A bone cancer treatment technology licenced by ASX-listed Radiopharm Theranostics has been granted orphan drug designation by the United States Food and Drug Administration.
The approval is for a tumour-killing antibody known as DUNP19 that targets LRRC15, a substance produced by aggressive cancer cells and cells in the surrounding micro-environment, but not healthy normal tissue.
DUNP19 is unique in its dual action in killing both the cancerous tumour and micro-environment cells that make up most of the mass of a solid tumour.
Orphan drug designation recipients receive benefits and incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity following the drug’s approval.
The orphan status can be granted by the US FDA for a drug or biologic product with the potential to diagnose, prevent or treat rare diseases and conditions.
In April, Radiopharm signed an exclusive licensing agreement with University of California Los Angeles Technology Development Group to licence the promising antibody.
The agreement permits Radiopharm to develop radiotherapeutic products using DUNP19, however UCLA retains ownership of the DUNP19 intellectual property.
It was developed by Dr David Ulmert PhD and assistant-professor-in-residence at UCLA Molecular and Medical Pharmacology whose department is described as one of the world’s premier developers of novel compounds to battle malignant diseases.
Radiopharm Theranostics Chief Executive Officer and Managing Director, Riccardo Canevari said: “This is a very positive development for one of the latest additions to Radiopharm’s portfolio of assets and demonstrates independent validation of the potential we saw in the DUNP19 technology. 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.”
A focus treatment usage for the antibody is on osteosarcoma, a bone cancer primarily affecting children, adolescents and the young adult population.
Aggressive osteosarcoma is one of the highest producers of LRRC15, making it an ideal candidate for proof-of-concept testing of DUNP19.
Radiopharm has a long pipeline of products, tackling a range of cancers, at various stages of pre-clinical and clinical trials.
In June the company signed a deal with Israeli company Isotopia Molecular Imaging that secures supply of a key component needed to develop its suite of radiopharmaceutical products.
Under the agreement, Isotopia will supply a high-quality radioisotope called Lutetium-177 for clinical research, development, manufacture and early-stage commercialisation of Radiopharm’s diagnostic and therapeutics products.
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