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IN8bio Receives FDA Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma
First-ever orphan drug designation for genetically modified gamma-delta T cell therapies This orphan drug designation offers potential 7-year market
About this update from In8bio, Inc.
[{"type":"text","content":"First-ever orphan drug designation for genetically modified gamma-delta T cell therapies This orphan drug designation offers potential 7-year market exclusivity for both autologous (INB-400) and allogeneic (INB-410) candidates INB-400 is an autologous, genetically engineered gamma-delta T cell therapy that was recently cleared by the FDA for a Phase 2 trial targeting newly diagnosed glioblastoma multiforme (GBM) NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, announces FDA orphan drug designation for INB-400 and INB-410, covering a broad range of malignant glioma treatments, including newly diagnosed GBM. As an industry leader in gamma-delta T cell development, this milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as 7-year market exclusivity. In December 2022, the FDA cleared IN8bio's investigational new drug application (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board (IRB) review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023. \"Our goal is to achieve our Mission of Cancer Zero by eradicating cancer cells and improving patient outcomes,\" said IN8bio CEO and co-founder, William Ho. \"Our novel approach combines engineered, chemo-resistant gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximize tumor killing, and eliminate more cancer cells. We eagerly anticipate enrolling our first Phase 2 patients for INB-400 later this year.\" GBM, a highly aggressive and difficult-to-treat brain cancer, has remained largely unchanged in treatment options for over 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months. Orphan drug designation benefits IN8bio through incentives such as potential additional market exclusivity following approval, tax credits on qualified US clinical trials, eligibility for orphan drug grants, and exemption from certain fees. With this milestone, IN8bio continues to progress its pipeline programs and will provide further clinical updates on its pipeline at medical meetings throughout the year. About INB-400 INB-400 is IN8b...