Atonco (Nantes-Saint Herblain, France) and Ionetix (Lansing, MI, USA) have signed a partnership agreement to ensure the manufacturing and GMP supply of the radiopharmaceutical product required for the successful completion of Atonco’s clinical studies and commercialization in the United States.
Atonco, a clinical-stage radiopharmaceutical company, aims to demonstrate through its clinical research program the relevance of a revolutionary therapeutic treatment, alpha immunotherapy, targeting non-musculo-invasive bladder cancer.
IONETIX Corporation operates a North American GMP manufacturing and supply chain for alpha emitting radiopharmaceuticals. Through this agreement, Ionetix will provide its production capabilities for the radioisotope, astatine-211, and its network of radiopharmacies to manufacture patient doses in accordance with good pharmaceutical manufacturing practices (GMP).
The agreement includes the supply of the radioisotope, astatine-211, the GMP manufacturing of the injectable doses and specifies the terms of the FDA agent agreement signed in August 2021.
IONETIX is leading the way in establishing the first commercial-scale supply of astatine-211 in North America from its cyclotron production facility in Lansing, MI.
“We are very excited about the partnership with Atonco, which will allow us to actively collaborate in their clinical development program and commercialization in the U.S., subject to the approval of Atonco’s drug candidates,” said David Eve, Vice President of Medical Affairs.
“This partnership agreement is a key step in the development of Atonco,” said Sylvain Fanier, President of Atonco. We are convinced that Ionetix is the most reliable and advanced partner to ensure optimal supply for our clinical development and commercialization in North America. With their expertise and experience in radiopharmaceutical manufacturing and FDA discussions, Ionetix will greatly contribute to our joint success in providing bladder cancer patients with a very promising therapeutic alternative.
IONETIX is leveraging its growing network of radiopharmaceutical manufacturing sites to support the development and commercialization of targeted alpha therapy (TAT). This is an emerging cancer therapy using alpha emitting radionuclides. TAT delivers high-energy alpha particles to cancer cells and the tumor microenvironment to treat cancer while preserving healthy tissue.
For more information, visit www.ionetix.com
ATONCO is a privately-held French company that develops targeted molecular radiation products 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).
For more information, visit www.atonco-pharma.com