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CEO presents Immunovia

Historic moment for early discovery of pancreatic cancer

Thanks to the great efforts of our employees, we achieved significant success during Q1 for our blood test IMMray™ PanCan-d. We reached the final milestone in the development phase and the next step was to apply for CLIA certification for IMMray™ PanCan-d to receive market approval in the US. IMMray™ PanCan-d blood test will be exclusively provided by Immunovia Inc., Marlborough, Massachusetts, USA. In addition, we have worked to improve the performance of the test in symptomatic high-risk patients. We presented new data that show both improved specificity and sensitivity.

I am very proud of the historic breakthrough for early detection of pancreatic cancer that our IMMray™ PanCan-d blood test means for patients, their families and healthcare in the fight against this deadly disease. An early and accurate diagnosis is crucial to increase survival in patients with pancreatic cancer. Today, 80% of patients receive their diagnosis too late, i.e. when the tumor is no longer resectable. This means that the average survival rate after diagnosis is as low as 4-5 months. It is therefore worth repeating that when pancreatic cancer is detected in stages I and II, the five-year survival rate rises to over 50% from 7-8% which is the survival rate if the pancreatic cancer is detected in stage III or IV.

Final milestone reached

At the end of Q1, Immunovia presented the results of two important studies. One of these was the blinded validation study for IMMray PanCan-d which showed that IMMray™ PanCan-d together with the marker CA 19-9 detects pancreatic cancer in early stages with the highest reported specificity and sensitivity to date in 98% and 85% respectively in cohorts of patients with familial/ hereditary risk. The blinded validation study was performed by the Immunovia DX Laboratory in Marlborough, Massachusetts, US. The validation study is the final milestone before applying for a Massachusetts State License and CLIA certification of the laboratory. The application for CLIA registration has been sent in and the certification process is estimated to take approximately 30 days after which the familial /hereditary risk group will be the first to be able to buy the test and pay ”out-of-pocket”. IMMray™ PanCan-d blood test will be exclusively provided by Immunovia Inc., Marlborough, Massachusetts, USA. We will then apply for cost reimbursement from the insurance system in connection with analyzing interim data from our large prospective study PanFAM-1, which is expected to take place during the second half of the year. To our knowledge, PanFAM-1 is the first major evaluation of individuals in the familial/hereditary high-risk group performed using a blood test for early detection of pancreatic cancer.

Improved test performance for symptomatic patients

The second study completed was a retrospective, clinical study conducted at our laboratory in Lund, Sweden. The study aimed to improve the test performance for early detection of pancreatic cancer in high-risk patients with symptoms. The results show that IMMray™ PanCan-d together with CA 19-9 can detect early stages of pancreatic cancer with 92% specificity and 80% sensitivity. This result is in line with the results from the commercial test model study and the expectations that our key opinion leaders in this area have of us. This data now also opens up the large market of the symptomatic at-risk patients. We thus have a result that means that in the near future we can also launch the test to the symptomatic high-risk group. Consequently, during Q2, we will reconfirm the results from our Lund based lab, at our laboratory in the US. This data will then be included in the dossier that we compile prior to the application for cost reimbursement for the use of the test in the symptomatic patient group.

Support from key opinion leaders

We have continuous dialogues with our key opinion leaders and they have expressed their great support for IMMray™ PanCan-d as an important diagnostic tool for clinicians to be able to make an early and correct diagnosis. This is what the well-known expert on pancreatic cancer Dr. Stephen P. Pereira, Professor at University College, London said: ”A blood test for the early detection of pancreatic cancer with the performance demonstrated in the validation study for IMMray™ PanCan-d meets all our criteria for a test to be used in the monitoring of high-risk individuals.”

Long-term goal

Immunovia’s long-term goal for IMMray™ PanCan-d is to achieve a market penetration of 30% after cost reimbursement from healthcare and insurance systems has been achieved. The need for continuous monitoring of the familial/hereditary risk group is great. The group currently consists of more than 300,000 individuals in the US who need to be tested once or twice a year. There is a great deal of interest in widening the group to include people with only one close relative who has died of pancreatic cancer. Two close relatives are currently required, which is related to lack of capacity and cost linked to today’s diagnostic methods. We know that currently only about 10% of people with a family history of pancreatic cancer are included in the monitoring programs. A simple blood test such as IMMray™ PanCan-d could therefore be used so that everyone in need of monitoring would receive it, including individuals with one close relative. The target group would then grow to over 3 million people in the US. As the CEO of Immunovia, I look forward to working with my colleagues to continue working with key opinion leaders, caregivers, authorities and insurance systems (”payers”) to make IMMray™ PanCan-d available to all patients at high risk of developing pancreatic cancer.

Thank you for your continued support of Immunovia!

28 April 2021

Patrik Dahlen, CEO, Immunovia AB

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