IN8bio presents Phase 1 data on INB-200 in newly diagnosed GBM

IN8bio (INAB) announced new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme. The data were presented in an oral session on May 30th at the 2025 American Society of Clinical Oncology Annual Meeting. The Phase 1 results of INB-200 demonstrate that repeated dosing of IN8bio’s proprietary Drug Resistant Immunotherapy – which utilizes genetically modified gamma-delta T cells delivered directly into the brain – in combination with SOC maintenance chemotherapy, led to an mPFS of 16.1 months. This represents an improvement of more than double the historical mPFS of 6.9 months under the SOC Stupp protocol. These mPFS results have already surpassed the historical mOS of 14.6 months associated with the SOC Stupp protocol alone. By comparison, a 2 to 3 month improvement in mPFS has historically been considered as clinically significant and the bar for approval by the Food and Drug Administration. Importantly, no dose-limiting toxicities, CRS, or ICANS have been observed among patients treated with INB-200. The majority of adverse events were Grade 1-2 and consistent with those typically associated with radiation and temozolomide. No treatment-related deaths have occurred. Highlights from the Clinical Data as of May 31, 2025: INB-200: Four patients who received repeated doses of INB-200 remain alive and progression free for a median of over two years, with three returning to work; No additional relapses were observed since the last data update on October 18, 2024; Among patients who received multiple doses of INB-200, mPFS reached 16.1 months, compared to 6.9 months with SOC and 8.3 months for patients who received only a single dose of INB-200; Repeat dosing demonstrated no additional safety risks, with most side effects being mild and attributable to the SOC therapy; 50% of patients receiving repeated doses remained progression-free greater than18 months versus 0% of patients who received a single dose. INB-400: Data from our Phase 2 clinical trial of INB-400 in patients with newly diagnosed GBM, including three additional clinical sites, also show encouraging preliminary results: current mPFS is at 10.8 months. Additional updates expected late 2025