On March 20, 2020 Immunovia reported that it has published the annual report for 2019 (Press release, Immunovia, MAR 20, 2020, View Source [SID1234555733]).
Mats Grahn, CEO, comments: "In December 2019, we reached a very important milestone with the results of the "Commercial Test Model Study", which showed 95% accuracy for IMMray PanCan-d, our product for diagnosing pancreatic cancer at an early stage when it is still possible to successfully remove the tumor surgically. This result paves the way for considerable improved treatment and survival rates for patients with this deadly disease. We are now fully focused on launching our blood-based test in Q3 2020.

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As we close 2019, we continue to make great strides and remain on track to launch our lead diagnostic candidate IMMray PanCan-d in the US market during Q3 2020. We ended the year with fantastic results from our "Commercial Test Model Study," which confirmed the very high accuracy of our test in differentiating stages I-IV of pancreatic cancer from clinically relevant control groups that best reflect the commercial and clinical situation (i.e. patients who do not have cancer but show similarly concerning symptoms, including type 2 diabetes, as well as healthy subjects). In 2019, we not only achieved the milestones needed to advance towards the commercialization of IMMray PanCan-d, but we also made progress with our pipeline projects in lung cancer and autoimmune diseases."

Major highlights include:

During the first quarter 2019, Immunovia concluded that for optimal performance of the test, the samples should be stored for a maximum of 24 months. Thanks to Immunovia’s large network of Key Opinion Leaders, access to fresh samples could quickly be secured. This moved the previously communicated timeline for the optimization study forward by about eight weeks and had an effect on the previous plan, which was to start sales in early 2020.
In February, Immunovia announced new cancer centers in Sweden and Spain had joined the PanFAM-1 study, broadening the ethnic and genetic diversity of the samples during the validation of IMMray PanCan-d.
In April, Immunovia and the University College London (UCL) announced the expansion of the prospective collection of blood samples that started with the PanSYM-1 pilot study.
Immunovia continued its strategic initiative of collaborating with primary care physicians in the US. This initiative began in 2018 with Immunovia’s primary care physician training program at Fenway Park during World Pancreatic Cancer Day. The program highlighted the important role of primary care physicians in detecting the early stages of pancreatic cancer in patients. The reception was overwhelmingly positive.
In May, two cancer centers in New York and Chicago joined Immunovia’s PanFAM-1, the largest prospective study to date, to contribute to the validation of the IMM- ray PanCan-d test.
In June, Immunovia announced excellent results from the optimization work on the commercial version of IMMray PanCan-d. The optimization work was successful and significantly improved the test results, which now show accuracy of up to 98% in the differentiation of stages I to IV of pancreatic cancer against the large symptomatic risk groups, i.e. patients with non-specific but concerning symptoms, including type II diabetes, where the cause is not pancreatic cancer. These results are outstanding and have never before been reported for pancreatic cancer. It was then announced that the "start of sales" milestone is planned for Q3 2020.
In July, Erlangen University Hospital became the first cancer center in Germany to join Immunovia’s global network of Key Opinion Leaders for the early detection of pancreatic cancer. In addition to Immunovia’s existing collaborations, Erlangen University Hospital will provide fresh blood samples for the last two steps prior to the launch of IMMray PanCan-d. The head of the blood test collection is Professor Christian Pilarsky from the surgical department at Erlangen University Hospital.
In September, Immunovia held its first online webinar on IMMray PanCan-d with the title: "Differentiating Pancreatic Ductal Adenocarcinoma (PDAC) from individuals with symptoms suggestive of PDAC, including type II diabetes, with ROC AUC values above 0.95". A link to the webinar can be found at www.immunovia.com.
In September, Immunovia and the world-leading university hospital Beth Israel Deaconess Medical Center (BIDMC) concluded a collaboration agreement for the collection of blood samples for pancreatic cancer for IMMray PanCan-d.
At the end of September, Immunovia announced that the company was proceeding according to plan with its "Commercial Test Model Study" for Immunovia’s IMMray PanCan-d, a blood-based test for the early detection of pancreatic cancer. Following the successful results of the Immunovia optimization study for IMMray PanCan-d, the last stages leading up to commercialization were the same: the results of the "Commercial Test Model Study", followed by verification and validation studies. After this, sales can begin during Q3 2020.
In October, Immunovia released an update on its ongoing lung cancer projects: an ongoing study scheduled to be completed during Q2 2020 and an internal program based on studies and Key Opinion Leader collaborations focused on the early detection of lung cancer.
At the end of October, Immunovia provided an update on the company’s rheumatoid arthritis (RA) development project and announced that it had successfully initiated the establishment of a network of Key Opinion Leaders that will support the design of the company’s RA program and provide high-quality blood samples for the various test phases required to get the test through its discovery phase.
Immunovia announced a collaboration with Professor Thomas Huizinga of Leiden University Medical Center’s Rheumatology Department, for a second retrospective study to differentiate patients with RA from individuals who show RA-like symptoms caused by non-RA conditions. The study continues the work of the first study and the use of Immunovia’s platform technology IMMray, which is designed to reflect the clinical environment in which such a test would be used.
In November, Immunovia announced that the company’s lung cancer collaboration had entered the next phase of development, where Immunovia will receive blood samples taken to initiate tests and analyses. The study will be completed during Q2 2020.
In December, Immunovia strengthened its management with the addition of two extremely experienced professionals: Hans Christian Pedersen was appointed Vice President Business Development and Peter Schulz-Knappe as Chief Technology Officer (CTO).
In December, Immunovia announced the excellent results of the company’s "Commercial Test Model Study" conducted on blood tests from 7 different cancer centers in the US and the EU. IMMray PanCan-d showed excellent robustness with samples from all these centers with an accuracy of 95% for the test for the earliest stages, I and II. With these results, the company is proceeding according to plan for the final stages prior to the commercialization of IMMray PanCan-d. The results, in combination with CA19-9, confirmed the accuracy shown in the optimization study performed earlier in 2019 for the differentiation of the early stages of pancreatic cancer from patients with non-specific but alarming symptoms, including type 2 diabetes and healthy people.
The annual report is available on Immunovia’s website: immunovia.com/en/investors/financial-reports/ and is also attached below.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on March 20, 2020.