BAMF Health is announcing a strategic partnership with Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need. The partnership is representative of BAMF Health’s capabilities not only as an advanced clinical trial platform, but also as a world-class Contract Development and Manufacturing Organization (CDMO) for manufacturing PET isotopes. BAMF Health will manufacture 18F-RAD 101, Radiopharm’s proprietary F18-tagged radiotracer for the detection and characterization of brain metastasis. BAMF Health is also anticipated to be the first clinical site to open and dose patients with brain metastasis as part of Radiopharm’s PIIb imaging study of 18F-RAD 101.
RAD 101 is a novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyzes fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. In October 2022, positive data from the Imperial College of London’s Phase IIa imaging trial of RAD 101 in patients with brain metastases showed significant tumor uptake that was consistent with and independent from the tumor of origin1. The U.S. multicenter PIIb 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 tumors of different origins and is anticipated to very shortly enroll the first patient in Q4 2024.
BAMF Health’s state-of-the-art radiopharmacy is equipped with dual cyclotrons, a solid target system, and multiple synthesis platforms, enabling the production of a broad spectrum of PET isotopes. The organization has the capacity and flexibility to manufacture a high volume of novel radiopharmaceuticals at a rapid pace. In addition, BAMF Health’s high-efficiency clinical trial platform, world-class imaging capabilities, and comprehensive clinical expertise pave the way for it to be the first site to activate as part of Radiopharm’s PIIb study.
“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, CEO and Managing Director of Radiopharm Theranostics Ltd. “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, PharmD, 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.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of six distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. The clinical program includes one Phase II and three Phase I trials in a variety of solid tumour cancers including breast, kidney and brain. Learn more at radiopharmtheranostics.com.
[1] Poster Presentation – 34th EORTC/AACR/NCI Annual Symposium, Barcelona, Spain, 26-28th October 2022
