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Drug intelligence / Profile preview
onfekafusp alfa
- Development stage
- Phase 3
- Lead developer
- Philogen
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
- Administration
- Intratumoral, Intralesional
01
Overview
Onfekafusp alfa (L19TNF) is an immunocytokine developed by Philogen S.p.A. that consists of the L19 antibody fragment, which selectively targets the Extra Domain B (EDB) of fibronectin, genetically fused to human tumor necrosis factor (TNF). EDB-fibronectin is a marker of angiogenesis and is highly expressed in the neovasculature of many solid tumors but is virtually absent in most healthy adult tissues. By targeting EDB, onfekafusp alfa delivers TNF directly to the tumor microenvironment, promoting an anti-tumor immune response and vascular disruption while minimizing systemic toxicity. For the treatment of non-melanoma skin cancers, including basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), onfekafusp alfa is administered via intratumoral injection in combination with bifikafusp alfa (L19IL2). This combination is developed under the brand name Nidlegy. As a standalone agent (Fibromun), onfekafusp alfa is also in Phase III clinical development for soft tissue sarcoma and glioblastoma.
- Brand names
- Fibromun
- Other names
- onfekafusp alfa
02
Targets
TNFRSF1A (Tumor necrosis factor receptor superfamily member 1A)TNFR2 (Tumor necrosis factor receptor superfamily member 1B)ED-B (Fibronectin extra domain B)
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