nir-vana innovation network

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.

Advantages & innovations

RA is characterized by immune cell infiltration in the joint. The presence of the identified biomarkers is a hallmark for the disease, since RA patients can be subdivided in autoantibody positive and negative disease. Autoantibodies can already be detected years before disease onset in a subgroup of patients and at symptom onset a broad isotype spectrum is observed. This suggests that various events occur prior to the development of RA in which the first autoantibodies develop in predisposed individuals. Therefore, the presence of these autoantibodies can be unique in predicting future RA patients. This suggests a completely new approach for early diagnostics, stratification of patients for optional therapies as well as for monitoring of therapy responses. Moreover there is a high need for RA diagnostic testing worldwide. The overall prevalence of RA ranges from 0.29% to 0.57% of the general European population while in USA, the prevalence is close to or even higher than 1%. The annual incidence varies between about 20 and 50 cases per 100.000 inhabitants, suggesting a very high market potential.

Stage of development

Available for demonstration

Partner sought

1. Technical cooperation agreement and license agreement Type of partner: The team is looking for an industrial partner for developing and commercializing biomarkers and technology. Field of activity: The partner sought could be a diagnostics company active in sero-test kit development or a pharmaceutical company interested in personalized treatment and diagnostics. It should ideally already be present at the autoimmune diagnostic test market or active in the RA-therapeutic area. Role of partner: co-development and commercialization of the designed kit internationally. - At the first stage the role of the partner would be to co-develop the commercial product, by means of validating the suggested markers and enter kit development (contract development agreement) - A further long-term license agreement to commercialize the technology worldwide is envisaged, by sharing patent-rights. The IPR and licensing strategy will be defined jointly. 2. Financial Agreement Type of partner: the team is looking for investors to fund the validation of biomarkers and to accelerate R&D activities in order to develop a diagnostic test kit for RA. Field of activity: The partner sought could be a systemic (venture capital, financial organisation) or non-systemic investor (business angel) interested or already active in personalized treatment and diagnostics markets. A financial agreement could also be considered with a relevant large corporate wishing to invest in this venture. Role of partner: to invest in the cooperation for the development and commercialization of the markers internationally through a financial agreement.