Radiopharm Theranostics (ASX:RAD) has announced that the US FDA has granted Orphan Drug Designation for its DUNP19 technology for the treatment of osteosarcoma.
Orphan Drug Designation can be granted by the FDA for a drug or biological product with the potential to diagnose, prevent or treat rare diseases and conditions.
Recipients of the designation 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.
Radiopharm signed an exclusive licensing agreement with the University of California Los Angeles (UCLA) Technology Development Group (UCLA-TDG) for the LRRC15 antibody 'DUNP19' in April 2022.
LRCC15 expression is produced by cancer cells and the surrounding tumour microenvironment, but not by healthy normal tissues, and LRRC15 production is very high in aggressive and treatment-resistant tumours.
DUNP19 is a first-in-class therapy thanks to its unique dual-action tumour targeting and to its fast internalisation.
Radiopharm CEO and managing director Riccardo Canevari said, “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. 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.”