Radiopharm scores second USFDA approval for cancer fight

A cancer treatment licenced by ASX-listed Radiopharm Theranostics has been recognised with another endorsement from the US Food and Drug Administration after receiving rare paediatric disease designation.

The approval is for a tumour-killing antibody known as DUNP19 used to treat osteosarcoma — a type of bone cancer that primarily affects children, adolescents and young adults.

The rare paediatric disease, or “RPD” program aims to advance the development of drugs with the potential to treat serious and rare paediatric diseases.

RPD designation allows a company to receive a priority review voucher that can expedite approval or be transferred or sold to another company once a product is authorised for market.

DUNP19 targets LRRC15, a substance produced by aggressive cancer cells and cells in the surrounding micro-environment, but not healthy normal tissue.

The antibody is unique in its ability to kill both the cancerous tumour and micro-environment cells that make up most of the mass of a solid tumour.

Just last week DUNP19 was granted orphan drug designation by the USFDA that allows Radiopharm 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.

Radiopharm Theranostics Chief Executive Officer 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.”

In April, Radiopharm signed an exclusive licensing agreement with University of California Los Angeles Technology Development Group to licence DUNP19.

The agreement allows Radiopharm to develop radiotherapeutic products using the antibody, 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 says because aggressive osteosarcoma has one of the highest expressions of LRRC15, it’s an ideal candidate for proof-of-concept testing as the disease can only currently be treated with surgery or chemotherapy.

The latest approval from the USFDA also has the potential to provide Radiopharm with a significant cash boost with recent sales of priority review vouchers netting more than $US100 million.

In February this year global biotechnology company BioMarin Pharmaceutical sold the priority review voucher it received from the USFDA for its VOXZOGO product for a lump sum of $US110 million.

Radiopharm has a long pipeline of products, tackling a range of cancers, at various stages of pre-clinical and clinical trials.

Earlier this week the ASX-listed company partnered with a US research centre to launch Radiopharm Ventures — a joint venture that aims to develop radiopharmaceutical therapeutic products to help in the fight against cancer.

The new company has been created in partnership with the University of Texas MD Anderson Cancer Centre and will initially focus on developing at least four therapeutic products based on the centre’s intellectual property.

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