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Highlights
- Radiopharm has secured the Orphan Drug Designation for its DUNP19 technology, studied in osteosarcoma.
- The development will offer a range of benefits and incentives to RAD including tax benefits and market exclusivity to the drug post approval.
- DUNP19 is the first-in-class therapy that can overcome a major limitation of currently available antibodies for cancer treatment.
- Osteosarcoma is a rare bone cancer with surgery and chemotherapy the only currently available treatments.
Radiopharm Theranostics (ASX:RAD) has provided an important update on one of the latest assets added to its portfolio.
The ASX-listed radiopharmaceuticals player has bagged the Orphan Drug Designation for its DUNP19 technology to treat a rare bone cancer known as osteosarcoma.
Radiopharm’s shares closed the day’s trade at AU$0.180 on 09 Sep 2022. The company has a market capitalisation of AU$43.21 million.
What does Orphan Drug Designation mean for RAD
The excellent recognition has been granted by the US Food & Drug Administration (FDA). The FDA grants the Orphan Drug Designation to biological products or drugs with the potential for diagnosis, prevention or treatment of rare diseases and conditions.
The Orphan drug designation provides benefits such as user fee exemptions, tax credits for qualified clinical trials, and a potential seven years of market exclusivity post approval.
RAD-UCLA Licensing agreement for DUNP19
In April this year, Radiopharm signed an exclusive licensing agreement with the University of California Los Angeles (UCLA) Technology Development Group (UCLA-TDG) for the LRRC15 antibody “DUNP19”.
Under the agreement, Radiopharm gained the rights to develop DUNP19 as an Antibody-Drug Conjugates (ADC) within radiotherapy as part of its clinical development pipeline. Its major indication is osteosarcoma.
The First-in-class therapy
Expression of LRRC15 is done by cancer cells and the surrounding tumour microenvironment (TME) cells with very high production in aggressive tumours resistant to treatment. However, it is not produced by healthy normal tissues.
DUNP19 is the first-in-class therapy that can overcome a major limitation of the currently available antibodies for cancer treatment, i.e., they omit TME cells. It is a promising antibody with the dual potential to find and destroy both cancer and TME cells that make up more than 50% of tumour masses. It also has faster internalisation properties.
Osteosarcoma is majorly prevalent in children, young adults, and adolescents. Currently, surgery and chemotherapy are the only available treatments for the disease.
The company believes that osteosarcoma is a perfect candidate for proof-of-concept testing as the aggressive form of this disease has one of the highest expressions of LRRC15.
