NEW YORK — German peptide array firm PepperPrint is looking to move into the diagnostics space with an assay for improving the early detection of rheumatoid arthritis.
The Heidelberg-based company presented data this month at the 13th International Congress on Autoimmunity on a set of peptide markers that detected rheumatoid arthritis with sensitivity of up to 89 percent in a validation study of 1,000 subjects.
PepperPrint is now looking to license the markers to diagnostic companies or laboratories in the US and Europe, said CEO Volker Stadler.
A spinout of the German Cancer Research Center, PepperPrint specializes in the production of high-density peptide microarrays for applications including epitope mapping, immune monitoring, and biomarker discovery.
Stadler said the company generates around $3 million in revenue annually, with about a third of that coming from sales of its peptide microarrays to outside labs and roughly two-thirds coming from research services done internally for customers. Its business is split roughly evenly between biotech, pharma, and academia, Stadler said, with the US being its biggest market, followed by Europe.
In addition to its Heidelberg headquarters, PepperPrint has offices in Cambridge, Massachusetts; Gujarat, India; and Vicosa, Brazil.
Stadler said that PepperPrint sees in diagnostics the opportunity to boost the company's growth and profitability, which he said has been sustained, but modest, since it launched operations in 2010.
"We started as a tool company … but we always intended as well to develop our own biomarkers, because such biomarkers could give the company a growth potential that microarrays and research services do not always show," he said.
Much of PepperPrint's research work has focused on autoimmunity and infectious disease, and the company has continued to focus in these areas in its diagnostics work. Stadler noted that it previously identified a peptide marker that showed promise for diagnosing Zika virus but that its commercial potential has become less certain as interest in the disease has waned.
"We have patents [on the marker], but I'm not sure if we will follow" their development, he said.
PepperPrint was also pursuing breast cancer markers but has put that effort on pause after being unable to reproduce its initial findings in validation work.
The company's RA test program emerged from its autoimmune research, Stadler said. "If you look at autoimmune disease, one of the most common is rheumatoid arthritis, so it is an attractive target."
Early detection and diagnosis of RA is an issue, with up to 50 percent of patients presenting a seronegative in the early stages of the disease. Research has linked delayed diagnosis due to seronegativity to lower likelihood of achieving disease remission, suggesting the importance of early detection and treatment.
"We saw that there was an opportunity that we could address with our high-density peptide microarrays," Stadler said.
The company produced microarrays containing peptides featuring the citrulline and homocitrulline post-translational modifications implicated in the disease and used them to discover peptides that could potentially be used to diagnose RA. They validated a set of these markers in serum samples from a group of roughly 1,000 subjects including patients with RA and other autoimmune conditions, and healthy controls.
Stadler said the company is still doing data analysis, but in two models it presented at the Congress on Autoimmunity meeting, its panels identified RA cases with 78 percent sensitivity and 89 percent specificity and 89 percent sensitivity and 73 percent specificity.
Protein biomarkers for RA have something of a mixed record. In 2014, Myriad Genetics acquired what was once the most prominent company in the space, Crescendo Bioscience, for $270 million — a deal that was a landmark for proteomics-based diagnostics. Crescendo's Vectra test measures the levels of 12 proteins to gauge disease activity in RA to help doctors and patients monitor disease severity and treatment effectiveness.
According to Myriad, the test has been used by more than 1 million RA patients and has been ordered by the majority of US rheumatologists, but it was never the commercial success Myriad had hoped for, and last year the company sold it to Laboratory Corporation of America for $150 million, a little more than half of what it paid for the business seven years before.
Stadler said that PepperPrint planned to explore whether its markers could be used for tracking disease progression similar to Vectra but said that its primary focus, at least initially, would be using the test for the early detection of RA.
Earlier detection, he said, has the potential to benefit patients by getting them treatment sooner. Additionally, it could benefit pharma companies that have anti-RA agents by expanding their market for those drugs, and healthcare systems by reducing overall treatment costs by catching the condition when it can more easily be managed.
Stadler said the company is now working to boost the performance of its RA test by looking at whether different combinations of peptides or different peptide structures could offer improvements. It is also in discussions with several diagnostic firms that work in the autoimmune space about licensing the markers, though he did not say which firms.
Stadler said that it was possible PepperPrint could ultimately decide to commercialize the markers itself, but noted that this would require raising outside money, something it has not done since receiving seed funding from the German public-private investment vehicle High-Tech Gründerfonds (HTGF).
"We are not a diagnostics company — at least, not yet," he said.