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Clinical validation of a serum protein biomarker signature for the early diagnosis of pancreatic cancer.

Periodic Reporting for period 3 - IMMPACT (Clinical validation of a serum protein biomarker signature for the early diagnosis of pancreatic cancer.)

Reporting period: 2017-09-01 to 2018-05-31

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.
The project was designed to validate a novel serum biomarker - IMMray™ PanCan-d assay - for the early diagnosis of pancreatic cancer. The validation plan included several retrospective investigations and the initiation of a large-scale prospective study involving multiple clinical centres in several geographical locations. The retrospective validation was aimed at confirming preliminary, highly promising results of the biomarker and the underlying technology platform. The prospective study has been initiated to evaluate Immunovia’s assay in a clinical setting and compare it with the current standard of detection, imaging (MRI, CT, EUS, MRCP). The primary objective is to demonstrate that the IMMray™ PanCan-d platform is equal or better to the reference standard imaging procedures for early detection of PDAC in asymptomatic high-risk individuals.
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 exploits the body’s own detection network for the diagnosis of cancer. Once validated, this biomarker 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. This diagnostic capacity translates into global business opportunities for Immunovia. The company has already attracted major international investor interest and takes significant steps towards the market, through a range of dissemination and communication activities included in the SME Instrument Phase 2 project.
Overall, in the third reporting period, Immunovia has concluded the project as planned.
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.

IMMUNOVIA’S PROGRESS BEYOND THE STATE-OF-THE -ART
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.
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