FDA grants Orphan Designation to MTG-20

FDA granted Orphan Drug Designation for MTG-201, a therapy targeting Dickkopf-3 gene defects in various cancers, for the treatment of malignant mesothelioma.

The Dickkopf-3 gene produces a protein called REIC (Reduced Expression in Immortalized Cells protein), which is a critical protein in the downstream mechanism of apoptosis and when absent cancer cells cannot die.

By expressing REIC protein from within cancer cells, MTG-201 induces selective apoptosis due to ER stress, directly killing the cancer and reducing cancer burden. MTG-201 also stimulates the production of activated T-cell lymphocytes that specifically target and destroy residual cancer cells.

MTG-201, developed by MTG Biotherapeutics, is currently in phase I clinical trials for the treatment of prostate cancer and mesothelioma. Preclinical programs are ongoing for the treatment of liver and bladder cancers. MTG-201 is also being evaluated for efficacy in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 antibodies.

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FDA grants Orphan Designation to MTG-20

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FDA grants Orphan Designation to MTG-20

YOU MAY BE INTERESTED IN

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

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FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence

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Advancing symptom science at City of Hope and across the globe

Never miss an issue!

Login

FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence