NEW YORK – Swedish diagnostics firm Elypta shared promising results this week from a clinical trial of its noninvasive metabolite-based test intended to aid clinicians in monitoring kidney cancer patients for recurrence while reducing the need for costly imaging.
The firm's chief business officer, Fredrik Härenstam, said in an interview that kidney cancer has been left out of some of the excitement around residual and recurrent cancer monitoring tests taking place in the DNA sequencing community. The company believes it can fill an unmet need with an alternative biomarker strategy.
"We've done a number of studies … across different cancers, but kidney cancer was always there from the beginning … because we have entirely new biomarker, which we believe is a very new sort of mechanism and new signal. And kidney cancer is one that really lacks any biomarker whatsoever," he said.
Elypta is a spinout from Chalmers University of Technology in Gothenburg, with the goal to commercialize a platform for measuring a class of metabolites called glycosaminoglycans, or GAGs, in blood or urine.
The company uses an enzymatic digestion assay that depolymerizes these metabolites into sugar molecules, which are then labeled and separated via liquid chromatography and detected using mass spectrometry. An algorithmic scoring system provides a readout between 1 and 100, which the company calls a GAGome, to indicate the likelihood of remaining or recurring cancer.
The researchers who developed this "were really taking a holistic view on what metabolic pathways might be perturbed in cancer at one point or another," said Härenstam.
Elypta's new results were presented at the European Association of Urology (EAU) Congress in Madrid on Monday and have also been accepted for publication in the journal European Urology Oncology.
The data come from an international study called AUR87A, which followed patients with clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer. This disease subtype accounts for approximately 90 percent of cases with around 400,000 patients diagnosed each year worldwide.
According to Elypta, about 20 percent of ccRCC patients who have surgery to remove their cancer will see it return, and the only available surveillance tools are imaging — usually a CT scan — with the frequency of screening determined by clinical risk factors.
At the EAU meeting, Elypta reported results from 134 patients recruited for its study at 23 hospitals across the UK, EU, US, and Canada. All had ccRCC that hadn't spread and were treated with surgery. They then had standard of care imaging scans alongside Elypta's urine test, which was performed every three months.
At up to 18 months of follow-up, 15 percent of the cohort had a recurrence. Of these, the GAGome test correctly identified 90 percent of patients whose cancer had returned using a test score cutoff where a result above 12 was counted as positive and a score of 12 or below as negative. At the same cutoff point, the test correctly ruled out just over half of those who remained cancer-free.
Study investigators calculated the test's negative predictive value at 97 percent, suggesting a negative score could be a reliable tool to de-escalate the use of imaging in patients highly unlikely to be experiencing a recurrence.
According to Saeed Dabestani, a professor at Lund University and the lead investigator of the study, this level of accuracy matches what has been seen with CT scans and offers advantages over using scans alone.
"CT scans often pick up small lesions that aren’t large enough to biopsy, and we currently don’t know whether they are a sign of the cancer returning or not," he said in a statement. "Our only option is to do more frequent scans to monitor more closely, which is unpleasant for patients and often brings little benefit."
"Based on the results we have so far, it’s likely that we could safely halve the number of scans that patients have to undergo," he added.
Carmen Mir Maresma, a member of the EAU Scientific Congress Office, cautioned that the field doesn't know yet whether finding recurrence sooner will save patients’ lives, but there are postoperative treatments being explored in the field, including immunotherapy.
"When you get a new biomarker out there, there will be a phase of exploration, which is not really necessarily driven by us. It will be driven by the clinical community, the needs they have, and what they want to test," said Härenstam.
"Obviously, we'd be very keen to explore how this could help guide adjuvant therapy. For instance, could we find low-risk patients that are today not getting adjuvant therapy that might benefit from it based on a GAGome test, or conversely, might there be patients who would not benefit from it that otherwise would get it," he added.
Härenstam said that AUR87A is currently nearing final recruitment of a second cohort of patients, with the results — expected early next year — hopefully validating the findings from the first cohort.
Elypta plans to bring its test to market in both the EU, under IVDR standards, and through the US Food and Drug Administration. Härenstam said discussions with both bodies are ongoing, and the company believes it will be able to file for potential approval next year.
In terms of capital, the company raised $21 million in Series A financing in 2022 in a round led by Bonnier Ventures. That joined $6.8 million in seed funding that the firm raised in 2020, as well as a $2.7 million grant from the European Union.
Elypta might face competition in the clinical market moving forward, but Härenstam said that kidney cancer appears to have been a challenge for other technologies including DNA-based tests.
"If you look across tumor types, the shedding of circulating tumor DNA varies. Some types shed a lot even for small tumors at early stages, but for kidney cancer it doesn't seem like a lot of that ... is happening, and that makes it difficult to detect a cancer whether it be at early stage or in recurrence [setting]," said Härenstam.
"I'm sure there's lots of research going on in that space. But we've been doing this now for several years and there's no other effort that we are aware of at a validation stage or a serious effort toward commercialization," he added.
Looking further forward, the company has data to support additional applications for its technology, including in bladder cancer, and potentially as a multi-cancer early detection tool. Härenstam said that the firm plans to revisit those possibilities after it establishes its ccRCC test.