IN8bio Announces FDA Clearance to Initiate a Phase 2 Clinical Trial of INB-400 Gamma-Delta T Cells for Glioblastoma
08 Dec 2022
Cell TherapyImmunotherapyPhase 1INDPhase 2
NEW YORK, NY, USA I December 08, 2022 I IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed glioblastoma (GBM). The study will assess the safety, efficacy and tolerability of genetically modified DeltEx drug-resistant immunotherapy (DRI) cells at leading medical centers across the United States.
“Obtaining clearance to begin the INB-400 Phase 2 clinical trial is an important milestone for IN8bio as it is our first company-sponsored IND. This milestone demonstrates the clinical, regulatory and CMC capabilities of the IN8bio team in continuing to advance novel gamma-delta T cell therapies to cancer patients,” said William Ho, Chief Executive Officer and co-founder of IN8bio. “The clinical program is designed to eventually assess DeltEx DRI with both autologous and allogeneic approaches in both the front-line and relapsed setting. We believe the insights we unlock in GBM will be essential as we apply our DeltEx platform across multiple solid tumor cancers.”
The Phase 2 clinical trial will commence with the enrollment of newly diagnosed GBM patients, with the initial arm assessing autologously derived MGMT-modified gamma-delta T cells. In line with recent FDA guidance, the Company is planning to expand the trial to include an allogeneic DeltEx DRI drug product in relapsed refractory GBM and potentially the frontline setting. The primary endpoint of the study is overall survival (OS); secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP).
Conference Call Details
IN8bio will host a conference call and webcast on Monday, December 12th at 8:30 a.m. ET to review recent clinical updates, including updated data from the Phase 1 clinical trial of INB-100 being presented at ASH. The webcast can be accessed by clicking the link: https://edge.media-server.com/mmc/p/vfodqi28 and can also be accessed on the Events & Presentations page of the Company’s website.
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 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.
SOURCE: IN8bio
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