NEW YORK – Supported by $34 million in Series B funding announced earlier this week, glycoproteomics firm InterVenn Biosciences is targeting a launch of its pelvic mass triage test in the first half of 2021.
The South San Francisco-based company is currently running a validation study of the test with plans to enroll a total of 1,200 subjects at multiple sites across the US, the Philippines, Malaysia, and Australia. The test uses mass spectrometry to measure glycoproteins and is designed to assess whether a pelvic mass is likely benign or malignant and whether its removal can be done by a gynecologists or should be performed by a gynecologic oncologist.
InterVenn was launched in March 2018 to commercialize glycoproteomic analysis methods developed by University of California, Davis professor Carlito Lebrilla and Stanford University professor Carolyn Bertozzi, both cofounders of the firm.
When it comes to market, the pelvic mass test will compete directly with the Aspira Women's Health OVA1 test, which is also intended to determine whether women with a pelvic mass should have their surgery done by a gynecologist or a gynecologic oncologist. While OVA1 has produced sluggish sales for most of its 10-year history, Aspira had managed, with the combination of a next-generation test with higher sensitivity and increased investment in an internal sales force, to nearly double OVA1 sales volume prior to the onset of the SARS-CoV-2 pandemic. In its recent Q3 2020 earnings report, the company said it had sold 3,596 OVA1 tests in the quarter, essentially flat from 3,602 tests in Q3 2019, and up 82 percent from 1,981 tests in Q3 2018.
InterVenn CEO Aldo Carrascoso said the company was targeting higher levels of sensitivity and specificity than OVA1 provides, but it has not yet published any peer-reviewed data to prove this. Data from 200 prospectively analyzed patients last year indicated the test distinguished between benign and malignant masses with a sensitivity of 91 percent and specificity of 92 percent, he said. He did not provide a breakdown of the test's performance by cancer stage but said that it had performed well across all stages.
InterVenn also last month signed a deal with Agilent Technologies to discover glycoproteomic biomarkers for diseases including cancer, with the ultimate aim of establishing a Center of Excellence of Glycoproteomics for Southeast Asia. The companies will launch the project at InterVenn Malaysia's laboratory at Technology Park Malaysia in Kuala Lumpur.
Protein glycosylation, in which sugars modify various amino acids, is a common post-translational modification and an important phenomenon in the biology of various diseases, including many cancers. Given this, researchers have long considered glycoproteins to have high potential as biomarkers, and, in fact, more than half of the cancer protein markers currently approved by the US Food and Drug Administration are glycoproteins.
In addition to the pelvic mass triage test, InterVenn is developing a glycoproteomic test for colorectal cancer. In a pilot study the company publicized earlier this year, the test was able to detect colorectal cancer with 98 percent sensitivity and 91 percent specificity and advanced adenomas with 98 percent sensitivity and 85 percent specificity. Those numbers were generated in a small retrospective cohort.
The company is also working on a glycoproteomic test for helping guide the use of immunotherapy in pancreatic cancer and melanoma.
According to John Leite, who joined the company this month as chief business officer following six years at Illumina, where he held roles including vice president of clinical business development, InterVenn has primarily focused in this space on developing assays that can identify patients likely to respond to immunotherapies.
He said the company is also interested in exploring markers that would predict patients likely to experience adverse treatment effects.
"We think that there is an evolving market for looking to understand not just exceptional responders, but in that case, it would be exceptional non-responders, people who have very deleterious effects on the therapy," he said. "It ends up having a very negative impact on patients and on the healthcare system and payors."
Leite said that the markers of immunotherapy response InterVenn is looking at have little overlap with markers traditionally used to identify likely responders.
"It’s a new dynamic in the biology of what constitutes prediction of response that is orthogonal to what has been discussed," he said.
He said the company believed that in addition to the performance of its platform, its requirement of only small sample material would make it attractive to collaborators and, eventually, clinical users.
"Because we only need 100 microliters as opposed to four or five mLs of plasma, partners from both academic centers and pharma are far more willing to collaborate and give the technology a try," he said.
Carrascoso said the immunotherapy test was the next product in the company's pipeline after the pelvic mass test.
Leite said InterVenn aims to ultimately develop companion diagnostics for immuno-oncology agents on the platform.
"The path for a technology like this is to ensure wide adoption by physicians through inclusion in the practice guidelines, through addition of our technology into the drug label, so absolutely, CDxs are a part of the roadmap," he said.
In addition to supporting commercialization of the tests in its pipeline, Carrascoso said the recently closed funding round, which was led by Anzu Partners with participation from Genoa Ventures, Amplify Partners, True Ventures, Xeraya Capital and the Ojjeh Family, will be used to further build out its services business.
He said that while the company does not want to be considered a "run of the mill RUO," it has received strong demand for its glycoproteomic platform from pharma and other customers. That demand has significantly outstripped its current capacity, he added, noting that the fundraising would help it expand this part of its business.
The company uses a variety of workflows, ranging from untargeted discovery experiments looking at thousands of glycoproteoforms to more narrowly tailored quantitative panels appropriate for clinical work.
The funding will also support work on expanding InterVenn's AI capabilities, Carrascoso said. "We are building newer AIs that are helping not only in sample prep, quality assurance, and [mass spec] peak integration, but also in the earlier parts [of the development process] where you are more in the untargeted validation part."