Drug intelligence / Profile preview

Nidlegy

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
01

Overview

Nidlegy is an investigational immunotherapeutic combination consisting of two immunocytokines: L19IL2 (darleukin) and L19TNF (fibromun). Developed by Philogen S.p.A., it is designed for intratumoral administration. Each component consists of a specific cytokine (Interleukin-2 or Tumor Necrosis Factor) fused to the L19 antibody fragment, which targets the Extra-Domain B (ED-B) of fibronectin. ED-B fibronectin is a marker of neo-angiogenesis that is highly expressed in the stroma of many solid tumors but virtually absent in most healthy tissues. By delivering IL2 and TNF directly to the tumor microenvironment, Nidlegy aims to induce a potent local inflammatory response and activate a systemic anti-tumor immune response while minimizing the systemic toxicities typically associated with these cytokines. It is currently in Phase III clinical trials as a neoadjuvant treatment for patients with resectable Stage III B/C melanoma.

Brand names
Nidlegy
Other names
Daromundarleukin + fibromun
02

Targets

ED-B (Fibronectin extra domain B)IL-2R (Interleukin-2/interleukin-15 receptor complex)TNFR2 (Tumor necrosis factor receptor superfamily member 1B)

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