New RAD202 Data Confirms Positive Tumor Uptake and Favorable Biodistribution
Radiopharm Theranostics (ASX:RAD) presented new data at EMIM 2025 demonstrating positive results for their RAD202 program targeting HER2-positive tumors. The imaging data showed that 68Ga-RAD202 specifically binds to HER2 in xenografts with high tumor-to-background ratio, while the removal of His-tag improved tumor-to-organ ratio for PET imaging.
Treatment with 177Lu-RAD202 demonstrated significant results, including tumor volume reduction and extended survival benefits. Notably, fractionated dosing proved more effective than single-dose therapy. The therapy was well-tolerated in preclinical studies.
These findings support an ongoing First-In-Human Phase I therapeutic trial of 177Lu-RAD202 in HER2-positive solid tumors, currently recruiting in Australia. The trial aims to evaluate safety and preliminary activity in patients with advanced HER2-positive solid tumors who have progressed on standard care or cannot tolerate current treatments.
Radiopharm Theranostics (ASX:RAD) ha presentato nuovi dati all'EMIM 2025 che dimostrano risultati positivi per il loro programma RAD202 mirato ai tumori HER2-positivi. I dati di imaging hanno mostrato che 68Ga-RAD202 si lega specificamente a HER2 in xenotrapianti con un alto rapporto tumore-sfondo, mentre la rimozione del His-tag ha migliorato il rapporto tumore-organo per l'imaging PET.
Il trattamento con 177Lu-RAD202 ha dimostrato risultati significativi, inclusa la riduzione del volume tumorale e benefici di sopravvivenza prolungati. È importante notare che la somministrazione frazionata si è rivelata più efficace rispetto alla terapia a dose singola. La terapia è stata ben tollerata negli studi preclinici.
Questi risultati supportano un trial terapeutico di Fase I First-In-Human di 177Lu-RAD202 in tumori solidi HER2-positivi, attualmente in fase di reclutamento in Australia. L'obiettivo dello studio è valutare la sicurezza e l'attività preliminare nei pazienti con tumori solidi HER2-positivi avanzati che hanno avuto progressione con le cure standard o non possono tollerare i trattamenti attuali.
Radiopharm Theranostics (ASX:RAD) presentó nuevos datos en EMIM 2025 que demuestran resultados positivos para su programa RAD202 dirigido a tumores HER2-positivos. Los datos de imagen mostraron que 68Ga-RAD202 se une específicamente a HER2 en xenoinjertos con una alta relación tumor-fondo, mientras que la eliminación de His-tag mejoró la relación tumor-órgano para la imagenología PET.
El tratamiento con 177Lu-RAD202 demostró resultados significativos, incluyendo reducción del volumen tumoral y beneficios de supervivencia prolongados. Notablemente, la dosificación fraccionada resultó ser más efectiva que la terapia de dosis única. La terapia fue bien tolerada en estudios preclínicos.
Estos hallazgos apoyan un ensayo clínico terapéutico de Fase I First-In-Human de 177Lu-RAD202 en tumores sólidos HER2-positivos, que actualmente está reclutando en Australia. El ensayo tiene como objetivo evaluar la seguridad y la actividad preliminar en pacientes con tumores sólidos HER2-positivos avanzados que han progresado en el tratamiento estándar o que no pueden tolerar los tratamientos actuales.
Radiopharm Theranostics (ASX:RAD)는 EMIM 2025에서 HER2 양성 종양을 표적으로 하는 RAD202 프로그램에 대한 긍정적인 결과를 보여주는 새로운 데이터를 발표했습니다. 이미징 데이터는 68Ga-RAD202가 높은 종양-배경 비율을 가진 제노이식에서 HER2에 특별히 결합함을 보여주었으며, His-tag의 제거는 PET 이미징을 위한 종양-장기 비율을 개선했습니다.
177Lu-RAD202로 치료한 결과, 종양 부피 감소 및 생존 기간 연장과 같은 중요한 결과가 나타났습니다. 특히, 분할 투여가 단일 투여 요법보다 더 효과적인 것으로 입증되었습니다. 이 요법은 전임상 연구에서 잘 견뎌졌습니다.
이러한 발견은 현재 호주에서 모집 중인 HER2 양성 고형 종양에 대한 177Lu-RAD202의 First-In-Human 1상 임상 시험을 지원합니다. 이 시험은 표준 치료에서 진행된 환자 또는 현재 치료를 견딜 수 없는 환자에서 안전성과 초기 활성을 평가하는 것을 목표로 하고 있습니다.
Radiopharm Theranostics (ASX:RAD) a présenté de nouvelles données lors de l'EMIM 2025 montrant des résultats positifs pour leur programme RAD202 ciblant les tumeurs HER2-positives. Les données d'imagerie ont montré que 68Ga-RAD202 se lie spécifiquement à HER2 dans des xénogreffes avec un rapport élevé tumeur-fond, tandis que l'élimination de l'His-tag a amélioré le rapport tumeur-organe pour l'imagerie PET.
Le traitement avec 177Lu-RAD202 a montré des résultats significatifs, y compris une réduction du volume tumoral et des bénéfices de survie prolongés. Il est à noter que la posologie fractionnée s'est révélée plus efficace que la thérapie à dose unique. La thérapie a été bien tolérée dans les études précliniques.
Ces résultats soutiennent un essai thérapeutique de phase I First-In-Human sur le 177Lu-RAD202 dans des tumeurs solides HER2-positives, actuellement en cours de recrutement en Australie. L'essai vise à évaluer la sécurité et l'activité préliminaire chez des patients atteints de tumeurs solides HER2-positives avancées qui ont progressé avec les soins standards ou qui ne peuvent pas tolérer les traitements actuels.
Radiopharm Theranostics (ASX:RAD) hat auf der EMIM 2025 neue Daten präsentiert, die positive Ergebnisse für ihr RAD202-Programm zur Behandlung von HER2-positiven Tumoren zeigen. Die Bildgebungsdaten zeigten, dass 68Ga-RAD202 spezifisch an HER2 in Xenotransplantaten mit hohem Tumor-Hintergrund-Verhältnis bindet, während die Entfernung des His-Tags das Tumor-Organ-Verhältnis für PET-Bildgebung verbesserte.
Die Behandlung mit 177Lu-RAD202 zeigte signifikante Ergebnisse, einschließlich der Reduktion des Tumorvolumens und verlängerten Überlebensvorteilen. Bemerkenswert ist, dass die fraktionierte Dosierung effektiver war als die Einzeldosistherapie. Die Therapie wurde in präklinischen Studien gut vertragen.
Diese Ergebnisse unterstützen eine laufende First-In-Human Phase-I-Therapiestudie zu 177Lu-RAD202 bei HER2-positiven soliden Tumoren, die derzeit in Australien rekrutiert wird. Die Studie zielt darauf ab, die Sicherheit und die vorläufige Aktivität bei Patienten mit fortgeschrittenen HER2-positiven soliden Tumoren zu bewerten, die auf die Standardbehandlung fortgeschritten sind oder die aktuellen Behandlungen nicht vertragen können.
- Successful preclinical results showing tumor volume reduction and survival benefits
- Fractionated dosing demonstrated superior efficacy compared to single-dose treatment
- Well-tolerated therapy with specific tumor targeting
- Active Phase I trial recruitment indicates development progress
- Currently only in early Phase I stage, far from potential commercialization
- to HER2-positive tumor types only
- Shows expected uptake in non-target organs (bladder and kidney)
Insights
Radiopharm's latest preclinical data for RAD202 provides compelling evidence supporting their ongoing Phase I clinical trial in HER2-positive tumors. The data demonstrates two critical achievements: specific tumor targeting with 68Ga-RAD202 and therapeutic efficacy with 177Lu-RAD202.
The removal of the His-tag from the nanobody structure represents an important technical optimization that significantly improved tumor-to-organ ratios for imaging applications. More crucially, the therapeutic findings showed that fractionated dosing of 177Lu-RAD202 delivered superior tumor growth inhibition compared to single-dose administration—a finding that could directly inform clinical dosing strategies.
HER2 represents a well-validated target in oncology, with expression across multiple tumor types beyond breast cancer. The radiopharmaceutical approach could potentially address resistance mechanisms that develop against conventional HER2-targeted therapies like trastuzumab, pertuzumab, or antibody-drug conjugates.
While promising, these remain preclinical results. The ongoing Phase I trial will need to establish safety and preliminary efficacy signals in humans before we can fully assess RAD202's potential clinical impact. The theranostic approach, using similar compounds for both diagnosis (68Ga-RAD202) and treatment (177Lu-RAD202), represents a personalized approach that could eventually allow clinicians to select appropriate patients and monitor treatment response with greater precision.
- Data presented at European Molecular Imaging Meeting (EMIM 2025) for imaging with 68Ga-RAD202 confirms specific accumulation in the tumor, favorable biodistribution and low uptake in non-target organs, except for the bladder and kidney as expected
- Treatment with 177Lu-RAD202 results in a relevant tumor volume reduction and survival benefit, further pronounced with fractionated therapy vs single-dose treatment.
- These data further support the rationale for the ongoing Phase I therapeutic trial with 177Lu-RAD202 in HER2-positive solid tumors.
SYDNEY, March 17, 2025 (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 a poster presentation at EMIM 20251, with findings that support the clinical utility of imaging and therapy with 68Ga-RAD202 and 177Lu-RAD202 respectively, and validate an optimized therapeutic dosing regimen in murine models.
The poster presentation is by Drs. Felix Mottaghy, Betul Altunay and colleagues, from the University Hospital RWTH Aachen in Germany.
The imaging data reported that 68Ga-RAD202 binds specifically to the Human Epidermal growth factor Receptor 2 (HER2) in HER2-positive xenografts, with a high tumor-to-background ratio. The removal of a His-tag from the RAD202 nanobody, a modification which impacts biodistribution and tumor targeting, was shown to be superior for PET imaging due to the higher tumor-to-organ ratio.
Furthermore, therapy with 177Lu-RAD202 was well-tolerated, demonstrating significantly prolonged survival time. Fractionated dosing proved more effective in inhibiting tumor growth compared to single-dose therapy.
HER2 is overexpressed in breast cancer as well as several other solid tumors, and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Previous data2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans. Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify First-In-Human (FIH) dose finding studies.
A FIH open-label dose escalation Phase 1 study of 177Lu-RAD202 is currently recruiting in Australia4. The trial is designed to evaluate the safety and preliminary activity of this novel radiotherapeutic in eligible individuals with advanced HER2-positive solid tumors.
“These data support the potential for RAD202 to address an unmet need for HER2-positive metastatic patients that are progressing on current standard of care, or unable to tolerate current treatment options,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The current comprehensive data with RAD202 further support our rationale for the Phase 1 FIH therapeutic dose escalating trial with 177Lu-RAD202, currently recruiting in HER2-positive advanced solid tumors.”
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 pipeline of six distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. 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 three Phase I trials in a variety of solid tumour cancers including breast, kidney and brain. Learn more at radiopharmtheranostics.com.
Authorized 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
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.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/
1 Altunay B. et al, Poster # IGT-015, PW-36, March 14th, EMIM 2025.
2 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-3622
3 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-z
4 ACTRN12625000191493
FAQ
What are the key findings of RAD202's latest clinical data presented at EMIM 2025?
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