On the threshold of commercial launch

Originating from research at Lund University, diagnostic company Immunovia is now extremely close to market launch and the first order for its early pancreatic cancer detection test.

“We are tremendously excited about having the very first blood test ordered for analysis in the laboratory. Behind that order is a real, concerned patient, who needs to get an accurate early detection of a very serious disease,” says Patrik Dahlen, CEO of Immunovia since November last year.

“We are tremendously excited about having the very first blood test ordered for analysis in the laboratory. Behind that order is a real, concerned patient, who needs to get an accurate early detection of a very serious disease.”

Although new in his role as CEO, Dahlen is not unfamiliar with the company’s journey. A few years ago he was on the Board of Immunovia.

“It is a privilege to lead the company through its market launch, truly a milestone that just happens once in a company’s history.”

In his role he brings over 30 years of experience from global diagnostics companies, which should come in handy for Immunovia. The company is focused on developing and commercializing highly accurate blood tests to detect cancers and autoimmune diseases and just recently, it announced its last development milestone – making them ready for the US market.

Highly specific biomarker signatures

But let’s start from the beginning. Researchers at the Department of Immunotechnology at Lund University and at CREATE Health, a Strategic Center for Translational Cancer Research in Lund, Sweden, started to develop a technology platform, IMMray.

The antibody-based platform used recognized immunoproteomics research expertise to measure the immune system’s response to diseases by detecting extremely small changes in the amount of protein in the blood. The technology is based on bioinformatics, finding the most clinically relevant changes that appear in the blood, and combining this knowledge into a biomarker signature that is highly specific to the particular disease. Their findings meant that a simple blood test was enough to detect a disease long before the patients developed any symptoms.

”Since early detection of cancer is the only way to increase survival rates, this represents a huge market. The company was founded in 2007, when it was clear that these discoveries and patents were able to be commercialized,” says Dahlen.

On March 29th 2021, the company reached their last development milestone before US commercialization. A blinded validation study data demonstrated that the IMMray PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls and with a specificity/sensitivity of 99%/85% vs healthy controls.

During the following years, the antibody technology platform was further developed and crucial patents were submitted. A number of important milestones have been achieved throughout the years, including clinical trials and multicenter studies regarding pancreatic cancer diagnosis, becoming listed, and collaboration agreements. In 2017, the company established a US office for the subsidiary Immunovia Inc in Marlborough, MA, US.

One of the deadliest cancer forms

The next step is now the market introduction of the first test for early detection of pancreatic cancer, called IMMray PanCan-d, firstly in the US, followed by markets in Europe and Canada. Pancreatic cancer is one of the deadliest cancer forms, with a current five year survival rate from diagnosis of only five to eight percent. Each year, 338 000 people globally are diagnosed and the number is growing.

“There are no other blood tests on the market for early detection of pancreatic cancer, so there is a large unmet medical need.”

“There are no other blood tests on the market for early detection of pancreatic cancer, so there is a large unmet medical need. The current diagnostic methods for detecting pancreatic cancer are imaging, biopsy and a type of blood test (serum CA 19-9) that is used in the post-surgical follow-up of patients. The imaging techniques include CT Scan, MRI and EUS, of which CT and MRI both have moderate sensitivity and low specificity. EUS has better sensitivity and specificity but involves a very invasive process. Biopsy is also a very invasive procedure that might cause severe illnesses such as acute pancreatitis,” Dahlen says.

The last development milestone

On March 29th 2021, the company reached their last development milestone before US commercialization. A blinded validation study data demonstrated that the IMMray PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls and with a specificity/sensitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls.

”The validation study was the final milestone and as soon as we get the CLIA-license we will begin to sell our test to this group on the US market. Thanks to the high specificity and sensitivity demonstrated in this group, we see the possibility to widen the patient group from patients having two close relatives with pancreatic cancer to patients with one close relative. There is also a need to change the inclusion criteria of the surveillance programs to include persons with one first degree relative,” says Dahlen.

Patrik Dahlen, CEO, Immunovia

In addition, the company also announced improved performance of the test in a clinical retrospective study.

”In this study, performed in Lund, we could see that we now are back on the same level of specificity and sensitivity that we saw in the commercial test model study and we have now performed what we expected to see in the verification study. These results will be confirmed very quickly in our laboratory in Marlborough and after that we will launch our test in the symptomatic group as well. This group consist of approximately 1 million persons in the US and with our test we will support gastro centres in providing accelerated and correct diagnosis to patients,” says Dahlen.

Immunovia has set a long-term goal of 30% market penetration after reimbursement and widespread insurance coverage. They will market the test for distinct risk groups.

“There is an increased risk of pancreatic cancer in the familial and hereditary risk group. Here we will market the test as a surveillance test. In the US there is about 100,000 people over the age of 45, that have two First Degree Relatives who have died from pancreatic cancer, and this population has a 20-30 fold increase in risk of getting the disease. There is another 1.2 million people in the US at the age of over 45 years, who has one First Degree Relative who has died from pancreatic cancer. This population has a 10 fold risk of getting pancreatic cancer. So the familial/hereditary risk group surveillance is a significant market opportunity for us. In the risk group of symptomatic, and new onset diabetes type II over 50 years of age, the test will be marketed based on symptoms,” describes Dahlen. “We have a solid reimbursement strategy and a long-term objective to be included in national guidelines.”

A stimulating innovation melting pot

Being a Swedish life science company originating from Lund University, close relationships with academia is essential, says Dahlen.

“The development studies of IMMray PanCan-d have for instance been performed in close collaboration with CREATE Health at Lund University. Also, Medicon Village, which we are a part of, is a stimulating innovation melting pot.”

The company today has over 60 employees in the Swedish and US organizations. “Finding the right employees is obviously crucial for our success and so far we have been able to attract the right competence, both locally and in the US. We hire persons we know have the right scientific or industrial experience and make sure that they are given the opportunity to develop within their area at the company,” states Dahlen.

Raising capital

Finding financing is always crucial to SMEs and has not been easy during the ongoing COVID-19 pandemic, but during 2020 Immunovia was able to raise SEK 400 million through a directed share issue, in which they attracted international investors as well as renewed confidence from both existing and new local investors. This was one of the largest capital acquisitions for a diagnostic company based outside the US.

“Our strategy going forward will be to raise capital on the international markets, which we think we will succeed with thanks to the trust we have from our current investors and with gaining inroads, particularly in the US market.”

“With the cash at hand, and sales of our test on a commercial basis, we have capital now for the next three years. Our strategy going forward will be to raise capital on the international markets, which we think we will succeed with thanks to the trust we have from our current investors and with gaining inroads, particularly in the US market,” says Dahlen.

The pandemic has affected Dahlen and his co-workers possibilities to collect further blood samples for the validation study, and they had to postpone the market launch in the US to this year, 2021, instead of last year. “Any delay is frustrating over the shorter perspective, however long-term, our achievement marks a giant leap for early detection of pancreatic cancer,” he says.

Photo: Immunovia