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data confirms positive tumor uptake and favorable biodistribution
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, is pleased to announce a poster presentation at EMIM 20251, with findings
that support the clinical utility of imaging and therapy with 68Ga-RAD202 and 177Lu-RAD202 respectively, and validate an optimized therapeutic
dosing regimen in murine models.
The poster presentation is by Drs.
Felix Mottaghy, Betul Altunay and colleagues, from the University Hospital RWTH Aachen in Germany.
The imaging data reported that
68Ga-RAD202 binds specifically to the Human Epidermal growth factor Receptor 2 (HER2) in HER2-positive xenografts, with a high tumor-to-background
ratio. The removal of a His-tag from the RAD202
nanobody, a modification which impacts biodistribution and tumor targeting, was shown to be superior for PET imaging due to the higher
tumor-to-organ ratio.
Furthermore, therapy with 177Lu-RAD202
was well-tolerated, demonstrating significantly prolonged survival time. Fractionated dosing proved more effective in inhibiting tumor
growth compared to single-dose therapy.
overexpressed in breast cancer as well as several other solid tumors, and represents a validated target in oncology. RAD202 is a proprietary
single domain antibody that targets HER2. Previous data2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans.
Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202.
Collectively, these data further justify First-In-Human (FIH) dose finding studies.
A FIH open-label dose escalation Phase 1 study
of 177Lu-RAD202 is currently recruiting in Australia4. The trial is designed to evaluate the safety and preliminary activity
of this novel radiotherapeutic in eligible individuals with advanced HER2-positive solid tumors.
"These data support the potential for RAD202 to address an unmet
need for HER2-positive metastatic patients that are progressing on current standard of care, or unable to tolerate current treatment options,"
said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "The current comprehensive data with RAD202 further
support our rationale for the Phase 1 FIH therapeutic dose escalating trial with 177Lu-RAD202, currently recruiting in HER2-positive advanced
Radiopharm Theranostics
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 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.
Authorized on behalf of the Radiopharm
Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
CEO & Managing Director
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Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia