Clovis Oncology has entered a development, manufacturing and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286). The companies intend to develop radiolabeling chemistry and analytical methods for use in potential future pre-clinical and clinical studies.

“This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimize our clinical development program for FAP-2286,” said Patrick J. Mahaffy, president and CEO, Clovis Oncology. “We are enthusiastic about exploring the potential of FAP-2286 labeled with actinium-225 in our targeted radiopharmaceuticals program. Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use.”

Actinium-225 (225Ac) is an alpha particle-emitting radionuclide uniquely suited to targeted radiotherapeutic applications based on its half-life of approximately 10 days, balancing the ability to deliver a meaningful dose of radiation to target tumors while allowing central manufacturing and distribution of 225Ac-FAP-2286. The high-energy radioactive decay emitted from tumor-targeted 225Ac delivery causes double-stranded DNA damage and cell death, however, given the limited distance traveled by alpha particles, damage is minimized to cells in the tumor mass and systemic toxicity is potentially limited.

Evergreen will develop 225Ac-FAP-2286 at its facility in Springfield, NJ. The facility was purpose-built to develop and manufacture a variety of therapeutic radiopharmaceuticals, including those based on alpha-emitting isotopes such as 225Ac, from early development to commercial scale manufacturing.

“We are excited to support Clovis and its targeted radionuclide development program with the development of an actinium-225-labeled FAP-2286. Actinium-based radiotherapies offer the potential to play an important role in the fight against cancer,” said James Cook, CEO, Evergreen Theragnostics. “We seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialization.”