NEW YORK – Blue Earth Therapeutics said on Wednesday that the US Food and Drug Administration has cleared the firm's investigational new drug (IND) application for its targeted radiopharmaceutical, 177Lu-rhPSMA-10.1, for certain advanced prostate cancer patients.
The Oxford, UK-based firm — a recent spinoff of Blue Earth Diagnostics, a Bracco Imaging subsidiary — will accordingly begin evaluating its product in a Phase I/II clinical study enrolling men with metastatic castration resistant prostate cancer (mCRPC) whose tumors express the prostate-specific membrane antigen (PSMA). The phase I portion of the trial is designed to evaluate the treatment's safety, tolerability, and dosage, and the Phase II portion will evaluate the recommended treatment dose established in Phase I. The first part will be US-based, and the Phase II portion will incorporate additional sites in both the US and Europe.
The radiopharmaceutical that Blue Earth is evaluating in this study, 177Lu-rhPSMA-10.1, consists of a radiohybrid ("rh") PSMA-targeting receptor ligand, which is designed to attach to prostate cancer, and a linked radioactive isotope payload, lutetium-177. The firm believes that its product could have advantages over other targeted radiotherapies in the space, such as Novartis' recently approved Pluvicto (177Lu-PSMA-617), due to its radiohybrid construction.
"We consider 177Lu-rhPSMA-10.1 to be a next-generation PSMA therapy with the potential to be best-in-class," Blue Earth Therapeutics CEO David Gauden said in a statement. "Excitingly, this optimized technology can be developed with both beta- and alpha-emitting therapeutic radioisotopes."