Full Press Release Details
RAD 202 receives approval to start Phase 1 therapeutic
Sydney, Australia - 20 December 2024 - 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 it has been granted Belberry Human Research
Ethics Committee (HREC) approval in Australia to initiate its First-In-Human (FIH) Phase 1 therapeutic clinical study of 177Lu-labelled
RAD 202 for the treatment of HER2-expressing solid tumors.
The open-label Phase 1 trial, entitled HEAT' (HER2 Antibody
Therapy with Lutetium-177), is a dose escalation trial of 177Lu-RAD202, and is designed to evaluate the safety and
preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. RAD 202 is a single-domain
monoclonal antibody (sdAb) that targets the Human Epidermal growth factor Receptor 2 (HER2), which is overexpressed in breast cancer as
well as several other solid tumors, and represents a validated target in oncology. The multicenter study is planned to recruit across
Australia, with the support of leading oncology care provider GenesisCare CRO.
demonstrated the safety and biodistribution of 99mTc-labeled RAD 202 in humans. Additional preclinical findings examining the therapeutic
effect in HER2-positive xenografts were also recently reported with 177Lu-labeled RAD 2022.
These data demonstrated tumor growth inhibition, significantly prolonged survival time, and further justify FIH dose finding studies.
"We are thrilled to receive approval to proceed with our Phase
1 FIH basket trial in Australia," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "RAD 202 has
the potential to address an unmet treatment gap in HER2-positive metastatic patients that are refractory to or unable to tolerate current
standard of care treatments. With RAD 202, we hope to provide an alternative strategy that can improve clinical outcomes for patients
with HER2-positive advanced cancers, while potentially preserving their quality of life."
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 has been listed on ASX (RAD) since November 2021. The company has a deep pipeline of highly differentiated
molecules spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development.
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 two Phase I trials in a variety of solid tumour cancers including brain, lung, breast and pancreas. Learn more at radiopharmtheranostics.com.
Authorised 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 Limited
Suite 1, Level 3, 62 Lygon Street,
Carlton South VIC 3053 Australia