Completion of preclinical data package for RAD 402
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
10 DECEMBER 2024
Completion of Preclinical Data Package for KLK3-Targeting
Radiotherapeutic (RAD 402)
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Successful completion of preclinical studies with 161Tb-labelled RAD 402 demonstrating
safety and a promising biodistribution profile.
Comprehensive preclinical dataset validates the potential of 161Tb-RAD 402 for advancing
into First-In-Human therapeutic studies.
Potential first-in-class, company sponsored trial using Tb161, a next generation isotope
with strong therapeutic activity.
Sydney, Australia – 10 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 the completion
of a comprehensive preclinical proof-of-concept dataset for its proprietary Kallikrein Related
Peptidase 3 (KLK3)-targeting radiotherapeutic, RAD 402.
The preclinical toxicology reported positive data, with no observed adverse effects. Biodistribution
studies of 161Tb-RAD 402 in mouse xenografts showed high tumor targeting, limited kidney and bone
marrow uptake, and a hepatic excretion profile as expected for a monoclonal antibody. The safety
findings from the toxicology and biodistribution studies provide a strong rationale for First-In-Human
(FiH) clinical studies.
GMP manufacturing of RAD 402 and the conjugate are currently ongoing and are expected to be
completed in Q1 2025. Radiopharm’s clinical development plans for RAD 402 continue to advance,
and the Company is on track to commence the Phase I FiH study in H2 2025.
KLK3 is expressed in the prostate, and most adenocarcinomas of the prostate, including their
metastases. Prostate Specific Antigen (PSA), a widely used biomarker to detect prostate cancer, is
encoded by the KLK3 gene. RAD 402 is an anti-KLK3 monoclonal antibody, labelled with the
radionuclide Terbium-161 (Tb-161). Compared to Lutetium-177, Tb-161 emits additional Auger and
conversion electrons alongside its β-radiation, with potentially improved antitumoral therapeutic
efficacy.
“There is an ongoing unmet need for next-generation radiotherapeutisc in advanced prostate
cancer,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “RAD 402
has been specifically designed as a next-generation radiotherapeutic with a novel target and isotope,
reinforcing its first-in-class potential as a novel treatment option in advanced prostate cancer. We
believe that our preclinical data reaffirms our clinical development strategy for RAD 402 and provide
translational support for advancing this program into FiH 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 has been listed on ASX (RAD) since November 2021.
The company has a deep pipeline of highly differentiated molecules spanning peptides, small
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
ASX ANNOUNCEMENT
10 DECEMBER 2024
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-inclass. 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:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
Radiopharm Theranostics Limited
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
ABN: 57 647 877 889
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