This story originally ran on July 8.
By Tony Fong
Belgian protein biomarker firm Pronota has completed the first close of its Series B financing, raising €4.9 million ($6.8 million) that it will use to advance its diagnostics development programs.
The company announced the close last week, and in an interview with ProteoMonitor, CEO Nick McCooke said that the second close on the financing round with a target goal of €5 million is expected before the end of the year.
The funds will be used to hasten Pronota's plans to bring to market diagnostic tests it is developing using its proprietary biomarker discovery and verification platforms. Pronota currently has four active diagnostic development programs with its lead effort focusing on acute heart failure.
Two existing biomarkers for heart failure are already being used for diagnostic purposes — brain natriuretic peptide, or BNP, and N-terminal fragment BNP, or NT-proBNP. But both have inherent limits, including no definitive level that delineates patients with heart failure from those without, and a diagnostic gray area, in which determination of heart failure is inconclusive.
According to McCooke, Pronota has discovered alternative biomarkers that "we're positioning to address some of the weaknesses of BNP and NT-proBNP."
Pronota has approximately 10 candidate biomarkers that it discovered on its MASStermind platform, an unbiased method that investigates which proteins are differentially expressed in sample groups. One candidate biomarker, McCooke said, shows particular promise, performing at a baseline level comparable to BNP, "but looks as if it's going to be better at discriminating in what is called BNP's gray zone," when BNP is unable to provide a definitive diagnosis of heart failure.
The company's plan, he said, is to target a test for use in hospital emergency rooms where patients may show symptoms, such as shortness of breath, and physicians need to be able to differentiate ”whether that's caused by acute heart failure or a basket of other causes, which includes COPD, asthma, or pneumonia."
The next step is to verify the biomarkers on Pronota's MASSterclass, a multiple reaction monitoring mass spectrometry-based technology.
"What we're really trying to understand more closely is the performance of the biomarkers, either individually or in combinations, and in particular, looking at sub-populations [and] subcategories of the disease to really understand the behavior of the biomarkers," McCooke said. That includes looking at the 10 biomarkers in combination with BNP and NT-proBNP, he added.
Work on the biomarkers has encompassed about 250 patient samples, and in continuing research another 450 samples will be investigated. The clinical validation stage will entail about 1,500 samples, McCooke said.
The ultimate goal would be to develop a test in an immunoassay format, though that is still three years away, he estimated.
The next program that is furthest along in development is a test that would allow physicians to distinguish patients with sepsis from those with systemic inflammatory response syndrome.
While sepsis and SIRS are closely related, sepsis is caused by an infection, while SIRS is not and may be the result of trauma, burns, ischemia, or other non-infectious causes. Pronota has identified about 10 candidate biomarkers for this indication and is evaluating their utility in larger sample sets, McCooke said.
The firm also is about to begin verifying a set of about 50 biomarkers for their value in assessing the risk for preeclampsia. And finally, Pronata is investigating biomarkers that can distinguish ovarian cancer from other ailments with similar symptoms.
"It's not a screening test, it's a diagnostic," McCooke said. Researchers at the company are going through a list of potential biomarkers found in the discovery stage to determine which ones would be appropriate for verification.
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Overall, the four programs could represent the homestretch for Pronota in its progression from a start-up technology firm to a biomarker discovery shop and now to developing diagnostic products based on its own discovery work. Founded in 2004 with €14.5 million in Series A financing, the company spent the early part of its history developing its MASStermind technology for discovery, and then building it out for verification and validation, resulting in the MASSterclass platform.
The diagnostic programs were started 18 months ago after Pronota felt confident that its two technologies could do what they were supposed to.
"In each case, the technology has done the job asked of it," McCooke said. "It has identified relevant biomarkers for that disease, and in many cases [these] are low-abundance proteins, which we believe would be difficult for other techniques to identify or discover."
In an economic climate in which raising capital is especially challenging , he added, it was the technology that allowed Pronota to secure the €4.9 million announced a week ago.
"I've been involved in biotech since 1985," said McCooke, who before becoming CEO of Pronata in 2006 was the founding CEO of Solexa, a gene sequencing firm that Illumina acquired in early 2007. "I've seen a few cycles during that time … but these are pretty much the most difficult conditions I've experienced personally."
"But we've got a platform that is clearly working and we can present masses of evidence to show that. We've got four programs that look very exciting in terms of their potential, and they're all making good progress," he said.
Participants in this financing round included existing investors LSP, Gimv, Biotech Fund Flanders, KBC Private Equity, Johnson & Johnson Development, and Baekeland Fund. A new investor, VIB, a non-profit scientific research institute that developed the technology upon which MASStermind is based, also participated.
In addition to its own technology and diagnostics development, Pronata also provides a protein biomarker fee-for-service business, mostly for pharma clients. In addition to short-term revenue generation from such work, "where possible, we look to gain rights of some kind," McCooke said. "If there's a diagnostic potential in there, we seek to obtain some kind of rights to that biomarker for diagnostic use. … We try to look beyond the pure fee-for-service model."
However, none of the four diagnostic programs under current development resulted from its service business, McCooke said.