Sweden is recognized for developing innovative technology-based platforms, such as Spotify and Skype. However, Sweden is also a major life sciences hub, with world-class medical research institutions and a rich history of biotech development, including the discovery and development of purified proteins and early-stage DNA sequencing.
This reputation was one reason Stockholm was the host site for BIO Spring, the largest biopharma partnering event in Europe. Attending this year was the Swedish company Immunovia, a biotech working on developing a serum-based cancer diagnostic.
Led by CEO Mats Grahn, Immunovia hopes to reverse the particularly grim diagnosis for pancreatic cancer by using its test to catch the cancer in earlier stages. There are currently no approved diagnostic tests for pancreatic cancers—leading Immunovia to believe it can fill an important therapeutic space.
A serum-based cancer diagnostic
Immunovia’s core diagnostic platform, IMMray, creates a biological snapshot of an individual’s immune response based on the presence of specific proteins associated with certain types of cancer. Unlike previous efforts to develop serum-based cancer diagnostics, IMMray has proven effective at producing highly sensitive and specific results.
The platform was developed by researchers at Lund University, who worked for many years mapping antibody responses to cancer.
Grahn explained the thinking behind the decision to narrow Immunovia’s focus to pancreatic cancer. “IMMray was designed as a platform that can ultimately be used to diagnose different types of cancer and autoimmune diseases, but we had to focus on one type of cancer. We chose pancreatic cancer because of the large unmet medical need and the high level of fatality associated with this disease,” he said.
As there are no approved pancreatic cancer diagnostics, some physicians resort to MRIs or other types of imaging to try to visualize potential cancers. But these tests are unapproved and therefore not reimbursable. They are also only marginally useful unless a patient has metastatic disease.
The challenge of diagnosing pancreatic cancer
Pancreatic cancer is highly fatal, mainly because late diagnoses are typical. There haven’t been any real breakthroughs in treatment for three decades, so early diagnosis is crucial.
Yet diagnosis is complicated by the location of the pancreas, which is embedded in the abdomen behind the stomach and in front of the spine. Because of its position, pancreatic cancer is largely asymptomatic until later stages when treatment options are limited.
The statistics are grim: Pancreatic cancer is the fourth leading cause of death in the US and on pace to become the second leading cause of death by 2020 as prevalence increases. It has a 4% to 6% five-year survival rate. Upon diagnosis, 80% of patients have cancers that have metastasized beyond the point that surgery is an option.
Grahn and his team at Immunovia are determined to shift these statistics in favor of patients. He said, “It takes five years for pancreatic cancer to progress from its earliest stages to metastatic disease. By providing physicians with actionable information at stage one or two, the cancer could be removed surgically. With early diagnosis, five-year survival rates could realistically be 60%.”
In order to validate its first test, called IMMray PanCan-d, Immunovia conducted the world’s largest retrospective diagnostic study using 1,400 blood samples. The test results were 96% accurate in diagnosing stage 1 and stage 2 pancreatic cancer, compared with healthy controls. When researchers tested to detect pancreatic cancer at any stage, the results were 98% accurate.
Sweden is a country of less than 10 million people, and because of this, Swedish companies tend to be export-oriented. Therefore, a key strategy for Swedish biopharma is taking steps to develop external markets as early as possible. Immunovia’s plan involves conducting a validation study of the PanCan-d in the US, in addition to a three-year prospective study.
“Our goal is to gain regulatory approval in the US first and then pursue other markets. In order to do that we need to show clinical utility in different settings in the real world,” Grahn explained.
Finding the right partners
The strength of Immunovia’s data has attracted high-caliber institutions, where oncology researchers are eager to address the unmet medical needs around pancreatic cancer. Earlier this year, Immunovia entered a partnership agreement with the Mount Sinai Health System in New York and the Knight Center Institute at Oregon Health & Science University (OHSU). The goal of these partnerships is to help confirm, validate, and commercialize IMMray PanCan-d.
Grahn is especially enthusiastic about the OHSU partnership. Recently, OHSU—the site of the Brenden-Colson Center for Pancreatic Care—received a $1 billion grant to launch the first large-scale, early-detection research program. This funding will allow OHSU researchers to use samples from its biobank to conduct a retrospective trial of PanCan-d and validate the European results. OHSU will also be involved in Immunovia’s three-year prospective study, handling everything from recruitment and lab work to analysis and distribution of results.
In other markets, Immunovia has a partnership with Liverpool University, which will support validation in the UK market—another important target for Immunovia. The company has also recently hired a life sciences law firm in Germany to help Immunovia entry there.
A strategic focus on payers first
By partnering with carefully chosen academic partners in the US, Immunovia is slowly building the evidence base it needs to gain reimbursement from payers in the US market.
Towards that end, Grahn has retained a reimbursement consultant to facilitate communication between Immunovia and the main payers across the US. The strategy seems to be paying off in early goings.
“Payers are interested in IMMray PanCan-d. Though their approach is very pragmatic, they realize that innovative diagnostics can significantly improve clinical outcomes and change peoples’ lives. They have given us hands-on support, including advice about how to design our prospective study to maximize chances of approval and reimbursability,” Grahn said.
Moving into the lab
While the validation process continues, Immunovia is also taking steps to move into hospital labs under the FDA’s Lab-Developed Test (LDT) guidelines, hopefully by 2017. This is also another way to help payers gain experience and insight into PanCan-d’s clinical utility, while allowing patients to benefit from it as early as possible.
Grahn emphasizes that for at-risk populations, such as patients with diabetes, having access to screening for pancreatic cancer is a major game-changer. Immunovia works closely with patient groups, such as the Pancreatic Cancer Action Network (PANCAN), the Pancreatic Cancer Alliance, and the Lustgarten Foundation.
Even as Immunovia is focused on building an evidence base, Grahn is adamant working with patients is an important part of the company’s strategy to make the test accessible to as many at-risk people as possible.
“Partnerships with patients and advocacy groups are as important to us as any other partnership,” he said.