BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the initiation of a development, manufacturing, and services agreement with Evergreen Theragnostics to develop actinium-225-labeled-FAP-2286 (225Ac-FAP-2286). Under the agreement, Clovis and Evergreen 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 of 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. i,ii
Ad Statistics
Times Displayed: 113248
Times Visited: 6741 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
Under the terms of the agreement, Evergreen will develop 225Ac-FAP-2286 at its facility in Springfield, N.J. 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 of 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.”
FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development. In the Phase 1/2 LuMIERE study (NCT04939610), the investigational therapeutic agent is linked to lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). Lutetium-177 (177Lu) is a beta-particle-emitting radionuclide with established supply and distribution networks ideally suited for clinical development of a PTRT. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) is being used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. FAP-2286 is the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.
