A pancreatic cancer treatment developed by ASX-listed Radiopharm Theranostics has been granted crucial orphan drug designation by the United States Food and Drug Administration just weeks before clinical trials begin.
The approval is for the company’s patented RAD301 integrin technology that aims to assist with the imaging and treatment of patients with pancreatic ductal adenocarcinoma.
Radiopharm’s treatment is designed to bind to a specific cellular marker commonly found in cancer and could help with early detection. The marker is found in high density on most pancreatic carcinoma cells, which the company says makes it an attractive diagnostic and therapeutic target.
Orphan drug designation recipients receive benefits and incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity following the drug’s approval. The orphan status can be granted by the USFDA for a drug or biologic product with the potential to diagnose, prevent or treat rare diseases and conditions.
In January, the USFDA granted Radiopharm investigational new drug approval to allow the company to test RAD301 in the real world with trials set to begin this month and continue until September.
The company has now received two approvals for orphan drug designation status for its treatments. The first was achieved in September for a tumour-killing antibody known as DUNP19 that targets LRRC15, a substance produced by aggressive cancer cells and cells in the surrounding micro-environment, but not in healthy normal tissue.
DUNP19 is unique in its dual action in killing both the cancerous tumour and micro-environment cells that make up most of the mass of a solid tumour.
The FDA’s decision highlights the significant demand for effective imaging agents for improved and earlier diagnosis of pancreatic cancer, which has one of the highest levels of unmet needs among all cancer types. Radiopharm chief executive officer and managing director Riccardo Canevari
RAD301 is among a swag of cancer diagnostic and therapeutic developments in Radiopharm’s arsenal that could prove game-changers in treating many forms of the disease.
In mid-December, its breast cancer-diagnosing product RAD201 scored well on test results when no adverse effects were recorded among six patients taking part in the imaging trial. In June, it penned a deal with a US biotech firm for an agent which could detect and treat aggressive brain tumours.
The company, alongside oncology provider GenesisCare, has also launched Australian trials of its potentially lung cancer-busting nanobodies. A tumour-killing antibody for bone cancer treatment has also passed an early approval stage in the US.
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