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A simple blood test to monitor disease progression in patients undergoing cancer therapy

Periodic Reporting for period 1 - ONCOCHECK (A simple blood test to monitor disease progression in patients undergoing cancer therapy)

Reporting period: 2015-09-01 to 2015-10-31

Life Length S.L. ( is the leading applied life sciences company in the field of telomere diagnostics and analysis worldwide. The company was born as a private initiative with the business goal of industrializing its world-class technology for telomere length determination. Over the last three years, the company has completed the applied R&D work needed to perfect and scale its technology as well as simultaneously undertaken business development initiatives to internationalize its activity by establishing strategic alliances with new clients including among hospitals, clinics and pharma/biotech companies globally. Through close collaboration with these clients, we have identified a substantial clinical and commercial need – to offer our Telomere Analysis Technology® as novel tool for monitoring patients suffering from and undergoing treatment for cancer. This business opportunity is the one presented as the ONCOCHECK project and it is summarized herein.
The ONCOCHECK project concept:
The ultimate objective of the ONCOCHECK project is to bring to the healthcare market a unique solution for cancer monitoring by providing a simple blood test that will allow oncologists the evaluation of disease progression in patients affected by the great majority of cancers, with no distinction between haematological or solid tumours. Our test is based upon the determination of telomere length in peripheral blood, which is a cancer biomarker that has been well established scientifically for the great majority of cancers.
The discovery of telomeres and telomerase was awarded with the Nobel Prize in 2009 and subsequently there has been a significant acceleration in healthcare community’s interest in incorporating and exploiting telomere measurements as a diagnostic tool for in cancer and other age-related diseases. Telomeres are regions of repetitive sequences of nucleotides (subunits of DNA and RNA) that protect the ends of chromosomes, stopping them from deterioration or from fusion with neighbouring chromosomes. As part of cells’ natural aging processes, every time cells replicate, the telomeres get a little shorter and once they reach a critical length, the cell stops replicating (cellular senescence) eventually entering into apoptosis. Telomere shortening is therefore a naturally occurring process, associated with aging. However, abnormal or accelerated shortening of blood cell´s telomeres has been linked to cancer onset and disease progression. Once a cell has become cancerous, it divides more often, so as telomere length is reduced by each replication, its telomeres are shortened at a higher rate. Therefore, the presence of short telomeres and the evaluation of how these telomeres are shortening over time (attrition rate), can provide invaluable information on how the patients are responding to the prescribed cancer therapy. Most importantly, what makes telomere length determination of huge interest under a clinical perspective is that telomeres length can be measured in peripheral blood, even for those patients affected by solid tumours, because it has been demonstrated that blood telomeres are shortened in the great majority of cancer patients independently of the type of tumour. Therefore, the great advantage of using telomeres length as a biomarker for cancer monitoring is that it can be performed in a simple and inexpensive way by a blood test for all cancers.
However, despite the enthusiasm placed on telomere length measurement and its potential use as a biomarker in cancer monitoring, this has not become a clinical reality yet mainly because telomere length analysis technologies are not sufficiently reliable, scalable and/or do not provide clinically relevant information (most of them only provide the average telomere length but not the percentage of short telomeres that is the information actually needed for cancer monitoring using peripheral blood). Our technology is the only one in the market place that gathers the ideal features for its use in cancer monitoring:
 Scalability: automated sample processing, which enables high-throughput analysis.

 Total reliability & reproducibility

 Clinical relevance: capable to measure telomeres individually on each chromosome including individual telomere length and the % of short telomeres in blood.
The ONCOCHECK test will offer to the healthcare community a test that is simpler (blood test), less costly, and more effective (regular monitoring will lead to improved efficiency) as an alternative to other cancer monitoring alternatives that are expensive, complex (need for specialized and very expensive equipment) and less effective (impossible to be performed regularly). Moreover, the great advantage of the ONCOCHECK tests over other newly developed competing blood tests based on validated biomarkers is that ONCOCHECK will serve for monitoring all types of cancer, while competing biomarker based solutions are useful only for a specific cancer/tumour. Therefore, Life Length´s test will offer a universal solution for cancer monitoring, with no competitors offering a similar approach. The figure below explains how our technology works in the real practice.

ONCOCHECK: Objectives of the action.

