We are proud to announce that Atonco, as the sponsor, received ANSM authorization on August 20, 2026 to launch the performance study of its in vitro diagnostic medical device (IVD) as part of the PERSEVERANCE EU clinical trial.
🔬 A Key Test for Patient Selection
This test, performed using immunohistochemistry in accordance with EU Regulation 2017/746, aims to detect the expression of CA-IX in order to select patients eligible for the PERSEVERANCE study. It is part of a precision medicine approach and paves the way for a future companion diagnostic (CDx) associated with targeted therapy.
🌍 A clinical first for astatine-211
The PERSEVERANCE EU study (NCT07260162) will evaluate, for the first time in humans, a radiopharmaceutical based on astatine-211—a promising alpha emitter in oncology—as part of an alpha-immunotherapy approach for non-muscle-invasive bladder cancer that is refractory to standard treatments. The two approvals granted by the ANSM for the clinical trial and the associated DMDIV therefore represent a pioneering milestone in the joint development of an innovative treatment and its patient selection test.
🤝 A major collaborative effort
- Therapeutic product under study: ATO-101 ([²¹¹At]At-girentuximab), supplied by Atonco
- Manufacturing and Release of the clinical doses: jointly carried out by the GIP Arronax and the Nantes University Hospital (APUI)
- Antibody used: girentuximab, licensed and supplied by Telix Pharmaceuticals
- Labeling method: based on research conducted by the CRCI2NA and scaled up by the GIP Arronax
- Clinical trial sponsor: ICO (Western Cancer Institute)
- Sponsor of the DMDIV performance study: Atonco
This breakthrough illustrates the power of public-private partnerships and healthcare centers in bringing about groundbreaking diagnostic and therapeutic solutions.
👏 A big thank you to all our partners, investigators, regulatory teams, and future patients who are making this project possible.