Radiopharm Theranostics Ltd (ASX:RAD) has gained a suite of tax credits, fee exemptions and market exclusivity benefits for its osteosarcoma treatment DUNP19 following an orphan drug designation (ODD) by the US Federal Drug Administration (FDA).
Orphan drug designations are awarded to drugs or biologic products that have potential to improve diagnoses, prevention or treatment of rare diseases and conditions.
Recipients receive several benefits and incentives, including tax credits for qualified clinical trials, exemptions from user fees and potentially seven years of market exclusivity should the treatment be approved.
ODD demonstrates independent validation
“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,” Radiopharm Theranostics CEO and managing director Riccardo Canevari said.
“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 has an exclusive licensing agreement with the University of California Los Angeles (UCLA) Technology Development Group (UCLA-TDG) for the promising LRRC15 antibody “DUNP19”.
An unmet medical need
The treatment targets LRCC15, an expression produced by cancer cells and the surrounding tumour microenvironment (TME), but not in healthy tissue. LRRC15 production is very high in aggressive and treatment-resistant tumours.
Current antibody treatments are unable to target this tumour microenvironment, while the DUNP19 antibody has a novel ability to effectively find, internalise and destroy both cancer and TME cells.
RAD sees DUNP19 as a first-in-class therapy due to this double-targeting action as well as its fast-paced internalisation.
Radiopharm chose osteosarcoma as the indication for DUNP19 because aggressive osteosarcomas have one of the highest levels of LRRC15 expression and are therefore an ideal candidate for proof-of-concept trials.
Surgery and chemotherapy are currently the only treatments available for osteosarcoma, a type of bone cancer that mostly affects children, adolescents and young adults.