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December 18th, 2017

Immunovia initiates the world’s largest study of new onset diabetic patients in a prospective pancreas cancer study supported by SWElife

LUND, Sweden – Immunova AB today announced the initiation of PanDIA-1, the world´s largest prospective study of the new onset diabetes (“NOD”) risk group for pancreatic cancer through a consortium with Lund and Uppsala Universities, Lund University Diabetes Center and Healthcare Region Skåne and Region Uppsala. The consortium will receive a 7.6 MSEK supporting grant from SWElife, the Swedish government’s strategic innovation program, for the project “Improved diagnostics and treatment of diabetes-related comorbidities”.

Through this project, Immunovia will be able to access up to 6 000 new onset diabetics, over 50 years of age, for prospective testing with the IMMray™ PanCan-d biomarker signature assay.

Sweden aims to be the first country with a national screening programme as evidence for addressing diabetic comorbidities and the SWElife sponsored program builds further on the largest biobank of new onset diabetes patients to date anywhere in the world, 17 000 newly diagnosed patients from two Swedish regions via the ANDIS (All New Diabetics in Skane) and ANDIU (All New Diabetics in Uppsala) studies.

Increasingly, new onset diabetics over 50 years of age are regarded as a key risk group for pancreatic cancer. Diabetes is the fastest increasing disease worldwide and one of the greatest threats to human health. Cardiovascular and renal complications are well known comorbidities, but pancreatic cancer is now also becoming recognised as a significant risk. Pancreatic cancer has one of the lowest survival rates of any major cancer type and a mortality exceeding breast cancer. The key to improving prognosis lies in early detection. Based on a number of retrospective clinical trials, Immunovia has developed the first blood based biomarker signature test, IMMray™ PanCan-d, which is now under validation in prospective studies for familiar & hereditary high-risk individuals (See http://immunovia.com/news/?id=14599).

“This additional prospective clinical validation of IMMray™ PanCan-d in up to 6 000 new onset diabetics over 50 years of age, PanDIA-1, provides a solid foundation for Immunovia’s reimbursement strategy and represents a major milestone in the early diagnosis of pancreatic cancer, not just in Sweden but globally. We are already in discussions with several other healthcare organisations internationally to expand the PanDIA-1 study even further for the risk group of newly onset diabetic patients over 50.

This is based on recent reports showing that as many as 3.2 million people are diagnosed with NOD in the USA and Europe every year and their risk for developing pancreatic cancer is up to 10 times greater than normal. Early detection of such high-risk groups is key to improved survival in this devastating disease and represents a tremendous opportunity for Immunovia,” commented Mats Grahn, CEO, Immunovia.

For more information, please contact: 

Mats Grahn

Chief Executive Officer, CEO, Immunovia

Tel.: +46-70-5320230

Email: mats.grahn@immunovia.com

About Swelife

Swelife is a strategic innovation programme, funded by the Swedish Government via the Swedish innovation agency, Vinnova, and by the programme’s collaborative partners in healthcare, academia and industry. Swelife’s goal is to strengthen Swedish Life Science and improve public health.

By challenging obstacles and stimulating and supporting new national solutions for innovation, Swelife’s work is to contribute to

1) the development, utilisation and evaluation of innovations in healthcare, as well as to personalised and values-based medical practice

2) making Swedish Life Science attractive and internationally competitive.

www.swelife.se

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)

This information is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above.

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.

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