0G8X Immunovia Ab (publ)

LUND, Sweden, April 10, 2019 /PRNewswire/ -- Immunovia today announced that Prof. Stephen Pereira and his team at the institute for Liver and Digestive Health, University College London (UCL) will expand the prospective collection of blood samples funded by Immunovia and that started with the PanSYM-1 pilot study.
The pilot PanSYM-1 study at UCL that started in 2017 (PR from November 2nd, 2017) is scheduled for readout in 2019 and, following today's news, will now support the continuation of PanSYM-1 as a prospective validation study.

The continued PanSYM-1 study aims to demonstrate the diagnostic value of IMMray™ PanCan-d in detecting PDAC (pancreatic ductal adenocarcinoma) earlier than the current standard.

PanSYM-1 aims to collect 2000 single samples. PanSYM-1 sample collection will through the UCL collaboration be expanded to include the active network of rapid diagnostic and assessment centers (RDACs) throughout the UK.

Additionally, UCL is also one of the UK's major screening centers for familial/hereditary pancreatic cancer, and thus becomes the latest member of PanFAM-1, Immunovia's global multi-center study (ClinicalTrials.gov) of familial/hereditary high risk groups of pancreatic cancer.

Prof. Stephen Pereira, Professor of Hepatology and Gastroenterology at UCL Institute for Liver and Digestive Health commented: "We are delighted to participate in the PanSYM-1 and PanFAM-1 prospective studies. They form one of the four work packages in the UCL ADEPTS Study (Accelerated Diagnosis of neuro Endocrine and Pancreatic TumourS) funded by Pancreatic Cancer UK. They also support significant elements of the NHS long term plan set this year by working towards faster detection, in close collaboration with RDACs and helping to diagnose cancers at a resectable stage which is one of the major cancer milestones."

PanSYM-1 is designed to assess IMMray™ PanCan-d utility in identifying high risk patients with non-specific but concerning symptoms attending secondary care centers and endoscopy / gastrointestinal units. Interim analysis is planned for early 2020 with final results expected in 2021.

Immunovia's CEO Mats Grahn added: "UCL's ADEPTS study provides the perfect platform for assessing the utility of IMMray™ PanCan-d. Professor Pereira is a leading advocate of the use of new diagnostic methods to improve pancreatic cancer outcomes and we are excited to  expand our successful collaboration with this prestigious center."

For more information, please contact:
Julie Silber
Director of Investor Relations
Email: julie.silber@immunovia.com
Tel: +46-7-93-486-277

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.
(Source: www.immunovia.com)

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

About the ADEPTS study
The ADEPTS Study (formally referred to as TRANSBIL: TRANSlational research in BILiary tract and pancreatic diseases) is a UCL (London) based early biomarker study which aims to detect pancreatic cancer in patients at a much earlier stage. It aims to develop a prospective biobank and an early diagnostic tool that can differentiate early PDAC (pancreatic ductal adenocarcinoma), PNETs (pancreatic neuroendocrine tumours) and high-risk pancreatic lesions from benign disease, by combining a risk factor / early symptom electronic clinical decision support tool (e-CDST) with novel panels of blood biomarkers of early disease. This diagnostic tool may then be used for surveillance of high-risk populations and triage of patients with non-specific symptoms concerning for pancreatic cancer.

Source: https://www.ucl.ac.uk/surgery/research/situ-trials/adepts-study-information

The study has four work packages focused on improving early symptom identification (WP1), development of a biomarker panel for PNETS (WP2), prospective blood sample collection from symptomatic patients (WP3) and stakeholder / health economic analysis (WP4).

About UCLH and rapid diagnostic centers

RDCs are being piloted in ten areas as part of NHS England's drive to catch cancer early and speed up diagnosis for people with cancer.

Each of the centres will operate in a different way to ensure they meet the needs of their local communities. However, all have the same purpose – to diagnose cancers early in people who do not have 'alarm symptoms' for a specific type of cancer.

People with vague, non-specific symptoms, such as unexplained weight loss, appetite loss or abdominal pain are often referred multiple times for different tests for different cancers, but these new centres will help end this cycle.

Rapid diagnostic centres are for patients with so-called 'vague' symptoms that could indicate cancer. These patients need to access appropriate tests quickly to improve early diagnosis. UCLH is the lead center of the RDC initiative.

Source: https://www.england.nhs.uk/2018/04/new-one-stop-shops-for-cancer-to-speed-up-diagnosis-and-save-lives/ 

A network of at least 20 "rapid diagnostic centres" will working by 2020, with further centres rolling out across the country before 2030.
Source: Theresa May, Oct 2018 

About NHS England

The National Health Service (NHS) is the publicly funded national healthcare system for England and one of the four National Health Services for each constituent country of the United Kingdom. It is the largest single-payer healthcare system in the world, established in 1948. The NHS provides the majority of healthcare in England, including primary care, in-patient care, long term healthcare. The NHS Long Term Plan is a new plan for the NHS to improve the quality of patient care and health outcomes. It sets out how the £20.5 billion budget settlement for the NHS, announced by the Prime Minister in summer 2018, will be spent over the 5 year period from 2019 to 2024, together with long term objectives over a 10 year period.

NHS England is an executive non-departmental public body of the Department of Health and Social Care. It oversees the budget, planning, delivery and day-to-day operation of the commissioning side of the NHS in England and holds the contracts for general practitioners and NHS dentists.

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