ASX-listed Radiopharm Theranostics (ASX: RAD) has teamed up with US-based BAMF Health to kick off phase 2b trials for its cancer treatment known as “F18-RAD 101 radiotracer”. The trials will be conducted in the US and will test the company’s radiopharmaceutical brain cancer treatment designed to target proteins that are commonly over-expressed in human tumours.
Recently cleared by the all-powerful US Food and Drug Administration (FDA) as an “investigational new drug”, or “IND”, F18-RAD 101 is a radiotracer called Pivalate that combines a molecule and the F18 radioactive isotope to target synthetase—a fatty acid protein that occurs in brain tumours but not in normal cells.
18F-RAD 101 can then detect, characterise and monitor brain metastases and particularly, glioblastoma – an aggressive brain cancer.
Disruption of target’s fatty acid synthase (FASN) activity allows for the accurate detection of cancer cells, representing a strongly viable target for the imaging of brain metastases. Our partnership with BAMF Health is instrumental in progressing our RAD 101 clinical program. With BAMF Health’s leadership in manufacturing and clinical trial conduct, we collectively pave the way to bringing innovative radiopharmaceuticals to oncology patients across the globe.
Radiopharm Theranostics CEO and Managing Director Riccardo Canevari
US-based BAMF Health is a cutting-edge radio-pharmacy, featuring dual cyclotrons and advanced synthesis platforms that can churn out a wide range of isotopes detectable by PET scans. Consequently, Radiopharm has chosen BAMF as a partner because of its ability to manufacture and dose quickly, key factors in supporting the upcoming trial.
Specifically, the company has been hired by Radiopharm to produce and administer 18F-RAD 101 for the advanced phase 2b trial targeting brain metastases. This positions BAMF as the first clinical site to enrol and treat patients as part of the trial scheduled to begin before the end of the year.
The trial will assess the diagnostic performance of RAD 101 in detecting brain metastases from various solid tumours and builds on the success of a 2022 phase 2a trial conducted at Imperial College London. Results from that study demonstrated significant tumour uptake by RAD 101, independent of the tumour’s origins, showing the radiotracer’s remarkable potential in identifying metastases.
Additionally, BAMF’s integrated platform, which combines advanced molecular imaging, theranostics and clinical expertise, will not only serve as the first trial site but also as a hub for regional deployment of the technology.
Radiopharm currently holds an exclusive global license for its Pivalate platform technology and has a collaboration agreement in place with the Imperial College in London to develop a therapeutic candidate leveraging the same mechanism of action.
The estimated market value for imaging brain metastases is in the region of a whopping US$1.25 billion (AU$1.91 billion) a year.
In June, Radiopharm attracted the interest of US Pharma giant Lantheus – a US$5.5 billion (AU$8.2 billion) Nasdaq-listed company that took a $7.5 million placement in Radiopharm and prepaid $3 million to secure rights on two other pre-clinical assets known as RAD 206 and RAD 502.
With more than 10 million people dying each year worldwide from lung, breast, bowel and prostate cancer alone, Radiopharm’s mission to develop products that can directly attack individual cancerous cells without damaging the surrounding tissues appears truly relevant. If the company can add brain cancer to the list, it is sure to attract the interest of the major pharmaceutical players as it nears its phase-three trials for several of its products.
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