On November 20, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies, reported data demonstrating that all patients treated with INB-200 who completed mandated doses have exceeded a progression-free survival (PFS) of seven months to date (Press release, In8bio, NOV 20, 2023, View Source [SID1234637839]). This survival data shows 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 (GBM). The poster highlighting the updated clinical data from the Phase 1 INB-200 trial was presented at the Society for Neuro-Oncology (SNO) 28th Annual Meeting in Vancouver, British Columbia on November 17, 2023.
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"Every patient in the Phase 1 trial that completed the mandated doses has exceeded the standard-of-care median progression-free survival of four to seven months, with one patient in Cohort 2 remaining alive and progression free past 28.5 months following three doses," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "We are excited by the safety and efficacy results across cohorts in this study and look forward to dosing additional patients with the added hope of improving their treatment outcomes. Following up on our oral presentation at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, these encouraging results demonstrate the early promise of IN8bio’s DeltEx DRI gamma-delta T cells for treating GBM patients and potentially other solid tumor cancers."
The current standard-of-care regimen for newly diagnosed GBM consists of primary resection, six weeks of chemoradiation therapy followed by six cycles of maintenance monthly temozolomide therapy, which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. The Phase 1 trial assesses the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to standard-of-care maintenance therapy. The trial assesses three different dosing regimens from a single dose delivered on cycle 1 day 1 in Cohort 1, to three doses delivered on day 1 of cycles 1-3 in Cohort 2, to finally six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1×107 cells per dose, however the number of doses varies depending on the cohort of enrollment.
The poster presentation at SNO included efficacy and safety data as of the data cutoff on October 20, 2023. Ten patients have been treated with INB-200: three in Cohort 1 (1 dose), four in Cohort 2 (3 doses) and three in Cohort 3 (6 doses). Key findings from the ongoing study include:
All patients who completed mandated doses surpassed a PFS of seven months, with most also exceeding the expected PFS based on their age and tumor status.
One patient (009) with an IDH-mutant glioma remains alive and progression free at 28.5+ months; comparative data published in the New England Journal of Medicine (NEJM) in August 2023 demonstrate that IDH-mutant patients in the control arm of a clinical trial demonstrated a median PFS of 11.1 months.
No treatment-related serious adverse events (SAEs), dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS) have been reported in any cohort.
The most common treatment-emergent adverse events (TEAEs) were mostly Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care temozolomide.
Preserved gamma-delta T cells found in relapsed tumor 148 days after initial DRI infusion, pointing to durability of gamma-delta T cells in treating cancer.
The poster is available on the Company’s website here.
About INB-200
INB-200 is a genetically modified autologous 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 treatment approach enabling 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 and our initial indication is in GBM.