FDA grants important designation to Radiopharm Theranostics' DUNP19 technology

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Radiopharm Theranostics (ASX:RAD) has announced that the US FDA has granted Rare Pediatric Disease (RPD) Designation for its DUNP19 technology for the treatment of osteosarcoma.

The company said the RPD program is aimed at advancing the 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 marketing authorisation is granted.

A PRV can be used to expedite approval. It can also be transferred or sold to other companies. The price of the two recent examples of PRVs sales has ranged from US$105 million to US$110 million.

Radiopharm signed an exclusive licensing agreement with the 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 treatment-resistant tumours.

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.

Radiopharm Theranostics CEO and managing director Riccardo Canevari 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.”