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news.MTG Biotherapeutics has received orphan drug designation from the US Food and Drug Administration for MTG-201, an advanced biologic therapy targeting Dickkopf-3 gene defects in various cancers, to treat malignant mesothelioma, a rare, aggressive cancer.
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The Dickkopf-3 gene produces a protein called Reduced Expression in Immortalized Cells protein (REIC), which is vital in the downstream mechanism of apoptosis and when absent cancer cells cannot die.
Mesothelioma most often affects the lining of the pleural cavity and the available treatments are very limited, particularly for patients with advanced disease.
The company noted that particularly, there is a need to develop therapies like MTG-201 that can directly attack the mesothelioma cancer cells and induce the immune system against the cancer, to put in combination with anti-CTLA-4 antibodies now in development for this disease.
MTG president and CEO Richard Lowenthal said: "There is a significant need for new treatment options for patients with mesothelioma given this is one of the most aggressive and poorly treated cancers.
"MTG-201 represents a very novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer.
"MTG has already demonstrated that ability of MTG-201 to induce selective apoptosis in Phase I studies for prostate cancer, another cancer immortalized by hypermethylation of the Dickkopf-3 gene.
"Mesothelioma has been found to be the most sensitive cancer to this mechanism of action and as such we are moving MTG-201 into Phase I development for this indication."
MTG-201 is part of a pipeline of immuno-oncology therapies based on REIC protein expression in cancers with hypermethylation of the Dickkopf-3 gene.
Apart from mesothelioma, MTG-201 is currently being developed for the treatment of prostate cancer, while preclinical programs are ongoing to treat liver (HCC) and bladder cancers.