The companies Atonco (Nantes-Saint Herblain, France) and Ionetix Corporation (Lansing, MI) 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.
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”.
IONETIX is leveraging its proprietary cyclotron technology platform for isotope production and growing network of GMP radiopharmaceutical manufacturing locations to support the development and commercialization of targeted alpha therapy (TAT). An emerging cancer therapy utilizing alpha radionuclides, TAT delivers high-energy alpha particles to cancer cells and the tumor microenvironment to treat cancer while preserving the surrounding healthy tissue.
ATONCO is a privately held French company developing Molecularly Targeted Radiation products for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, ATONCO and its academic partners are committed to the clinical use of alpha emitting radionuclides, particularly astatine-211 (211At).
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