8-K: IN8bio Reports Groundbreaking Phase 1 Data for Glioblastoma Therapy INB-200, Doubling Progression-Free Survival

IN8bio, Inc. announced positive long-term Phase 1 clinical data for its INB-200 therapy in newly diagnosed glioblastoma multiforme, demonstrating a significant extension in progression-free survival compared to standard of care.

Summary

• IN8bio announced new long-term clinical data from its fully enrolled Phase 1 trial of INB-200 in newly diagnosed glioblastoma multiforme (GBM) patients.
• The data, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showed a median progression-free survival (mPFS) of 16.1 months for patients receiving multiple doses of INB-200.
• This mPFS of 16.1 months is more than double the historical mPFS of 6.9 months observed with the standard-of-care (SOC) Stupp protocol.
• The mPFS results have already surpassed the historical median overall survival (mOS) of 14.6 months associated with the SOC Stupp protocol alone.
• INB-200 was well-tolerated, with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) observed among 13 treated patients.
• The majority of adverse events were Grade 1-2 and consistent with those typically associated with radiation and temozolomide; no treatment-related deaths occurred.
• Four patients (40%) who received repeated doses remain alive and progression-free for a median of over two years, with three of them returning to work.
• No additional relapses have been reported since the last data update on October 18, 2024.
• Preliminary results from the Phase 2 clinical trial of INB-400 in newly diagnosed GBM also show encouraging results, with a current mPFS of 10.8 months.

Sentiment

Score: 9

Explanation: The clinical data for INB-200 in glioblastoma shows a highly significant improvement in progression-free survival and a favorable safety profile compared to standard of care, with mPFS exceeding historical mOS. This represents a major positive development for a severe disease with high unmet medical need.

Positives

• INB-200 demonstrated an extended median progression-free survival (mPFS) of 16.1 months, more than double the expected 6.9 months with standard-of-care (SOC) Stupp protocol.
• The mPFS of 16.1 months for INB-200 has already surpassed the historical median overall survival (mOS) of 14.6 months with the SOC Stupp protocol.
• INB-200 was well-tolerated, showing no serious toxicities beyond those typically observed with chemotherapy, and importantly, no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed.
• Four patients (40%) who received repeated doses of INB-200 remain alive and progression-free for a median of over two years, with three of them returning to work.
• No new relapses have been reported since the last clinical update in October 2024 for INB-200.
• Repeat dosing of INB-200 demonstrated no additional safety risks, with most side effects being mild and attributable to the SOC therapy.
• 50% of patients receiving repeated doses remained progression-free for over 18 months, versus 0% of patients who received a single dose.
• Preliminary results from the Phase 2 INB-400 trial also show encouraging results with a current mPFS of 10.8 months.

Risks

• Risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio's ability to meet anticipated deadlines and milestones.
• Uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio's product candidates.
• The risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations.
• IN8bio's ability to continue to operate as a going concern.
• The risk that IN8bio may not realize the intended benefits of its gd-TCE platform or DeltEx platform.
• The availability and timing of results from preclinical studies and clinical trials.
• Whether the outcomes of preclinical studies will be predictive of clinical trial results.
• Whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials.
• The risk that trials and studies may be delayed and may not have satisfactory outcomes.
• Potential adverse effects arising from the testing or use of IN8bio's product candidates.
• The uncertainty of regulatory approvals to conduct trials or to market products.
• IN8bio's reliance on third parties, including licensors and clinical research organizations.

Future Outlook

IN8bio aims to achieve deeper responses and eliminate more cancer cells to ultimately extend the time patients can remain progression-free and alive. The company believes INB-200 represents a novel direction in therapy for solid tumor cancers like GBM. Additional updates for the Phase 2 clinical trial of INB-400 are expected in late 2025. The company's approach of delivering gamma-delta T cells directly to the tumor cavity after surgery is designed to apply sustained immune pressure to eliminate residual cancer cells and address chemo-resistant cells.

Management Comments

• "These early data highlight the potential of repeated intracranial dosing of IN8bio's gamma-delta T cells to extend mPFS in GBM, including in patients with chemotherapy-resistant tumors." Burt Nabors, M.D., Principal Investigator.
• "Half of the patients who received multiple doses remained progression free for greater than a year and a half, demonstrating functional recoveries, with several patients also having the ability to return to work. No new relapses have been reported since the last clinical update in October 2024." Burt Nabors, M.D., Principal Investigator.
• "Our goal is to achieve deeper responses and eliminate more cancer cells to ultimately extend the time patients can remain progression free and alive." William Ho, CEO and cofounder of IN8bio.
• "The data presented at ASCO by Dr. Nabors speaks to the potential of IN8bio's gamma-delta T cells to provide a game-changing immunotherapy for this dire and life-threatening cancer." William Ho, CEO and cofounder of IN8bio.
• "We believe that INB-200 represents a novel direction in therapy for the treatment of solid tumor cancers like GBM." William Ho, CEO and cofounder of IN8bio.
• "The complete data from our Phase 1 trial and supporting data from our Phase 2 trial represent the first time a gamma-delta T cell therapy has shown the potential to extend mPFS beyond historical benchmarks." William Ho, CEO and cofounder of IN8bio.

Industry Context

Glioblastoma multiforme (GBM) is described as a "dire and life-threatening cancer" with significant unmet medical needs. IN8bio's gamma-delta T cell therapy approach is presented as a "novel direction in therapy" and potentially a "game-changing immunotherapy" for solid tumor cancers like GBM. The therapy aims to address chemo-resistant cancer and stem cells that often survive standard-of-care treatment and lead to relapse, a common challenge in oncology.

Comparison to Industry Standards

• The standard-of-care (SOC) for newly diagnosed GBM is the Stupp protocol (surgery, radiotherapy plus maintenance temozolomide), which has a historical median progression-free survival (mPFS) of 6.9 months and a historical median overall survival (mOS) of 14.6 months.
• INB-200 demonstrated an mPFS of 16.1 months, which is more than double (+9.2 months or +132.6%) the historical SOC mPFS of 6.9 months.
• The INB-200 mPFS of 16.1 months has already surpassed the historical SOC mOS of 14.6 months.
• Historically, a 2 to 3 month improvement in mPFS has been considered clinically significant and the bar for approval by the Food and Drug Administration (FDA); INB-200's improvement of 9.2 months significantly exceeds this benchmark.

Stakeholder Impact

• Patients: Potential for significantly extended progression-free survival, improved functional recovery, and ability to return to work for patients with newly diagnosed glioblastoma, a highly aggressive and life-threatening cancer.
• Shareholders: Positive clinical trial results for a lead candidate in a severe disease indication are highly likely to increase investor confidence and potentially the company's valuation.
• Medical Community: The data suggests a novel and potentially game-changing immunotherapy approach for GBM, which could influence future treatment paradigms and research directions.

Next Steps

• Additional updates for the Phase 2 clinical trial of INB-400 are expected in late 2025.
• IN8bio will continue to advance its clinical development plans and seek regulatory approvals.

Key Dates

Recommendation

Keywords

Glioblastoma, GBM, INB-200, INB-400, Gamma-delta T cells, Immunotherapy, Oncology, Clinical trial, Phase 1 data, Progression-free survival, ASCO, Brain cancer, Biopharmaceutical, Cell therapy