ONCOlogic patient profiling and personalized treatment through SMART bedside diagnostics

Personalised medicine is the future of medicine, offering tailor-made prevention and treatment strategies for individuals or groups of individuals. As a result, patients receive the specific therapies that work best for them, and no money is wasted on trial and error treatments. Oncology is one of the most important fields of personalized medicine as a majority of efforts in this field have recently centered on targeted cancer drug development. Acute myeloid leukaemia is an aggressive and devastating blood cancer mainly affecting people over age 60. It is one of the most common types of acute leukaemia in adults, accounting for approximately one third of all adult leukaemias in the Western world and with one of the lowest survival rates of all leukaemias. ONCOSMART is a precision medicine lab on chip for quick affordable analysis to accurately predict anticancer drug efficacy before administering drugs to patients. The platform consists of readout optical platform embedding a microfluidic cartridge which analyses the sample of each patient after exposure to different anticancer drugs or combinations thereof, to guide clinical decision-making and support clinical practitioners and drug developers within clinical development activities. ONCOSMART will re-designing ex-vivo drug response analysis to support biology-driven therapy selection.

During the Phase 1 feasibility assessment, CellPly accomplished a full analysis of the technical and business potential of ONCOSMART platform. Throughout the duration of the project, CellPly expanded its knowledge of the medical device market, including regulations, medical device reimbursement standards, market size and competitors. During the Feasibility Study, the internal clinical validation was extended and interim results on 7 patients reported a correct prediction of the outcome of the therapy in more than 85% of the cases; a new design of the disposable diagnostic kit was developed, according to a series of specifications identified through interviews with the end users; the business model and go-to-market strategy were defined and include a first phase where the innovative platform will be used to offer services to pharmaceutical companies supporting their drug development needs, possibly leading to the development of Companion Diagnostic products, followed by a second phase where sales of the platform to hospitals when certifications will be obtained and reimbursement issued will be overcome. The product development was decided accordingly, foreseeing the need to conduct a multicentre clinical trial in Europe to eventually obtain the CE-IVD mark, followed by FDA approval in the US , with the aim to start commercialising the device to hospitals in Europe and later in the US. A deep assessment concerning the right business model which held in consideration the right path in terms of time to market and company strategy and vision led to consider the model of the service to pharma as the most promising to start the commercialization. In addition, CellPly established a commercialisation plan supporting direct sales to hospitals.

ONCOSMART platform wants to be a real breakthrough in the field drug testing and precise medicine replacing the traditional standard techniques like flow cytometry and the current molecular diagnostic device. Cellply plans to develop a second generation of diagnostic tests assessing the activity of immune cells on tumor cells in presence of the drug. This development will follow a first generation of tests supporting drugs with a direct mechanism of action, which is currently under development. Nonetheless, proof of concepts showed the possibility to include both tumor and immune cells in the same microwell of a lab-on-a-chip device and to force cell-cell interactions by using electric fields. The concept is also included in a patent granted in EU, US and China. Healthcare costs for blood cancer represented a total of €16 billion and more than two thirds of this was spent on hospital inpatient care (€7 billion) and medications (€4 billion). Societal implications are huge because this lab on chip promise to reduce the long time AML patients have to wait before the right therapy, at the right dose, with more effectiveness and less side effects.

Periodic Reporting for period 1 - Oncosmart (ONCOlogic patient profiling and personalized treatment through SMART bedside diagnostics)

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