RAD 202 Receives Approval to Start Phase 1 Therapeutic Trial

Rhea-AI Summary

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.

Positive

• 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

Negative

• Early-stage Phase 1 trial with no guaranteed success
• Faces competition in established HER2-positive cancer treatment market

Insights

Oncology Research Analyst

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 $50+ billion HER2-targeted therapy market, particularly for patients who have exhausted current treatment options.

Clinical Development Expert

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

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/
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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

What is the purpose of Radiopharm's HEAT trial for RAD202?

The HEAT trial is a Phase 1 First-In-Human study designed to evaluate the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202 in patients with HER2-expressing advanced cancers.

What previous data supports RAD202's development?

Ten HER2-positive breast cancer patients were previously dosed in a Phase 1 diagnostic study, demonstrating safety and biodistribution. Preclinical studies also showed tumor growth inhibition and prolonged survival.

Which types of cancer will RADX's RAD202 trial target?

The trial will target HER2-expressing solid tumors, particularly focusing on breast cancer and other solid tumors where HER2 is overexpressed.

Where will RADX conduct the RAD202 Phase 1 trial?

The multicenter study will be conducted across Australia with support from GenesisCare CRO, a leading oncology care provider.