IN8bio to Present INB-200 Phase 1 Glioblastoma Data at 2024 ASCO Meeting

NEW YORK, May 23, 2024 - IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on gamma-delta T cell therapies, is set to present updated results from its Phase 1 study of INB-200 during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place from May 31st to June 4th in Chicago, Illinois. This study centers on INB-200, an autologous Drug Resistant Immunotherapy (DeltEx DRI), aimed at providing a first-line treatment for newly diagnosed glioblastoma multiforme (GBM) patients.

The current standard treatment for newly diagnosed GBM has not significantly improved progression-free survival (PFS) beyond 4-7 months or overall survival beyond 14-16 months over the past 20 years. William Ho, CEO and co-founder of IN8bio, expressed enthusiasm about the upcoming presentation, noting that the updated patient status for INB-200, combined with the standard-of-care, could reinforce the therapy's potential. Ho emphasized the importance of their gamma-delta T cell therapy in addressing the unmet medical needs of GBM patients and hinted at more trial results being shared at ASCO and throughout the year.

The details of the 2024 ASCO poster presentation are as follows:
- Poster Title: INB-200: Fully enrolled Phase 1 study of gene-modified autologous gamma-delta (γδ) T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ)
- Authors: Mina Lobbous, Trishna Goswami, Lawrence Lamb, Kate Rochlin, Thriumaine Pillay, Mariska ter Haak, Louis Nabors
- Date/Time: Saturday, June 1, 2024, from 10:00 a.m. – 1:00 p.m. EDT
- Presenter: Dr. Mina Lobbous, University of Alabama at Birmingham
- Session Title: Central Nervous System Tumors
- Abstract #: 2042
- Poster Board: #341

The Phase 1 study included 23 patients with newly diagnosed GBM who had sufficient organ function and a Karnofsky Performance Status (KPS) of 70% or higher. Participants received 1, 3, or 6 doses of DeltEx DRI, with each dose containing 1 x 10^7 DRI cells, administered into the resection cavity. This was accompanied by 150 mg/m^2 of intravenous TMZ on Day 1 and oral TMZ on Days 2-5 of each Stupp maintenance cycle. The DeltEx DRI was successfully infused alongside peripheral TMZ-based lymphodepletion, which maintained near or below normal range T, B, and NK cell subsets for up to a year.

The majority of patients exceeded the expected median PFS of 7 months with Stupp therapy alone, showing an encouraging trend in PFS. Long-term follow-up continues to assess PFS and overall survival (OS) durability. No dose-limiting toxicities, cytokine release syndrome, or neurotoxicity were reported. Common adverse events included reduced white blood cell and platelet counts, asthenia, fatigue, hydrocephalus, headaches, decreased appetite, urinary tract infections, thrombosis, and balance disorders.

DeltEx DRI is a gene-modified autologous gamma-delta T cell therapy intended for newly diagnosed GBM patients undergoing maintenance TMZ treatment. Gamma delta T cells can target NKG2D ligands upregulated on tumor cells after exposure to alkylating chemotherapy, allowing for continued tumor cell surveillance.

IN8bio, a company specializing in gamma-delta T cell-based immunotherapies for cancer, is conducting various trials including INB-400 in a Phase 2 trial for GBM and Phase 1 trials for solid and hematologic tumors. 

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