8-K: IN8bio Announces Promising Phase 1 Data for INB-200 Glioblastoma Therapy at ASCO

IN8bio's INB-200 shows encouraging preliminary results in a Phase 1 study, with 92% of evaluable glioblastoma patients exceeding the standard progression-free survival.

Summary

• IN8bio presented preliminary data from its Phase 1 study of INB-200, a gamma-delta T cell therapy for glioblastoma, at the 2024 ASCO Annual Meeting.
• The study showed that 92% of evaluable patients treated with INB-200 exceeded the median progression-free survival (PFS) of 7 months achieved with the standard-of-care Stupp regimen.
• The median follow-up for the study was 11.7 months, with data cut off on May 30, 2024.
• One patient in Cohort 2 remains alive and progression-free for almost three years.
• The study included 13 patients across three cohorts, with varying doses of INB-200.
• The safety profile of INB-200 was strong, with no cell therapy-related toxicities reported.
• Radiographic evaluations showed positive treatment effects, including changes in MRI enhancement and resolution of mid-line shift.
• The company is now dosing patients in a Phase 2 study with INB-400, evaluating up to six infusions of autologous gamma-delta T cells.

Sentiment

Score: 8

Explanation: The document presents very positive preliminary clinical data with a strong safety profile, suggesting a promising outlook for the therapy. The results are better than the standard of care, which is a significant positive.

Positives

• The majority of fully dosed patients exceeded the expected median PFS based on age and tumor status.
• The safety profile of gamma-delta T cells was strong across all three dose cohorts.
• The treatment showed positive effects on radiographic evaluations.
• The study suggests the potential for extending progression-free survival in glioblastoma patients.

Negatives

• The most common treatment emergent adverse events were Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care TMZ.

Risks

• The study is still in Phase 1, and further trials are needed to confirm the efficacy and safety of INB-200.
• The results are preliminary and may not be indicative of final outcomes.
• The company relies on third parties for clinical research and may face delays or challenges.
• Regulatory approvals are required to market the product.

Future Outlook

IN8bio plans to report additional results from a long-term follow-up of cohort 3 at future medical meetings and is currently dosing patients in a Phase 2 study with INB-400.

Management Comments

• Burt Nabors, M.D., stated that the addition of multiple intracranial injections of IN8bio's DeltEx DRI gamma-delta T cells shows the potential for extending progression-free survival in glioblastoma patients.
• Trishna Goswami, M.D., noted the strong safety profile of gamma-delta T cells across all three dose cohorts.
• William Ho, CEO and co-founder, mentioned that they look forward to reporting additional results from a long-term follow-up of cohort 3 at future medical meetings.

Industry Context

The announcement is significant as it addresses the unmet need for improved treatments for glioblastoma, a challenging cancer with limited therapeutic advancements. The use of genetically modified gamma-delta T cells represents a novel approach in cancer immunotherapy.

Comparison to Industry Standards

• The standard-of-care Stupp regimen for glioblastoma achieves a median PFS of 7 months, which was exceeded by 92% of evaluable patients in the INB-200 study.
• A recently published clinical trial of an IDH inhibitor demonstrated a median PFS of 11.1 months in the control arm and 28.5 months in the experimental arm, while one patient in the INB-200 study with an IDH-mutant glioma remains alive and progression free at 34.9+ months.
• The results suggest that INB-200 may offer a significant improvement over existing treatments for glioblastoma.

Stakeholder Impact

• Shareholders may view the positive clinical data favorably.
• Patients with glioblastoma may benefit from this potential new treatment option.
• The company's employees may be motivated by the positive results.
• The results may attract potential partners and investors.

Next Steps

• IN8bio will report additional results from a long-term follow-up of cohort 3 at future medical meetings.
• The company is currently dosing patients in a Phase 2 study with INB-400.

Key Dates

Keywords

IN8bio, INB-200, Glioblastoma, Gamma-delta T cells, Cancer Therapy, Clinical Trial, ASCO, Progression-Free Survival, DeltEx DRI, Temozolomide