Siemens Healthineers to supply F-18 RAD101 for trial
Siemens Healthineers will radiolabel and distribute F-18 RAD101 doses in the U.S. to support Radiopharm’s planned Phase 3 registrational trial.
Radiopharm Theranostics has signed a clinical supply agreement with Siemens Healthineers for RAD101, an F-18-labeled PET imaging agent targeting fatty acid synthase.
Siemens Healthineers will radiolabel and distribute RAD101 doses in the U.S. The supply arrangement is intended to support Radiopharm’s planned multicenter Phase 3 registrational trial.
RAD101 is being developed for the diagnosis of suspected recurrent brain metastases from solid tumors. The agent targets fatty acid synthase, or FASN, which is associated with tumor metabolism.
Interim Phase 2b data showed 90% concordance between RAD101 PET imaging and MRI, according to Radiopharm. The company also reported significant and selective tumor uptake in brain metastases.
The U.S. Food and Drug Administration has granted RAD101 Fast Track designation for distinguishing recurrent disease from treatment effect in brain metastases from solid tumors, including leptomeningeal disease.
Radiopharm said the partnership is intended to ensure sufficient U.S. supply of RAD101 for the Phase 3 trial. The company expects the trial to follow topline Phase 2b data.
BAMF Health previously partnered with Radiopharm to manufacture and dose F-18 RAD101 for the Phase 2b imaging study of brain metastases. That collaboration was announced in October 2024.
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