Radiopharm Theranostics and Cyclotek Sign Clinical Supply Agreement for ¹⁶¹Tb-KLK3-mAb Phase I Clinical Trial in Australia
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.
Radiopharm Theranostics (NASDAQ:RADX) ha firmato un accordo di fornitura clinica con Cyclotek per la produzione di RAD 402 marcato con ¹⁶¹Tb in vista di un prossimo studio clinico di Fase 1 sul cancro alla prostata. RAD 402, un radioterapico monoclonale anti-KLK3, mira a KLK3, che è altamente espresso nel tessuto prostatico con espressione limitata altrove.
L'accordo rappresenta un passo fondamentale per avviare il primo studio di Fase I sponsorizzato dall'azienda che utilizza il Terbio-161 nel cancro alla prostata, previsto per la seconda metà del 2025. Il pacchetto dati preclinici è completo, dimostrando sicurezza e una biodistribuzione promettente. In particolare, il ¹⁶¹Tb offre potenziali vantaggi rispetto al ¹⁷⁷Lu grazie all’emissione aggiuntiva di elettroni Auger e di conversione oltre alla radiazione β, migliorando potenzialmente l’efficacia terapeutica antitumorale.
Radiopharm Theranostics (NASDAQ:RADX) ha firmado un acuerdo de suministro clínico con Cyclotek para la producción de RAD 402 marcado con ¹⁶¹Tb para un próximo ensayo clínico de Fase 1 en cáncer de próstata. RAD 402, un radioterapéutico con anticuerpo monoclonal anti-KLK3, se dirige a KLK3, que se expresa altamente en el tejido prostático con expresión limitada en otros lugares.
El acuerdo representa un paso crucial para iniciar el primer ensayo de Fase I patrocinado por la empresa que utiliza Terbio-161 en cáncer de próstata, programado para la segunda mitad de 2025. El paquete de datos preclínicos está completo, mostrando seguridad y una biodistribución prometedora. Notablemente, el ¹⁶¹Tb ofrece ventajas potenciales sobre el ¹⁷⁷Lu mediante la emisión adicional de electrones Auger y de conversión junto con radiación β, lo que podría mejorar la eficacia terapéutica antitumoral.
Radiopharm Theranostics (NASDAQ:RADX)는 전립선암 1상 임상 시험을 위해 ¹⁶¹Tb 표지 RAD 402 생산을 위해 Cyclotek과 임상 공급 계약을 체결했습니다. RAD 402는 KLK3에 대한 단클론 항체 방사선 치료제로, KLK3는 전립선 조직에서 높게 발현되며 다른 부위에서는 제한적으로 발현됩니다.
이번 계약은 Terbium-161을 사용하는 회사 주도 1상 임상 시험을 시작하는 중요한 단계로, 2025년 하반기에 예정되어 있습니다. 전임상 데이터 패키지는 안전성과 유망한 생체 분포를 보여 완성되었습니다. 특히 ¹⁶¹Tb는 β-방사선과 함께 추가적인 오거 및 변환 전자를 제공하여 ¹⁷⁷Lu보다 항종양 치료 효능을 향상시킬 가능성이 있습니다.
Radiopharm Theranostics (NASDAQ:RADX) a signé un accord d'approvisionnement clinique avec Cyclotek pour la production de RAD 402 marqué au ¹⁶¹Tb en vue d'un prochain essai clinique de phase 1 sur le cancer de la prostate. RAD 402, un radiothérapeutique à anticorps monoclonal anti-KLK3, cible KLK3, qui est fortement exprimé dans le tissu prostatique avec une expression limitée ailleurs.
L'accord constitue une étape cruciale pour lancer le premier essai de phase I parrainé par l'entreprise utilisant le Terbium-161 dans le cancer de la prostate, prévu pour le second semestre 2025. Le dossier de données précliniques est complet, démontrant sécurité et biodistribution prometteuse. Notamment, le ¹⁶¹Tb offre des avantages potentiels par rapport au ¹⁷⁷Lu grâce à des électrons Auger et de conversion supplémentaires en plus du rayonnement β, ce qui pourrait améliorer l'efficacité thérapeutique antitumorale.
Radiopharm Theranostics (NASDAQ:RADX) hat eine klinische Liefervereinbarung mit Cyclotek für die Herstellung von ¹⁶¹Tb-markiertem RAD 402 für eine bevorstehende Phase-1-Studie bei Prostatakrebs unterzeichnet. RAD 402, ein anti-KLK3 monoklonaler Antikörper-Radiotherapeutikum, zielt auf KLK3 ab, das im Prostatagewebe stark exprimiert wird und sonst nur begrenzt vorkommt.
Die Vereinbarung stellt einen wichtigen Schritt zur Einleitung der ersten unternehmensgesponserten Phase-1-Studie mit Terbium-161 bei Prostatakrebs dar, die für die Zweite Hälfte 2025 geplant ist. Das präklinische Datenpaket ist abgeschlossen und zeigt Sicherheit sowie vielversprechende Biodistribution. Bemerkenswert ist, dass ¹⁶¹Tb potenzielle Vorteile gegenüber ¹⁷⁷Lu durch zusätzliche Auger- und Konversionselektronen neben β-Strahlung bietet, was die antitumorale therapeutische Wirksamkeit verbessern könnte.
- 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
- Early-stage development with Phase 1 trials yet to begin
- Success in clinical trials and eventual FDA approval not guaranteed
Insights
Radiopharm advances prostate cancer treatment RAD 402 to Phase 1 trials after securing critical radiolabeling partnership with Cyclotek.
Radiopharm Theranostics has reached a significant development milestone with the completion of the RAD 402 preclinical data package and securing a supply agreement with Cyclotek for radiolabeling with Terbium-161. This partnership represents the final prerequisite before ethics submission and initiating their Phase 1 clinical trial in prostate cancer, scheduled for the second half of 2025.
The company's approach is technically differentiated - RAD 402 targets Kallikrein Related Peptidase 3 (KLK3), a protein highly expressed in prostate tissue with minimal presence elsewhere, providing potential for precise targeting. The use of Terbium-161 as the radioisotope is particularly noteworthy, as it emits additional Auger and conversion electrons alongside β-radiation compared to the more commonly used Lutetium-177, potentially enhancing anti-tumor efficacy.
This trial will be the first company-sponsored Phase 1 study using Terbium-161 in prostate cancer, positioning Radiopharm at the forefront of radiopharmaceutical innovation in this indication. The preclinical data package demonstrating safety and promising biodistribution suggests the company has addressed critical early-stage concerns before advancing to human trials.
This agreement follows the industry trend of developing targeted radiopharmaceuticals for cancer treatment, an area seeing increased investment following successful commercialization of similar approaches in prostate cancer therapy. The progression to Phase 1 represents early-stage clinical development, with several years and multiple clinical trial phases still required before potential commercialization.
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?
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What are the advantages of RAD 402's Terbium-161 compared to Lutetium-177?
How does Radiopharm's RAD 402 target prostate cancer?
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