NEW YORK (GenomeWeb) — Swedish diagnostics firm Immunovia has completed a 1,400-sample retrospective trial evaluating its IMMray PanCan-d proteomic test for pancreatic cancer.
The company, which last week completed its initial public offering on the Nasdaq First North exchange, now plans to move the test into additional retrospective and prospective trials with the goal of a 2017 commercial launch.
In the recently completed trial, the PanCan-d test was able to distinguish between 149 patients with stage I and II pancreatic cancer and 700 healthy controls with accuracy of 96 percent. It distinguished between these healthy controls and patients in all stages of pancreatic cancer with accuracy of 98 percent.
The trial did not look at the test's accuracy in distinguishing between pancreatic cancer patients and controls with conditions that present similarly to pancreatic cancer, such as pancreatitis. In a previous, smaller-scale study published in 2008, a version of the test distinguished between 34 pancreatic cancer cases and 16 patients with chronic pancreatitis, 23 with autoimmune pancreatitis, and 30 healthy controls with an area under the curve of .85.
In a separate trial of 213 Han Chinese patients performed in collaboration with China's Tianjin Medical University Cancer Institute and Hospital, the test distinguished between stage I disease and health controls with an AUC of .71, stage II and healthy controls with an AUC of .86, stage III and healthy controls with an AUC of .90, and stage IV and healthy controls with an AUC of .93.
The test's performance in early-stage patients is of particular note, as early detection is one of the biggest challenges in treating pancreatic cancer. According to Immunovia, the five-year survival rate for the disease is between 4 percent and 6 percent. This could rise to between 50 percent and 60 percent were the disease detected at stage I or II, when tumors can be resected via surgery, the company said.
Immunovia is now undertaking another retrospective trial in collaboration with the lab of Brian Drucker at Oregon Health & Science University's Knight Cancer Institute, Mats Grahn, the company's CEO, told GenomeWeb. That trial will also include patients with non-cancerous pancreatic conditions like pancreatitis.
"We're doing a similar study on US-based samples to validate the signature on an American population," he said, adding that the company expected results from that study in Q2 of 2016.
It plans to follow that study with a final blinded validation study and then a prospective validation study, Grahn said. He said the company is currently in discussions with several large US-based insurers regarding the design of the latter study. The study is slated to run for three years and look at around 1,000 different patients from at least three different centers — OHSU, Mount Sinai Hospital in New York, and Liverpool University Hospital.
In addition to using data from the prospective trial to secure reimbursement for the test, Immunovia plans to use it as part of a US Food and Drug Administration submission.
Immunovia plans to launch the test in the US and Europe in 2017, making it accessible to patients willing to pay out of pocket, Grahn said, adding that lining up insurance coverage would take somewhat longer. The company then plans to offer the test in the US initially through partnerships with existing CLIA labs.
It is also developing an in-house laboratory, out of which it plans to offer clinical testing, and it plans to apply to the Swedish Board for Accreditation and Conformity Assessment for ISO/IEC 17025 accreditation in 2016.
Supporting Immunovia's efforts are funds from its recent IPO, through which the company raised SEK 60 million ($7.1 million) before transaction costs. The company also this year received a €4.2 million grant from the EU's Horizon 2020 program.
Founded in 2007 by Lund University scientists including Carl Borrebaeck, Immunovia uses antibody microarray technologies developed in Borrebaeck's lab for its protein diagnostics work. In addition to its lead program in pancreatic cancer, the company also has projects focused on prostate and breast cancer and autoimmune diseases including lupus.
The company's IMMray platform uses arrays of human recombinant scFv antibodies. The discovery version of the platform contains antibodies to around 500 plasma proteins targets, focused mainly on proteins related to the immune system as well as secreted proteins. The company processes the data from this discovery platform using a proprietary bioinformatics pipeline and winnows down the original discovery panel to diagnostic panels of typically between 15 and 25 proteins, Grahn said.
The pancreatic cancer panel consists of around 25 proteins, he said, adding that the company is currently in the process of filing the final patents covering the test.
Immunovia also uses an immunoaffinity-based mass spec platform developed by Borrebaeck for some of its discovery work, though it did not use this platform in the development of the pancreatic cancer test.
While immunoaffinity is typically combined with mass spec to isolate specific target proteins prior to mass spec analysis in order to address issues like sensitivity, resolution, reproducibility, and dynamic range, Borrebaeck and his colleagues have devised a way to use such workflows in a discovery proteomics context.
Specifically, they have generated antibodies that bind not to specific proteins but instead to short amino acid motifs common to up to several hundred different proteins. Dubbed context-independent motif specific, or CIMS, antibodies, these reagents allow researchers to isolate proteins for mass-spec analysis in a semi-untargeted fashion, combining the enhanced sensitivity of targeted approaches with the breadth of a discovery workflow.
The researchers published a paper in Molecular & Cellular Proteomics in 2013 detailing use of the platform for grading breast cancers, and Immunovia is currently developing a breast cancer grading assay based on this work.