Immunovia Publishes the Annual Report for the Financial Year 2019
LUND, Sweden, March 20, 2020 /PRNewswire/ --
Immunovia has today published the annual report for 2019. It is available on Immunovia's website.
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(TM) 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.
As we close 2019, we continue to make great strides and remain on track to launch our lead diagnostic candidate IMMray(TM) 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(TM) 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(TM) 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(TM) PanCan-d test.
-- In June, Immunovia announced excellent results from the optimization
work on the commercial version of IMMray(TM) 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(TM)
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(TM)
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(TM) 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(TM) PanCan-d, a blood-based test for the early
detection of pancreatic cancer. Following the successful results of the
Immunovia optimization study for IMMray(TM) 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(TM), 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(TM) 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(TM) 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.
For more information, please contact:
Julie Silber, Director of Investor Relations, Immunovia
Email: julie.silber@immunovia.com
Tel: +46 7 93 486 277
About Immunovia
Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia's proprietary test platform called IMMray(TM). Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique "disease biomarker signature".
The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden.
The first product, IMMray(TM) PanCan-d, is undergoing clinical evaluation in some of the world's largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is currently entering the final validation for sales start Q3 2020. When validated, IMMray(TM) PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.This information was brought to you by Cision http://news.cision.com
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https://mb.cision.com/Main/13121/3064478/1214667.pdf
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