An Italian-made patch to treat the deadliest form of brain cancer

‘The cancer cells that the surgeon is forced to leave behind are not a technical failure, but a biological and anatomical limitation.’

To overcome this therapeutic hurdle, the NeuroMESH research programme was launched, coordinated by Riva at Humanitas and now funded with €2.7 million over five years by the Italian Fund for Applied Sciences (FISA) of the Ministry of University and Research, which brings together the clinical expertise of the Italian Institute of Technology (IIT) with its nanotechnology expertise.

The project aims to take a biodegradable polymer film developed by the IIT – known as μMESH – from preclinical trials to clinical application.

The approach itself is not new: over the last thirty years, methods of local administration that do not require crossing the blood-brain barrier have been tested, including wafers – rigid discs impregnated with chemotherapy drugs placed in the cavity at the end of the operation – without, however, managing to substantially change clinical practice. The limitation of the wafers is physical rather than pharmacological: a rigid device does not adapt to the irregularities of brain tissue, leaving areas of insufficient contact and resulting in uneven drug release.

μMESH is based on a different design: a thin, flexible film with an internal microstructure that conforms to soft tissue and releases drugs in a controlled manner over a period of weeks.

The technology has already reached a level of maturity (Technology Readiness Level – TRL 3) close to that required for clinical trials. “μMESH can be loaded with different combinations of chemotherapeutic and immunotherapeutic agents, releasing them locally,” says Paolo Decuzzi, Senior Scientist at the IIT and professor of oncology at Stanford, who heads the group that developed the technology. “The aim is to target residual cancer cells without exposing the rest of the body to the systemic toxicity of the drugs.” I

IT produces the optimised μMESH configurations, which are tested by third-party clinical centres. In addition to Humanitas, which has a cell bank derived from surgical patients, used for transplantation into mouse models, the project involves Stanford Medicine, the University of California, San Francisco (UCSF), Harvard Medical School and the MD Anderson Cancer Centre in Houston, each with their own preclinical models and protocols. ‘At a time when international scientific collaborations are under political pressure, this project demonstrates how Italia and the United States can work together efficiently,’ notes Decuzzi.

Over the five-year duration of the project, μMESH will be validated in accordance with the requirements set by the European (EMA), Italian (AIFA) and US (FDA) medicines agencies. “We have the opportunity to replicate the entire treatment protocol, including radiotherapy, in animal models,” explains Riva. “Phase 1 clinical trials on patients could begin within this timeframe, whilst large-scale application will take at least ten years.” Just as with the development pipeline for a new drug, “it is the patients of the future, not those of today, that we are trying to help,” he concludes.