IN8bio, Inc. (Nasdaq: INAB) announced the publication of peer-reviewed clinical data from its Phase 1 trial of INB-200 in The Journal of Clinical Oncology, reporting results from a first-in-human study of its DeltEx Drug Resistant Immunotherapy (DRI) in patients with newly diagnosed glioblastoma (GBM).

The Phase 1 frequency-escalation study enrolled 13 patients across three cohorts receiving one, three, or up to six doses of DeltEx DRI in 28-day cycles during maintenance chemotherapy, in combination with the standard of care Stupp regimen. DeltEx DRI consists of autologous gamma-delta T cells genetically engineered to resist alkylating chemotherapy and delivered intracranially to the tumor site.

Across all 13 treated patients, median progression-free survival (mPFS) was 9.9 months, compared to approximately 6.9 months reported with standard of care alone. In repeat-dose patients — those receiving three to six doses — mPFS reached 16.1 months. Median overall survival in repeat-dose patients was 19.5 months, compared to a historical standard of care median of approximately 14.6 months. No dose-limiting toxicities, cytokine release syndrome, or immune effector cell-associated neurotoxicity were observed.

GBM is described in the press release as the most common malignant primary brain tumor in adults, with overall survival of approximately 11 months and a five-year survival rate of approximately 5%. The press release states that no new drug approvals have occurred for GBM in more than 20 years.

"This trial demonstrates that intracranial delivery of chemotherapy-resistant γδ T cells is feasible and well tolerated," said Burt Nabors, M.D., Professor of Neurology and Director of Neuro-Oncology at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham, and lead investigator of the study.

IN8bio stated it expects to provide additional updates to the DeltEx DRI program in newly diagnosed GBM later this year.