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IN8bio Announces FDA Clearance to Initiate a Phase 2 Clinical Trial of INB-400 Gamma-Delta T Cells for Glioblastoma
Phase 2 clinical trial initiation expected in 2023 Company to host conference call to discuss recent clinical updates, including updated data from the Phase 1
About this update from In8bio, Inc.
[{"type":"text","content":"Phase 2 clinical trial initiation expected in 2023 Company to host conference call to discuss recent clinical updates, including updated data from the Phase 1 clinical trial of INB-100 being presented at the American Society of Hematology (ASH) on Monday, December 12th at 8:30 a.m. ET NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- 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 DetailsIN8bio 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 cl...