IN8bio Prioritizes INB-100 for Acute Myeloid Leukemia

IN8bio, Inc., a biopharmaceutical firm in the clinical stage focused on pioneering gamma-delta T cell therapies for cancer treatment, has announced a strategic shift in its resource allocation. The company aims to streamline its operations through pipeline prioritization and a significant workforce reduction of about 49%. This move is intended to enhance their clinical data generation from their ongoing Phase 1 trial of INB-100 for acute myeloid leukemia (AML) and to maintain a robust focus on this promising therapy.

The company has decided to halt its glioblastoma (GBM) development initiatives, specifically suspending enrollment in its Phase 2 INB-400 trial. Despite this, IN8bio will continue monitoring patients who have already been treated in both its INB-200 and INB-400 trials for long-term remissions and overall survival outcomes. This decision reflects a strategic pivot to concentrate on their most promising program and to explore possible partnerships for their GBM solid tumor program.

William Ho, CEO and co-founder of IN8bio, emphasized the positive data from both INB-100 and INB-200 trials and the necessity of focusing on fewer projects to optimize spending and achieve critical milestones. He underscored the importance of INB-100, noting that patient outcomes in this trial have exceeded those of similar AML patients undergoing standard treatments. The company plans to continue enrolling more patients in the INB-100 expansion cohort, targeting around 25 patients at the designated Phase 2 dose. They aim to complete this enrollment in the first half of 2025, with long-term follow-up results expected by late 2025 and into 2026.

In a recent Type B meeting with the FDA, IN8bio received regulatory guidance on advancing INB-100 for post-transplant maintenance therapy in AML, with relapse-free survival as the primary endpoint. The company plans to add a control cohort to its trial to compare outcomes between patients receiving INB-100 and those undergoing standard haploidentical transplantation. As of August 30, 2024, data shows that all AML patients treated with INB-100 have remained relapse-free after a median follow-up of 18.7 months.

In conjunction with its focus on INB-100, IN8bio is implementing a workforce reduction strategy. This will affect approximately 49% of its employees across various functional areas in its New York City and Birmingham, Alabama locations. The company expects to incur one-time costs of around $0.3 million related to severance payments, primarily cash expenditures, during the third quarter of 2024.

IN8bio specializes in developing gamma-delta T cell-based immunotherapies for cancer patients. These unique T cells can differentiate between healthy and diseased tissues, offering a novel approach to cancer treatment. INB-100, their leading program, focuses on AML by using haplo-matched allogenic gamma-delta T cells post-hematopoietic stem cell transplant. Additionally, the company is investigating autologous DeltEx DRI gamma-delta T cells in combination with standard care for GBM.

Through these strategic adjustments, IN8bio intends to enhance its cash preservation, achieve clinical cost savings, and focus on key milestones that can generate near-term interest and value. By concentrating its efforts on INB-100 and exploring partnerships for its GBM program, the company aims to continue developing groundbreaking gamma-delta T cell therapies.

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