In our special feature on blood cancer in issue 65 of Research*eu magazine, we interviewed the CEO of Italian SME Cellply, Dr Massimo Bocchi. He gave us a deeper insight into the company’s novel ex vivo diagnostic system that would be the first ever fully-automated diagnostic system to evaluate the response of fresh tumour specimens to anticancer drugs in a clinical setting. More than a year later, we catch up with him to see how much further along the road to full commercialisation they’ve travelled.
It has been a good year for Cellply. Back in September 2017, Dr Bocchi expressed his hope that in 2018 and 2019 the SME would be industrialising and clinically validating its ex vivo diagnostic platform on a larger set of patients – and thankfully it is happening!
“Indeed, we completed a pilot study on leukaemia that confirmed the performance we initially observed in predicting a patient’s response to the treatment,” Dr Bocchi explains. “We are now working on [the system’s] commercialisation with a relevant partner in the medical manufacturing field. We also established important clinical collaborations in Europe to support our 2019 activities that will focus on expanding our clinical validation – both by increasing the number of patients enrolled and by addressing multiple blood cancer types.”
Regulatory clearance in Europe and the United States is still on the cards as well. “Our ongoing commercialisation and clinical studies are going to support the following certification process that will require further clinical studies dedicated to validation,” Dr Bocchi says. “Our regulatory strategy is currently being updated to consider the EU’s new In Vitro Diagnostic Device Regulation (IVDR) that is impacting on the certification pathway in Europe.”
But what has really made a deep impact on Cellply’s future ambitions for its impressive oncology diagnostic system was the news in May 2018 that it had been granted a further EUR 2.34 million through Horizon’s 2020 Phase Two SME Instrument. “Our initial support from the European Commission will now continue with this new grant that will fund our commercialisation and clinical validation activities,” Dr Bocchi enthuses. “Taking part in the SME Instrument programme has been a great opportunity in terms of not just funding but also visibility. It has allowed us to create important and vital relationships with relevant clinical and industrial partners.”
The new ONCOSMART (ONCOlogic patient profiling and personalized treatment through SMART bedside diagnostics) project grant officially began in September 2018 and will run until August 2020. Watch this space, as we’ll definitely want to catch up with Dr Bocchi and his team again in another couple of years to find out more. In the meantime, we wish Cellply all the best in their work to bring their diagnostic system – one that could potentially improve the treatment course of thousands of cancer patients throughout Europe – fully onto the market!