Periodic Reporting for period 1 - SkinXCare (Integral cell-biology platform for the development of the first effective treatment of radiodermatitis.)
Reporting period: 2016-12-01 to 2017-03-31
Our platform is the only one in the market that integrates novel bioinformatic tools (in silico) based on cellular proteome/kinome data (SkinSim and INCOS) and in vitro assays (SimDerma) for the rational design and development of new dermatological formulations (see image attached).
The combined use of these tools in the platform allows us to identify the molecular and cellular targets involved in complex skin diseases, testing specific active ingredients for these targets and obtaining the combinations with the highest synergistic activity to develop the final formulation. This makes our platform a key enabling technology for the development of new dermatological products to address skin diseases, even for those ones without a known efficient therapeutic solution because of the complexity in the cellular and biochemical damages underlying the specific disease. The figure above shows how our technology works towards this ultimate goal.
In this project, we seek demonstrating the potential of our platform by its use in the development of the first effective dermatological solution for radiodermatitis, a severe skin condition that affects cancer patients undergoing radiotherapy, which remains an unsolved clinical problem. Our major goal is to prevent X-Ray-induced skin damages thus allowing the completion of the radiation cycle. Next, we summarize the SkinXCare opportunity.
WHY IS SKINXCARE A CLEAR BUSINESS OPPORTUNITY?
Radiodermatitis is the most common side effect of radiotherapy. This undesired side effect is a severe skin condition that can range from a mild, red rash (erythema) and itchy, peeling or flaking skin (dry desquamation) to a more severe reaction with blisters and wet, peeling skin (moist desquamation). In terms of incidence, it is estimated that approximately 85-87% of cancer patients receiving radiotherapy experience a moderate to severe skin reaction of which 10-15% progress to moist desquamation. Two major consequences are caused by these undesired side effects: a) the quality of life of cancer patients is negatively affected to a high extent and b) these side effects too often limit the radiotherapy program duration and intensity, challenging the effectiveness of cancer treatment. It is therefore essential to minimize skin damages as much as possible. However, nowadays there is a lack of efficient skin care interventions for radiodermatitis, but only some guidelines for their clinical management based on recommendations given to patients2 (continuous washing and skin hydration, avoidance of perfumes, gels, soaps or creams not prescribed by the oncologist, etc.), which are completely insufficient.
Considering the lack of solutions to address this severe skin condition and the fact that 50-60% of all cancer patients receive radiation therapy (more than 7million people initiating a radiotherapy program each year around the world ), the SkinXCare opportunity seems unquestionable.
HOW DO WE INTEND TO EMBRACE THIS OPPORTUNITY?
The first question we must answer is why there is not a single skin care product in the market for effectively addressing radiodermatitis, to help reducing its progression and severity along a radiotherapy regimen. The answer to this question is because of the complexity of the cellular biology mechanisms involved in the skin damages caused by ionizing radiation that include at least: DNA damage, oxidative stress, inflammation and cytotoxicity. This complexity challenges the development of effective solutions because many cellular and molecular targets are involved and so the therapeutic solution must be designed upon the identification of all of them and the formulation of a product combining active ingredients with biological activity in each of these targets. Currently all solutions have failed because the cellular and molecular targets underlying radiodermatitis are still not well-identified and so the few market available products don´t consider the complexity of the disease mechanisms, but only partial approaches.
In the SkinXCare project we will be able to develop the first effective dermatological therapy for patients under a radiotherapy regimen, capable of preventing radiodermatitis intensity progression and alleviating the symptoms. This will be possible thanks to our platform that will allow identifying all the cellular and molecular targets involved in the disease and the development of a range of dermatological products for the effective management of radiodermatitis, based on combinations of active ingredients acting synergistically on these targets. Thanks to the uniqueness of the solution proposed in the SkinXCare project, we seek becoming a leading player of therapeutic dermatology market. This market segment was valued at €24.5 billion on 2015 and is predicted to grow at a CAGR of 6.7% until 2025, key figures that further sustain the SkinXCare business opportunity.
SKINXCARE PHASE 1 PROJECT OBJECTIVES:
The ultimate objective of this Phase 1 project was to assess the feasibility of our business innovation project, with a major focus on its technical and commercial feasibility, so to enter the next stages of our innovation project SkinXCare under a minimum risks scenario. Therefore, the specific objectives for the action were as follow:
Definition of the parameters to optimize in our platform for turning it up into a TRL9 for the development of the SkinXCare product (full technological readiness for this specific purpose).
a) To build up a 2 years’ work plan for platform optimization, product development and clinical validation of its efficiency. This work plan should describe the tasks, timing, key milestones, risks analysis.
b) To determine the regulatory situation in EU and the US for commercialization of SkinXCare product and the regulatory requirements (if any), so to consider them in our plan to reach the market.
c) To perform a patentability analysis and determine our freedom to operate regarding the SkinXCare formulation.
d) To assess the best go-to-market strategy and to define a plan for commercialization, enabling the identification of the key stakeholders to get involved.
