IN8bio, Inc. operates as a clinical stage biopharmaceutical company, which focuses on developing novel therapies for the treatment of cancers, including solid tumors, by employing allogeneic, autologous and genetically modified gamma-delta T cells. The company was founded by Lawrence S. Lamb and William T. Ho on February 8, 2016 and is headquartered in New York, NY.
Clinical Trials
1
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2016
Active, not recruiting
1
100.0%
No approval data available
- IN8bio has expanded its Phase 1 clinical trial of INB-100 by adding The Ohio State University as a new clinical site to accelerate enrollment. - INB-100 is a donor-derived allogeneic gamma-delta T cell therapy designed to reduce graft-versus-host disease and relapse risk in leukemia patients undergoing haploidentical stem cell transplantation. - The therapy has shown encouraging long-term survival outcomes with multiple patients demonstrating leukemic remissions beyond four to five years relapse-free. - The trial aims to evaluate safety, durability, and anti-leukemic activity of the gamma-delta T cell therapy in the post-transplant setting.
- IN8bio presented preclinical data for INB-619, a first-in-class pan-gamma delta T cell engager that achieved complete B cell depletion with efficacy equivalent to FDA-approved compounds blinatumomab and mosunetuzumab. - The novel therapy demonstrated minimal adverse cytokine release, including significantly lower IL-6 concentrations compared to existing T cell engagers, potentially enabling safer deep B cell depletion. - INB-619 selectively expanded gamma-delta T cells without activating conventional T cells, supporting an improved safety profile for treating B cell-driven autoimmune disorders like systemic lupus erythematosus.
- TC Biopharm's OmnImmune is advancing through a pivotal Phase 2/3 trial for acute myeloid leukemia, representing one of the most advanced gamma delta T cell therapies globally. - The company's TCB008 candidate achieved complete molecular remission in a relapsed patient with detectable minimal residual disease after just two doses in the Phase 2 ACHIEVE trial. - More than 25 gamma delta T cell therapies are currently in clinical development worldwide, with the highest phase reaching Phase 2/3, though no therapies have achieved commercial availability as of June 2025. - The field remains predominantly focused on hematologic malignancies, with fewer programs targeting solid tumors due to complex tumor microenvironments and immune evasion mechanisms.
- IN8bio's allogeneic gamma-delta T cell therapy INB-100 demonstrated remarkable efficacy with no relapses in AML patients over a median follow-up of 20.1 months. - The therapy achieved impressive survival metrics with 90.9% progression-free survival and 100% overall survival at one year, surpassing historical outcomes. - INB-100 exhibited a favorable safety profile with no cytokine release syndrome, neurotoxicity, or treatment-related deaths, positioning it as a potential breakthrough in post-transplant care.
- The market for gene and cell therapies targeting CNS disorders was valued at approximately USD 1 billion in 2021 and is projected to grow significantly by 2034. - Several companies are developing gene and cell therapies for CNS disorders, with some therapies already approved for conditions like spinal muscular atrophy (SMA). - Clinical trials are showing positive trends, such as uniQure's AMT-130 for Huntington's disease demonstrating encouraging results in mean CSF NfL levels.
- IN8bio has suspended enrollment in the phase 2 trial of INB-400, a gamma-delta T-cell therapy, for newly diagnosed glioblastoma multiforme in combination with temozolomide. - The company will explore partnership opportunities for its solid tumor drug development program while focusing on its INB-100 program for acute myeloid leukemia (AML). - IN8bio's decision is part of a strategic plan to optimize resource allocation and prioritize programs with the potential for near-term value creation. - Patients already enrolled in the INB-400 and INB-200 trials will continue to be monitored for long-term remissions and overall survival.
- IN8bio is prioritizing its INB-100 program for acute myeloid leukemia (AML) due to promising results and a challenging financing environment. - The company is reducing its workforce by approximately 49% and pausing its glioblastoma multiforme (GBM) program to cut costs. - A $12.4 million private placement will fund the expansion of the INB-100 Phase I trial, with enrollment expected to complete in H1 2025. - Early data from the INB-100 trial shows 100% relapse-free survival in AML patients, supporting the shift in focus and investment.
