Development of a nanobody based medical diagnostic kit that detects Interleukin-1 Receptor Antagonist/Anakinra

Coordinator of the program: University of Nova Gorica, contact person: prof. dr. Ario de Marco: https://cris.cobiss.net/ecris/si/sl/researcher/35787

Slovene partner: UNG (Ario de Marco). Turkish partner: Batu Erman, Acibadem University

UNG group members: Marco Orlando, Claudia D’Ercole, Klara Kropivšek

Duration: July 2025 - June 2028

Topic:

Therapeutic drug and immunogenicity monitoring (TDIM) is a rapidly developing field where monitoring of biologic drug levels is used for detecting therapeutic outcome. TDIM is not yet in clinical practice but is critical for determining inter-individual variability, patient treatment outcomes and anti-drug antibody concentrations. The aim of this project is to generate novel nanobody (VHH) based proteins that detect the Interleukin-1 Receptor antagonist protein. The IL-1R signaling pathway plays a key role in the initiation of inflammation. The IL-1R antagonist is a naturally occurring anti-inflammatory protein that competitively binds to the IL-1 Receptor and inhibits signaling. A recombinant mimic of this protein named Anakinra/Kineret, has been produced and is used in the clinic for hyper inflammatory diseases such as Familial Mediterranean Fever (FMF), Still's disease and Recurrent pericarditis. The project team will use their expertise to generate a novel anti-IL1Ra/Anakinra Nanobody to be developed into a Medical Diagnostic Kit that detects the levels of this protein from the serum of these patients.

In June 2026 the two teams co-organized a Nanobody workshop in İstanbul attended by more than 100 participants.