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The first predictive test for radio-sensitivity. A step towards an improved and personalised radiation therapy cancer treatment.

Periodic Reporting for period 1 - NovaTests (The first predictive test for radio-sensitivity. A step towards an improved and personalised radiation therapy cancer treatment.)

Reporting period: 2018-05-01 to 2018-09-30

Cancer is an extremely complex disease with high prevalence and heavy economic and societal burdens - both breast and prostate cancers are among the most prevalent types of cancer and, in both cases, Radiotherapy (RT) is a standard medical treatment used in approximately 50% of the patients. Since the survival rates of breast/prostate cancer are increasing, so are the burdens associated with the long term-side-effects of RT. 5 to 10% of patients treated with RT will suffer from several long-term side effects and this number can go up to 50% for mild-to-severe side effects. RT side effects appear 3 months up to 3 years after treatment and severely impact the quality of life of patients. Furthermore, these side effects result in significant financial expenditures for both patients and health care systems that must manage a whole new set of health conditions. The major challenge with the current RT regimens is that they are designed to treat average populations while bypassing different sensitivities to radiation levels and thus the fundamental heterogeneity in human biology.
Radiation oncologists define radiation treatment through their peers, own experience and ICRP guidelines without any tool to consider individual patient factors. Moreover, the risk of developing late side-effects by some individuals limits the potential curative doses that could be used for most individuals - current radiation practices aims at limiting the toxicity rate to 10-25% based on risk estimates for the general population. Therefore, most patients receive sub-optimal doses, which results in inefficient cancer treatment as sub-optimal doses lead to sub-optimal survival chances and sub-optimal recovery with higher chances of relapse.
The ability to stratify patients according to their radiosensitivity will pave the way towards adjusted RT regimens to avoid deleterious health side-effects or lead to other treatment modalities (e.g. surgery, proton therapy or prostate spacer). Ultimately, stratifying patients is expected to result in higher survival rates. However, there are no tools in the market to stratify patients for radiosensitivity based on a biological test. There are imaging tools that support oncologists in personalizing the treatment, but these are qualitative and give no information about the patient’s susceptibility to radiation. There is thus an unmet clinical and societal need for diagnostic solutions able to stratify patients based on high/low radio-sensitivity (and respective risk of long-term side-effects) and at the same time deliver to radio-oncologists a decision tool fundamental to enable personalised RT for cancer patients.
To meet this need and seize a major market opportunity, NovaGray has developed a unique diagnostic test that only requires a blood sample for the stratification of breast/prostate cancer patients based on their level of radiosensitivity and hence likelihood of developing side-effects. By introducing this invaluable diagnostic tool into the current clinical practice, oncology healthcare will take a step forward into the personalisation of breast/prostate cancer RT regimens based on the implementation of sound knowledge-based decisions.
NovaGray has led the maturation of NovaGray Breast® and NovaGray Prostate® to clinical validation and CE-marking. However, to ensure the large-scale uptake of the tests and get reimbursement, the overall objective is to demonstrate their clinical utility, i.e. demonstrate that cancer treatment modifications based on RT patient stratification lightens/avoid the development of RT late side-effects and improves the overall outcome of RT efficacy.
Therefore, the key objective of the Phase 1 project was to define and plan the utility trials with 900 patients. Furthermore, a key objective of the Phase 1 was to analyze the business model in detail to plan for scale-up and internationalization. Finally, the Phase 1 was key to update the preliminary freedom to operate analysis.
The main activities of this project and the main results were:
1. Plan clinical trials - Establish the clinical roadmap. Identify and enroll clinical Research Organisation (CRO) and radiotherapy centers. Plan large scale clinical trials for 900 patients (500 for breast and 400 for prostate) – decide type of participants, diagnosis protocol and reference analyses needed to validate the product.
Results: a multi-center utility trial will be run with 5 hospitals in EU and US during 24 months to get cost-utility and apply for reimbursement models.

2. Business model verification - Establish the organizational plan and full operations management (incl. personnel’s growth) to scale up business. Estimate 5-years financial projections, cash flow, profit and loss, break even and ROI.
Results: A new business model has been analysed focusing on establishing commercial partnerships with EU centralized biomedical labs. It has been concluded that this business model is more viable for scale-up and internationalization, with biomedical labs being responsible for the biological tests under licensing agreement. First discussions initiated with EU biomedical laboratories. Sales forecasts predict a sound business case with strong expected growth.

3. Market assessment - Analyse target customer segments and their willingness to pay. Identify and contact potential Hospitals, oncology centres and pharmaceutical companies in the initial target countries. Review/update competition analysis.
Results: There is a wide appraisal for NovaGray’s solutions by the medical community. No competitors have started a validation trails, hence NovaGray has an estimated 4 years lead over competitors.

4. IP analysis - Establish next steps in a sound IP management strategy. Validate FtO.
Results - No filed patent2028indicates blood analyses to2028measure the impact of radiation on healthy cells, ensuring the2028freedom to pursue our proprietary2028development activities. Filing of a patent, first patent fully owned by NovaGray (June 2018).

5. Regulatory compliance – Obtain CE mark and ISO accreditations.
Results: NovaGray Prostate® CE-mark application completion. NovaGray is now ISO 13485.

Conclusions: Considering that: 1) there is wide appraisal for Nova Tests by the medical community, 2) the feasibility analysis, comprising both clinical and market-related activities, has validated the high market potential and business roadmap for our unique technology (Phase 1), and 3) we have verified Freedom to Operate, we have decided to apply to the Phase 2 of the SME Instrument programme, in order to ensure fast-track commercialization and market adoption of our solution.
With the current approach, decisions on cancer treatment are made by the oncologists and can include surgery, chemotherapy, hormonal treatment, targeted drugs when available, immune therapy and radiation therapy. However, currently, clinical decision-making for radiation therapy is qualitative, population-based, and does not take into account differences in terms of tolerance to treatment in individual patients.
The ability to stratify patients using a set of biomarkers, which predict toxicity risk would serve as a highly valuable tool for precision medicine and personalized RT. NovaGray Breast®/Prostate® is the first biological test that can effectively achieve this, stratifying cancer patients according to their likelihood to develop long term side-effects as a consequence of RT regimens. The introduction of NovaGray tests in the clinical practice would represent a major step forward, providing great support to oncologists in improving treatments according to the individual biological specificities of patients, increasing treatment efficiency, efficacy and safety, and reducing costs. More specifically, several strategies have already been presented to improve cancer treatment according to the risk of toxicity. For a patient at low risk of developing radiation-associated toxicity, use of a hypo fractionated protocol (higher doses in shorter period of time) could be proposed leading to treatment time reduction and a cost–utility advantage. Conversely, for patients predicted to be at high risk for toxicity, either a more conformal treatment or a new technique of RT (e.g. photon therapy which is more effective, has less side effects, but is much more expensive), or a multidisciplinary approach employing surgery could be included in the treatment.
To sum-up, it is of utmost importance to improve and personalise RT treatments in order to achieve better outcomes and reduce the side-effects of RT. Several treatments adaptations have been suggested to achieve this but there are currently no tests that can effectively stratify patients. NovaGray has developed a technology to fill this gap.

Expected results until the end of the project:
To get reimbursement for NovaGray Breast®/Prostate®, we expect, through trials with 900 patients, to demonstrate the clinical and cost utility of NovaGray tests - i.e. demonstrate that cancer treatment modifications based on RT patient stratification lightens/avoid the development of RT late side-effects and improves the overall outcome of RT efficacy. This will ensure the large uptake of the biological tests. Furthermore, we expect to secure commercial partnerships with large biomedical labs to scale-up the business.