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IMMPACT Report Summary

Project ID: 672454

Periodic Reporting for period 1 - IMMPACT (Clinical validation of a serum protein biomarker signature for the early diagnosis of pancreatic cancer.)

Reporting period: 2015-06-01 to 2016-05-31

Summary of the context and overall objectives of the project

The objective of the project is to validate a serum biomarker signature for the early diagnosis (yes/no diagnosis) of pancreatic cancer (pancreatic ductal adenocarcinoma – PDAC). The validation will enable Immunovia to respond to the growing health economics market need by offering a diagnostic tool at a stage where no efficient tools are available today.

The biomarker signature is based on the world’s most advanced recombinant antibody microarray platform - IMMray™ which is owned by Immunovia. The underlying technology is affinity proteomics. The biomarker signature hence exploits the body’s own detection network for the diagnosis of cancer. The European dimension of the project lies in the validation of the biomarker signature that will make it possible for the first time ever to accurately diagnose pancreatic cancer in an asymptomatic stage (I and II) when the patient can undergo surgery.
While pancreatic cancer is only the 14th most common cancer, it has recently passed breast cancer and is now the 3rd most deadly, with a five-year survival rate of about 6 %. This poor prognosis could be significantly improved if cases were detected and treated early. The cancer is, however, characterized by general and non-specific symptoms until it reaches an advanced stage. At this time, the established treatment regimens are not effective. Current diagnostic standards do not contribute to solving the prevailing pancreatic cancer problem, as they are complex and not designed for differential diagnosis at an early stage. As a result, there is currently no standard diagnostic tool or established early detection method for pancreatic cancer.

Hence, there is a great clinical need for a novel, non-invasive test enabling early (differential) diagnosis of pancreatic cancer. If the cancer is detected early, a 5-year survival rate could be improved to 50-60%. The results of the project will help to build up evidence that pancreatic cancer can be detected at an early stage, thus laying the basis for the future implementation of screening and risk surveillance programmes of population groups at risk.

IMMray™ PanCan–d is the first blood-based test for early and specific (differential) diagnosis, providing clinicians with actionable information. Immunovia has defined a clinically relevant condensed panel of serum biomarkers (a biomarker signature) associated with pancreatic adenocarcinoma. The test is suitable for screening risk groups as well as investigating patients with suspected symptoms.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The key results achieved to date and disseminated to the broad audiences through press releases and clinical reports are the performance of two retrospective clinical investigations:

1) Herlev Study (retrospective study using serum samples from the University Hospital, Herlev, Denmark)
In a retrospective study on a South Scandinavian cohort, conducted by Immunovia in cooperation with CREATE Health Translational Cancer Center, 1355 blood samples were analysed. PDAC stage I-IV was detected with 98% accuracy. 148 patients in PDAC stage I and II were differentiated from 888 healthy controls with 96% accuracy. The manuscript of the Herlev Study is still in preparation. This largest ever study for diagnosing pancreatic cancer paved the way for early intervention to significantly improve survival rates.

2) OHSU Study (retrospective study using serum samples from the Brenden-Colson Center for Pancreatic Care at Oregon Health & Science University (OHSU) in Portland, USA)
This was the second validation study to Immunovia´s IMMray™ PanCan-d test for the early detection of pancreatic cancer. It showed 96% accuracy for the early detection of 90 early stage I and II North American pancreatic cancer patients, which perfectly matches the previously reported Herlev (Scandinavian) study results. 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 OHSU. Immunovia and the OHSU Knight Cancer Institute formed a collaboration to validate Immunovia’s blood test for the detection of pancreatic cancer, IMMray™ PanCan-d. Conclusions drawn from the accomplished retrospective studies:
• PDAC stage I and II patients were detected with 96% accuracy and validated with a distinct patient cohort,
• PDAC stage I to IV patients were detected with 98% accuracy and validated with a distinct patient cohort,
In total Studies covering 2482 samples has demonstrated robustness and high accuracy of the IMMray™ PanCan-d platform.