TECHNICAL FEASIBILITY ASSESSMENT:
The work performed during the action and the main achievements have been the following:
1) Analysis of the parameters required to adapt our platform for the purpose of developing a dermatological therapy for radiodermatitis management. We have defined the necessary parameters for training the SkimSimTM tool to simulate the radiation intensity and distribution during radiotherapy, in order to obtain a virtual model of radiation-induced skin injuries. In addition, we have also performed a deep review about the main results published in prestigious scientific journals and databases on effect of radiation in skin proteome/kinome (altered proteins and pathways as consequence of radiation). This accurate revision of ionizing radiation and its deleterious effects in human skin have allowed us to define the experimental models that will best mimic these deleterious effects, so we will be able to identify the biological and molecular targets involved in radiodermatitis thanks to our platform.
2) We have defined an precise 2 years´work plan for technology development (defining the main tasks, key milestones…) and we have also accomplished a comprehensive risk assessment.
COMMERCIAL FEASIBILITY ASSESSMENT:
The key activities to be performed in the commercial feasibility assessment in this phase 1 have been the following:
1) Analysis of the regulatory pathways that apply for different products´ compositions. The regulatory analysis performed during Phase 1 has allowed determining that the type of dermatological products we are planning to develop in the SkinXCare project do not require any mandatory approval by regulatory bodies (FDA/EMA) for their commercialization. This is because, the type of active ingredients we will include the final product formulations (all of them categorized as INCI code) will exert their activity only in the epidermis level (outer skin layer), so the formulations will not be considered pharmacological products, thus neither EMA/FDA approval will be required nor a clinical trial to get the approval for commercialization. However, we have decided anyway to perform a clinical study to assess the real efficiency of SkinXCare as a dermatological solution to address radiodermatitis when administered along the radiotherapy regime. This clinical study will be performed with a two-fold aim: a) convince oncologist/radiologist/dermatologists (prescribers) to recommend it to their patients, b) seek for the post-project approval by the EMA/FDA as a product for treatment of radiodermatitis instead of a product for skin care in patients undergoing radiotherapy, as we see in it a competitive advantage for positioning the product in the market.
2) Patentability and freedom to operate analysis regarding the final product: We have searched for patents related to “dermatological products to address radiodermatitis” in order to assess the patentability of the final formulation we are planning to develop in the SkinXCare project. We have been able to determine that there are no patents that will endanger our freedom to operate or the patentability of the proposed concept.
3) We have planned and compared different go-to-market strategies, considering investment requirements, geographic issues, timing, risks, breakeven and ROI for each of them. The following strategies have been evaluated during this phase 1 SkinXCare project.
a) Industrial production with a contract manufacturer and commercialization under our own brand.
b) Full licensing of our formulation to reputable pharma companies
c) Industrial production and commercialization under a Joint Venture with a partner consolidated in the market.
Based on this analysis we have elaborated a business plan for the SkinXCare project. This business plan has been built upon a detailed commercialization plan for the geographic regions of interest, which has allowed us to prepare our financial projections for the first 5-selling years and to perform a financial sensitivity analysis.
Regarding the expected impact of the SkinXCare project, under a societal point of view it might be enormous because we will offer cancer patients a solution to an unsolved problem that affects negatively their quality of life to a high extent and that limits the radiotherapy treatment duration, reducing its efficiency, and putting their life at huge risk.
The expected impact of the SkinXCare project under our company´s growth perspective is equally huge, as the successful consecution of the project objectives will allow us to become a leading player of therapeutic dermatology market, given the impact a product like SkinXCare might have in the market and the market growth perspectives. Moreover, our technological approach warrants the further development of personal care products for other major dermatological conditions. As for understanding the magnitude of the business opportunity we pursue, there are more than 35 million people affected by cancer worldwide and cancer incidence is predicted to experience a significant increase over the next decades. Therefore, we expect a great demand for our product because: a) 50-60% of all cancers required radiotherapy as first-line therapy and b) currently, there is not a single product in the market for effective treatment and prevention of Radiodermatitis and therefore there is a huge potential market for it.