SuppreMol employs Protagen biomarkers in SLE study
"We will use the unique biomarker portfolio of Protagen for the rapid identification of autoantibody signatures in the serum of SLE patients enrolled in our current phase IIa study of our lead product SM101," said Prof. Peter Buckel, CEO of SuppreMol. "With these signatures we aim to identify patients who are most likely to respond favorable to SM101. In addition, our findings may allow the classification of patients into subgroups as SLE is a disease with very diverse manifestations. The UNIarray® technology platform of Protagen offers a unique opportunity to explore the potential for a personalized SLE therapy concomitant to the clinical development of SM101."
"SuppreMol is the first innovative clinical stage company building on the early integration of our indication-specific biomarker panels at the beginning of Phase IIa. We are very happy to enter into this collaboration project. Both of our companies are convinced that this approach will allow for specific enrollment as well as better stratification of SLE patients, and that it will significantly reduce the development risks of upcoming clinical studies," added Dr. Stefan Müllner, CEO of Protagen.
Financial details of the collaboration are not disclosed. The cooperation as well as SuppreMol's phase IIa SLE study are supported by the German Federal Ministry for Education and Research (BMBF) as part of the Leading Edge Cluster m4.
SuppreMol is a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases and allergies. The company is pioneering the development of soluble Fc gamma receptors (sFcgRs), which are recombinant autologous therapeutic proteins with a proven, strong immunosuppressive potential. The company plans to develop sFcgRs for the treatment of Primary Immune Thrombocytopenia (ITP), Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) and other autoimmune conditions.
SuppreMol's pipeline comprises three early antibody development programs against Fcg receptor IIb (FcgRIIb) suitable for alternative treatment strategies and indications (e.g. hypersensitivities) as well as an anti IL-3 antibody to treat RA for which the company obtained an exclusive license option recently.
SuppreMol was founded in 2002 as a spin-off from the laboratory of Prof. Dr. Robert Huber, Nobel Prize for Chemistry in 1988, at the Max Planck Institute for Biochemistry in Martinsried, Germany. The company has raised EUR 35.2 million in three financing rounds since May 2006 and investors include MIG AG, BioMedPartners AG, Santo Holding GmbH, FCP Biotech Holding GmbH as well as KfW Mittelstandsbank, Bayern Kapital GmbH, Max Planck Society, and Z-Cube.
SuppreMol received BMBF research grants of over EUR 2 million since 2007.
SuppreMol's lead candidate SM101 is a recombinant, soluble, non-glycosylated version of the Fcg receptor IIb. The protein binds to autoantibody/autoantigen complexes and blocks the triggering of Fc receptors on the surface of immune cells.
As a result, the immune response is downregulated and the activation of the inflammation cascade typically seen in autoimmune diseases is prevented.
SM101 has been validated in relevant animal models and has shown strong efficacy by decreasing inflammation and immune reactions.
At present, SM101 is being developed in Primary Immune Thrombocytopenia (ITP).
SuppreMol has been granted orphan medicinal product designation in the EU as well as orphan drug designation in the US for this indication. The company believes SM101 may also have potential in Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) and other autoimmune diseases.
Über Protagen AG
Protagen AG (www.protagen.de) is an international leading specialist in the fields of in-vitro diagnostics and GMP-compliant protein analysis. The innovations of Protagen are UNIarray®, a technology platform for the development of novel serum based diagnostics, as well as UNIchip®, a versatile product family of protein microarrays for faster development of antibodies.