Radiopharm Theranostics (ASX: RAD) Announces Key Milestone in RAD101 Phase 2b Trial
Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) has reached a significant development milestone in its Radiopharm Theranostics RAD101 Phase 2b clinical trial programme. In a recent investor update, the clinical-stage biopharmaceutical company confirmed it has achieved 50% patient enrolment in its brain metastases imaging study. This ASX announcement also included encouraging early data demonstrating significant and selective tumour uptake compared to standard MRI imaging techniques.
The achievement represents critical progress for the company’s flagship imaging technology, RAD101, which addresses a substantial unmet medical need in distinguishing between tumour recurrence and radiation necrosis in patients with brain metastases following anticancer treatments. With 15 patients now enrolled in the 30-patient study, Radiopharm remains on track to deliver topline results during the first half of 2026.
Chief Executive Officer and Managing Director Riccardo Canevari emphasised the clinical significance of this milestone: “Enrolling 50% of the patients in our Phase 2b study of RAD101 is a meaningful achievement for our RAD101 development program that brings us closer to demonstrating its clinical benefit in distinguishing between tumour recurrence and radiation necrosis in patients with brain metastasis following anticancer treatments, like SRS/radiation.”
What Is the Novel Mechanism Behind the Radiopharm Theranostics RAD101 Phase 2b trial?
RAD101 represents an advanced approach to cancer imaging through its targeted mechanism. The technology functions as a novel imaging small molecule that specifically targets fatty acid synthase (FASN), a multi-enzyme protein responsible for catalysing fatty acid synthesis that becomes overexpressed in numerous solid tumours, including brain metastases.
This precision targeting mechanism allows for enhanced cancer cell detection, offering superior diagnostic capabilities compared to current standard-of-care imaging methods. The approach addresses a critical challenge in oncology where distinguishing between actual tumour recurrence and radiation damage from previous treatments has remained problematic with conventional imaging techniques.
Furthermore, the technology’s focus on metabolic activity rather than purely structural changes provides oncologists with more accurate information for treatment decisions. FASN overexpression occurs specifically in active cancer cells, reducing false positives that can arise from radiation-damaged healthy tissue in traditional imaging approaches.
What Are the Key Design Elements of the Radiopharm Theranostics RAD101 Phase 2b Trial?
The U.S. multicentre, open-label, single arm Radiopharm Theranostics RAD101 Phase 2b study evaluates the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumours of different origins. The trial design reflects a comprehensive approach to validating the imaging technology’s clinical utility across diverse patient populations.
The primary objective focuses on measuring concordance between 18F-RAD101 positive lesions and those identified through conventional imaging using MRI with gadolinium in participants with suspected recurrent brain metastases. Consequently, this comparison provides critical validation data demonstrating RAD101’s performance against established imaging standards.
Secondary endpoints evaluate the accuracy, sensitivity and specificity of RAD101 in identifying tumour recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. These measurements will provide comprehensive data on the technology’s diagnostic capabilities across different clinical scenarios.
Critical Trial Parameters:
| Parameter | Current Status |
|---|---|
| Patient Enrolment | 50% Complete (15/30 patients) |
| Study Design | Open-label, Single Arm |
| Expected Completion | First Half 2026 |
| Primary Endpoint | Concordance with conventional MRI |
| Secondary Endpoints | Accuracy, sensitivity, specificity |
The trial’s multicentre design ensures diverse patient representation and strengthens the generalisability of results across different clinical settings. This approach also demonstrates the feasibility of implementing RAD101 imaging across multiple healthcare institutions.
How Significant Is the Early Patient Data From the Radiopharm Theranostics RAD101 Phase 2b Study?
Data from the first three patients enrolled in the Radiopharm Theranostics RAD101 Phase 2b trial revealed significant and selective tumour uptake in brain metastases. The imaging results confirmed metabolic activity in brain metastases when compared to equivocal MRI findings, providing early validation of RAD101’s enhanced diagnostic capabilities.
These promising initial results align with previously published Phase 2a results from Imperial College London, which demonstrated significant tumour uptake independent of tumour origin. The Imperial College study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall survival, warranting larger studies to validate this potential prognostic capability.
The early data becomes particularly meaningful when considering the challenges inherent in brain metastases imaging. Traditional contrast-enhanced MRI, whilst representing the preferred method for imaging intracranial metastatic disease, faces significant limitations in follow-up surveillance scans designed to optimise patient care.
If these positive results are confirmed across the full 30-patient cohort, Radiopharm plans to trigger preparation for a multicentre, global Phase 3 registrational trial. This represents a major advancement towards potential regulatory approval and commercial availability of the imaging technology.
Why Does Brain Metastases Imaging Represent a Substantial Commercial Opportunity?
The market opportunity for improved brain metastases imaging is considerable and expanding. In the United States alone, more than 300,000 patients receive diagnoses of cerebral metastases annually, creating a substantial addressable market for enhanced diagnostic technologies.
The incidence of intracranial metastatic disease continues to increase, partly due to improvements in systemic therapy resulting in more durable control of primary tumours. This paradoxical situation means that whilst patients live longer with controlled primary cancers, brain metastases become an increasingly relevant clinical challenge requiring accurate diagnostic capabilities.
This diagnostic gap creates a substantial unmet medical need that RAD101’s enhanced capabilities could address. The technology’s ability to detect metabolic activity specifically associated with active cancer cells provides information that structural imaging alone cannot deliver.
Market Dynamics Supporting Commercial Potential:
- Growing brain metastases incidence driven by improved cancer treatments
- Large addressable market exceeding 300,000 annual U.S. diagnoses
- Significant diagnostic limitations in current imaging technologies
- Unmet medical need in post-treatment surveillance imaging
- Potential applications across multiple solid tumour origins
The commercial potential extends beyond initial diagnosis to include treatment monitoring and response assessment. This broader application spectrum increases the potential frequency of RAD101 utilisation per patient, enhancing the technology’s overall market opportunity.
What Regulatory Advantages Support Radiopharm’s Development Timeline?
RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumours of different origin, including leptomeningeal disease. This designation provides several significant advantages for Radiopharm’s development programme.
Fast Track Designation facilitates more frequent communications with the FDA throughout the development process, allowing for earlier resolution of questions and more efficient clinical trial design refinement. This ongoing dialogue can substantially reduce development timelines by addressing potential regulatory concerns proactively.
The designation also provides eligibility for Accelerated Approval and Priority Review if relevant criteria are met, potentially reducing the time from clinical trial completion to market availability. These regulatory pathways become particularly valuable in areas of high unmet medical need.
How Does Radiopharm’s Diversified Pipeline Strengthen Investment Positioning?
Beyond RAD101, Radiopharm Theranostics operates a comprehensive radiopharmaceutical platform spanning peptides, small molecules and monoclonal antibodies. The clinical programme currently includes one Phase 2 trial and four Phase 1 trials across various solid tumour cancers including lung, breast and brain metastases.
This diversified approach reduces single-asset risk whilst providing multiple pathways to commercial success across different cancer types and treatment modalities. The platform’s breadth demonstrates the company’s expertise in radiopharmaceutical development and its ability to apply its technology across a range of oncology indications, offering multiple avenues for long-term value creation.
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