital Zurich, the murine surrogate of Fibromun has demonstrated a striking single-agent anti-cancer activity in preclinical models bearing orthotopic glioblastoma. The treatment induced long-term tumor eradications in a proportion of the treated animals. These results provided a strong rationale for the ongoing clinical development of Fibromun in patients with brain tumors.
ONGOING CLINICAL TRIALS
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