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Immunovia Preparing to Launch Laboratory-Developed Test for Pancreatic Cancer

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NEW YORK ─ Swedish diagnostic company Immunovia is preparing to launch a laboratory-developed test for the early detection of pancreatic cancer following recent validation studies for its antibody biomarker microarray platform and first assay called PanCan-d.

The firm, a Lund University spinout, said that pending approval by the state of Massachusetts Clinical Laboratory Program, it expects to begin testing from its CLIA-certified laboratory in Marlborough within about two months.

With the availability of the blood test, patients who are diagnosed with pancreatic cancer early could be candidates to have their tumors removed and have a better chance for long-term survival, the company said.

"Our recent validation studies have shown that a positive test result with PanCan-d for high-risk individuals will accelerate the diagnostics process and treatment for pancreatic cancer," Thomas King, medical director of Immunovia's US laboratory, said in an interview.

Immunovia believes there is a large addressable market for the pancreatic cancer assay. The company said that up to 350,000 individuals have a familial/hereditary risk for pancreatic cancer and would qualify for pancreatic cancer surveillance using its Immray PanCan-d test. Further, around 1 million people per year qualify for symptomatic screening using the test, the firm said.

The impending launch of Immunovia's test on its Immray antibody microarray platform comes after several delays in its planned release. Most recently, the firm said that it planned to roll out PanCan-d as a laboratory-developed test in the third quarter of 2020.

King said that the coronavirus pandemic delayed the launch of its laboratory-developed test until the current quarter as most of its clinical sites were required to stop seeing patients and were unable to provide samples for testing.

Additionally, though the firm's US laboratory has been up and running for the past year, Immunovia needed to put the finishing touches to its assay's development prior to applying for a CLIA certificate, CEO Patrik Dahlen said in an interview.

Through the years, the firm has worked to improve the performance characteristics of the test, adding tumor protein biomarkers and carbohydrate antigen 19-9 to the immunoregulatory biomarkers it was already using in its panel.

With the recent completion of blinded validation studies, the firm has reached a milestone that sets it up for the launch of the laboratory-developed test, said Dahlen, who took over from Mats Grahn as the firm's CEO last November.

The firm's PanCan-d assay is a serum-based multiplexed test that uses eight biomarkers ─ a mix of the immunoregulatory and pancreatic tumor markers and CA 19-9 – to obtain a disease biomarker signature. To detect the biomarkers, the test leverages single-chain, variable-fragment antibodies attached to resin-coated slides in a microarray. The test's disease signature detects biomarker concentrations by decoding signal intensities from the microarray, using a single drop of serum.

In a recent assay validation study, Immunovia evaluated about 600 serum samples, including about 170 samples collected from people in the US and Europe with pancreatic cancers at various stages that were compared with the remaining samples from healthy donors. The assay detected stage I and II two pancreatic cancers with 85 percent sensitivity and 99 percent specificity, King said.

Immunovia is further participating in a large prospective clinical study called PanFAM-1 that is ongoing and designed to support reimbursement for its blood test. The study collected samples from 23 familial/hereditary pancreatic cancer high-risk surveillance programs in the US and Europe, and Immunovia expects to report the results of the study in the fall.

King said that the company recently evaluated about 200 random samples from the PanFAM-1 study and found that for people who are at increased risk for pancreatic cancer, the test had 85 percent sensitivity for early-stage pancreatic cancer and 98 percent specificity.

People considered at high risk for pancreatic cancer ─ because of family history or germline mutations, or both ─ comprise one of the initial target groups for testing using the PanCan-d assay. Immunovia will also target people with symptoms associated with pancreatic cancer or whose imaging findings suggest the potential for pancreatic cancer, King said.

The study recently announced by Immunovia for its test validation has not yet been published in a peer-reviewed journal. However, the company has in the past published studies that describe the development of the biomarker signature.

