2016-05-30

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).

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 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 and Twitter.

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