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- The US Food and Drug Administration grants Radiopharm Theranostics’ (RAD) DUNP19 technology Orphan Drug Status
- The company is busy developing the product as a treatment for bone cancer osteosarcoma, which mainly affects children and young adults
- Orphan Drug status is used to incentivise the development of new drugs that treat rare diseases and comes with benefits like tax credits for clinical trials and market exclusivity
- Radiopharm says DUNP19 differs from other available antibodies because it uniquely targets the surrounding microenvironment of tumours, which can make up over 50 per cent of tumour masses
- RAD shares were up 5.9 per cent and trading at 18 cents at 12:51 pm AEST
The US Food and Drug Administration (FDA) has granted Radiopharm Theranostics’ (RAD) DUNP19 bone cancer treatment technology Orphan Drug Status.
This designation is granted by the FDA to support the development of new drugs that treat rare diseases, and it comes with a number of benefits such as tax credits for clinical trials, the waiving of user fees and a potential seven years of market exclusivity post-approval.
Radiopharm’s DUNP19 product is designed to treat a type of bone cancer that mainly affects children and young adults.
Specifically, the antibody was developed to treat LRRC15 expression, which is produced by cancerous cells and the surrounding tumour microenvironment but not by healthy tissue.
Radiopharm applied for Orphan Drug Designation to use DUNP19 to treat bone cancer osteosarcoma, which has one of the highest expressions of LRRC15 in aggressive cases.
The company said because of the high prevalence of LRRC15 in osteosarcoma, it was an “ideal candidate for proof-of-concept testing”.
RAD said DUNP19 was unique in that it not only targeted LRRC15 in cancerous cells but also in the surrounding microenvironment, which no current antibodies on the market do.
The surrounding microenvironment of tumours can account for over 50 per cent of tumour masses.
Currently, the only treatments available for osteosarcoma are surgery and chemotherapy.
The Orphan Drug designation follows RAD signing an exclusive licensing agreement with the University of California Los Angeles (UCLA) Technology Development Group for the development of DUNP19 in April.
“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,” Radioopharm CEO and Managing Director Riccardo Canevari.
“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.”
RAD shares were up 5.9 per cent and trading at 18 cents at 12:51 pm AEST.
