On May 23, 2024 IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported an upcoming presentation of updated results from its fully enrolled Phase 1 study of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 31st – June 4th in Chicago, Illinois (Press release, In8bio, MAY 23, 2024, View Source [SID1234643604]). INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delta T cells as a potential first-line treatment for patients with newly diagnosed glioblastoma multiforme (GBM).
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"The current standard-of-care for newly diagnosed GBM has not advanced progression-free survival (PFS) beyond 4-7 months or overall survival beyond 14-16 months for over two decades," said William Ho, CEO and co-founder, IN8bio. "We’re excited to update the status of patients who received INB-200 for front-line GBM in addition to standard-of-care at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. We believe these findings will continue to validate the potential of DeltEx DRI as a novel therapy for patients with GBM. We are advancing our gamma-delta T cell therapy to help address this significant unmet need and look forward to presenting additional trial results at ASCO (Free ASCO Whitepaper) and throughout the year."
Details of the 2024 ASCO (Free ASCO Whitepaper) poster presentation are provided below:
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
Abstract: The Phase 1 study enrolled 23 patients with newly diagnosed GBM who exhibited adequate organ function and a Karnofsky Performance Status (KPS) of ≥ 70%. Patients were administered 1, 3, or 6 doses of DeltEx DRI, consisting of 1 x 107 DRI cells, into the resection cavity along with 150 mg/m2 of intravenous TMZ on Day 1 and oral TMZ on days 2-5 of each Stupp maintenance cycle.
DeltEx DRI was successfully infused with peripheral TMZ-based lymphodepletion evidenced with near or below normal range T, B, and NK subsets for up to one year. The majority of patients dosed exceeded the expected median PFS of 7 months with Stupp therapy alone, demonstrating a continued encouraging trend in PFS. Long-term follow-up for durability of PFS and OS continue.
The Phase 1 study results reported no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity. The most common adverse events were decreased white blood cell and platelet count, asthenia, fatigue, hydrocephalus, headache, decreased appetite, urinary tract infection, thrombosis, and balance disorder.
Autologous DeltEx DRI is a gene-modified autologous gamma-delta T cell therapy designed for the treatment of newly diagnosed GBM patients receiving maintenance TMZ therapy. Gamma delta T cells can target NKG2D ligands that are upregulated on tumor cells following exposure to alkylating chemotherapy, leveraging the unique capabilities of this investigational therapy to enable concomitant therapy and continued surveillance against tumor cells.
More details of the Phase 1 study can be found at www.clinicaltrials.gov (NCT04165941).
Abstract can be accessed online at View Source beginning at 5:00 p.m. EDT on May 23, 2024.