Positive Interim Results for Radiopharm Theranostics' RAD101 Imaging Trial

Radiopharm Theranostics, a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals, has announced positive interim results from its Phase 2b imaging trial of 18F-RAD101, a novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18. The trial, which evaluated the diagnostic performance of 18F-RAD101 in participants with suspected recurrent brain metastases from solid tumors, achieved a 93% concordance rate between MRI and PET imaging across all evaluable lesions. This result meets the trial's primary endpoint and has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26) in Philadelphia.

The company plans to meet with the U.S. Food and Drug Administration (FDA) on October 1st to align on the protocol for a pivotal Phase 3 imaging trial of RAD101. The Phase 2b trial involved 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective was to assess the concordance between 18F-RAD101 PET-positive lesions and equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints included sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

According to Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, "Having these data selected for a late-breaking oral presentation at SNO26 is a meaningful recognition of the potential clinical importance of RAD101. The neuro-oncology community understands better than anyone the challenges associated with distinguishing active brain metastases from treatment effects using current imaging approaches. Knowing whether metastatic disease is present can fundamentally alter a patient's treatment path and prognosis. We believe these data underscore RAD101’s potential to address a significant unmet need by helping physicians make more informed decisions and potentially changing the course of disease management for patients with suspected recurrent brain metastases."

The company highlighted that brain metastases imaging has a substantial market potential, with an estimated total addressable market of approximately $600 million. Currently, there are no approved PET products for brain metastases imaging. RAD101 has received Fast Track Designation from the FDA to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origins, including leptomeningeal disease. Radiopharm Theranostics has also entered into a partnership with Siemens Healthineers, which will manufacture and distribute doses of 18F-labeled RAD101 to support the upcoming Phase 3 pivotal trial in the U.S.

The U.S. alone sees more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, partly due to improvements in systemic therapy that result in a more durable control of tumors outside the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but it has limitations, particularly in follow-up surveillance scans to optimize patient care. RAD101 is designed to offer a more accurate detection of cancer cells in the central nervous system, potentially leading to improved patient outcomes.

The Phase 2b clinical trial of RAD101 is part of a broader pipeline of innovative radiopharmaceutical products developed by Radiopharm Theranostics for diagnostic and therapeutic applications in areas of high unmet medical need. The company's pipeline includes one Phase 2 and five Phase 1 trials in various solid tumor cancers, including lung, breast, prostate, and brain.