SuppreMol GmbH, an autoimmune disease specialist, today announced a licensing agreement with the University Hospital of Regensburg to develop SM401, a humanized anti-IL-3 monoclonal antibody for early diagnosis and treatment of Rheumatoid Arthritis (RA). SuppreMol will advance preclinical development of SM401 for treatment of RA. Simultaneously, the Company will further validate a highly sensitive human IL-3 diagnostic assay for patient stratification.
SuppreMol's preclinical candidate SM401 has demonstrated, in a murine model for RA, that it significantly reduces progression and severity of the disease. At the same time, levels of the inflammatory cytokines IL-6 and TNF-alpha, which are reduced by several established RA drugs, are also lowered.
Furthermore, it has been demonstrated that IL-3 concentrations were only elevated at the onset of arthritis and fell to low levels during the course of the disease in the animal model. Using the newly developed IL-3 diagnostic assay, SuppreMol expects to develop a biomarker for the stratification of RA patients.
'This SM401 program advances SuppreMol's strategy to target very early events in the development of autoimmune diseases,' said Dr. Peter Sondermann, CSO and co-founder of SuppreMol GmbH. 'Through this early intervention approach we expect to stop progression of the autoimmune disease rather than simply treating symptoms of inflammation. We expect to begin clinical trials in 2014.'
The anti-IL-3 monoclonal antibody was generated by the group of Professor Dr. Matthias Mack at Regensburg University Hospital - Internal Medicine II, following the discovery that increased levels of IL-3 indicate early onset and activity of RA. Prof. Mack is a member of SuppreMol's Scientific Advisory Board.
'This licensing agreement with Bayerische Patentallianz GmbH provides SuppreMol a very strong portfolio of autoimmune therapies and a potential companion RA diagnostic,' said Professor Dr. Peter Buckel, CEO of SuppreMol GmbH. 'Along with our Fc gamma receptor platform with three clinical and two further preclinical programs targeting autoimmune diseases and allergies, this SM401 program is another building block in the strong foundation of the company's future,' he added.
Bayerische Patentallianz GmbH is the central patent and marketing agency of the Bavarian Universities and Universities of Applied Sciences, including the University of Regensburg.
Early development of SM401 is being funded by a grant of EUR 1.37 million from the German Federal Ministry of Education and Research (BMBF). The project was funded in Prof. Mack's laboratory through BayImmuNet, the Bayerisches Immuntherapie Netzwerk; the development of a therapeutic anti-IL-3 antibody including a highly sensitive IL-3 assay is supported by the German Federal Ministry of Education and Research within the Leading-Egde Cluster 'm4 - Personalized Medicine and Targeted Therapies' in Munich.