IN8bio 的 INB-400/410 获得 FDA 孤儿药指定，用于治疗新诊断的胶质母细胞瘤

IN8bio's INB-400/410 Receives FDA Orphan Drug Designation for the Treatment of Newly Diagnosed Glioblastoma, the first Orphan Drug Designation for a genetically engineered gamma-delta T cell therapy. This orphan drug designation provides potential 7 years of 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 granted by the FDA. Approved for use in a Phase 2 trial in newly diagnosed glioblastoma multiforme (GBM).

IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, announced that INB-400 and INB-410 have received FDA Orphan Drug Designation for the treatment of a broad range of malignant gliomas, 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 provides potential incentives such as seven years of market exclusivity.

In December 2022, the FDA approved IN8bio's Investigational New Drug Application (IND) for a Phase 2 clinical trial of INB-400 in newly diagnosed GBM. Patient enrollment is expected to begin in the second half of 2023 as Institutional Review Board (IRB) review and site activation are underway.

"Our goal is to achieve our Zero Cancer mission by eradicating cancer cells and improving patient outcomes," said William Ho, CEO and co-founder of IN8bio. "Our new approach combines engineered, chemoresistant gamma-delta T cells with standard-of-care therapies to amplify immune signals, maximize tumor killing, and eliminate more cancer cells. We eagerly look forward to enrolling the first Phase 2 patients for INB-400 later this year."

GBM is a highly aggressive and difficult-to-treat brain cancer with treatment options that have remained largely unchanged for 18 years, with a median progression-free survival of 6-7 months and an overall survival of 14-16 months.

Orphan drug designation benefits IN8bio through incentives such as potential additional market exclusivity upon approval, tax credits for qualified U.S. clinical trials, orphan drug funding eligibility, and exemption from certain fees. With this milestone, IN8bio continues to advance its pipeline plans and will provide further clinical updates on its pipeline at medical conferences 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 use of DRI gamma-delta T cells to 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 with unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio's DeltEx platform uses allogeneic, autologous, iPSC and transgenic 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 candidate: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of leukemia patients undergoing hematopoietic stem cell transplantation. IN8bio is initiating INB-400, a company-sponsored Phase 2 clinical trial in newly diagnosed glioblastoma following IND approval in late 2022. IN8bio also has an extensive portfolio of preclinical programs focused on addressing other solid tumor types.