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Radiopharm Theranostics

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Introduction

Radiopharm Theranostics Ltd is a Australian based clinical-stage radiotherapeutics company which is targeting cancer. The company has a pipeline of around four licensed platform technologies, with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development. The company is engaged in research, development and commercialisation of health technologies.

Radiopharm Theranostics Advances Phase 1 Trial of PD-L1 Targeting Radiotherapeutic for Advanced Cancers

• Data Safety Monitoring Committee has approved continuation of Radiopharm's Phase 1 trial for 177Lu-RAD204, allowing progression to a higher dose cohort without protocol modifications. • The PD-L1-targeting radiotherapeutic is being developed for multiple advanced solid tumor types, potentially expanding treatment options for patients with limited therapeutic alternatives. • Radiopharm has simultaneously strengthened its financial position with a US$5 million investment from Lantheus Holdings, which increased its stake to 12.16% and will support advancement of the company's clinical pipeline.

Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds

• The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates. • Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets. • The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.

ITM and Alpha-9 Oncology Partner to Supply Rare Actinium-225 for Advanced Cancer Therapies

• ITM Isotope Technologies Munich and Alpha-9 Oncology have signed a supply agreement for Actinium-225, a rare medical radioisotope crucial for developing targeted cancer radiopharmaceuticals. • The agreement leverages Actineer Inc., a joint venture between ITM and Canadian Nuclear Laboratories, to produce industrial-scale quantities of Ac-225, addressing growing global demand for this scarce therapeutic resource. • Actinium-225's unique properties include emitting high-energy alpha particles with short tissue penetration range, enabling precise tumor targeting while minimizing damage to surrounding healthy tissue.

Radiopharm's Novel Brain Metastases Imaging Agent Shows 100% Detection Rate in Clinical Study

• Radiopharm Theranostics' imaging molecule RAD 101 successfully detected brain metastases in all 22 patients during an observational trial, including both treatment-naïve and previously treated individuals. • The innovative approach combines 18F-RAD101 with PET-mpMRI technology to target fatty acid metabolism in solid tumors, potentially offering improved diagnostic accuracy over current standard-of-care methods. • Results have prompted advancement to a Phase IIb trial (NCT06777433) to evaluate 18F-RAD101's performance in patients with suspected recurrent brain metastases, addressing a market expected to reach $34.3bn by 2027.

Radiopharm and Lantheus Form Strategic Partnership for Radiopharmaceutical Development in Australia

Radiopharm Theranostics has entered into a strategic partnership with Lantheus to advance radiopharmaceutical development in Australia, with an initial focus on a Phase 1 imaging trial for multiple solid tumors. The collaboration includes up to USD 2 million in milestone payments for Radiopharm, with Lantheus covering all clinical development costs.

Radiopharm Theranostics' RAD 202 Receives Ethics Approval for Phase 1 Trial in HER2-Expressing Solid Tumors

• Radiopharm Theranostics has received ethics approval in Australia to begin a Phase 1 trial of 177Lu-RAD202 in HER2-expressing solid tumors. • The Phase 1 'HEAT' trial will assess the safety, tolerability, and preliminary clinical activity of 177Lu-RAD202 in advanced cancer patients. • Previous data in breast cancer patients showed the safety of 177Lu-RAD202, validating its potential for treating HER2-expressing cancers. • Preclinical studies demonstrated tumor growth inhibition and prolonged survival with 177Lu-RAD202, supporting its further clinical development.

AtomVie and Radiopharm Ventures Partner to Advance 177Lu-BetaBart Radioantibody

• AtomVie Global Radiopharma partners with Radiopharm Ventures to manufacture 177Lu-BetaBart, a radioantibody targeting B7-H3 for multiple solid tumors. • 177Lu-BetaBart, a 177Lutetium-conjugated radioantibody, is the first targeted radiopharmaceutical against the 4Ig subtype of B7-H3. • Clinical trials for 177Lu-BetaBart are scheduled to begin in mid-2025, following production at McMaster University and later at AtomVie's new facility. • The radioantibody utilizes a monoclonal antibody engineered at MD Anderson Cancer Center with reduced off-target toxicity for improved human trials.
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