Radiopharmaceutical specialist, Radiopharm Theranostics (ASX:RAD), announced that the US FDA has granted an Orphan Drug Designation for its DUNP19 technology for the treatment of osteosarcoma.

The grant follows the agreement signed with University of California Los Angeles (UCL) in April to license the LRRC15 antibody, DUNP19, to Radiopharm.

Studies have shown that LRCC15 expression is produced by cancer cells and the surrounding tumour, but not by healthy normal tissues. LRCC15’s production is also very high in aggressive and treatment-resistant tumours.

While currently available antibodies for cancer treatment omit tumour micro-environment (TME) cells, the DUNP19 antibody has a unique ability to effectively find, internalise and destroy both cancer and TME cells.

Osteosarcoma meanwhile is a type of bone cancer that primarily affects children, adolescents and young adults, with surgery and chemotherapy the only currently available treatments.

As aggressive osteosarcoma has one of the highest expressions of LRRC15, Radiopharm believes it’s an ideal candidate for proof-of-concept testing.

The FDA’s Orphan Drug Designation will allow Radiopharm to receive benefits including tax credits for clinical trials, exemption form user fees, and a potential seven years of market exclusivity following the drug’s approval.

“This is a very positive development for one of the latest additions to RAD’s portfolio of assets, and demonstrates independent validation of the potential we saw in the DUNP19 technology,” said Riccardo Canevari, CEO of Radiopharm.

“The resulting benefits of orphan designation will allow us to continue the development work of DUNP19’s inventor Dr David Ulmert with an even greater level of confidence.”

Radiopharm aims to become a leader in the development of both diagnostic and therapeutic radiopharmaceuticals products for use in areas of high unmet medical needs like cancer.

Radiopharmaceuticals are deemed to be safe radioactive drugs that can be used as diagnostic or therapeutic tools.

In diagnostics, patients are given a very small amount of safe radioactive medication injected into the bloodstream. Then low energy radioisotopes are used to allow physicians to see and measure disease within the body, via imaging.



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