Delivering anti-cancer drugs beyond the blood-brain barrier

Project Information

DOMEUS

Grant agreement ID: 960141

DOI

10.3030/960141

Project closed

EC signature date 15 October 2020

Start date 1 October 2020

End date 30 September 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 995 353,50

EU contribution

€ 2 064 325,00

Coordinated by

CARTHERA
France

Periodic Reporting for period 2 - DOMEUS (Delivering anti-cancer drugs beyond the blood-brain barrier)

Reporting period: 2021-10-01 to 2022-09-30

Summary of the context and overall objectives of the project

Carthera is a clinical stage company that develops first-in-class medical devices using therapeutic ultrasound to treat severe brain disorders (Glioblastoma, Brain Metastasis, Alzheimer’s Disease). The company has developed the SonoCloud device, a skull implant emitting Low Intensity Pulsed Ultrasound (LIPU), to improve the delivery of drugs to the brain by temporarily disrupting the blood-brain-barrier (BBB). This device is offering for the first time in decades a means for clinicians to delay the recurrence or to prevent the worsening of severe brain diseases.

Encouraging results from a first-in-man Phase 1/2a clinical trial in recurrent Glioblastoma were published in prestigious medical journals (Carpentier et al, 2016; Idbaih et al, 2019). Carthera is now gathering data from an international (American/French), multi-center, pilot clinical study with an enlarged version of the device (SonoCloud-9). The company is ready for large scale clinical deployment. With the DOMEUS project, Carthera will scale-up its processes and organizational structure to bring its technology to an increasing number of patients around the world. The project will make it possible to carry out a pivotal phase 2b/3 clinical trial through manufacturing and regulatory actions, and prepare the industrialization of the device and its introduction on the international market.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

One year after the launch of the DOMEUS project, Carthera obtained authorizations from ANSM in France and FDA in the United-States to run a clinical study extension to test a different treatment sequence on additional patients of its on-going pilot trial. The recruitment of this study is now completed and preliminary results look promising, giving good perspectives to the upcoming pivotal trial. For this next pivotal trial, all the SonoCloud-9 devices have been manufactured, with biocompatibility, chemistry and sterility tests completed and compliant with norms.

As part of the scale-up process and in view of the industrialization of the device production, additional subcontractors have been qualified and the manufacturing processes is being validated for the first commercial batch. Regulatory paths have been discussed and agreed with the selected notified body and competent authorities in Europe and in the United-States. For the protection of its future activity, Carthera also consolidated it patent portfolio and additional patents were granted. Moreover, an FTO study was performed confirming the freedom to operate of the company.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Increased interest in the technology from both scientific corpus and corporates raised after this first year of project.

The leadership of Carthera in the field of therapeutic ultrasound for the treatment of brain diseases is reinforced.

Manufacturing of SonoCloud-9 implants