On September 9, 2022 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, reported that the US Food & Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for its DUNP19 technology for the treatment of osteosarcoma (Press release, Radiopharm Theranostics, SEP 9, 2022, View Source [SID1234619598]).
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The RPD program is aimed at advancing development of drugs with the potential to treat serious, rare pediatric diseases.
RPD allows companies to receive a priority review voucher (PRV) from the FDA at the time a marketing authorization is granted. A PRV can be used by the Company to expedite approval, or can be transferred/sold to other companies for use in the same manner. The price of two recent examples of PRVs sales have ranged from US$105,0001 to US$110,0002.
Radiopharm signed an exclusive licensing agreement with University of California Los Angeles (UCLA) Technology Development Group (UCLA-TDG) for the promising 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 treatmentresistant tumours.
While currently available antibodies for cancer treatment omit tumour micro-environment (TME) cells, such as stromal and immune cells, which comprise >50% of tumour masses, the DUNP19 antibody has a unique ability to effectively find, internalize and destroy both cancer-, and TME cells. DUNP19 is a first-in-class therapy thanks to its unique dual action tumour targeting and to its fast internalization.
Osteosarcoma 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, it’s an ideal candidate for proof-of-concept testing.
Riccardo Canevari, CEO and Managing Director of RAD, said: "This is again excellent recognition of the work to date by Dr David Ulmert and his team and the potential for DUNP19 to make a significant difference to young patients in need. The RPD and associated PRV can be incredibly valuable and we look forward to progressing the DUNP19 program and eventually taking advantage of this."