96 % of early stage pancreatic cancer patients detected in a clinical validation study with a North American sample cohort

Second study validates Immunovia´s IMMray™ PanCan-d test for early detection of
pancreatic cancer
(LUND, Sweden) ― Immunovia announced today that they have completed a second
retrospective clinical validation study showing 96% accuracy for early detection
of 90 early stage I & II North American pancreatic cancer patients, which
perfectly matches the previously reported Scandinavian study results (link to
press release (http://immunovia.com/immray-pancan-d-detects-98-of-pancreatic
-cancers-in-retrospective-study-with-1400-blood-samples/)).

To confirm the performance of the test in a U.S. population, this study was
conducted on 362 blood samples from a patient cohort provided by the Brenden
-Colson Center for Pancreatic Care at Oregon Health & Science University (OHSU)
in Portland USA. When analyzing all stages of pancreatic cancer, the accuracy of
Immunovia´s test remains as high as 96%.

Brian Druker, M.D., Director of the Knight Cancer Institute at Oregon Health &
Science University said: “Pancreatic cancer is rarely diagnosed at an early
enough stage to achieve a cure. Together with Immunovia, we are working to
develop a test that can make a significant difference in pancreatic cancer
patients’ lives by improving their chances of survival. These results are a
ground-breaking step in the Knight Cancer Institute’s mission to detect lethal
cancers at a stage when they are most treatable.” Dr. Sheppard, Co-director of
the Brenden-Colson Center for Pancreatic Care, Professor and Vice Chair of
Surgery added: ”This test provides new hope in fighting this devastating
disease.”

Immunovia and the OHSU Knight Cancer Institute formed a collaboration to
confirm, validate and commercialize Immunovia’s blood test for the detection of
pancreatic cancer, IMMray™ PanCan-d.

Pancreatic cancer is one of the deadliest and difficult to detect and diagnose
cancers, as the signs and symptoms are similar to many other diseases. There are
more than 40,000 deaths and over 50,000 new cases diagnosed each year in the
U.S. alone, and the five-year survival rate for pancreatic cancer is currently
7%. It is predicted to become the second leading cause of cancer death by 2020.
Early detection is, however, the key to significantly improving pancreatic
cancer patients’ 5-year survival rates from 7% to potentially 50-60%.
Mats Grahn, CEO Immunovia said: “We have now confirmed that Immunovia´s test,
IMMray™ PanCan-d can detect pancreatic cancer in early stage patients with an
accuracy as high as 96%, in two completely different patient cohorts collected
independently on different continents. We are grateful to have reached this
first ground-breaking milestone in our collaboration with OHSU’s Brendan Colson
Center. Their biobank of blood samples from patients with pancreatic cancer and
other pancreatic diseases has proven very valuable, particularly with regard to
the early stages of pancreatic cancer. These extremely encouraging results of
96% accuracy from two retrospective studies covering in total 238 blood samples
from stages I and II, 586 blood samples from stages I to IV and 1107 healthy
controls justifies our strategy to perform a large, multicenter prospective
study for early detection of pancreatic cancer ".

IMMray™ PanCan-d utilizes the company's proprietary IMMray™ technology platform
based on antibody microarray analysis. A serum protein signature that can
discriminate between pancreatic cancer patients with stage I, II, III, and IV
has been derived from clinical studies covering about 2500 patient samples. In
the previous retrospective clinical validation study finalized in October 2015,
IMMray™ PanCan-d could discriminate 148 pancreatic cancer patients stages I and
II from 888 healthy controls with 96% accuracy.

A prospective study designed to validate IMMray™ PanCan-d will run for three
years across sites in both the US and Europe, starting in the second half of
2016.

For more information please contact:

Mats Grahn
Chief Executive Officer, CEO, Immunovia
Tel: +46-70-5320230
Email: mats.grahn@immunovia.com

About Immunovia
Immunovia AB was founded in 2007 by investigators from the Department of
Immunotechnology at Lund University and CREATE Health, the Center for
Translational Cancer Research in Lund, Sweden. Immunovia’s strategy is to
decipher the wealth of information in blood and translate it into clinically
useful tools to diagnose complex diseases such as cancer, earlier and more
accurately than previously possible. Immunovia´s core technology platform,
IMMray™, is based on antibody biomarker microarray analysis. The company is now
performing clinical validation studies for the commercialization of IMMray™
PanCan-d that could be the first blood based test for early diagnosis of
pancreatic cancer.  In the beginning of 2016, the company started a program
focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. The
first test from this program, IMMray™ SLE-d, is a biomarker signature derived
for differential diagnosis of lupus, now undergoing evaluation and validation.
(Source: www.immunovia.com)

Immunovia’s shares (IMMNOV) are listed on Nasdaq First North in Stockholm and
Wildeco is the company’s Certified Adviser. For more information, please visit
www.immunovia.com.

About the Brenden-Colson Center
The OHSU Brenden-Colson Center for Pancreatic Care is a patient centric hub for
clinical and research programs that focus on three main areas essential for
alleviating suffering from pancreatic diseases: Early Detection, Advanced
Therapy, and Quality of Life. The heart of the program is a close collaboration
among five program leaders in a "center-without-walls" that connects clinical
activities to laboratory research on pancreas disease across OHSU and the Knight
Cancer Institute. For additional information on the Brenden-Colson Center:
https://www.ohsu.edu/xd/research/centers-institutes/brenden-colson-center/.

About the Knight Cancer Institute
The Knight Cancer Institute (http://www.ohsu.edu/xd/health/services/cancer/) at
Oregon Health & Science University is a pioneer in the field of precision cancer
medicine. The institute's director, Brian Druker, M.D., helped prove it was
possible to shut down just the cells that enable cancer to grow. This
breakthrough has made once-fatal forms of the disease manageable and transformed
how cancer is treated. The OHSU Knight Cancer Institute is the only National
Cancer Institute-designated Cancer Center between Sacramento and Seattle – an
honor earned only by the nation's top cancer centers. It is headquarters for one
of the National Cancer Institute's largest research collaboratives, SWOG, in
addition to offering the latest treatments and technologies as well as hundreds
of research studies and clinical trials. For additional information on the OHSU
Knight Cancer Institute visit www.ohsu.edu/xd/health/services/cancer or follow
us
on Facebook (https://www.facebook.com/OHSUKnight/) and Twitter (https://twitter.
c 
om/OHSUKnight).


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