Radiopharm Theranostics (ASX:RAD) has announced a strategic partnership with BAMF Health, a global leader in molecular imaging and theranostics.
BAMF Health's platform also includes Contract Development and Manufacturing Organization (CDMO) services for manufacturing PET isotopes.
BAMF Health will manufacture Radiopharm's F18-tagged radiotracer for the detection and characterisation of brain metastasis, 18F-RAD 101.
BAMF Health is also anticipated to be the first clinical site to open and dose patients with brain metastasis as part of Radiopharm’s Phase 2b imaging study of 18F-RAD 101.
RAD 101 is a novel imaging small molecule that targets fatty acid synthase (FASN). This multi-enzyme protein catalyses the fatty acid synthesis and is overexpressed in many solid tumours, including cerebral metastasis.
In October 2022, positive data from the Imperial College of London’s Phase 2a imaging trial of RAD 101 in patients with brain metastases showed significant tumour uptake consistent with and independent from the tumour of origin.
The multicenter Phase 2b trial is an open-label, single-dose, single-arm study to establish the imaging performance of 18F-RAD 101 in participants with suspected recurrent brain metastases from solid tumours of different origins and is anticipated to enrol the first patient very shortly.
“Disruption of FASN activity allows for the accurate detection of cancer cells, representing a strongly viable target for the imaging of brain metastases,” said Riccardo Canevari, the CEO and managing director of Radiopharm Theranostics. “Our partnership with BAMF Health is instrumental in progressing our RAD 101 clinical program. With BAMF Health’s leadership in manufacturing and clinical trial conduct, we collectively pave the way to bringing innovative radiopharmaceuticals to oncology patients across the globe.”
“Our mission is to ensure patients have affordable access to novel agents like RAD 101. And that mission extends beyond our own patients and clinical trial participants,” said Matt DeLong, VP of Radiopharmacy at BAMF Health. “As a manufacturer of RAD 101, we’re enabling access to clinical trial sites all across the state and region. When access is increased, potentially life-saving drugs get into the hands of patients faster."