8-K: IN8bio's GBM Therapy Shows Promising Survival Data

IN8bio, Inc. reported positive clinical data from its INB-200 and INB-400 trials for glioblastoma, showing extended progression-free and overall survival.

Summary

• Consolidated data from Phase 1 (INB-200) and Phase 2 (INB-400) clinical trials for newly diagnosed glioblastoma (GBM) were presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting.
• 17 patients were treated with the company's DeltExTM Drug Resistant Immunotherapy (DeltEx DRI) gamma-delta T cells across both trials.
• 14 of these patients received repeated doses (3 to 6 doses) of the DeltEx DRI cells.
• A control group of 10 additional patients received only the standard-of-care (SOC) Stupp protocol.
• Patients receiving repeated doses of DeltEx DRI cells achieved a median progression-free survival (mPFS) of 13.0 months (n=14), compared to 6.6 months for patients receiving only SOC (n=10).
• Median overall survival (mOS) for patients receiving repeated DeltEx DRI cells has not yet been reached, continuing to climb at 16.4+ months as of October 31, 2025, while SOC patients attained an mOS of 11.0 months.

Sentiment

Score: 8

Explanation: The clinical trial results show a significant improvement in both progression-free survival and overall survival compared to standard-of-care for a highly aggressive cancer, which is a strong positive indicator for the company's therapeutic approach.

Positives

• Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival (mPFS) of 13.0 months, nearly double the 6.6 months observed in standard-of-care (SOC) patients.
• Median overall survival (mOS) for patients receiving repeated DeltEx DRI doses has not yet been reached and continues to climb at 16.4+ months as of October 31, 2025, significantly exceeding the 11.0 months for SOC patients.
• The data suggests a positive and clinically meaningful impact of DeltEx DRI therapy on survival outcomes for newly diagnosed glioblastoma patients.

Future Outlook

The filing presents current clinical data without explicit forward-looking statements or guidance regarding future trial phases, regulatory submissions, or commercialization timelines.

Industry Context

Glioblastoma (GBM) is an aggressive and difficult-to-treat brain cancer with a very poor prognosis, making any significant improvement in progression-free survival (PFS) and overall survival (OS) highly impactful. The standard-of-care (Stupp protocol) has limited efficacy, so novel immunotherapies like IN8bio's DeltEx DRI gamma-delta T cells represent a critical area of research and development in neuro-oncology.

Comparison to Industry Standards

• The median progression-free survival (mPFS) of 13.0 months for DeltEx DRI patients significantly surpasses the 6.6 months for patients receiving the standard-of-care (SOC) Stupp protocol, which is a widely accepted benchmark for newly diagnosed GBM.
• The median overall survival (mOS) for DeltEx DRI patients, which continues to climb at 16.4+ months and has not yet been reached, compares favorably to the 11.0 months for SOC patients. Typical mOS for newly diagnosed GBM with SOC is often cited in the range of 12-15 months, suggesting IN8bio's therapy is showing promising results relative to current treatment paradigms.
• While direct comparisons to other specific experimental therapies are not provided in the filing, the substantial improvement over SOC in both mPFS and mOS indicates a potentially competitive profile within the challenging GBM treatment landscape.

Stakeholder Impact

• Shareholders: Positive clinical data could increase investor confidence and potentially lead to an increase in share price.
• Patients: The therapy offers a potential new treatment option with improved survival outcomes for patients with newly diagnosed glioblastoma, a disease with limited effective treatments.
• Medical Community: The data presented at SNO could generate interest and further research into gamma-delta T cell therapies for GBM.

Key Dates

Recommendation

The clinical data presented for INB-200 and INB-400 in newly diagnosed glioblastoma shows a substantial and clinically meaningful improvement in both median progression-free survival (mPFS) and median overall survival (mOS) compared to the standard-of-care. Given the aggressive nature of GBM and the limited treatment options, these results are highly encouraging and suggest a strong therapeutic potential for IN8bio's DeltEx DRI platform. The mOS not yet being reached for the treatment group, while significantly outperforming SOC, indicates a robust and durable response. This positive clinical update significantly de-risks the development program and could lead to substantial value creation for shareholders.

Keywords

IN8bio, INAB, Glioblastoma, GBM, DeltEx DRI, gamma-delta T cells, clinical trial, Phase 1, Phase 2, oncology, neuro-oncology, cancer therapy, biotechnology, mPFS, mOS