Following publication of its findings in “Frontiers in Nuclear Medicine”, Radiopharm Theranostics revealed a clinical study of its cutting-edge imaging agent, 68Ga-RAD 301 on 44 pancreatic cancer patients - the biggest cohort yet - has delivered strong results.
The trial, conducted by Dr. Rehm and colleagues from the Technische Universität Dresden was able to not only identify the primary tumour but also pick up secondary and tertiary metastases in the liver, lymph nodes, peritoneum, lung, bone, spleen, pleural cavity and soft tissues.
Importantly, the visual response was excellent with a high tumour-to-background ratio and no adverse events were recorded, which, according to the company, suggests RAD301 is a suitable and safe diagnostic agent for imaging αvβ6-protein expression in pancreatic cancer.
68Ga-RAD 301, otherwise known as 68Ga-Trivehexin, is a peptide-based molecule which targets αvβ6, a specific protein which tends to be over-expressed on pancreatic cancer cells and other cancers with decreased survival rates, making it a useful diagnostic and therapeutic target.
By delivering precise imaging, RAD-301 holds the potential to revolutionise the detection and management of pancreatic cancer. The development appears to be a significant leap in addressing pancreatic ductal adenocarcinoma (PDAC), one of the deadliest forms of cancer.
The trial results have come at the same time as Radiopharm continues its phase one imaging study at Montefiore Medical Centre in New York, evaluating the safety, dosage level and imaging characteristics of RAD-301 in patients with advanced PDAC.
The RAD-301 agent had previously received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA), giving it a running start with addressing an urgent unmet medical need.
Radiopharm Theranostics CEO and managing director Riccardo Canevari said: “Current imaging standards of care for the detection of PDAC have significant limitations, making this one of the highest areas of unmet medical need and posing a major challenge for healthcare providers in imaging PDAC patients. These findings reinforce the clinical potential of RAD 301 as an imaging agent for the more sensitive and selective detection of pancreatic cancer and its metastases, ultimately advancing PDAC patient management.”
As well as developing diagnostic products to identify carcinomas, Radiopharm’s is also progressing specific therapies to irradiate individual cancer cells. By combining a monoclonal antibody and a radioisotope together, the “radiotracer” is then able to target and deliver a specific dose of radiation to each cancer cell without affecting the surrounding healthy tissue.
The global radiopharmaceuticals market size is estimated to be USD 6.74 billion (AUD$10.2 billion) in 2024 and is expected to grow to USD 13.67 billion (AUD$20.7 billion) by 2033, representing a healthy compound annual growth rate of 8.2 per cent in the next nine years.
Radiopharm currently has an ambitious pipeline in the burgeoning sector including six platform technologies spanning peptides, small molecules and monoclonal antibodies to targeting a range of cancers.
With clinical trials underway for breast, kidney and brain cancers, one of which is in phase two and three in phase one trials, the company appears to be positioning itself as a leader in the radiopharmaceutical space.
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