In accordance with a new supply agreement, Bayer will utilize NorthStar’s environmentally friendly, non-carrier-added actinium (Ac-225) in several of its radiopharmaceutical programs for cancer treatment.

The high-energy alpha radioisotope directly targets and delivers radiation to a localized area of a cancer cell to destroy it by breaking down its double-strand DNA to overcome its resistance to chemotherapy. The short range of the radiation limits damage to nearby healthy tissue. It is part of an emerging area in cancer treatment known as radiopharmaceutical therapy, which combines specific molecules with therapeutic radioisotopes to treat difficult forms of cancer.

Bayer will use NorthStar's supply to develop targeted Actinium-225 conjugates. It is currently preparing to start its Ph1 trial for producing the PSMA-targeted actinium-225 conjugate (PSMA-TAC) to treat patients living with metastatic castration-resistant prostate cancer (mCRPC). It will be its first Ac-225 asset in the clinic.
NorthStar, which is on track to be the first commercial-scale producer of n.c.a Ac-225, is building an entire facility dedicated to producing the radioisotope in Beloit, Wisconsin, where the company is headquartered. It is also the sole source of domestic molybdenum-99 (Mo-99) and poised to be the first commercial-scale producer of copper-67 (Cu-67), and will utilize the same accelerator technology in these production lines for that of n.c.a Ac-225.

"These assets can unlock a broad opportunity space and may have significant potential in hard-to-treat tumors, regardless of pretreatment and/or mutational status," Prof. Dr. Dominik Rüttinger, SVP and global head of research and early development oncology (RED Oncology) at Bayer Pharmaceuticals, told HCB News.

It recently installed its electron accelerator, which will produce high-purity, n.c.a. Ac-225, which is free of long-lived radioactive contaminants and byproducts found with other production methods, eliminating regulatory and waste management challenges for hospitals and health systems. Initial production is scheduled to begin in 2024.

The company plans to submit a Drug Master File to the FDA immediately, which, once approved, will allow it to distribute cGMP grade Ac-225.

Before Bayer, NorthStar entered into similar agreements with Fusion Pharmaceuticals, Aktis, and Clovis. It also partnered with Convergent to use Ac-225 to treat prostate cancer.

Bayer entered a supply agreement with BWXT Medical last July to use its Ac-225 in alpha-targeted therapies.

"With more and more companies focusing on the development of actinium-225-based assets, more clinical doses will and are being applied to patients. This will also result in simplified logistics in the future, and also potentially change the regulatory environment and approval processes," said Rüttinger.

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