Atonco (Nantes-Saint Herblain, France) and Ionetix (Lansing, MI, USA) have signed a partnership agreement to ensure GMP manufacturing and supply of the radiopharmaceutical product required for the success 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 groundbreaking therapeutic treatment — alpha immunotherapy — targeting non-muscle-invasive bladder cancer.
IONETIX Corporation operates a GMP-compliant North American manufacturing and supply chain for alpha-emitting radiopharmaceuticals. Through this agreement, Ionetix will make available its astatine-211 radioisotope production capabilities and its network of radiopharmacies to manufacture patient doses in accordance with Good Manufacturing Practice (GMP).
The agreement covers the supply of the astatine-211 radioisotope, GMP manufacturing of injectable doses, and specifies the terms of the FDA agent agreement signed in August 2021.
IONETIX is pioneering the first commercial-scale supply of astatine-211 in North America from its cyclotron production facility in Lansing, MI.
David Eve, Vice President of Medical Affairs: “We are very excited about the partnership with Atonco, which will allow us to actively collaborate in its clinical development program and commercialization in the United States, subject to approval of Atonco’s drug candidates.”
Sylvain Fanier, Chairman of Atonco: “This partnership agreement is a key milestone in Atonco’s development. 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. Thanks to their expertise and experience in radiopharmaceutical manufacturing and FDA discussions, Ionetix will greatly contribute to our shared success in offering bladder cancer patients a highly promising therapeutic alternative.”
About IONETIX
IONETIX leverages its growing network of radiopharmaceutical manufacturing sites to support the development and commercialization of targeted alpha therapy (TAT). TAT is an emerging cancer treatment using alpha-emitting radionuclides that delivers high-energy alpha particles to cancer cells and the tumor microenvironment to treat cancer while sparing healthy tissues.
For more information, visit www.ionetix.com
About ATONCO
ATONCO is a French private company developing targeted molecular radiation products for oncological applications. Originating from the world-class nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (211At).
For more information, visit www.atonco-pharma.com