Drug intelligence / Profile preview

Fibromun + Darleukin

Development stage
Unknown
Lead developer
Philogen
Modality
Cytokines & Interferons → Recombinant Proteins and Enzymes, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Administration
Intratumoral
01

Overview

Fibromun + Darleukin is a combination immunotherapy developed by Philogen S.p.A. consisting of two antibody-cytokine fusion proteins. **Fibromun** (L19TNF) is a fusion of the human L19 antibody fragment (scFv) and human tumor necrosis factor-alpha (TNFα), while **Darleukin** (L19IL2) is a fusion of the L19 fragment and human interleukin-2 (IL-2). The L19 antibody fragment specifically targets the Extra-Domain B (EDB) of fibronectin, a marker of neo-angiogenesis that is highly expressed in the tumor microenvironment and neovasculature but virtually absent in normal adult tissues. By delivering these potent cytokines directly to the tumor site, the combination aims to induce localized inflammation, promote tumor necrosis, and stimulate a systemic anti-tumor immune response. This combination is primarily administered intratumorally to maximize local efficacy and minimize systemic toxicity, and it is currently being evaluated in Phase II clinical trials for locally advanced cutaneous squamous cell carcinoma (cSCC), melanoma, and soft tissue sarcoma, particularly in patients who have failed immune checkpoint inhibitor therapy.

Other names
L19TNF + L19IL2L19-TNF + L19-IL2tasonermin-L19 + aldesleukin-L19
02

Targets

IL-2R (Interleukin-2/interleukin-15 receptor complex)ED-B (Fibronectin extra domain B)

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