Periodic Reporting for period 2 - DOMEUS (Delivering anti-cancer drugs beyond the blood-brain barrier)
Berichtszeitraum: 2021-10-01 bis 2022-09-30
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.
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.
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.
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.
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.
The leadership of Carthera in the field of therapeutic ultrasound for the treatment of brain diseases is reinforced.