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Report

Teaser, summary, work performed and final results

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

Teaser

Summary

ONCOSMART is the first analytical platform that determines the effectiveness of anticancer drugs for a specific patient, testing live tumor cell response to one or multiple cancer drugs. ONCOSMART is currently applied to haematological cancers and analyses bone marrow or blood samples from a specific cancer patient to provide a personalized report within 24-48 hours.
Every year about 20 million people are diagnosed with cancer and about 10 million cancer patients see their disease advancing and becoming hard to treat, e.g. refractory to treatments and/or developing metastases. At the same time 95% oncology trials fail mainly because of a lack of efficacy of the new treatment. There is an urgent need to better match patients and drugs. Precision medicine based on genomic profiling can be applied only to a minority of advanced cancer patients (about 15%) and eventually provide a benefit to some 7% of â€œhard-to-treatâ€ cancer patients.
The â€œfunctional profilingâ€ approach pursued by ONCOSMART is applicable to any cancer patient, independently from the genetic makeup. Moreover, in lab-based tests it has shown superior performance â€“ compared to molecular/genomic profiling â€“ in predicting individual patientâ€™s response to treatments.
ONCOSMART key objective is to develop the first fully automated and standardised platform allowing to advance functional precision medicine from a lab-based to a device-based approach. ONCOSMART system enables de-centralized execution of functional profiling tests and aims at supporting a wide adoption in research and clinical labs, with the goals to identify the most suitable cancer therapy for individual patients and support drug repurposing and patient selection in clinical trials.
ONCOSMART can test anticancer drugs including targeted, chemo and immunotherapies alone or in combination.
The platform is being developed and tested on leukemia patients (AML), proving its predictive power, and is meant to be extended to other hematologic and solid tumors in future developments.
Within this project, CellPly has the goal to industrialise the platform, validate its analytical and clinical performance and support the first commercialisation activities releasing the platform for research first, then for clinical use.

Work performed

Since its start, the project reached the following key results:

Platform Development
- Mark I platform high-level design completed (requirements, risk analysis)
- Signed agreement with multinational contract manufacturer for Mark I industrialization
- Research-grade analytical software released, in use for day-by-day analysis of data acquired from real patientsâ€™ samples
- 3 disposable kits for AML, CLL and MM developed
- First roof of concept completed for immunotherapy profiling

Preclinical and clinical validation
- Quality management procedures issued to manage core processes, e.g. platform industrialization and clinical validation activities according to ISO13485 requirements
- Completed testing of BETA analyzer allowing installation in remote clinic (CharitÃ© hospital, Berlin);
- Pilot study carried out at 2 main hospitals (Santâ€™Orsola Malpighi Hospital, Italy and CharitÃ© hospital, Germany
- 6 hospitals currently involved in sample collection (including also Ravenna hospital, IRST oncology institute in ForlÃ¬, Parma hospital, San Raffaele hospital in Milan)
- Validation of BETA system completed through pilot study on about 40 patients, still ongoing, achieving a prediction accuracy of about 85-90%

Marketing, commercialization and dissemination activities
- 4 Key Opinion Leaders (KOL), i.e. medical doctors with top-level publication rates, involved in our clinical studies (at least one KOL for each study)
- 1 abstract accepted at ASH 2019 (largest international hematology congress)
- Company and project presented at 14 international events (business, partnering, pitch events)
- Early-engagement agreement signed with Roche, as a follow-up of interactions started within the EICâ€™s Business Acceleration Services program

Project management
- project amended to include the collaboration with CharitÃ©, the largest EU hospital
- advisory board established, including 4 members with strong scientific and industrial experience

Intellectual property
- 7 patent families
- 3 pending patent families allowed in Italy
- 2 pending patent families allowed in the US (Oct. 2019)
- 1 new patent filed (Oct. 2019)

Ethics requirements
- 3 clinical protocols (1 sponsored by Cellply, 2 sponsored by partner clinics) supporting clinical testing

Final results

ONCOSMART targets two customer segments: biopharmaceutical companies and clinics/hospitals. End beneficiaries are cancer patients who receive treatments tailored to their specific disease, through functional profiling data generated by ONCOSMART. Impact is both on improvement of cancer care and better allocation of financial resources.
For biopharmaceutical companies, blood cancers are a relevant field as, among 600 drugs under phase 2-3 development in oncology, 200 are being developed in blood cancers. ONCOSMART can support drug development by:
a) previewing the efficacy of drugs in patient sets and for indications never tested before;
b) stratifying patients and tailoring recruitment of patients in different phases of clinical trials;
c) supporting Companion Diagnostic (CDx) programs.
In clinical settings, mutational/genetic are mainly used as prognostic markers and have poor predictive value. ONCOSMART has the opportunity to introduce predictive biomarkers with high predictive value.
Functional profiling approaches are being developed by a growing number of companies and research groups. CellPly, thanks to the current development and the latest IP developed within the project, is aligned to the most advanced methods developed by state-of-the-art companies in the field, allowing to precisely evaluate the efficacy of drugs on the tumor subpopulation separated from healthy cells and to analyze the immune system activity for immunotherapy profiling. Beyond this, ONCOSMART advances existing solutions by providing, for the first time, an integrated system enabling decentralized analysis of ex-vivo tumor response to treatments. This is as fundamental step towards the adoption of functional precision medicine in diagnostic procedures, including CDx.
ONCOSMART is being validated in clinical settings where high-cost treatments, e.g. targeted therapies, combination regimens and immunotherapies, are in use. Therapy cost has reached, in many cases, the range of â‚¬0.1-1 million per patient, posing a serious concern about economic sustainability and general access to latest-generation treatments. Healthcare expenditure in the EU is about â‚¬60 billion for cancer treatment, â‚¬6-8 billion only for blood cancers. ONCOSMART can deeply impact on these costs and support value-based healthcare models providing payers with data-driven reimbursement strategies.