Targepeutics lead drug, GB13, molecularly targets and kills cancers, including high grade glioma with promise against numerous other solid tumors.HERSHEY, PA, USA, January 21, 2021 /EINPresswire.com/ -- Targepeutics Inc, a biopharmaceutical company advancing targeted oncology conjugates, today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted its lead therapeutic, GB13, orphan drug status for the treatment of malignant glioma.
“Malignant glioma broadly includes many types of brain cancer, including glioblastoma, that remain difficult to treat with a large unmet medical need. This orphan drug designation is an important milestone for Targepeutics as we strive to broaden the clinical utility of GB13,” said Sil Lutkewitte, President of Targepeutics.
Orphan drug status is granted by the FDA to support development of drugs and biologics for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation includes various development incentives, including tax credits for qualified clinical studies, a waiver of the new drug application fee, and market exclusivity following approval. Orphan designation covers the active moiety, IL13.E13K, targeting cancer cells and other principal molecular structural features of GB13.
GB13 is the lead product and the most advanced program in Targepeutics unique targeted-drug conjugate (TDC) platform. GB13 is a cancer targeted toxin directed against the Interleukin 13 Receptor alpha 2, IL13Ra2, a cell-surface protein present on many solid cancers but not on normal cells. GB13 binds to IL13Ra2 on cancer cells via its functional targeting element, IL13.E13K, delivers the connected toxin, pseudomonas exotoxin (PE), and kills the targeted cancer cell. Targepeutics has a streamlined development program for GB13, including multiple viable target cancers and delivery in combination with other agents. Visit www.Targepeutics.com
About Malignant Glioma
Glioma is the most common type of primary brain tumor with subtypes such as glioblastoma (GBM), astrocytoma, ependymoma, and oligodendroglioma. Among these brain cancers, GBM is the most aggressive with median survival from diagnosis of 15-17 months. Another target of interest is Diffuse Intrinsic Pontine Glioma (DIPG), a pediatric brain stem cancer, with less than a 10% two-year survival rate. Many malignant glioma express very high levels of the GB13 target receptor, IL13R2, allowing targeted therapeutics to selectively bind and kill cancer cells.
Targepeutics has an intellectual property portfolio including several issued patents and numerous additional patens pending, focused on novel targeted oncology therapeutics and diagnostics. Targepeutics patents and patents pending include the use of a mutant form of Interleukin 13, IL13.E13K, which preferentially binds to cancer specific IL13Ra2 but not to the broadly expressed, non-cancer specific IL13Ra1. This Orphan drug designation provides regulatory and other incentives accelerating clinical development of GB13 and facilitating funding opportunities. Targepeutics is currently securing funds to support clinical development of GB13.