Fibromun (L19TNF) is a fully-human immunomodulatory product consisting of the L19 antibody and TNF (a strong pro-inflammatory cytokine). Recombinant TNF has so far been approved only for certain clinical applications.
The fusion of TNF to the L19 antibody, which is specific to the EDB domain of fibronectin, results in a tumor-targeted product, which preferentially localizes at the site of disease, while sparing healthy organs.
Fibromun has shown potent anti-tumor activity, both as single agent and in combination with other drugs, in several immunocompetent preclinical models, inducing long-lasting complete responses in most cases.
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 procedure.
In preclinical models of sarcoma, Fibromun has, when combined with doxorubicin or dacarbazine (which are standard therapies for first line and third line sarcoma, respectively), cured all treated animals.
Based on the encouraging results observed in the phase Ib study conducted in patients with metastatic Soft Tissue Sarcoma, three clinical trials with registration potential are currently ongoing in first line and third line metastatic Soft Tissue Sarcoma in Europe and in the United States.
Fibromun has also shown promising activity in orthotopic mouse models of glioblastoma and in high-grade glioma patients (studies performed in collaboration with the University Hospital Zurich). On the basis of the promising results observed in a phase I/II monotherapy study in patients with recurrent glioma, three clinical trials with registration potential in newly diagnosed and in recurrent glioblastoma patients are currently ongoing in Europe and in the United States.
The program is partnered with SUN Pharmaceuticals.
ONGOING CLINICAL TRIALS
- Two pivotal clinical trials with Fibromun in combination with doxorubicin in metastatic Soft Tissue Sarcoma are ongoing in Europe (EudraCT:2016-003239-38) and in the USA (NCT03420014).
- A phase II clinical trial with Fibromun in combination with dacarbazine in pretreated Soft Tissue Sarcoma (EudraCT:2018-004104-19).
- A phase I/II clinical trial with Fibromun (monotherapy) in grade III/IV glioma at first relapse (NCT03779230).
- A phase I/II/IIb clinical trial with Fibromun in combination with radiotherapy and temozolomide in newly diagnosed glioblastoma (NCT04443010).
- A phase I/II clinical trial with Fibromun in combination with lomustine in grade III/IV glioma at first relapse (NCT04573192).
ONGOING CLINICAL TRIALS
- Two pivotal clinical trials with Fibromun in combination with doxorubicin in metastatic Soft Tissue Sarcoma are ongoing in Europe (EudraCT:2016-003239-38) and in the USA (NCT03420014).
- A phase II clinical trial with Fibromun in combination with dacarbazine in pretreated Soft Tissue Sarcoma (EudraCT:2018-004104-19).
- A phase I/II/IIb clinical trial with Fibromun in combination with radiotherapy and temozolomide in newly diagnosed glioblastoma (NCT04443010).
- A phase I/II clinical trial with Fibromun in combination with lomustine in grade III/IV glioma at first relapse (NCT04573192).
- A phase II clinical trial with Fibromun in combination with lomustine in patients with Glioblastoma at progression or recurrency in the United States (NCT06336291)
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