NEW YORK – Fusion Pharmaceuticals on Wednesday said it will begin evaluating the radiopharmaceutical [225AC]-FPI-2068 and accompanying imaging agent [111ln]-FPI-2107 in a Phase I clinical trial as a treatment for solid tumors expressing EGFR and cMET.
The Ontario, Canada-based Fusion is developing the radiotherapy and imaging agent in collaboration with AstraZeneca, and the US Food and Drug Administration recently cleared an investigational new drug application allowing the firms to begin studying the treatment in a Phase I trial.
[225AC]-FPI-2068, which Fusion abbreviates to just FPI-2068, is a targeted alpha therapy that involves the therapeutic radioactive isotope actinium-225 linked with a bispecific antibody developed by AstraZeneca. For the imaging agent, [111ln]-FPI-2107, which Fusion and AstraZeneca will use to identify patients most likely to respond to the therapy, the EGFR- and cMET-targeting bispecific antibody is linked to the radioactive imaging isotope indium-111.
"FPI-2068, which we believe will be the first [targeted alpha therapy] for two validated targets to enter the clinic, was designed to provide enhanced tumor specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets," Fusion CEO John Valliant said in a statement. "We are excited about the innovative work with AstraZeneca as we advance this and other programs under our broad collaboration agreement."
AstraZeneca and Fusion announced they were collaborating to develop these products in 2020. Fusion is contributing its expertise in targeted alpha therapies to the partnership, and is supplying actinium and guiding the development of manufacturing infrastructure. AstraZeneca, meanwhile, is providing the antibody that carries the actinium to the intended cancer cells. The firms are also exploring whether therapeutic assets in their portfolios could lend themselves to new combination treatment strategies. Fusion will be responsible for the operational aspects of this Phase I FPI-2068 trial, and AstraZeneca will be in charge of subsequent clinical development. The firms will split the development costs.
Fusion will provide additional guidance on timelines for the FRP-2068 program after it starts screening patients for the Phase I trial.