Full Press Release Details
Theranostics Doses First Patient with 18F-RAD101 in
U.S. Phase 2b Imaging Study of Brain Metastasis
2b study evaluating diagnostic performance of 18F-RAD101 for suspected recurrent
brain metastases from solid tumors of different
Underscores Radiopharm's commitment to
developing transformative oncology
radiopharmaceuticals
Sydney, Australia - 28 April 2025 - Radiopharm Theranostics
(ASX:RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on
developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient
in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis.
The U.S. multicenter, open-label, single arm
Phase 2b clinical trial1 is evaluating the
diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins.
The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with
gadolinium) in participants with suspected recurrent brain metastases.
RAD101 is a novel imaging small molecule that
targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors,
including cerebral metastasis. Disruption of FASN activity allows for the accurate detection of cancer cells, representing a strongly
viable target for the imaging of brain metastasis. Positive data from the Imperial College of London's Phase 2a imaging trial of
18F-RAD101 in patients with brain metastases showed significant tumor uptake that was consistent with and independent from the tumor
"We are proud to pioneer the first U.S. clinical trial of RAD101,"
said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and Principal Investigator
of this Phase 2b study. "This marks an important step toward improving diagnostic precision and enabling more evidence-based, individualized
treatment decisions for patients with brain metastases following stereotactic radiosurgery."
"This trial is an excellent illustration of BAMF Health's
clinical trials platform in action," added BAMF Health's Director of Clinical Trials. "Our Radiopharmacy is producing
the imaging agent on-site, our clinic team is caring for the patient and providing the best image in the world, and our clinical trials
team expertly coordinates it all. BAMF's facility and team were built to do trials just like this."
standard of care imaging is less sensitive in discriminating between tumor recurrence and radiation necrosis in patients with brain metastasis
who have received anticancer treatments, including radiation," said Riccardo Canevari, CEO and Managing Director of Radiopharm
Theranostics Ltd. "18F-RAD101 has the strong potential to improve diagnostic accuracy of brain metastases, and holds promise for
discriminating between treatment effect and true progression in the more than 300,000 patients diagnosed with brain metastasis each year
in the U.S. alone. We look forward to advancing this clinical trial and to reporting topline data in the second half of 2025."
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
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 is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated
platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one
Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
BAMF Health is the world's first vertically integrated platform
for intelligence-based precision medicine. Headquartered in Grand Rapids, Michigan, BAMF Health employs the most advanced theranostic
imaging technology to detect and treat cancer and other diseases and conduct advanced clinical trials. Our overriding mission is to empower
patients to become people again. With a team of data scientists, researchers, software engineers, and clinicians -all working in
lockstep-we're making good on it. To learn more about BAMF Health, visit www.bamfhealth.com.
Authorized on behalf of the Radiopharm
Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
CEO & Managing Director
Radiopharm Theranostics
Precision AQ (formerly Stern IR)
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Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia