On June 3, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies, reported encouraging preliminary clinical data of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 1, 2024 (Press release, In8bio, JUN 3, 2024, View Source [SID1234644014]).

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The preliminary data demonstrated that 92% of evaluable patients treated with INB-200 exceeded a median PFS of 7 months (median follow-up: 11.7 months) with concomitant temozolomide (TMZ), as of a data cutoff date of May 30, 2024. The survival data along with radiographic improvements are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with newly diagnosed glioblastoma (GBM).

The Phase 1 study assessed the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to maintenance therapy with TMZ. The trial assessed the administration of 1×107 cells per dose across three different dosing regimens increasing from a single dose delivered on cycle 1 day 1 during maintenance in Cohort 1, to three doses delivered on day 1 of cycles 1-3 in Cohort 2, to six doses delivered on day 1 of cycles 1-6 in Cohort 3. Thirteen patients have been enrolled and treated with INB-200, including three patients in Cohort 1 (1 dose), four patients in Cohort 2 (3 doses) and six patients in Cohort 3 (6 doses).

"For far too long, there has been little advancement for patients with GBM to improve their treatment outcomes," said Burt Nabors, M.D., Division Director, Neuro-oncology at the Heersink School of Medicine at the University of Alabama at Birmingham. "The addition of multiple intracranial injections of IN8bio’s DeltEx DRI gamma-delta T cells shows the potential for extending progression-free survival in this patient population when administered in combination with the current standard of care used to treat newly diagnosed glioblastoma patients."

The current standard of care for newly diagnosed glioma patients consists of primary resection, six weeks of daily chemoradiation therapy followed by six cycles of monthly maintenance TMZ therapy (Stupp regimen), which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. All of the patients in the Phase 1 study that received all of their protocol defined treatments with INB-200 exceeded a median PFS of 7 months, including one patient in Cohort 2 that remains alive and progression free for nearly three years.

"The safety profile of gamma-delta T cells continues to be strong across all three dose cohorts with no cell therapy-related toxicities such as immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome reported in patients receiving up to the maximum dose of six infusions of the therapy," said Trishna Goswami, M.D., Chief Medical Officer, IN8bio. "We are now dosing newly diagnosed patients in Arm A of the Phase 2 study with INB-400, evaluating up to six infusions of our autologous gamma-delta T cells in combination with the Stupp protocol."

The poster presentation at ASCO (Free ASCO Whitepaper) included promising activity and safety data for the fully enrolled trial, as of the data cutoff date of May 1, 2024.

Key findings from the ongoing Phase 1 study:

All patients who completed all protocol mandated doses surpassed a median standard-of-care PFS of 7 months, with a majority also exceeding the expected PFS based on their age and MGMT status of their tumors.
92% of evaluable patients treated with INB-200 for GBM exceeded a median PFS of 7 months achieved with the standard-of-care regimen (Stupp regimen).
One patient with an IDH-mutant glioma remains alive and progression free at 34.9+ months; IDH-mutant patients in a recently published clinical trial of an IDH inhibitor demonstrated a median PFS of 11.1 months in the control arm and 28.5 months in the experimental arm.
No treatment-related serious adverse events, dose-limiting toxicities, cytokine release syndrome, infusion reactions, or immune effector cell-associated neurotoxicity syndrome have been reported in any cohort.
The most common treatment emergent adverse events were Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care TMZ.
Preserved gamma-delta T cells were found in relapsed tumor 148 days after initial DRI infusion in one patient with paired biopsies, pointing to durability of DRI gamma-delta T cells.
Radiographic evaluation pre- and post-treatment included resolution of midline shift in one patient with evidence of changes in enhancement attributed to treatment effect in multiple patients. One subject was found to have a 36% decrease in a lesion attributed to positive treatment effect.
"As these encouraging results from our ongoing INB-200 Phase 1 study continue to mature, we look forward to reporting additional results from a long-term follow-up of cohort 3 at future medical meetings," said William Ho, CEO and co-founder, IN8bio.

Poster details:
Abstract #: 2042
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)
Presenter: Mina Lobbous, MBChB, MD, MSPH, University of Alabama at Birmingham
Session Name: Central Nervous System Tumors
Date and Time: Saturday, June 1, 2024 from 10:00 a.m. – 1:00 p.m. EDT
Poster Board: #341

The poster presentation is accessible on the Company’s website here.

About INB-200
INB-200 is a genetically modified autologous DeltEx DRI product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy-resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic investigational treatment approach designed to enable gamma-delta T cells to persist in the presence of chemotherapy and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors in an initial indication of GBM.