IN8bio (INAB) TD Cowen 46th Annual Health Care Conference summary

Key program updates

• Gamma delta T cell therapies and T cell engagers are being developed for oncology and autoimmune diseases, with two clinical programs showing patients in remission for over 4 years in AML and glioblastoma and a favorable safety profile, including low rates of CRS and neurotoxicity.

• The DeltEx platform enables efficient manufacturing and clinical translation, overcoming historical challenges in cell therapy and TCE development.

• INB-100 targets leukemia patients post-transplant, while INB-200/400 focus on genetically modified gamma delta T cells for solid tumors, especially glioblastoma.

• Enrollment in the glioblastoma trial was suspended in September 2023 to preserve capital, with robust long-term survival data now being prepared for publication and FDA guidance.

• Two programs (INB-300, INB-500) are on hold due to capital constraints, but additional data updates are expected later in the year.

Clinical and preclinical data highlights

• Repeat dosing of gamma delta T cells in glioblastoma patients led to a median progression-free survival of 13 months and overall survival of 17.2 months, outperforming controls and historical standards.

• Survival benefit is dose-dependent, with more doses correlating to longer survival; unmethylated MGMT status remains a key relapse risk.

• Head-to-head preclinical assays show the T cell engager candidate matches or exceeds FDA-approved drugs in B cell depletion, with a wider therapeutic window and lower cytokine release.

• No cytokine release syndrome or neurotoxicity observed in trials, even at high doses delivered directly to the brain.

• Kaplan-Meier analysis demonstrates statistically significant improvement in progression-free survival for repeated DRI dosing compared to standard-of-care.

Pipeline and development milestones

• The pipeline includes allogeneic and autologous gamma-delta T cell therapies for hematologic malignancies, solid tumors, and autoimmune indications, with multiple candidates in preclinical to Phase 2 stages.

• Key milestones for 2024 include animal model data, regulatory guidance from the FDA, and potential publication of pivotal clinical results.

• INB-619, a novel gamma-delta TCE, is advancing with IND-enabling work and initial animal data expected in 2026.

• Additional capital raises are anticipated to support ongoing and future clinical programs.

• Key upcoming milestones in 2026 include completion of expansion cohort dosing, long-term follow-up data presentations, and FDA discussions for potential registrational pathways.