Last year, it also presented the results of a multicenter study at the European Pancreatic Club annual meeting that described the ability of its eight-plex signature along with CA 19-9 to differentiate between pancreatic ductal adenocarcinoma stages I and II and controls.

Early detection of pancreatic cancer can be crucial for patients as it could enable early intervention through surgery as well as provide more time for other interventional treatments, including chemotherapy, radiation, and targeted therapies.

Research into the "use of biomarker signatures, such as that developed by Immunovia, is a very active field right now," James Farrell, a gastroenterologist and director of Yale Center for Pancreatic Diseases at the Yale School of Medicine, said in an interview. "There have been some improvements in treatments, but to make a significant impact on this disease, we're going to have to get better early detection, and right now we're not especially good at it."

A high-risk group of people that has a 5 to 10 percent greater probability of developing pancreatic cancer than the rest of the population, in particular, stands to benefit from the availability of a blood test, he said. It's important to study the performance of the biomarker panel, including its sensitivity and specificity, in this cohort, "and to Immunovia's credit they have done that" in the blinded validation studies, said Farrell, who is also a clinical investigator participating in PanFAM-1 seeking to validate Immunovia's test.

It's encouraging that Immunovia has begun to validate the panel in this high-risk group, but separately, the PanFAM-1 study will provide more information "about whether the panel is going to be useful in that high-risk population," Farrell added.

As Immunovia awaits the results from PanFAM-1 and a decision about the test's reimbursement, the company plans to charge $600 for the PanCan-d pancreatic cancer test performed out of its US laboratory. Patients will have to shoulder the cost out of pocket. 

The company is planning additional validation studies in the US to demonstrate the clinical utility and potential economic impact of its test, Dahlen said, adding that Immunovia will use the data to apply for a proprietary laboratory analyses (PLA) code that would enable test reimbursement. It will also seek reimbursement from the Centers for Medicare and Medicaid Services as well as private payors.

"If everything goes well … our expectation is to have initial reimbursement in place for our LTD before the end of 2022," he added.

The company has an internal group working on test marketing and reimbursement and plans to expand a small internal team to target test sales, Dahlen said.

The company, which is traded on the Nasdaq Stockholm, has cash on hand to fund at least three years of business activities, and anticipates booking revenues from sales of its pancreatic cancer test this year for testing from its US laboratory.

Immunovia sees several emerging competitors developing IVD tests for pancreatic cancer, but Dahlen noted that it seeks to differentiate itself by focusing on high-risk and symptomatic patient groups just for pancreatic cancer, while many firms are developing IVD tests for multiple cancers to screen the general population.

Among several companies working in the space, Interpace Biosciences said in February that it has signed an exclusive licensing agreement with Rutgers University and Massachusetts General Hospital for a novel monoclonal antibody, Das-1, for the risk assessment of pancreatic cysts that could lead to cancer.

Additionally, an experimental blood test being developed by researchers at Van Andel Institute in Grand Rapids, Michigan could provide clinicians with information on pancreatic cancer patients who won't respond to traditional treatments such as chemotherapy.

Burning Rock is evaluating ELSA-seq, a blood-based methylation sequencing assay, for early cancer detection and is participating in a large patient trial to support the commercial launch of an assay targeting nine cancer types ─ lung, colorectal, liver, ovarian, pancreatic, esophageal, gastric, head and neck, and cholangiocarcinomas.

Meanwhile, Immunovia has a strong focus on the commercial launch of the pancreatic cancer assay in the US and is using its Immray platform to develop a test that differentiates among autoimmune diseases. It expects to release preliminary validation data for the test later this year.

While the firm continues its clinical validation studies in Europe of the Immray PanCan-d pancreatic test, "The important thing for us now from a European perspective is to service very large studies that are ongoing for people who are symptomatic" and, separately, for people who are considered high-risk, Dahlen said.

"We need to assess carefully our commercialization approach in Europe and will [release] timelines fairly soon," he added.

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