On December 1, 2015, Immunovia was accepted for trading on the Nasdaq First North in Stockholm.
Before the introduction on First North, the company carried out a promising share issue that was oversubscribed five times. The share issue period ended on 16 November 2015 and provided the company with SEK 60 million before issue costs and about 1 100 new shareholders, including many existing, new and international investors. Trading in Immunovia AB’s shares commenced on Nasdaq First North in Stockholm on 1 December 2015. Interest among investors was high and at closing the share price had surged 60% compared to the introduction price. The trading turnover was SEK 28.5 million during the day, which set a new record among comparable First North listings during 2015. Immunovia’s Certified Adviser on Nasdaq First North is Wildeco Ekonomisk Information AB.

The positive validation results coupled with significant business development progress have positioned Immunovia as an SME with significant impact on the advancement of possibilities to diagnose pancreatic cancer in an early stage. The results achieved to date have strengthen the confidence of the investors in Immunovia and its assay and allow the company to intensify its efforts to validate the biomarker through other retrospective and prospective investigations.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Pancreatic cancer is one of the most deadly 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 4-6%. 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 4-6% to potentially 50-60%.
Several different PDAC biomarkers are used in the clinical practice worldwide, including C-reactive protein (CRP), CA 242, GDF-15, haptoglobin, M2-pyruvate kinase, serum amyloid A, platelet factor 4, and IGF-binding protein (IGFBP)-1. However, none of them has proven to be clinically superior to CA 19-9, the most common PDAC biomarker today. Nevertheless, the clinical utility of CA 19-9 is disputed as it has been found to be elevated in both non-malignant conditions (e.g., pancreatitis and acute cholangitis) and other gastrointestinal cancers (e.g., gastric cancer and colorectal cancer), and thus is not PDAC specific. Moreover, CA 19-9 may be absent in about 10% of the population, as some genotypic subjects cannot produce the CA 19-9 epitope. As a result, CA 19-9 has yielded a moderate sensitivity (69% -98%; 83,5% on avg.) and specificity (46%–98%; 72% on avg.) when screening for PDAC. Given the limitations of the biomarkers, PDAC diagnostics relies today heavily on other methods, such as biopsy, CT, MRI, EUS, PET, MRCP or ERCP. However, those are not designed to detect PDAC in its early stages and require access to expensive and specialized diagnostic facilities. As a result, those methods should be considered as the secondary diagnostic tools, enabling more precise diagnosis once the presence of PDAC in the patient’s organism has been confirmed by a biomarker.


In the course of the project, Immunovia has already conducted the largest ever studies for diagnosing pancreatic cancer that pave way for early intervention to significantly improve survival rates.
The IMMray™ PanCan-d test is able to differentiate with 96% accuracy patients with early resectable stages of pancreatic cancer, stage I and II, from the healthy controls. When analysing all stages of pancreatic cancer, the accuracy of Immunovia´s test is reported as high as 98%.
Our biomarker signature is highly specific and sensitive for stage I, II, III, and IV patients. The results from the studies performed to date are extremely encouraging, especially due to the large number of early stage patient samples. These results clearly show that our biomarker signature is able to detect the early stage patients when the cancer is still resectable by surgical methods.

IMMray™ PanCan-d detected pancreatic cancer with an unprecedented 96% accuracy in early stages of the disease, stages I and II and with 98% accuracy for all stages I-IV. Until now, the studies covered more than 3000 patient samples from Europe, US, and Japan.
We now have a strong confirmation that IMMray™ PanCan-d is able to detect pancreatic cancer in all stages, even in stage I and II. These very encouraging results provide us with confidence to perform large scale prospective pancreatic cancer study that will be conducted by Immunovia in collaboration with Dr. Brian Druker and his team at Knight Cancer Institute at Oregon Health & Science University (OHSU) in Portland, USA. Together, we are aiming to make a significant difference in pancreatic cancer patients’ lives and improve their chances of survival.

WHITE PAPER “Improved early-stage diagnosis of pancreatic cancer offers a major opportunity to improve overall survival”
On December, 18, 2015, Immunovia prepared a White Paper regarding the results of the previous studies to enable healthcare professionals, providers, regulatory bodies and patient groups to understand the full background of pancreatic cancer early detection in all stages, even in stage I and II, and the potential to improve the patients’ overall survival.

The white paper is available to download on:

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