Clovis Oncology and Evergreen Theragnostics have initiated a development, manufacturing, and services agreement for actinium-225-labeled-FAP-2286 (225Ac-FAP-2286).
Under the deal, the companies will develop radiolabelling chemistry and analytical methods which will be utilised in future pre-clinical and clinical studies.
Actinium-225 (225Ac) is an alpha particle-emitting radionuclide which is suitable for targeted radiotherapy applications depending on its half-life of about ten days.
It has the ability to provide a meaningful radiation dose to target tumours while enabling the central manufacturing and distribution of 225Ac-FAP-2286.
Clovis Oncology president and CEO Patrick Mahaffy said: “This agreement with Evergreen Theragnostics represents an important step forward for Clovis in our efforts to optimise our clinical development programme for FAP-2286.
“We are enthusiastic about exploring the potential of FAP-2286 labelled with actinium-225 in our targeted radiopharmaceuticals programme.
“Actinium-225 represents an emerging radionuclide that is generating significant interest for its potential for therapeutic use.”
An investigational clinical candidate, FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent which targets fibroblast activation protein (FAP).
It comprises two functional elements that include a targeting peptide which binds to FAP as well as a site that can be used to attach radioactive isotopes for use in imaging and therapy.
The investigational therapy agent is connected to lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) in the Phase I/II LuMIERE study (NCT04939610).
As per the terms of the deal, Evergreen will be responsible for the development of 225Ac-FAP-2286 at its facility located in Springfield, New Jersey.
Evergreen Theragnostics CEO James Cook said: “Actinium-based radiotherapies offer the potential to play an important role in the fight against cancer.
“We seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialisation.”