Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹⁶¹Tb-KLK3-mAb Phase I Clinical Trial in Australia

Rhea-AI Summary

Radiopharm Theranostics (NASDAQ:RADX) has signed a clinical supply agreement with Cyclotek for the production of ¹⁶¹Tb-labeled RAD 402 for an upcoming Phase 1 clinical trial in prostate cancer. RAD 402, an anti-KLK3 monoclonal antibody radiotherapeutic, targets KLK3 which is highly expressed in prostate tissue with limited expression elsewhere.

The agreement marks a crucial step toward initiating the first company-sponsored Phase I trial using Terbium-161 in prostate cancer, scheduled for 2H 2025. The preclinical data package is complete, showing safety and promising biodistribution. Notably, ¹⁶¹Tb offers potential advantages over ¹⁷⁷Lu through additional Auger and conversion electrons alongside β-radiation, potentially improving antitumoral therapeutic efficacy.

Positive

• Completed preclinical data package demonstrates safety and promising biodistribution profile
• Strategic partnership secured for clinical trial supply production
• Phase 1 trial initiation planned for second half of 2025
• RAD 402 shows highly specific targeting of prostate tissue with limited expression elsewhere

Negative

• Early-stage development with Phase 1 trials yet to begin
• Success in clinical trials and eventual FDA approval not guaranteed

News Market Reaction

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RAD 402 preclinical data package complete; demonstrates safety and promising biodistribution profile

Ethics approval and Phase 1 clinical trial start in prostate cancer anticipated in 2H 2025

SYDNEY and BUNDOORA, Australia, June 24, 2025 (GLOBE NEWSWIRE) -- 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 signing of a supply agreement with Cyclotek to radiolabel RAD 402 with Terbium-161 (¹⁶¹Tb) in Australia, which supports the initiation of a Phase 1 clinical trial. RAD 402 is an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic labelled with the radionuclide ¹⁶¹Tb for treatment of prostate cancer.

“This agreement is an important milestone for the development of RAD 402 and is the last step needed to submit for ethics approval and begin our Phase 1 clinical trial in prostate cancer,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are very appreciative of the entire team at Cyclotek for their support as we work together to bring an innovative new treatment option to patients battling prostate cancer.”

RAD 402 has been designed to target KLK3, which is highly expressed in the prostate, with very limited/no expression in other tissues and organs. Compared to ¹⁷⁷Lu, ¹⁶¹Tb emits additional Auger and conversion electrons alongside its β-radiation, which can lead to potentially improved antitumoral therapeutic efficacy. ¹⁶¹Tb-RAD 402 is the first company-sponsored Phase I trial in prostate cancer using ¹⁶¹Tb.

Under the agreement, Cyclotek will produce and provide doses of ¹⁶¹Tb-labeled RAD 402 to support Radiopharm’s upcoming Phase 1 clinical trial in prostate cancer in Australia. The Phase 1 trial is anticipated to start in the second half of 2025.

“We are pleased to partner with Radiopharm to facilitate the development of their innovative radiotherapeutic, RAD 402, for the treatment of prostate cancer,” stated Greg Santamaria, CEO of Cyclotek. “Our mission at Cyclotek is to improve the accessibility of radiopharmaceuticals to enhance patient outcomes. As we support the Radiopharm Theranostics team, we look forward to RAD402 advancing toward market approval while demonstrating the value radiotherapeutics can bring to patients.”

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.

About Cyclotek

Cyclotek is the leading radiopharmaceutical manufacturer in Australia and New Zealand. We manufacture diagnostic and therapeutic radiopharmaceuticals for supply into clinical trials and for clinical use.

At Cyclotek, we are committed to improving patient outcomes by making diagnostic and therapeutic radiopharmaceuticals accessible. PET tracers provide patient specific insights into their disease state, leading to earlier diagnosis, more accurate assessment of disease extent, and improved treatment planning and monitoring. Paired with radionuclide therapies, these products offer a comprehensive, non-invasive disease management option.

Our dedication to innovation drives our continuous development of new radiopharmaceuticals.
This helps provide our customers a growing range of tools that enhance the understanding of each patient’s health, contributing to more cost-effective healthcare solutions.

At Cyclotek, we are not just a manufacturer, we are a hub of innovation. Our commitment to quality, safety, supply and customer service ensures that healthcare providers have the best tools available for precise diagnostics and therapies, fostering improved patient care.
Through our unwavering focus on excellence, we aim to make a lasting, positive impact on healthcare.

Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.

For more information:

Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com

Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com

Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au

Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm  
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/

FAQ

What is the significance of Radiopharm's (RADX) agreement with Cyclotek?

The agreement enables Cyclotek to produce and provide ¹⁶¹Tb-labeled RAD 402 doses for Radiopharm's Phase 1 clinical trial in prostate cancer, representing the final step before ethics approval and trial initiation.

When will Radiopharm (RADX) begin Phase 1 trials for RAD 402?

Radiopharm plans to initiate the Phase 1 clinical trial for RAD 402 in prostate cancer during the second half of 2025.

What are the advantages of RAD 402's Terbium-161 compared to Lutetium-177?

¹⁶¹Tb emits additional Auger and conversion electrons alongside β-radiation compared to ¹⁷⁷Lu, potentially leading to improved antitumoral therapeutic efficacy.

How does Radiopharm's RAD 402 target prostate cancer?

RAD 402 targets Kallikrein Related Peptidase 3 (KLK3), which is highly expressed in prostate tissue with very limited expression in other tissues and organs.

What stage of development is Radiopharm's (RADX) RAD 402 currently in?

RAD 402 has completed its preclinical data package demonstrating safety and promising biodistribution, and is preparing to enter Phase 1 clinical trials.