ATONCO S.A.S. (‘ATONCO’) announced today that it has entered into a clinical research partnership agreement with the Institut de Cancérologie de l’Ouest (ICO Nantes Angers) regarding the clinical study of its CA-IX-binding antibody, ⁸⁹Zr-girentuximab, with PET imaging to document the absence of extravasation of radioactivity into the systemic circulation after intravesical instillation, and to visualize targeted papillary tumors.

This imaging and dosimetry study using ⁸⁹Zr-girentuximab is considered a “clinical proof of concept” prior to the subsequent therapeutic use of astatine-211 in a Phase I/II clinical development.

The clinical project will include 6 patients (3 men and 3 women), and is based on the license and development agreement between Telix and ATONCO for ATONCO to investigate the use of Telix’s Molecularly Targeted Radiation (MTR) intellectual property for the treatment of non-muscle-invasive bladder cancer resistant to standard therapies.

Under the agreement, ATONCO has a license to conduct R&D activities on girentuximab, radiolabeled with At-211, for the intravesical treatment of chemotherapy- or BCG-resistant bladder cancer, and subsequent commercialization of this product, if successful.

ATONCO will accelerate its therapeutic development targeting BCG-resistant bladder cancer. Dr. Caroline Rousseau, Head of Nuclear Medicine at the ICO (Institut de Cancérologie de l’Ouest) in Nantes, the clinical site and sponsor of the study, will lead the feasibility study as principal investigator.

Jean-François Chatal, ATONCO’s founder and medical director, said: “The unmet clinical need for non-muscle-invasive bladder cancer refractory to BCG or chemotherapy fits well with the radiophysical characteristics of astatine-211 with tumor targets rapidly accessible after intravesical instillation of girentuximab and consisting of thin superficial tumor layers corresponding to the short path length of the alpha particles. This alpha-immunotherapy should make it possible to avoid very uncomfortable radical cystectomies and thus prolong the life and improve the quality of life of our bladder cancer patients. We are confident that this is the first successful step in our partnership with ICO.”

Sylvain Fanier, President of ATONCO, said, “We are delighted to partner with ICO, one of the most respected clinical institutions in the field of oncology, and to develop with our local academic and preclinical CRO partners in Nantes an innovative Molecular Targeted Radiation (MTR) solution to improve the management of patients with non-muscle-invasive bladder cancer.”

In 2018, bladder cancer was the fifth most common cancer in the United States, with an estimated 82,501 new cases diagnosed and 17,755 deaths resulting from bladder cancer.

About ICO (Institut Cancérologie de l’Ouest) 

ICO is a 1,400 professional strong not-for-profit center fighting against cancer. It welcomes close to 48,000 patients per year, and conducts the mission and service of a public hospital. Strengthened by its 4 missions – Prevention, Care, Research and Teaching – ICO offers broad, state-of-the-art expertise that is exclusively dedicated to cancerology.

The integration of care, research and innovation is integral to ICO. Research activities, which are a specific mission at ICO, are undertaken from concept all the way through to clinical trials. Research is conducted in all disciplines of cancerology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery, support care, and human sciences. Patients who are cared for at ICO receive privileged access to cutting edge clinical trials in cancerology. The Innovation Centre, opened in 2021, is dedicated to accompanying innovation in oncology, and thus supports internal and external projects, from concept, all the way to operational deployment.

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ATONCO is a privately held French company that develops molecularly targeted radiopharmaceuticals for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, France, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, in particular astatine-211 (²¹¹At).

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