On November 10, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported that the Company will present two posters at the Society for Neuro-Oncology (SNO) 28th Annual Meeting, taking place November 15-19, 2023, in Vancouver, British Columbia (Press release, In8bio, NOV 10, 2023, View Source [SID1234637463]). The posters highlight the potential of IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI), genetically modified and chemotherapy-resistant gamma-delta T cells to treat patients with newly diagnosed glioblastoma multiforme (GBM). The first poster is a TIPs poster detailing the study design for INB-400, the company-sponsored Phase 2 trial and the second will be a "late-breaker" poster providing updated clinical data from the Phase 1 INB-200 trial.

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"Having recently initiated enrollment in our Phase 2 trial, we are excited to share details on the study’s design and look forward to providing updates as the trial progresses," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "We are encouraged by the safety and preliminary efficacy signal we have seen in our Phase 1 trial treating GBM patients with autologous, genetically modified gamma-delta T cells. Using this approach, we hope to provide a new treatment for patients living with this cancer who currently have few therapeutic options and limited survival."

Details for the SNO 2023 presentations:

Abstract #: CTIM-42 (Late-breakers)
Title: INB-200: Phase 1 Study of Gene Modified Autologous Gamma-delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)

Presenter: Mina Lobbous, MD, MSPH, Cleveland Clinic, Case Western Reserve University
Session Name: Clinical Trials: Immunologic
Date and Time: Friday, November 17, 2023, 7:30 – 9:30 PM PT
Location: Exhibit Hall A/B

Abstract #: CTIM-35 (TIPs)
Title: INB-400 Phase 1b/2 Drug Resistant Immunotherapy with Activated, Gene Modified Allogeneic or Autologous γδ T Cells in Combination With Maintenance Temozolomide Recurrent or Newly Diagnosed Glioblastoma

Presenter: Burt Nabors, MD, Heersink School of Medicine, University of Alabama at Birmingham
Session Name: Clinical Trials: Immunologic
Date and Time: Friday, November 17, 2023, 7:30 – 9:30 PM PT
Location: Exhibit Hall A/B

Phase 2 Clinical Trial of INB-400 in GBM
The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in "Arm A" of the study. The primary endpoint of this arm is the 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.

INB-400 was granted Orphan Drug Designation (ODD) by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a disease with significant unmet need, with limited treatment options and poor associated outcomes. The treatment for this highly aggressive brain cancer, has remained largely unchanged for more than 18 years, with a median progression-free survival (PFS) of 6-7 months and median overall survival (OS) of only 14-16 months.

About INB-400
INB-400 is IN8bio’s DeltEx autologous and allogeneic drug-resistant immunotherapy (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 DeltEx DRI technology.