Nihon Medi-Physics Attains World’s First Manufacturing of Actinium-225 with Cyclotron on Production Scale for Investigational Drugs

– Core Material Used for Targeted Alpha Therapy (TAT) Expected to Be Novel Treatment for Cancer –

Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan, announced on April 5, 2022, that the company has successfully manufactured actinium-225 (Ac-225), a core material used for Targeted Alpha (*1) Therapy (TAT), on a GBq (*2) scale at its drug production facility (*3). The success represents the world’s first (*4) manufacturing of Ac-225 with cyclotron at a quality level of materials for investigational drugs on a GBq scale.

Photo: Drug research facility “CRADLE Building”
https://kyodonewsprwire.jp/prwfile/release/M107116/202203309354/_prw_PI1fl_9KZ9EEj5.jpg

TAT, in a form of Theranostics (*5), is a new therapeutic concept to attack cancer cells in the body, applying a therapeutic agent in which alpha particle-emitting radionuclides that can kill cancer cells are bound to antibodies selectively accumulated in protein in cancer cells. In particular, following the report on its high therapeutic effects in patients with prostate cancer with systemic metastases in 2016 (*6), clinical studies on TAT with alpha particle-emitting Ac-225 have been globally and increasingly conducted.

Image: Conceptual diagram of NMP’s Theranostics
https://kyodonewsprwire.jp/prwfile/release/M107116/202203309354/_prw_PI2fl_VEP8UH2J.jpg

Active development and manufacturing of Ac-225, a radionuclide not naturally present, are ongoing accordingly. The manufacturing technology developed by NMP applies a commercially used small accelerator using radium-226 (Ra-226) as a material. This method using (p, 2n) nuclear reaction (*7) is economically efficient and ensures more stable production than other methods with an electron accelerator similarly using Ra-226 as a material because the former uses less Ra-226.

NMP aims at early commercialization of Theranostics by promoting a research project (*9) adopted in 2017 in (the second) Cyclic Innovation for Clinical Empowerment (CiCLE (*8)) conducted by the Japan Agency for Medical Research and Development (AMED). NMP’s manufacturing technology allows production of sufficient Ac-225 required for clinical development at its production facility. Thus, the company can further accelerate the research and development of TAT with collaboration among industry, academia and government.

For notes, visit the following website:
https://kyodonewsprwire.jp/attach/202203309354-O2-p9j9cUm7.pdf

About Nihon Medi-Physics Co., Ltd.
Nihon Medi-Physics is engaging in ensuring stable supply and research and development of the products as a leading manufacturer of radiopharmaceuticals in Japan. Based on the technological proficiency and trust built over the years, the company is also working on research and development of “Theranostics (a combination of therapy and diagnosis),” which is a novel medical technology to provide optimal medical service to each patient, as well as on the dissemination of nuclear medicine in Asian countries by licensing its products. The company will continue contributing to society by creating values as a life science company.
Official website: https://www.nmp.co.jp/eng/index.html

Source: Nihon Medi-Physics Co., Ltd.