IN8bio Reports Ongoing Remissions in Phase 1 INB-200 Trial at SNO Annual Meeting

A recent presentation at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX, showcased promising results from a Phase 1 trial of INB-200, a novel gamma-delta T cell therapy developed by IN8bio, Inc. This clinical-stage biopharmaceutical company is focused on creating innovative treatments for cancer patients, particularly those with solid tumors like glioblastoma (GBM).

The trial's findings indicate that 50% of patients who received multiple doses of INB-200 remained alive and in remission beyond the expected median overall survival (OS) associated with the standard-of-care Stupp regimen. In contrast, none of the patients who only received a single dose met this outcome. Additionally, biopsy results confirmed the presence and persistence of gamma-delta T cells, along with CD3+ and CD8+ T cells, within the brain tumor microenvironment in two patients treated with INB-200. This suggests a potential immune system benefit, as multi-dose cohorts showed improved peripheral T cell recovery.

Most patients surpassed their expected progression-free survival (PFS) based on their age and tumor status. Notably, five patients are still alive, and three have resumed their daily occupations, with one patient remaining progression-free 40.5 months post-treatment. These results demonstrate the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a first-in-class therapy for GBM.

Dr. Burt Nabors, Division Director of Neuro-Oncology at the Heersink School of Medicine at the University of Alabama at Birmingham, highlighted the feasibility and well-tolerated safety profile of this novel immuno-cell therapy. William Ho, co-founder and CEO of IN8bio, emphasized the significant advancement this treatment represents for solid tumor cancers like GBM, which are typically characterized as cold, immune desert tumors due to limited immune cell infiltration. Ho noted the confirmed infiltration of gamma-delta T cells into these tumors following treatment with INB-200.

A key aspect of the trial was the administration of DeltEx drug-resistant immunotherapy (DRI) gamma-delta T cells in combination with the current standard-of-care treatment for newly diagnosed GBM patients. The study assessed three different dosing regimens: a single dose in Cohort 1, three doses in Cohort 2, and six doses in Cohort 3. A total of 13 patients were treated, with three in Cohort 1, four in Cohort 2, and six in Cohort 3.

Key findings from the trial included:
- 92% of evaluable patients treated with INB-200 for GBM exceeded the median PFS of 6.9 months associated with the Stupp regimen.
- One patient with an IDH-mutant glioma remained alive and progression-free for over 40.5 months.
- No treatment-related serious adverse events or dose-limiting toxicities were reported.
- The most common treatment-emergent adverse events were Grade 1-2 toxicities related to standard-of-care TMZ.
- Gamma-delta T cells and other immune subsets were found in relapsed tumor biopsies, indicating persistence of DRI gamma-delta T cells.

The patients' immune response demonstrated that gamma-delta T cells remained within the normal range post-resection and stayed stable with repeated doses in Cohorts 2 and 3. This suggests that repeat dosing may benefit the peripheral immune environment. Radiographic evaluations showed positive treatment effects, including the resolution of midline shift and changes in tumor enhancement.

Overall, the Phase 1 trial of INB-200 supports the potential of gamma-delta T cell-based therapies to improve outcomes for patients with GBM, offering a promising new approach in the fight against this challenging cancer.