Biomarker validation for improving diagnosis of rheumatoid arthritis offered under a cooperation and licensing agreement

An interdisciplinary team from an Austrian research institution and a medical university has identified molecular biomarkers for improving sero-diagnostics for RA. The team has conducted discovery studies on high density protein arrays and bioinformatics analysis to search for novel human autoantigens suitable for serologic testing of RA patients, particularly focusing on sero-negative samples. Currently existing biomarkers in use for RA diagnostics are rheumatoid factor and anti-citrullinated protein/peptide antibodies (ACPA), both of which have low sensitivity for early diagnosis of RA, as they are detectable in only 2/3 of the patients. This poses a diagnostic challenge, since there are no biomarkers for RA patients testing negative for the currently used routine biomarkers (known as sero-negative patients) and diagnosis is based solely on clinical grounds. Thus, critical time for starting early treatment may be lost and irreversible damage due to ongoing autoimmune and inflammatory processes will affect patients, which could be avoided when a definite diagnosis is improved. In addition, since RA is a chronic, progressive autoimmune disease diagnosed patients need continuous treatment, even lifelong in many cases. Usually disease modifying anti-rheumatic drugs (DMARDs) are administered initially, followed by various biologics, particularly biologics targeting TNF (tumour necrosis factor), in different treatment regimens when DMARD treatment proves ineffective. However, a substantial proportion of patients fail at anti-TNF therapy and alternative biologics must be used to improve the therapeutic response. This causes a high economic and patient’s health burden, which would be best avoided by using objective measures such as biomarkers to define a patient’s susceptibility to a specific therapy. However, currently no biomarkers are available to predict therapy response. The candidate markers identified by the research team show the potential to improve sero-diagnostics of RA because they may also be present in sero-negative patients. The available combination of a highly multiplexed platform and a biobank with a large number of well-characterized specimens enables fast and reliable confirmation and validation. Thus, the identified candidate biomarkers are best suited for further development of early diagnostics as well as patient stratification (personalized medicine) to predict therapeutic responses. The team seeks: - industrial partners interested in sero-tests and diagnostics who wish to validate the biomarkers and co-develop the diagnostic kits. The team envisages to enter a subsequent long-term cooperation via license agreement, offering the patent rights to commercialize the biomarkers. The team also offers to jointly define the IPR and licensing strategy, depending on the cooperation modalities with the commercial partner. - commercial partners to invest in the cooperation for the development and commercialization of the markers internationally through a financial agreement.