Radiopharm Theranostics Ltd (ASX:RAD) shares were trading 9% higher intra-day, at 18 cents, after securing a rare paediatric disease (RPD) designation for its DUNP19 technology for treating osteosarcoma by the US Food & Drug Administration (FDA).
The RPD program is aimed at advancing the development of drugs with the potential to treat serious, rare paediatric diseases.
Osteosarcoma is a type of bone cancer that primarily affects children, adolescents and young adults, with surgery and chemotherapy the only currently available treatments
RPD allows companies to receive a priority review voucher (PRV) from the FDA at the time a marketing authorisation 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$105,000 to US$110,000.
Background
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 treatment-resistant 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.
An ideal candidate for proof-of-concept testing
DUNP19 is a first-in-class therapy thanks to its unique dual-action tumour targeting and to its fast internalisation.
As aggressive osteosarcoma has one of the highest expressions of LRRC15, it’s an ideal candidate for proof-of-concept testing.
Radiopharm 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.”