On May 18, 2022 The companies Atonco (Nantes-Saint Herblain, France) and IONETIX Corporation (Lansing, MI) reported that they have signed a partnership agreement to ensure the radioisotope production and supply of the radiopharmaceutical necessary for the success of Atonco’s clinical studies and commercialization in the United States (Press release, IONETIX, MAY 18, 2022, View Source [SID1234614839]).
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Atonco, a radiopharmaceutical company at the clinical stage, aims to demonstrate through its clinical research program the relevance of a breakthrough therapeutic treatment, alpha immunotherapy, targeting superficial bladder cancer.
IONETIX Corporation operates a North American good manufacturing practice ("GMP") manufacturing and supply chain of positron and alpha-emitting radiopharmaceuticals. Ionetix through this agreement will produce astatine-211 and manufacture patient doses for clinical use, according to CGMP regulations. The agreement includes the supply of the radioisotope, astatine-211, the GMP manufacturing of the injectable doses and specifies the terms of the U.S. FDA agent agreement signed in August 2021.
IONETIX is leading the way by establishing the first North American commercial scale supply of astatine-211, from its new cyclotron facility in Lansing, MI that is dedicated to the production and distribution of alpha-emitting radioisotopes. "We are very excited about the partnership with Atonco which will enable us to fully support their clinical development program and commercialization in the United States, subject to FDA approval of Atonco’s drug candidates", declared David Eve, Vice President of Medical Affairs.
"This partnership agreement is a key step in the development of Atonco", declared Sylvain Fanier, President of Atonco. "We are convinced that Ionetix is the most reliable and advanced partner to ensure optimal sourcing for our clinical development and commercialization in North America. Thanks to their expertise and experience in the manufacture of radiopharmaceuticals and in discussions with the FDA, Ionetix will greatly contribute to our common success, in order to offer patients suffering from bladder cancer a very promising therapeutic alternative".