Periodic Reporting for period 1 - TACTICS (Transferring Activomics into the Clinical Setting) Reporting period: 2015-12-01 to 2016-05-31 Summary of the context and overall objectives of the project Vision: “Promoting global health through better clinical management of chronic inflammation”.Mission: To improve the clinical management of chronic inflammatory diseases, initially focusing on inflammatory bowel disease, by bringing a new generation of innovative diagnostic and prognostic biomarkers into routine clinical use. Chronic inflammation is a major health burden yet remains a large unmet socioeconomic need. Chronic inflammation is a common feature in many debilitating diseases including inflammatory bowel disease (IBD), rheumatoid arthritis, type 2 diabetes, chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD), chronic back pain and cancer. It imparts a major toll on public health and carries with it a concomitantly vast economic burden. Many chronic diseases with an underlying inflammatory component are however poorly served with a general lack of sensitive, accurate diagnostics to enable early disease diagnosis, stratification and monitoring of targeted therapies. Poorly managed or untreated chronic inflammation contributes a large part of the soaring costs of overstretched health and social services, creating a global financial burden well over 100 billion € annually. At the heart of the problem lies a difficulty in the detection and interpretation of the many inflammatory signals in relation to each specific disease type. More reliable, informative biomarkers of chronic inflammation are urgently required to address this problem, and allow resources to be redirected into more cost-effective patient treatments. This need has yet to be met with the appropriate clinical products.Activomics®, disruptive innovation in clinical diagnostics : Permeation of blood with disease-specific patterns of protein modification enzymes is a promising and for the most part uncharted path to diagnose, stratify and monitor chronic disease progression and its treatment. The Activomics® platform employs a systematic approach to detect and quantify post-translational modification (PTM) enzymatic activities, offering novel means to identify and/or stratify diverse pathological mechanisms. The biomarker Act2 that we propose here as a new and necessary IVD for IBD was born out of an EU challenge for the discovery and commercialization of new diagnostic markers for chronic inflammatory diseases (FP7-HEALTH-2012-INNOVATION-1). Indeed, IBD is a global problem, affecting EU and citizens worldwide from all socioeconomic classes with no distinction for gender, generating an annual financial burden exceeding 30 billion USD. Screening of sera obtained from large patient cohorts led us to identify a novel Activomic biomarker that can differentiate IBD (Inflammatory Bowel Disease) patients from healthy and unhealthy controls with high accuracy (86%) and sensitivity (86%). This first effective serological marker for IBD promises to be a major breakthrough in the diagnostics and/or prognostics of this debilitating disease that counts millions of sufferers worldwide. In Europe alone, over 1 million people currently have the disease, bringing with it a major toll on public health and a concomitant heavy economic burden for the healthcare system and taxpayer. Better diagnosis and targeted therapy of IBD would reduce suffering and costs alike. We participated in this call in order to progress towards this goal, allowing us to devise a comprehensive business plan that will act as a roadmap to bring our biomarker into clinical diagnostic laboratories. SME-phase 2 funding and/or further private investment will be sought using the detailed business plan in order to fully validate clinical utility.The TACTICS mission and vision remains firmly on course. Our position is considerably strengthened by the submission of two patents in parallel to an in-depth freedom to operate analysis. A market survey, backed up by interviews with KOLs, adds precision to our knowledge of market needs and trends. Discussions with an ISO9001 accredited kit manufacturer allow us to encompass many aspects of the value chain to meet the regulatory requirements of the In Vitro Diagnostic Directive (IVDD) 98/79/EC and the ISO13485:2016 standard for medical devices. 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 TACTICS mission and vision has progressed through the aid of the SME Instrument Phase I. Our position is considerably strengthened by the submission of two patents in parallel to an in-depth freedom to operate analysis. A market survey, backed up by interviews with KOLs, adds precision to our knowledge of market needs and trends. Discussions with an ISO9001 accredited kit manufacturer allow us to encompass many aspects of the value chain to meet the regulatory requirements of the In Vitro Diagnostic Directive (IVDD) 98/79/EC and the ISO13485:2016 standard for medical devices. The product concept remains the same as specified in the grant agreement, to bring to the clinical diagnostic market new opportunities to better manage chronic inflammatory diseases, with emphasis on Inflammatory Bowel Disease (IBD). Identification and treatment of IBD remains challenging, where new treatments and best-practice are difficult to establish in the absence of reliable biomarkers of disease severity and response to therapy. Such clinical tools would both revolutionize patient care, and drive down healthcare costs, both highly desired outcomes. From the millions of IBD sufferers to the 100s of millions of persons suffering from one or more of a panoply of chronic inflammatory diseases, there is a clear and as yet unmet need for better guided treatments. Our Activomics biomarker represents disruptive innovation in progress, and many of the potential extended uses towards stratification of chronic inflammation will widen market prospects further. We have elaborated an initial draft of the financial plan that will evolve further in line with ongoing clinical research. Company reorganisation and associated business strategy will likely also evolve over this period. Several aspects of the business plan will be refined with the aid of external experts and further discussions with potential clinical and industrial partners. 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) Potential impact: Stage 2 SME Instrument application and associated clinical validation studies, new start-up company or company reorganisation associated with company growth, employment of more skilled employees, and venture capital fund raising for product development. The major socioeconomic factor is projected to be enhanced cost-effective management of chronic inflammatory diseases. TACTICS
