DECEMBER 15, 2025
In the spotlight, astatine-211, an alpha-emitting radionuclide with high cytotoxic potential that will enable a major step forward in nuclear medicine, in the highly promising field of targeted radionuclide therapy (TRT).
A collaboration between Atonco and the Institut de Cancérologie de l’Ouest.
- ATONCO designs and develops targeted treatments for cancers resistant to conventional approaches, particularly using astatine-211.
- ICO has obtained authorization for the first Phase I clinical trial, PERSEVERANCE EU, using astatine-211 in the treatment of bladder cancer.
PRESS RELEASE
A deep dive into cutting-edge medicine, with an ultra-targeted radiotherapeutic treatment.
The PERSEVERANCE EU clinical trial evaluating the safety, tolerability and response to ATO-101™ authorized: a first in France with astatine-211.
The Institut de Cancérologie de l’Ouest (ICO) has obtained authorization to launch the Phase I clinical trial PERSEVERANCE EU (NCT07260162), entitled A First In Human Phase I Trial Evaluating Safety, Tolerability and Response of [211At]At-Girentuximab (ATO-101™) in Patients With Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment.
This trial aims to evaluate the safety, tolerability and response to ATO-101™ treatment in patients with non-muscle-invasive bladder cancers resistant to standard treatments. The study marks an important milestone in the development of innovative therapeutic treatments based on alpha emitters.
An innovative treatment using astatine-211
ATO-101™ ([²¹¹At]At-girentuximab), supplied by Atonco, is composed of an antibody directed against the CA-IX antigen (girentuximab) coupled with astatine-211, an alpha-emitting radionuclide with high cytotoxic potential. Its very short particle range should enable effective targeting of tumor cells while preserving surrounding healthy tissue.
« This trial follows on from the PERTINENCE study (NCT04897763), which validated the feasibility of imaging and safety of intravesical administration of a radiopharmaceutical (composed of the same antibody (girentuximab) but coupled with Zirconium-89) for both the patient and radiation protection of staff. This trial notably showed that the product remained only in the bladder, which is precisely what is sought in this type of non-metastatic cancer, suggesting minimal or even non-existent toxicity at the whole-body level in the PERSEVERANCE EU trial. »
Dr. Caroline Rousseau, ICO Coordinating Physician for the PERSEVERANCE EU study
« PERSEVERANCE EU fully illustrates Atonco’s medical ambition: to offer targeted treatments using alpha emitters for patients with limited therapeutic options. With ATO-101™, the objective is to demonstrate that astatine-211 can provide local tumor control while maximally preserving healthy tissue, thereby paving the way for a new generation of innovative radiotherapies in urothelial oncology. »
Dr. Jean-François Chatal, Medical Director, Atonco
The production of the investigational drug will be carried out by GIP Arronax and CHU de Nantes, two leading French institutions in the field of radiopharmacy and nuclear medicine research. Girentuximab is licensed to the Australian company Telix Pharmaceuticals, which will also supply the antibody for the study.
A clinical first in France
This is the first clinical trial in France involving astatine-211, paving the way for a new generation of targeted radiotherapeutic treatments. Enrollment of the first patients will begin at ICO Saint-Herblain as soon as all prerequisites are met.
« ATONCO is taking a decisive step by entrusting the promotion of this pioneering study to ICO. This collaboration marks a first for ICO’s Promotion Department! The enrolled patients will be the first to benefit from this therapeutic advancement, paving the way for a new era of innovative care. »
Nadia Allam and Laëtitia Himpe, ICO Project Managers for this project
« The authorization of the PERSEVERANCE EU trial confirms the potential of our targeted radiotherapy approaches and Atonco’s ability to bring its innovative radiopharmaceuticals to clinical trials. We are fully committed to ensuring that our developments such as ATO-101™ translate concretely into benefits for patients, with the highest standards of quality, safety and clinical evidence. »
Alexandra Paillard, Chief Operating Officer, Atonco
ABOUT
ATONCO
Atonco is a French biotechnology company specializing in the development of innovative radiopharmaceutical therapies based on alpha emitters, particularly astatine-211.
In collaboration with research centers and hospital partners, Atonco designs and develops targeted treatments for cancers resistant to conventional approaches. Its mission is to offer new safe, effective and personalized therapeutic options for cancer patients.
For more information, please visit www.atonco-pharma.com
ClinicalTrials.gov – NCT07260162
Institut de Cancérologie de l’Ouest (ICO): An Expert Center
ICO is a Cancer Treatment Center, non-profit and without additional fees, fulfilling public hospital service missions. As an expert center for care pathway coordination, it aims to provide patients and partners with its expertise and specific skills in oncology. OECI-accredited in 2023, it received the High Quality of Care distinction from HAS in January 2024. Each year, ICO’s 1,600 professionals welcome nearly 48,000 patients across its two facilities in Angers and Saint-Herblain.
CUTTING-EDGE MEDICINE AT THE SERVICE OF PATIENTS
Specialized in oncology, ICO professionals support patients at every stage of their care journey, in a personalized, innovative and multidisciplinary manner. From rapid diagnosis to surgery, chemotherapy, radiotherapy, care also extends to supportive care, which is highly developed within the institution.
INTEGRATING CARE, RESEARCH AND INNOVATION
ICO’s research activity, a full-fledged mission, spans from fundamental research to clinical trials through translational research. It covers all oncology disciplines: medical oncology, radiotherapy, surgery, anesthesia, nuclear medicine, medical imaging, supportive care, and human sciences. Being treated at ICO means having privileged access to cutting-edge clinical trials in oncology.
Through its teaching mission and university expertise, the institution contributes to training tomorrow’s oncology professionals.
With its 4 missions — Prevention, Care, Research and Teaching — ICO offers cutting-edge and comprehensive expertise in the region, exclusively dedicated to oncology.
CONTACT US
Press Contacts
Sylvain FANIER – ATONCO
President
Tel.: 06 07 59 01 67
Email: sylvain.fanier@atonco-pharma.com
Édith LEGRAND – Institut de Cancérologie de l’Ouest
Communications Project Manager
Tel.: 02 41 35 27 26 / 06 74 38 26 71
Email: edith.legrand@ico.unicancer.fr
Sophie NOBLET – Institut de Cancérologie de l’Ouest
Communications Director
Tel.: 02 40 67 98 68 / 06 82 20 81 48