British-Swedish drugmaker AstraZeneca has obtained orphan drug designation from the US Food and Drug Administration (FDA) for its anti-CTLA-4 monoclonal antibody, tremelimumab to treat malignant mesothelioma.
Mesothelioma is a rare and aggressive cancer that affects the lining of the lungs and abdomen, and limited treatments are available for this cancer.
Tremelimuma is a fully human monoclonal antibody that stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.
AstraZeneca global medicines development and immuno-oncology head and senior vice-president Robert Iannone said: “There is a significant need for new treatment options for patients with mesothelioma because fewer than 5% of patients currently survive beyond five years, even when they receive timely diagnosis and care.
“Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients.”
Along with its biologics research and development arm MedImmune, AstraZeneca has developed tremelimumab. It is part of the broad pipeline of immuno-oncology assets being developed by both firms to harness the body’s own immune system to fight cancer.
Tremelimumab is currently being studied in combination with AstraZeneca’s anti PD-L1 investigational immunotherapy MEDI4736 in tumour types, including non-small cell lung cancer and head and neck cancer.
In addition, it is being studied in combination with Iressa (gefitinib) in EGFR mutated non-small cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.
Image: Micrographs showing mesothelioma in a core biopsy. Photo: courtesy of Robertolyra.