The ultimate objective we sought for the ONCOCHECK project during Phase 1 was to minimize any potential risk that could endanger the success of our business innovation project from all perspectives: technical/scientific, commercial and financial perspectives. With this ultimate objective in mind, the Phase 1 was designed as a feasibility study aimed at determining those key aspects for the successful implementation of our telomere length analysis technology in the clinical setting for cancer monitoring, including haematological cancers and solid tumours. The specific objectives for the action were as follows:

 To establish, through our National and International partners, relationships with oncology units of hospitals, to search for appropriate sources of clinical samples and evaluate, with the physicians involved, the clinical study requirements.
 To design the clinical study, delineating: (i) the correct cohorts and number of samples needed for statistical power (ii) the type and source of samples (iii) the complementary assays and additional testing needed that would allow us to obtain sufficient data to correlate telomere length with cancer progression.
 To prepare the ethics committee documentation and receive the approval for the clinical validation study.
 To build up a work plan for technology development: tasks, key milestones, risks analysis.
 To validate our market hypothesis with key opinion leaders, so to ensure the ONCOCHECK test will find the expected market acceptance.
 To perform an in-depth market analysis and to identify the priority markets and the optimal channels to enter these markets.
 To define a five-year business plan for product development and commercialization setting up milestones, evaluating different commercial scenarios and potential risks, defining a risk contingency plan, calculating the financial projections and defining a sales strategy.
During Phase 1, we have performed an in-depth assessment of the feasibility of the ONCOCHECK project. The work performed and main achievements are as follows:
COMMERCIAL FEASIBILITY ASSESSMENT: The Commercial feasibility study was planned for this Phase 1 project as a way to understand better the market we aim to enter, so to help us in the definition of the most optimal strategy for commercialization. The work performed during the action has been the following:
 Performing a market research study: Key market features, geographical segmentation, value chain analysis (key stakeholders) and a complete analysis of competitors.
 Update our commercialization plan: go-to-market strategy, timeline, commercial goals for the first 5 selling years and resources required to achieve our commercial goals.

TECHNICAL/SCIENTIFIC FEASIBILITY ASSESSMENT: Under a technical/scientific perspective, the ONCOCHECK project is a clinical study for the validation of telomere length as a biomarker for monitoring the great majority of cancer types including haematological cancers and solid tumours. For this Phase 1 project we planned the design of the clinical study in collaboration with Key Opinion Leaders (KOLs) from our network of collaborators and the definition of a scientific/technical roadmap for the next 2 years (development phase). The work performed during the action has been the following:
 Partner engagement. We have set up strategic alliances with the oncology units of hospitals that will be our collaborators in the clinical validation study for the development phase in the ONCOCHECK project (phase 2). Under a close collaboration with these Key Opinion Leaders, we have gained a better understanding of the potential of the ONCOCHECK test as tool for clinical cancer management. Fundamentally, we have confirmed its potential as a cancer monitoring tool but also as a tool for cancer prognosis, which means the ONCOCHECK test can also be a useful tool in the early prediction of patient outcome.
 Design of the clinical study. We have determined that the large scale clinical validation study will be performed as four independent clinical studies:
o Clinical study for the validation of telomere length in monitoring of haematological cancers in children.
o Clinical study for the validation of telomere length in monitoring of solid tumours in children.
o Clinical study for the validation of telomere length in monitoring of haematological cancers in adults.
o Clinical study for the validation of telomere length in monitoring of solid tumours in adults
These 4 clinical studies have been designed separately and we have achieved the ethics committee approval for conducting them over the next 2 years.
 Elaboration of a work plan for the ONCOCHECK project, including a risk assessment.

FINANCIAL FEASIBILITY ASSESSMENT: The financial feasibility study was planned for this Phase 1 as a way to carefully analyse the funding requirements for the ONCOCHECK project and to determine the project profitability (Return of Investment, R.O.I.). The work performed during the action has been the following:
 Calculation of the total financing needs for the ONCOCHECK project: funding requirements to reach the go to market stage.
 Update of our financial and cash flow projections for the following 5 years of ONCOCHECK commercialization.
Cancers figure among the leading causes of morbidity and mortality worldwide, with approximately 35 million people affected by this disease and 8.2 million cancer related deaths in 2014. The total economic impact of cancer worldwide is estimated at more than €900 billion per year, representing a 1.5% of the world´s gross domestic product (GDP) and being by far the leading cause of economic loss globally. Having looked at the cancer statistics, it is easy to understand why addressing this disease has become a major priority for the healthcare systems all over the world. This scenario sustains the likelihood for succeeding in the commercial exploitation of ONCOCHECK as an inexpensive and simple test for cancer monitoring.
Through the ONCOCHECK project, we seek positioning our company as a leading player on the Advanced Next Generation Cancer Diagnostic Market, which is estimated globally at €7.1 billion in 2015 and expected to reach €13.21 billion by 2020, representing a huge opportunity for us. The main market drivers are the development of less invasive and costly tools that can contribute to a more efficient and sustainable management of cancer. In this sense, the solution we are bringing to the market with the ONCOCHECK project as a simple blood test to monitor all cancer patients, will be a huge step forward in cancer management with an enormous social and economic impact. Under a social perspective ONCOCHECK will contribute to improved cancer management and reduced mortality rates. Under an economic perspective, ONCOCHECK will contribute to the sustainability of the healthcare systems through significant cost reduction associated with cancer management.