Radiopharm Theranostics has reported encouraging early results from a Phase 1 imaging trial of its experimental agent RAD301 in patients with pancreatic ductal adenocarcinoma, one of the most lethal and hardest to treat forms of cancer.
The Sydney-based, dual-listed biopharmaceutical company, which trades on the ASX under the code RAD and on Nasdaq as RADX, said the trial produced a favourable safety profile in every dosed participant, alongside biodistribution results that support the molecule's potential as both a diagnostic and future therapeutic tool.
RAD301 is a peptide-based compound bound to the radioactive isotope Gallium-68. It is designed to seek out and bind to a protein called αvβ6 integrin, a marker strongly associated with tumour invasion and the spread of cancer to other parts of the body. Because this integrin is found in unusually high concentrations on the surface of most pancreatic cancer cells, researchers have viewed it as a promising target for both imaging and treatment. RAD301 has already secured Orphan Drug Designation from the United States Food and Drug Administration, a status intended to support the development of therapies for rare and serious conditions.
The trial set out to test the safety, biodistribution and dosimetry of RAD301 in a mix of healthy volunteers and patients diagnosed with pancreatic ductal adenocarcinoma.
According to the company, imaging data from every evaluable patient showed significant tumour uptake, meaning the agent successfully found and lit up cancerous tissue. That result matched what researchers had already observed in the first five patients assessed earlier in the study.
Riccardo Canevari, the company's chief executive and managing director, said the findings marked an important step for people living with advanced pancreatic cancer. He noted that RAD301 showed significant and selective uptake in metastatic lesions, at a time when patients with this disease have very few imaging or treatment options. Canevari pointed out that pancreatic cancer is notoriously difficult to image using conventional methods such as FDG PET scans, which can be thrown off by the disease's variable biology and by uptake that isn't specific to tumour tissue. He argued that the new data support a more targeted, tumour-specific approach through αvβ6 integrin imaging, and that the results strengthen the case for moving RAD301 into a Phase 2 trial.
One element of the results was the low background signal seen in the liver, lungs and bowel, the organs where pancreatic cancer most commonly metastasises. This matters because it suggests RAD301 can help clinicians distinguish actual cancer spread from the normal tissue surrounding it, a distinction that has long frustrated efforts to accurately stage and monitor the disease.
The company said the combination of high unmet need in earlier stages of pancreatic cancer, together with the disease's persistently high mortality rate, provides a clear rationale for progressing to a larger Phase 2 imaging study.
