IN8bio DeltEx DRI Shows 13-Month PFS and >19.5-Month OS in GBM
INAB•IN8bio reported median progression-free survival of 13.0 months for repeat-dose DeltEx DRI, nearly double the 6.6-month standard-of-care benchmark, and overall survival has exceeded 19.5 months versus 13.2 months with standard treatment. 43% of treated patients remained alive at 24 months compared with 20% under standard care.
1. Updated Clinical Efficacy Data
In a cohort of 17 newly diagnosed glioblastoma patients receiving up to six repeat doses of DeltEx DRI with standard-of-care, median progression-free survival reached 13.0 months versus 6.6 months for standard treatment alone. Overall survival has not yet been reached and currently exceeds 19.5 months, compared to a final 13.2 months for patients on standard therapy, with 43% of DeltEx patients alive at 24 months versus 20% in the control group.
2. Safety and Tolerability
Intracranial delivery of DeltEx DRI was generally well tolerated, with no dose-limiting toxicities, cytokine release syndrome events, or neurotoxicity reported. These findings support the safety profile of genetically modified gamma-delta T cell therapy in combination with temozolomide-based regimens.
3. Mechanistic Insights from Translational Analyses
Advanced histopathology and AI-driven analyses revealed a shift from a cold to hot tumor microenvironment, marked by broad T cell infiltration and reduced immunosuppressive granulocytes. Higher cumulative gamma-delta T cell and CD4+ levels correlated significantly with overall survival, suggesting a dose-dependent immune reconstitution mechanism.
4. Development Outlook and Potential Impact
These data bolster the case for DeltEx DRI as a potential breakthrough in glioblastoma treatment, a field without survival improvements in over two decades. Upcoming milestones include finalizing Phase 2 results, engaging regulatory agencies for potential expedited review, and planning larger randomized trials.
