This section highlights FDA-related milestones and regulatory updates for drugs developed by IN8bio (INAB).
Over the past two years, IN8bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INB-100, INB-200, INB-400, and INB-619. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
INB-100 - FDA Regulatory Timeline and Events
INB-100 is a drug developed by IN8bio for the following indication: Leukemia undergoing haploidentical stem cell transplant (HSCT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB-100
- Announced Date:
- February 11, 2025
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc announced encouraging new clinical data from the ongoing Phase 1 investigator-sponsored trial of INB-100, an allogeneic gamma-delta T cell therapy designed to help patients with complex leukemias, including AML.
AI Summary
IN8bio, Inc has shared promising early clinical data from its ongoing Phase 1 investigator-sponsored trial of INB-100. This allogeneic gamma-delta T cell therapy is designed for patients with complex leukemias, including acute myeloid leukemia (AML). The trial results show that 100% of AML patients remain in complete remission, with a median follow-up of 20.1 months and some patients being relapse-free for over three years. These patients achieved impressive one-year progression-free and overall survival rates compared to real-world historical data. Moreover, the sustained persistence of gamma-delta T cells beyond one year suggests a durable response and the potential for long-term remission. The safety profile has been encouraging, with patients experiencing minimal aside effects, thus offering a hopeful new treatment option for those facing high relapse risks post-stem cell transplantation.
Read Announcement- Drug:
- INB-100
- Announced Date:
- December 10, 2024
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc announced updated data from the ongoing Phase 1 trial of INB-100, an allogeneic, haploidentical gamma-delta T cell therapy in older patients with hematologic malignancies undergoing haploidentical stem cell transplant (HSCT) with reduced intensity conditioning (RIC) at the 2024 American Society of Hematology (ASH) Annual Meeting, being hosted in San Diego, CA.
AI Summary
At the 2024 American Society of Hematology Annual Meeting in San Diego, CA, IN8bio, Inc. presented updated data from its ongoing Phase 1 trial of INB-100, an allogeneic, haploidentical gamma-delta T cell therapy. The trial focuses on older patients with hematologic malignancies undergoing haploidentical stem cell transplant (HSCT) with reduced intensity conditioning (RIC). Notably, the data show durable complete remissions with no relapses observed in acute myeloid leukemia (AML) patients, including those with high-risk disease, after a median follow-up of 19.7 months. The study also highlighted the long-term in vivo expansion and persistence of the gamma-delta T cells, observed up to 365 days post-treatment – a first in allogeneic cellular therapy. These encouraging results, along with a well-tolerated safety profile, have led to an expansion of the trial, with further data expected in early 2025.
Read Announcement- Drug:
- INB-100
- Announced Date:
- September 4, 2024
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc announced a plan to optimize its resource allocation through a pipeline prioritization and a workforce reduction of approximately 49%.
AI Summary
IN8bio, Inc. announced a major restructuring aimed at optimizing resource allocation and streamlining its operations. As part of its strategic focus on priority programs, the company will reduce its workforce by about 49% across all functional areas at both New York City and Birmingham, Alabama. This significant reduction will be implemented by the third quarter of 2024 and is intended to preserve cash and achieve clinical cost savings without compromising the integrity of its pipeline.
By focusing on the INB-100 program for acute myeloid leukemia (AML), IN8bio aims to generate robust clinical data that could drive near-term value creation. The company’s decision to scale back its pipeline is part of a broader effort to reallocate resources towards initiatives with the most promising outcomes, ensuring that it continues to refine its approach to developing innovative gamma-delta T cell therapies for challenging cancers.
Read Announcement- Drug:
- INB-100
- Announced Date:
- August 12, 2024
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc announced updated positive clinical data from both of the Company's Phase 1 investigator-sponsored trials of INB-100 for hematological malignancies and INB-200 for GBM.
AI Summary
IN8bio, Inc. recently announced positive results from its Phase 1 investigator-sponsored trials for two therapies. The INB-100 trial, aimed at treating hematological malignancies, has shown promising outcomes with patients remaining in remission longer than expected when compared to standard treatments. In parallel, the INB-200 study for glioblastoma (GBM) has also demonstrated encouraging results with several patients experiencing extended periods of remission. These updated clinical data highlight the potential of IN8bio’s gamma-delta T cell therapies to effectively target both blood cancers and GBM. The improvements in relapse-free survival observed in these trials support the continued development of these therapies into Phase 2 clinical studies. Overall, the findings emphasize IN8bio’s growing leadership in advancing innovative cellular therapies for difficult-to-treat cancers.
Read Announcement- Drug:
- INB-100
- Announced Date:
- August 12, 2024
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc. announced that it has received guidance on the registrational path to advance INB-100 for the treatment of AML.
AI Summary
IN8bio, Inc. has received FDA guidance on the registrational path to advance its INB-100 therapy for the treatment of acute myeloid leukemia (AML). INB-100 is an investigational allogeneic gamma-delta T cell therapy designed to serve as a post-transplant maintenance treatment for AML patients, with relapse-free survival as the primary endpoint. Clinical results from Phase 1 trials show that 100% of AML patients treated with INB-100 remain in complete remission, highlighting its potential advantage over current standard therapies. With these promising outcomes, IN8bio plans to submit an Investigational New Drug (IND) application to the FDA in the first quarter of 2025, which could lead to a registrational trial for AML later that year. This guidance from the FDA marks a significant step forward in developing new cellular therapies for challenging cancers.
Read Announcement- Drug:
- INB-100
- Announced Date:
- June 13, 2024
- Indication:
- Leukemia undergoing haploidentical stem cell transplant (HSCT)
Announcement
IN8bio, Inc. presents updated data from its Phase 1 trial of INB-100 at the European Hematology Association (EHA) 2024 Hybrid Congress.
AI Summary
IN8bio, Inc. presented updated data from its Phase 1 trial of INB-100 at the European Hematology Association 2024 Hybrid Congress. The trial results are promising, with 100% of the evaluated leukemia patients remaining in complete remission and progression-free at one year after treatment. The updated data highlight that even high-risk and relapsed acute myeloid leukemia patients, who had previously failed multiple therapies, achieved durable remission. Additionally, the study showed that a single administration of the gamma-delta T cell therapy led to long-term expansion and persistence of these cells for at least 365 days, a first for an allogeneic cellular therapy. These encouraging outcomes suggest that INB-100 might provide new treatment options for patients with hematologic malignancies and help address the significant challenge of relapse following stem cell transplantation.
Read Announcement
INB-200 - FDA Regulatory Timeline and Events
INB-200 is a drug developed by IN8bio for the following indication: For the treatment of newly diagnosed GBM solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB-200
- Announced Date:
- June 9, 2025
- Indication:
- For the treatment of newly diagnosed GBM solid tumors.
Announcement
IN8bio, Inc announced that Patient 009 in the Phase 1 trial of INB-200 for newly-diagnosed GBM has recently reached a significant clinical milestone.
AI Summary
IN8bio, Inc. announced a major milestone in their Phase 1 trial of INB-200 for newly diagnosed glioblastoma (GBM). Patient 009, who was diagnosed with a grade 4, IDH-mutant glioma, has reached a significant point by remaining in remission for four years after receiving treatment with INB-200. This outcome far exceeds the typical progression-free results seen in similar patients, underlining the potential of gamma-delta T cell therapies in treating aggressive cancers.
The patient’s continued good health and ability to return to work demonstrate not only a breakthrough in clinical progress but also offer hope for a better quality of life for others battling GBM. This milestone is a strong indicator of the promising impact of INB-200 and reinforces the importance of innovative treatments in combatting some of the most challenging cancers.
Read Announcement - Drug:
- INB-200
- Announced Date:
- June 2, 2025
- Indication:
- For the treatment of newly diagnosed GBM solid tumors.
Announcement
IN8bio, Inc. announced new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM).
AI Summary
IN8bio, Inc. recently shared promising long-term clinical results from its fully enrolled Phase 1 trial of INB-200 in patients with newly diagnosed glioblastoma multiforme (GBM). The study focused on repeated intracranial doses of INB-200, a gamma-delta T cell therapy, administered with standard maintenance chemotherapy. Notably, patients receiving multiple doses achieved a median progression-free survival (mPFS) of 16.1 months, which is more than double the historical mPFS of 6.9 months seen with the standard Stupp protocol.
The trial also highlighted INB-200’s favorable safety profile, with no dose-limiting toxicities, cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) detected. Furthermore, four patients remain alive and progression-free for a median of over two years, with several experiencing functional recoveries and returning to work, underscoring the therapy's potential impact on GBM treatment.
Read Announcement- Drug:
- INB-200
- Announced Date:
- November 25, 2024
- Indication:
- For the treatment of newly diagnosed GBM solid tumors.
Announcement
IN8bio, Inc. , presented results from the fully enrolled Phase 1 trial of INB-200 in a plenary oral presentation at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX.
AI Summary
IN8bio, Inc. presented promising Phase 1 trial results for its INB-200 therapy during a plenary oral session at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX. The trial evaluated the effects of repeated versus single doses of INB-200, a treatment using genetically modified gamma-delta T cells designed to resist chemotherapy. Notably, 50% of patients who received repeated doses remained alive and in remission longer than expected compared to standard therapy, while none of the single-dose patients reached this outcome.
Biopsy samples in two patients confirmed the presence of gamma-delta T cells along with CD3+ and CD8+ T cells within the brain tumor environment. These findings highlight a trend toward improved peripheral T cell recovery and suggest that repeat dosing of INB-200 may enhance immune response in patients with glioblastoma.
Read Announcement
INB-400 - FDA Regulatory Timeline and Events
INB-400 is a drug developed by IN8bio for the following indication: For the treatment of newly diagnosed glioblastoma, or GBM.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB-400
- Announced Date:
- September 4, 2024
- Indication:
- For the treatment of newly diagnosed glioblastoma, or GBM.
Announcement
IN8bio, Inc announced a plan to optimize its resource allocation through a pipeline prioritization and a workforce reduction of approximately 49%.
AI Summary
IN8bio, Inc. revealed a strategic plan aimed at optimizing its resource allocation. As part of this initiative, the company will reduce its workforce by about 49%, affecting employees at both its New York City and Birmingham, Alabama locations. This workforce reduction is expected to be completed by the third quarter of 2024 and comes with one-time severance costs of roughly $0.3 million. The decision is part of a broader effort to preserve the company’s cash resources and achieve clinical cost savings. IN8bio intends to streamline its portfolio by prioritizing the INB-100 trial for acute myeloid leukemia (AML), which has so far shown promising progression-free survival results. By focusing on this key clinical program, the company aims to create near-term value and strengthen its approach to developing innovative cellular immunotherapies for cancer patients.
Read Announcement- Drug:
- INB-400
- Announced Date:
- April 30, 2024
- Indication:
- For the treatment of newly diagnosed glioblastoma, or GBM.
Announcement
IN8bio, Inc. announced that the first patient in its Phase 2 clinical trial evaluating INB-400 in patients with newly diagnosed glioblastoma multiforme (GBM) has been successfully dosed at the Cleveland Clinic in Ohio.
AI Summary
IN8bio, Inc. has reached a key milestone in its effort to treat glioblastoma multiforme (GBM) with its investigational INB-400 therapy. The company successfully dosed the first patient in its Phase 2 clinical trial at the Cleveland Clinic in Ohio. INB-400 is designed to work alongside standard treatments, using genetically engineered gamma-delta T cells that can survive chemotherapy and target cancer cells effectively. In this trial, up to 40 patients with newly diagnosed GBM will receive the therapy in combination with temozolomide. The study will examine the overall survival rate at 12 months, as well as evaluate safety, tolerability, response rates, and progression-free survival. This novel approach offers hope for improving treatment outcomes for patients facing the challenging diagnosis of GBM.
Read Announcement
INB-619 - FDA Regulatory Timeline and Events
INB-619 is a drug developed by IN8bio for the following indication: T Cell Engager (TCE) Platform.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INB-619
- Announced Date:
- May 14, 2025
- Indication:
- T Cell Engager (TCE) Platform
Announcement
IN8bio, Inc. announced new preclinical data from its INB-619 program at the 2025 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.
AI Summary
At the 2025 American Society of Gene & Cell Therapy Annual Meeting, IN8bio, Inc. shared new preclinical data from its INB-619 program. This innovative therapy, a CD19-targeted gamma-delta T cell engager, successfully eliminated harmful B cells from lupus patient samples by precisely targeting cells that produce damaging IgG1 and IgM antibodies. The preclinical results also showed that INB-619 not only depletes these pathogenic cells but boosts both Vδ1+ and Vδ2+ gamma-delta T cell subtypes. These specific T cells are important for eliminating both circulating and tissue-resident B cells, which could lead to deeper B cell depletion. Importantly, INB-619 appears to clear B cells without triggering the strong inflammatory responses often seen with other T cell engagers. This data supports the potential of INB-619 as a safer, targeted treatment option for autoimmune diseases.
Read Announcement- Drug:
- INB-619
- Announced Date:
- April 28, 2025
- Indication:
- T Cell Engager (TCE) Platform
Announcement
IN8bio, Inc announced new preclinical data from its innovative γδ T cell engager (γδ-TCE) platform.
AI Summary
IN8bio, Inc recently shared new preclinical data on its innovative gamma-delta (γδ) T cell engager (γδ-TCE) platform. The data show that this next-generation TCE significantly expands and activates γδ T cells, specifically the Vδ1+ and Vδ2+ subsets. This is important because many cancer patients have low counts of these cells, which are key in naturally fighting tumors.
The platform’s lead molecules, INB-619 and INB-633, demonstrated powerful and precise anti-cancer activity in leukemia models. In these studies, the molecules were able to deplete tumor cells effectively while avoiding the dangerous release of inflammatory cytokines that often leads to cytokine release syndrome (CRS) in traditional CD3-based approaches. These promising results suggest that the new γδ-TCE platform might offer a safer and more effective alternative for treating cancer and potentially certain autoimmune diseases.
Read Announcement
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