FIBROMUN

FIBROMUN

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

  • 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 with Fibromun (monotherapy) in grade III/IV glioma at first relapse (NCT03779230).
  • A phase I/II/IIb with Fibromun in combination with radiotherapy and temozolomide in newly diagnosed glioblastoma (NCT04443010).
  • A phase I/II with Fibromun in combination with lomustine in grade III/IV glioma at first relapse (NCT04573192) will start soon.

SELECTED REFERENCES

Weiss et al., (2020) Sci Transl Med, 12 (564):eabb2311
Probst et al., (2019) Clin Cancer Res, 25, 698-709
Probst et al., (2017) Cancer Res, 77, 3644-3654
Hemmerle and Neri (2013) Br J Cancer, 109, 1206-13
Papadia et al. (2013) J Surg Oncol, 107, 173-179
Spitaleri et al (2013) J Cancer Res Clin Onc, 139, 447-455
Balza et al. (2010) Int J Cancer, 127, 101-10
Schliemann (2009) Leuk Res, 33, 1718-22
Balza et al. (2006) Clin Cancer Res, 12, 2575-2582
Borsi et al. (2003) Blood, 102, 4384-4392
Halin et al. (2003) Cancer Res, 63, 3202-10
Santimaria (2003) Clin Cancer Res, 9, 571-9
Castellani et al. (2002) Am J Pathol, 161, 1695-1700

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