Mån 4 mar / År 42 / Nr 5 2023

Using information from blood to build disease profiles

Formed in 2007 by researchers from Lund University and CREATE Health (the Center for Translational Cancer Research) in Lund, Sweden, Immunovia uses its IMMray technology platform to create diagnostic tools.

There are many known biomarkers in blood, and researchers are finding more every day. Understanding the profiles of biomarkers in health and disease could play an important role in predicting and diagnosing disease and monitoring treatment.
Swedish company Immunovia is putting its knowledge of immune markers to good use by building antibody-based multiplex microarrays, using its IMMray technology platform. These assays detect levels of immuno-regulatory factors, cytokines, enzymes, complement proteins, innate factors, and other disease-associated proteins, creating serum protein signatures that can be used for early diagnosis of cancer and autoimmune disease.

Building on its core technology
Immunovia’s IMMray platform is based around the company’s vast library of antibodies and its bioinformatics technology, including machine learning algorithms. These are used to create a disease ‘fingerprint’ from around 30 or 40 proteins, and this represents the body’s immune response to disease.
“Our core technology measures the relative concentrations of specific proteins in the blood. It is a general platform using about 400 different antibodies when researching for a new signature test to answer a clinical question and has potential applications in a variety of diseases,” said CEO Mats Grahn. “This allows us to compare and find the difference between diseased and controls.”

Detecting cancer
IMMray PanCan-d will be Immunovia’s first product to reach the market. Pancreatic cancer is hard to diagnose, with up to nine months and 18 visits to the doctor to get a definite diagnosis. Immunovia’s assay, which can differentiate between patients with stage I, II, III, and IV cancer, could mean that patients are diagnosed, and therefore treated, much earlier.
The assay has been validated in large retrospective studies, which showed detection of stage I and stage II pancreatic cancer with 96% accuracy. Prospective validation studies are ongoing, including in higher-risk patients with familial pancreatic cancer, or with new-onset diabetes type II.
“Pancreatic cancer was our first focus because of the large unmet needs, but we are now moving onto other cancers,” said Grahn. “We need to optimise the assay and rerun some studies, but we expect to reach the U.S. and European market in late 2019.”
There are many other potential oncology applications for the IMMray technology including lung cancer. Immunovia, in collaboration with a global top 10 pharma, is working on a non-small cell lung cancer diagnostic. In a study of 50 cancer samples and 50 controls, the IMMray diagnostic differentiated the two with 95% accuracy.

Moving into autoimmune disease
Early results in 2017 showed that the IMMray technology could differentiate between a number of different autoimmune diseases, supported by data and samples from the University of Lund. Immunovia’s current focus in autoimmune disease is rheumatoid arthritis, RA and systemic lupus erythematosus (SLE), a chronic inflammatory rheumatic disease affecting the connective tissues. Pre-validation studies have been completed, and complementary studies and validation studies are in the planning phase.
“We have carried out a large study in collaboration with Linköping University, and this showed a greater than 90% accuracy in patients with rheumatoid arthritis. More interestingly, it showed that IMMray technology can identify patients with rheumatoid arthritis that test negative with antibodies against cyclic citrullinated peptides [CCP], one of the gold standard tests used to diagnose patients and predict prognosis. This group of patients, which represents around 25-30% of all rheumatoid arthritis patients, are currently missed,” said Grahn.