RAD 202 Receives Approval to Start Phase 1 Therapeutic Trial
Radiopharm Theranostics (ASX:RAD) has received ethics approval in Australia to initiate a Phase 1 First-In-Human therapeutic trial of 177Lu-RAD202 for treating HER2-expressing solid tumors. The open-label trial, named 'HEAT' (HER2 Antibody Therapy with Lutetium-177), will evaluate safety and preliminary clinical activity in patients with HER2-expressing advanced cancers.
The multicenter study follows previous successful data showing safety and biodistribution of 99mTc-labeled RAD 202 in humans. Preclinical findings with 177Lu-labeled RAD 202 demonstrated tumor growth inhibition and significantly prolonged survival time in HER2-positive xenografts. The treatment targets HER2, which is overexpressed in breast cancer and other solid tumors.
Radiopharm Theranostics (ASX:RAD) ha ricevuto l'approvazione etica in Australia per avviare uno studio terapeutico di Fase 1 First-In-Human con 177Lu-RAD202 per il trattamento di tumori solidi che esprimono HER2. Il trial in aperto, denominato 'HEAT' (HER2 Antibody Therapy with Lutetium-177), valuterà la sicurezza e l'attività clinica preliminare in pazienti con tumori avanzati positivi per HER2.
Lo studio multicentrico segue dati precedenti di successo che hanno mostrato sicurezza e biodistribuzione di RAD 202 etichettato con 99mTc negli esseri umani. I risultati preclinici ottenuti con RAD 202 etichettato con 177Lu hanno dimostrato un'inibizione della crescita tumorale e un prolungamento significativo del tempo di sopravvivenza in xenotrapianti positivi per HER2. Il trattamento si rivolge a HER2, che è sovraespresso nel cancro al seno e in altri tumori solidi.
Radiopharm Theranostics (ASX:RAD) ha recibido aprobación ética en Australia para iniciar un ensayo terapéutico de Fase 1 First-In-Human de 177Lu-RAD202 para tratar tumores sólidos que expresan HER2. El ensayo abierto, denominado 'HEAT' (Terapia Anticuerpo HER2 con Lutecio-177), evaluará la seguridad y la actividad clínica preliminar en pacientes con cánceres avanzados positivos para HER2.
El estudio multicéntrico sigue datos previos exitosos que muestran la seguridad y biodistribución de RAD 202 etiquetado con 99mTc en humanos. Los hallazgos preclínicos con RAD 202 etiquetado con 177Lu demostraron la inhibición del crecimiento tumoral y un tiempo de supervivencia significativamente prolongado en xenoinjertos positivos para HER2. El tratamiento está dirigido a HER2, que está sobreexpresado en el cáncer de mama y otros tumores sólidos.
Radiopharm Theranostics (ASX:RAD)는 HER2를 발현하는 고형 종양 치료를 위한 177Lu-RAD202의 1상 최초 인간 임상 시험을 시작하기 위해 호주에서 윤리적 승인을 받았습니다. 'HEAT'라고 명명된 공개 라벨 시험(HER2 항체 치료 및 루테늄-177)은 HER2를 발현하는 고급 암 환자에서 안전성과 초기 임상 활동을 평가할 것입니다.
다기관 연구는 인간에서 99mTc로 표지된 RAD 202의 안전성과 생체 분포에 대한 이전 성공적인 데이터를 따릅니다. 177Lu로 표지된 RAD 202의 전임상 결과는 HER2 양성 이식에서 종양 성장 억제와 생존 기간의 유의미한 연장을 입증했습니다. 이 치료는 유방암 및 기타 고형 종양에서 과발현되는 HER2를 표적으로 합니다.
Radiopharm Theranostics (ASX:RAD) a obtenu l'approbation éthique en Australie pour lancer un essai thérapeutique de Phase 1 First-In-Human avec 177Lu-RAD202 pour traiter les tumeurs solides exprimant HER2. L'essai ouvert, nommé 'HEAT' (Therapie par anticorps HER2 avec Lutécium-177), évaluera la sécurité et l'activité clinique préliminaire chez des patients atteints de cancers avancés positifs pour HER2.
