News & Events zu Radiopharm Theranostics Ltd (RADX)RADXRadiopharm Theranostics Ltd

Radiopharm Theranostics Aligns with FDA on RAD101 Phase 3 Trial Design

Radiopharm Theranostics announced receipt of the final meeting minutes following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, at which Radiopharm reached alignment with the FDA on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with indeterminate brain metastases following radiotherapy. The trial is expected to enroll about 280 patients with indeterminate brain metastases from various solid tumor types after previous radiotherapy. The co-primary endpoints of the study will be sensitivity and specificity of RAD101 PET against a defined reference standard. Radiopharm expects to complete contract research organization selection in the fourth quarter, initiate site activations and begin dosing patients in first half 2027. "Accurately distinguishing recurrent tumor from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases. This determination has profound implications for patient care, helping clinicians decide whether a patient requires additional intervention and treatment or can be managed with continued observation and surveillance. Existing imaging modalities often leave uncertainty, creating difficult clinical decisions for both physicians and patients. RAD101 has shown the potential to resolve diagnostic uncertainty in lesions that are equivocal on MRI, potentially offering a clearer assessment of active disease. We are grateful to the FDA for its constructive review of our clinical data and for aligning with us on a single, multicenter pivotal study design. Importantly, the approximately 280-patient trial is substantially smaller than many historical registrational imaging studies. We believe this reflects the significant unmet medical need faced by patients with brain metastases from solid tumors. We look forward to advancing RAD101 into this pivotal study as we work to provide physicians and patients with a more reliable tool to guide critical treatment decisions," said Riccardo Canevari, CEO and managing director of Radiopharm Theranostics.

Radiopharm Completes FDA EOP2 Meeting for RAD101

Radiopharm announced the completion of an End-of-Phase 2, or EOP2, meeting with the FDA regarding RAD101, the company's investigational radiopharmaceutical imaging agent for the detection of brain metastases. RAD101 is the company's Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase, or FASN, and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors. Previously reported data from the Phase 2b clinical trial showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint. The company expects to receive the FDA's official meeting minutes within approximately 30 days. The minutes will provide the formal record of the meeting and the Agency's feedback on the proposed pivotal clinical development program. RAD intends to provide a further update following receipt and review of the official minutes. Building on the momentum from the meeting, RAD is moving immediately to advance Phase 3 readiness activities, including clinical and operational planning, in order that the program is positioned to progress efficiently once the Agency's formal feedback is received.

Radiopharm RAD 301 Phase 1 Trial Shows Favorable Safety Profile

Radiopharm announced data from the Phase 1 imaging trial designed to evaluate the safety, biodistribution and dosimetry of RAD 301 in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma. Data from the Phase 1 trial of RAD301 demonstrated a favorable safety profile in all evaluable participants. Additionally, RAD301 had favorable biodistribution along with significant tumor uptake in pancreatic cancer metastases, consistent with initial results from the first five patients evaluated. The results showed significant and selective tumor uptake in pancreatic cancer metastases, which supports the potential of alphavbeta6-integrin as a target for future therapeutic development and potentially as a theranostic pair. Importantly, the low background uptake observed in liver, lung and bowel - the sites where pancreatic cancer most often spreads - supports the potential of RAD301 to distinguish metastatic lesions from surrounding normal tissue. The unmet medical need in the earlier stages of disease and the high mortality of the disease provide a rationale for a future Phase 2 imaging trial of RAD301.