Fusion Pharmaceuticals has nominated the first targeted alpha therapy (TAT) candidate under its partnership agreement with AstraZeneca to commence Phase I clinical trials.
The companies will co-develop the new TAT through a Phase I trial.
The new TAT leverages the Fast-Clear linker technology of Fusion to radiolabel an AstraZeneca-owned bispecific antibody with actinium-225 alpha-emitting isotope.
According to the prior partnership agreement, Fusion will handle the preclinical development through first-in-human trials while AstraZeneca will oversee the following clinical development.
Fusion and AstraZeneca will split clinical development expenditures equally, with investigational new drug (IND)-enabling studies underway.
Fusion Pharmaceuticals CEO John Valliant said: “Fusion is at the forefront developing a new wave of cancer therapies using alpha-emitting medical isotopes and various targeting vehicles.
“One of the pillars of our platform is to create next-generation immunoconjugates, and we are excited to be working with AstraZeneca to pursue a novel radioimmunoconjugate for oncology.
“We had strong alignment among our joint development committee to move this novel TAT forward into a planned Phase I study and we look forward to sharing more information as we approach the investigational new drug application (IND) filing.”
Fusion and AstraZeneca currently have a partnership for the co-development of up to three new TATs.
Up to five combination programmes would also be explored between TATs of Fusion and AstraZeneca’s DNA damage response inhibitors and immuno-oncology agents.
A lead programme of Fusion, FPI-1434 acts on the insulin-like growth factor 1 receptor and is presently being analysed in a Phase I trial.
The company’s pipeline comprises FPI-1966 and FPI-2059, the latter being a small molecule acquired by Fusion from Ipsen.
Last December, AstraZeneca and Ionis Pharmaceuticals entered an agreement for the development and commercialisation of eplontersen.