IN8bio Receives FDA Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma
Cell TherapyOrphan DrugImmunotherapy
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
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)
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.
"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 IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic DRI technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or “off-the-shelf” DeltEx DRI technology.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio is initiating INB-400, a company-sponsored Phase 2 clinical trial in newly diagnosed glioblastoma following IND clearance in late 2022. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.
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