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Colodetect Report Summary

Project ID: 666540
Funded under: H2020-EU.3.1.3.

Periodic Reporting for period 2 - Colodetect (Development of a novel blood-based diagnostic test for colorectal cancer)

Reporting period: 2016-10-01 to 2017-09-30

Summary of the context and overall objectives of the project

Several colorectal cancer (CRC) epidemiology reports demonstrated a significant CRC burden in European countries, which is still associated with very high mortality rates. The overall objective of COLODETECT® project is the development and commercialization of a blood test for the early detection of CRC in population at risk (men and woman from 50 to 75 years old). The test is based on the detection and measurement of a reduced number of cancer-specific autoantibodies (biomarkers) that are present in the blood of patients, which were generated by the own body against antigens/proteins present in the tumor. COLODETECT® will allow surpassing the obvious limitations of the invasive detection techniques extensively used, as the colonoscopy, while retaining a good detection capacity. The test will also offer additional advantages compared to traditional CRC screening methods (Fecal immunochemical test - FIT), such its simplicity in use, high detection capacity, improved accuracy and an affordable cost. The expected outcome of COLODETECT® project will be a non-invasive and easy to use CRC diagnostic test, a high profit product, aimed for the screening of populations at risk.
The early diagnostic of CRC is essential to decrease the current mortality rates, being also associated with better treatment options and improving patient’s outcome.

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

During this period of the project implementation, the clinical trial for validation of the kit in development was defined and procedures for recruitment of selected patients’ serum/plasma were implemented, being the initial target of 3,000 samples in total. At month 24, ProAlt had incorporated to the project reached a total of 3,038 samples, more than 100% of those initially expected. In each case, sample-associated information was obtained as well, and most critical information was harmonized in a database. Subcontractors Centro de Investigaciones Biológicas (CIB-CSIC), Biobank of the Hospital Ramón y Cajal (RyC) and Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS) made a great contribution to reach this milestone. Samples and associated data from patients were obtained, processed and released to ProAlt following standard operation procedures with appropriate approval of the Ethical and Scientific Committees. All biomarkers in study (tumoral antigens produced as recombinant proteins) that were used in the different technological platforms of COLODETECT® project (ELISA and Luminex®) were continuously produced, improved and tested by their ability to bind the autoantibodies present in samples from a patients. Scale-up procedures were also implemented during this period for the manufacturing of kits for the clinical validation phase.
ELISA studies involved 14 different antigens and a pre-selected validation group of serum/plasma samples from patients (N=576; validation cohort: CRC patients vs. ‘healthy’ donors). ELISA plates were manufactured separately with each individual tumoral antigen. Plates were then used to analyze 576 patients’ samples. A total of 16.128 tests were performed in year-1 and statistical algorithms where designed and implemented to determine the best combination of antigens, or what is the same, the establishment of the preliminary predictor panel for colorectal cancer diagnosis which guided researchers during the procedure for multiplexing the assay. During year-2, the project was focus of on the transformation of the ELISA immunoassay into a multiplex assay for CRC diagnosis able to be commercialized. For this purpose, and based on preliminary results obtained in year-1, Luminex® technology (low-density bead-based liquid arrays) was selected by ProAlt. The assay transformation was implemented, assessing at every time that the detection capacity of each biomarker in study was maintained during the conversion of the ELISA immunoassay into Luminex. The same validation cohort used with ELISA was studied with the multiplexed immunoassay developed. A preliminary predictor panel with Luminex® was defined as well. At the end of year-2, ProAlt started with the large-scale manufacturing of the multiplexed assay for colorectal cancer diagnosis. Currently the company is conducting the clinical validation phase using a large number of blood samples from patients that are already part of ProAlt’s collection. Activities developed in business and exploitation plan were focused in the extension of the intellectual property related to COLODETECT® project. New patents were filled in Italy, France, Spain, Ireland, Poland, Switzerland, Netherland, Germany and United Kingdom from the beginning of the project. Europe, Australia, Canada and US patents requests were also managed during that period. Annual maintenance fees were also payed. COLODETECT® trademark registration was also performed. Competitors have been monitored systematically. The commercialization strategy was continuously updated and a preliminary plan was defined. Regulatory issues were partially implemented as expected. Dissemination and communication activities were focused in promoting and exploiting the results of the project. Most relevant actions included: attendance to international and national leading trade fairs in biotechnological sectors (BIO Philadelphia 2016, BioSpain 2016, BIO San Diego 2017,…), exhibit

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)

The outcome of this project will be a non-invasive CRC diagnostic kit, a high profit type of product, easy to use for screening of large populations at risk, low cost compared with high complexity tools competing technologies (colonoscopy/sigmoidoscopy), achieving good detection capacity at early stages, which will involve better treatment options to improve patient’s survival. During years 1 and 2 we have transformed the ELISA singleplex assay into a multiplex assay (Luminex technology), capable to measure several biomarkers simultaneously in the same sample. Multiplex assay is also faster and more amenable to automation and more frugal with reagents than individual single-plex assays.
COLODETECT is the first diagnostic test based on the novel auto-immunity strategy applied to colorectal cancer (CRC) early diagnosis, a strategic and high impact area of the human healthcare system worldwide, being the early identification of CRC the main therapeutic area where the company expect to become a reference company during next years. Additionally the company will increase significantly its personnel in all business areas, consolidating the R&D department and increasing the investments in current and future research projects following the same auto-antibodies strategy, the competitive advantage of the company compared with competitors working in the same field. Other benefits will be the creation of a complete management structure within the company, including manufacturing, quality control, customer service, technical assistance, sales, marketing, business development, intellectual property, accounting, financial and administrative departments, employing qualified professionals according to each specific area. The result will be the transformation of ProAlt in a big reference company within Europe.

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