NEW YORK – Fresh off a $201 million Series C funding round, glycoproteomics firm InterVenn Biosciences is targeting the cancer immunotherapy market with a new clinical assay to predict treatment response.
The South San Francisco-based company has shifted from its initial focus on ovarian and colorectal cancer to prioritize its Dawn product, a blood-based glycoproteomic assay intended to help doctors predict which patients will respond to checkpoint inhibitors, said John Leite, InterVenn's chief business officer, adding that the company aimed to launch that product in 2022.
"That is going to be our marquee product to go to market and to really introduce [InterVenn's glycoproteomics] platform to the industry," he said.
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. 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.
With regard to the relationship between circulating glycoproteins and patient response to cancer immunotherapies, "the precise biology … is still a matter of investigation," Leite said. "In our current data, we see very tight and statistically significant associations between certain glycosylated states of certain circulating serum proteins and the status of patients as responders or non-responders to a variety of different checkpoint inhibitors."
InterVenn is one of many life science firms trying to tackle the cancer immunotherapy market, where new and better markers for predicting patient response are sorely needed.
"The landscape of biomarkers that can effectively stratify patients into responders and non-responders is not great," Leite noted. "Tumor mutation burden, microsatellite instability, PDL-1 expression, they all have limitations and have proven not to be as effective as we once hoped they would be."
Leite said the company is now building on its initial validation work for the Dawn assay with new validation sets "to comprise what in essence will be the validation data that we will go to market with."
He said that this validation work would be "a multi-institutional, retrospective study." He declined to say how many samples InterVenn has evaluated the assay in thus far or how many it plans to analyze in total.
Leite said InterVenn aims to launch the assay commercially next year out of its South San Francisco CLIA facility.
While Dawn is now the company's lead product, InterVenn is continuing work on its ovarian cancer diagnostic, Glori, which uses glycoprotein measurements to assess whether a pelvic mass is likely benign or malignant, and whether it should be removed by a gynecologist or a gynecologic oncologist.
The company began enrolling for its VOCAL, short for InterVenn Ovarian CAncer Liquid Biopsy, prospective validation study for the test in 2019 and aims to complete enrollment by the end of the year, said Erwin Estigarribia, InterVenn's chief operating officer. It is recruiting patients at 23 locations across the US, Malaysia, and the Philippines, with the goal of enrolling around 1,200 subjects.
The company said in June that an interim analysis of the Glori test showed it performed with an overall accuracy of 86 percent, though the firm has not provided performance data by stage or presented it in a peer-reviewed publication.
Leite said that "it is our intent to put that product to market as quickly as we can," adding that it planned to commercialize the test through a distribution partner.
If Glori does come to market, its primary competitor will be Aspira Women's Health's OVA1 assay, 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.