Radiopharm Theranostics Administers 18F-RAD101 to First U.S. Phase 2b Brain Metastasis Patient

Radiopharm Theranostics, a biopharmaceutical firm dedicated to advancing oncology radiopharmaceuticals, has recently embarked on a significant clinical journey by administering the first dose in its U.S. Phase 2b study. This trial focuses on the diagnostic efficacy of 18F-RAD101 for patients with suspected recurrent brain metastases originating from various solid tumors.

This U.S.-based, multicenter clinical trial is structured as an open-label, single-arm study involving 30 participants diagnosed with recurrent brain metastases from diverse solid tumors. The primary objective is to evaluate the concordance between lesions identified using 18F-RAD101 and those detected via conventional imaging techniques, such as MRI with gadolinium, in patients who are suspected of having recurrent brain metastases.

18F-RAD101 represents a novel approach in imaging, targeting the fatty acid synthase (FASN) protein, which is involved in the synthesis of fatty acids and is typically overexpressed in numerous solid tumor types, including cerebral metastases. By disrupting FASN activity, this compound enables more precise detection of cancerous cells, making it a promising candidate for imaging brain metastases. Previous data from a Phase 2a trial conducted by Imperial College London demonstrated notable tumor uptake that aligned with the tumor's origin, supporting the potential of 18F-RAD101.

Dr. Harshad R. Kulkarni, Chief Medical Advisor at BAMF Health and Principal Investigator of the Phase 2b study, expressed pride in leading the first U.S. clinical trial involving RAD101. He highlighted the trial's significance in enhancing diagnostic accuracy and paving the way for more tailored treatment strategies for patients with brain metastases post-stereotactic radiosurgery.

The trial exemplifies BAMF Health’s comprehensive clinical trial capabilities. The organization's Radiopharmacy is responsible for onsite production of the imaging agent, while their clinical team ensures the provision of top-tier imaging services. The clinical trials team is tasked with the seamless coordination of all trial-related activities. This facility was specifically designed to conduct such advanced trials effectively.

Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics Ltd., noted the limitations of current imaging methods in distinguishing between tumor recurrences and radiation necrosis in patients with brain metastases who have undergone anticancer treatments, including radiation. He emphasized that 18F-RAD101 has significant potential to enhance the diagnostic accuracy of brain metastases. This advancement could significantly aid in differentiating between treatment effects and actual disease progression, benefiting the over 300,000 patients diagnosed with brain metastasis annually in the U.S. Canevari expressed eagerness to advance the clinical trial and anticipates sharing topline data in the latter half of 2025.

Radiopharm Theranostics is a forward-thinking radiotherapeutics firm developing a world-class portfolio of radiopharmaceutical products for diagnostic and therapeutic use in areas of significant unmet medical need. The company is publicly traded on both ASX and NASDAQ and boasts a pipeline of distinct and innovative platform technologies. These include peptides, small molecules, and monoclonal antibodies designed for use in various cancers, such as lung, breast, and brain. Their clinical program is extensive, comprising one Phase 2 and three Phase 1 trials targeting a range of solid tumor cancers.

BAMF Health, based in Grand Rapids, Michigan, is a pioneer in intelligence-driven precision medicine. The organization employs state-of-the-art theranostic imaging technology to both diagnose and treat cancer, alongside other diseases, while facilitating advanced clinical trials. Their mission revolves around empowering patients through precision medicine, backed by a dedicated team of data scientists, researchers, software engineers, and clinicians.