Full Press Release Details
Theranostics Granted U.S. Food and Drug
Administration Fast Track Designation for RAD101 Imaging in Brain
RAD101 in U.S. Phase 2 clinical trial to distinguish
between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin
Sydney, Australia - 11 June 2025 - 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, today announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating
from solid tumors of different origin including leptomeningeal disease.
RAD101 is the Company's 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 metastases.
"The FDA's Fast Track Designation for RAD101 highlights
the seriousness of recurrent brain metastases as a condition and the unmet medical need for innovative products that can differentiate
between tumor recurrence and radiation necrosis or pseudprogression," said Riccardo Canevari, CEO and Managing Director of Radiopharm
Theranostics. "RAD101 represents a promising advancement in improving diagnostic precision for brain metastases, offering hope for
more effective clinical decision-making in the over 300,000 patients diagnosed annually in the U.S. We are excited to advance our Phase
2 clinical trial and anticipate sharing topline results in the second half of 2025."
The FDA's Fast Track designation is designed to facilitate the
development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential
to address an unmet medical need. A Sponsor that receives Fast Track designation may be eligible for more frequent meetings and communications
with the FDA and rolling review of any application for marketing approval. A Sponsor's drug receiving Fast Track designation also
may be eligible for Priority Review if relevant criteria are met.
About the Phase 2 Clinical Trial of RAD101
The U.S. multicenter, open-label, single arm Phase 2b clinical
trial 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. Secondary
endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in
previously stereotactic radiosurgery (SRS)-treated brain metastases.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
RAD101 is the Company's 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. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant
method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101
in patients with brain metastases (both SRS pre-treated and treatment na ve patients)showed significant tumor uptake that was independent
from the tumor oforigin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival,
warranting larger studies.
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 metastases. Learn
more at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (Formerly Stern IR)
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia