IN8bio Presents Updated Phase I/II Data Demonstrating Meaningful and Durable Survival Improvements in Newly Diagnosed Glioblastoma
MWN-AI** Summary
IN8bio, Inc. has announced promising updated results from its Phase I/II trials evaluating the effectiveness of their investigational therapy, DeltEx™ Drug-Resistant Immunotherapy gamma-delta (??) T cells, for newly diagnosed glioblastoma (GBM). Presented at the 2025 Society for Neuro-Oncology Annual Meeting, the data indicates significant improvements in patient survival rates compared to those treated with the standard-of-care (SOC) Stupp protocol.
Key findings from the trials show that repeated doses of DeltEx DRI nearly doubled median progression-free survival (mPFS) to 13.0 months—an impressive 97% increase over the SOC group's mPFS of 6.6 months. Furthermore, the median overall survival (mOS) for patients receiving DeltEx DRI reached 17.2 months as of December 31, 2025, and continues to climb, contrasting with the SOC's final mOS of 13.2 months.
In terms of patient durability, over half (57%) of DeltEx DRI recipients remained progression-free for longer than expected based on their demographic and clinical profiles, while only 10% of SOC patients achieved the same. Treatment with DeltEx DRI was well tolerated, with no severe adverse events or significant toxicities reported.
IN8bio's CEO, William Ho, emphasized the need for innovative therapies in a field where GBM treatments have stagnated for over two decades. The reported data underscores the potential of DeltEx DRI to change treatment paradigms. Additionally, the successful multi-center application of the therapy lays a strong foundation for future studies and possible FDA discussions on accelerated approval pathways for the promising treatment.
Overall, these findings contribute a compelling narrative of hope for GBM patients, suggesting that DeltEx DRI could provide meaningful, long-term benefits.
MWN-AI** Analysis
IN8bio, Inc. (Nasdaq: INAB) has recently presented updated Phase I/II clinical data demonstrating significant advancements in the treatment of newly diagnosed glioblastoma (GBM), showcasing the potential of their investigational DeltEx™ Drug-Resistant Immunotherapy gamma-delta T cells (DRI). The findings reveal a remarkable increase in both median progression-free survival (mPFS) and median overall survival (mOS) compared to the historical standard-of-care (SOC), indicating the therapy's efficacy and tolerability.
The mPFS for patients receiving DeltEx DRI was reported at 13.0 months, almost doubling the SOC's 6.6 months, while the mOS remains encouragingly strong at 17.2+ months for DeltEx DRI patients, with many demonstrating long-term progression-free status. This improvement highlights the urgent need for innovative therapies in the face of GBM's aggressive nature, where patients typically face dire prognoses.
The absence of severe adverse events (SAEs) or dose-limiting toxicities further strengthens the case for DeltEx DRI as a potentially viable treatment option. With recent financing bolstering IN8bio’s capacity, the company is positioned to advance discussions with the FDA regarding potential accelerated approval pathways.
Investors should consider the following when evaluating IN8bio’s market potential: the strong clinical results indicating a superior treatment option for GBM, the company’s strategic positioning within a niche market with significant unmet needs, and their commitment to developing gamma-delta T cell therapies that offer a robust safety profile.
As competition in oncology continues to heat up, IN8bio's promising data sets it apart. However, investors should keep an eye on forthcoming regulatory milestones and additional clinical data releases that could substantially impact stock performance. Given the ongoing research and positive trajectory, IN8bio presents an intriguing opportunity for growth in the biopharmaceutical landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Repeat-doses of DeltEx™ Drug-Resistant Immunotherapy gamma-delta (??) T cells (DRI) nearly doubled median progression-free survival (mPFS) to 13.0 months compared to only 6.6 months (+97%) in a control cohort treated with the standard-of-care (SOC) Stupp protocol
- Median overall survival (mOS) continues to climb, currently at 17.2+ months as of December 31, 2025, with several patients who remain progression-free for multiple years (1.4 – 4.6 years) compared to only 13.2 months for SOC (+30.3%)
- Treatment remains well tolerated with no treatment related severe adverse events (SAEs) or dose limiting toxicities (DLTs) observed
NEW YORK, Jan. 12, 2026 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (?? ) T cell therapies for cancer and autoimmune diseases, reported updated clinical data from its INB-200 Phase 1 and INB-400 Phase 2 trials in newly diagnosed glioblastoma (GBM). The prior results were presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting. The data continue to demonstrate meaningful and durable improvements in progression-free survival when compared with both historical standard-of-care (SOC) Stupp protocol data and concurrently enrolled SOC treated patients.
Patients in both the Phase 1 and 2 who received repeated doses of the Company’s investigational therapy, DeltEx™ Drug-Resistant Immunotherapy gamma-delta (??) T cells (DeltEx DRI) (N=14), experienced substantial improvements in both median progression-free (mPFS) and median overall survival (mOS) across multiple clinical centers. This data is put into greater context compared to contemporaneously enrolled patients treated only with SOC at the same clinical trial sites (N=10), forming a concurrently treated control cohort:
- Median progression-free survival (mPFS): DeltEx DRI 13.0 months vs. 6.6 months with SOC (a +97% improvement).
- Median overall survival (mOS): DeltEx DRI, not yet reached, currently 17.2+ months and rising, compared with 13.2 months (final mOS) for SOC.
- Durability: DeltEx DRI, eight of fourteen patients (57%) remained progression-free longer than their expected overall survival (OS) based on age and MGMT status (a biomarker used to stratify GBM patients and impacting response to chemotherapy), compared with just a single patient (10%) in the control group.
- Long-term benefit: Several DeltEx DRI treated patients remain progression-free beyond two years without experiencing any significant DRI related SAEs or DLTs.
William Ho, CEO and Co-founder of IN8bio, commented, “GBM is an extremely aggressive and devastating brain cancer, with a short median survival of only ~12 months and no meaningful innovation in over twenty years. The contrast between our repeat-dose DeltEx DRI patients and the SOC controls treated at the same centers demonstrates a profound improvement. The increase in mPFS, particularly in the newly diagnosed GBM setting, is meaningful time for these patients. The durability of these mPFS results, combined with a well-tolerated safety profile, underscore the potential of our ?? T cell therapy to meaningfully improve newly diagnosed GBM treatment and patient outcomes.”
For the first time, IN8bio presented data from a control group of patients that were contemporaneously enrolled and treated only with the SOC protocols at the same clinical centers with the same treating physicians as the DeltEx DRI cohorts. The SOC control patients performed in-line with expectations based on historical GBM mPFS of 6.9 months, despite a greater number of patients receiving gross total resections. This demonstrates both the aggressive nature of GBM, even with SOC treatment, and the significant need for new treatment options. The funds received from IN8bio’s recent financing announced late in 2025 will support further discussions with the FDA on potential clinical pathways, including any potential for accelerated approval.
Across both Phase 1, INB-200, and Phase 2, INB-400, trials at multiple centers, DeltEx DRI ?? T cells continued to demonstrate a well-tolerated safety profile, with:
- No DLTs
- No cytokine release syndrome (CRS)
- No immune effector cell-associated neurotoxicity (ICANS)
- No unexpected infections or SAEs
Kate Rochlin, PhD, Chief Operating Officer, IN8bio, added, “These results show a consistent biological and clinical story. In the DeltEx DRI treated patients, we observed persistent and elevated levels of ?? T cells in circulation, immune cell infiltration within the tumors, and broader systemic immune activation. This is significant in understanding the immune impact in patients treated with this therapy, particularly in a setting traditionally considered a “cold” tumor combined with long-term lymphodepleting chemotherapy. Furthermore, these findings indicate that localized intracranial delivery of DeltEx DRI can drive systemic immune responses, an aspect that could be important in fighting GBM. This is a disease marked by profound treatment-induced lymphodepletion, rapid progression, and poor outcomes.
The data presented at SNO was the first time IN8bio had presented multi-center DeltEx treated and control SOC patient data from the both 1 and Phase 2 trials. Across all sites, early trends in mPFS and mOS were consistent with the original INB-200 trial, reinforcing:
- Reproducibility across clinical centers
- Scalability of the repeated-dose approach
- A strong foundation for further development
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing ?? T cell product candidates for unmet medical needs. ?? T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company's lead program, INB-100, is focused on acute myeloid leukemia, evaluating haplo-matched allogeneic ?? T cells given to patients following a hematopoietic stem cell transplant. The Company is also evaluating autologous DeltEx DRI ?? T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel ?? T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, visit www.IN8bio.com.
Investors & Company Contacts:
IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com
Media Contact
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com
FAQ**
How does the performance of DeltEx™ Drug-Resistant Immunotherapy gamma-delta (??) T cells by IN8bio Inc. (Nasdaq: INAB) compare with historical mPFS and mOS data for glioblastoma treatments?
Can you elaborate on the specific mechanisms by which DeltEx DRI enhances immune response in glioblastoma patients, as suggested by IN8bio Inc. (INAB)?
Given the promising safety profile observed with DeltEx DRI, what are the expected next steps for IN8bio Inc. (Nasdaq: INAB) in terms of FDA discussions and potential clinical pathways?
How does the observed durability of patient responses to DeltEx DRI in IN8bio Inc. (Nasdaq: INAB) trials inform future research directions and treatment strategies for glioblastoma?
**MWN-AI FAQ is based on asking OpenAI questions about IN8bio Inc. (NASDAQ: INAB).
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