LANSING–Ionetix, a leading cyclotron technology innovator, isotope producer and radiopharmaceutical manufacturer, announced today the successful production of Astatine-211 at its new Alpha Isotope Manufacturing plant in Lansing.
This first-of-its-kind plant is dedicated exclusively to producing alpha-emitting radionuclides, which can be used in medical treatments, using cyclotrons. The company completed the installation of the first of two cyclotrons earlier this year and initial commissioning was successfully completed in March. The cyclotron is a multiparticle, 30 million electron volt (MeV) unit and once fully optimized will be used to generate high-yields of Astatine-211 (At-211) and Actinium-225 (Ac-225).
“Producing At-211 for the first time is a significant and timely milestone for our alpha isotope program,” said David Eve, vice president of medical affairs for Ionetix. “We are seeing an acceleration in demand for alpha-emitting radionuclides as researchers and drug developers begin to move into early phase clinical trials.”
“Increasing access to alpha-emitting radionuclides to meet growing demand requires implementing new cyclotron solutions,” said Xiaoyu Wu, vice president of cyclotron research and development at Ionetix. At-211 production requires a cyclotron that can accelerate alpha particles up to an energy of 29 MeV, which is a capability currently found on only a few legacy cyclotrons at academic research institutions. Therefore, in order to increase the availability of At-211 for current clinical research needs and future commercial scale, the industry requires investments in new cyclotrons with a 30 MeV alpha particle beam, which Ionetix is committed to do. We specifically chose a 30 MeV cyclotron to provide us with a cyclotron platform that we can fully leverage to produce alpha-emitting radionuclides, including Astatine-211.”
With extensive accelerator engineering and cyclotron operating expertise, the Ionetix team has successfully enabled the 30 MeV cyclotron for At-211 production.
“We accelerated the alpha beam to the desired energy, designed and implemented a new target station to improve At-211 production and completed several At-211 production runs,” said Wu. The company now has a new cyclotron solution that will enable commercial scale production and distribution of At-211 and is currently working to do the same with Ac-225.”
Added Eve: “This is a great first step towards establishing a secure and robust supply chain for alpha-emitting radionuclides. We look forward to building upon this early success and working alongside our partners and collaborators to scale up production of both At-211 and Ac-225 to meet their needs as they work to advance the clinical development of these promising new cancer therapies.”
Ionetix expects the alpha facility to be fully operational in the fourth quarter of 2023 and ready to initiate supply high-purity, non-carrier-added (n.c.a.), GMP grade alpha-emitting radionuclides. Ionetix currently plans to submit a Drug Master File (DMF) for Ac-225 in early 2024.
Ionetix is a cyclotron and technology company providing full-service radioisotope production and end-to-end radiopharmaceutical manufacturing solutions. Using a proprietary cyclotron technology platform, Ionetix has developed technology that emables access to scarce radioisotopes used for both diagnostics and therapeutic radiopharmaceuticals. Ionetix offers both high-purity Actinium-225 (Ac-225) and Astatine-211 (At-211) for use in targeted alpha therapies. Ionetix’s decentralized production and distribution supply chain includes contract drug manufacturing and “white glove” distribution logistics, allowing global access to these alpha-emitting isotopes and targeted radiotherapies. To learn more, visit www.ionetix.com/alpha-therapy