L'étude multicentrique fait suite à des données antérieures réussies montrant la sécurité et la biodistribution de RAD 202 marqué au 99mTc chez l'homme. Les résultats précliniques avec RAD 202 marqué au 177Lu ont démontré une inhibition de la croissance tumorale et une prolongation significative du temps de survie dans les xénogreffes positives pour HER2. Le traitement cible HER2, qui est surexprimé dans le cancer du sein et d'autres tumeurs solides.
Radiopharm Theranostics (ASX:RAD) hat in Australien die ethische Genehmigung erhalten, um eine Phase-1-First-In-Human-Therapystudie mit 177Lu-RAD202 zur Behandlung von HER2-expressierenden soliden Tumoren zu beginnen. Die offene Studie mit dem Namen 'HEAT' (HER2 Antikörpertherapie mit Lutetium-177) wird die Sicherheit und die vorläufige klinische Aktivität bei Patienten mit fortgeschrittenen HER2-positiven Krebserkrankungen bewerten.
Die multizentrische Studie folgt früheren erfolgreichen Daten, die die Sicherheit und Biodistribution von mit 99mTc-markiertem RAD 202 beim Menschen zeigen. Die präklinischen Ergebnisse mit mit 177Lu-markiertem RAD 202 zeigten eine Hemmung des Tumorwachstums und eine signifikante Verlängerung der Überlebenszeit bei HER2-positiven Xenotransplantaten. Die Behandlung zielt auf HER2 ab, das bei Brustkrebs und anderen soliden Tumoren überexprimiert wird.
- Ethics approval received for Phase 1 therapeutic trial in Australia
- Previous successful safety data from 10 HER2-positive breast cancer patients
- Preclinical findings showed tumor growth inhibition and prolonged survival
- Early-stage Phase 1 trial with no guaranteed success
- Faces competition in established HER2-positive cancer treatment market
Insights
The approval to initiate a Phase 1 therapeutic trial for 177Lu-RAD202 represents a important milestone in developing targeted radiopharmaceutical treatments for HER2-positive cancers. The study's design as a basket trial is particularly strategic, allowing for evaluation across multiple HER2-expressing tumor types. The existing safety data from ten breast cancer patients in the diagnostic phase provides a solid foundation for this therapeutic trial.
The technology leverages two key advantages:
- The single-domain antibody structure of RAD 202 potentially offers better tumor penetration compared to traditional antibodies
- The combination with Lutetium-177 enables targeted radiation delivery to cancer cells while minimizing exposure to healthy tissue
Previous preclinical data showing tumor growth inhibition and survival benefits strongly supports the therapeutic potential. The progression to human trials positions RADX to potentially capture a share of the
The HREC approval in Australia marks a significant regulatory advancement that demonstrates the robust preclinical package supporting 177Lu-RAD202's safety profile. The selection of Australia for the trial is strategically advantageous due to its:
- Streamlined regulatory pathway
- High-quality healthcare infrastructure
- Favorable R&D tax incentives
The partnership with GenesisCare CRO, a leading oncology care provider, should facilitate efficient patient recruitment and high-quality trial execution. The open-label design will allow for real-time assessment of clinical responses, potentially accelerating development timelines if positive signals are observed early in the dose-escalation phase.
- Ethics approval received in Australia for the initiation of RAD’s Phase 1 therapeutic trial of 177Lu-RAD202 in Breast and Gastric Cancers
- The Phase 1 First-In-Human study is designed to assess the safety, tolerability & preliminary clinical activity of 177Lu-RAD202 in individuals with HER2-positive metastatic solid tumors
- Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study demonstrated the safety and biodistribution of 177Lu-RAD202, validating its potential for the treatment of advanced HER2-expressing cancers
SYDNEY, Dec. 20, 2024 (GLOBE NEWSWIRE) -- 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.
Previous data1 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.”
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:
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
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Website – https://radiopharmtheranostics.com/
Twitter – https://twitter.com/TeamRadiopharm
Linked In – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
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1 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-3622
2 Altunay B. et al, Sept 19-20 2024, “Radiolabeling of HER2 targeting single domain antibody with 68Ga and 177Lu” Poster Presentation, CIO ABCD MSSO Science Day, Cologne, Germany
FAQ
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