INB-200 / IN8bio - LARVOL DELTA

INB-200: Fully enrolled phase 1 study of gene-modified autologous gamma-delta (γδ) T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ). (ASCO 2024) - P1 | "γδ T cells successfully infused with peripheral TMZ-based lymphodepletion evidenced with near or below normal range T, B, and NK subsets for up to 1 year. The majority of dosed patients who received DRI exceeded the expected median PFS of 7 months (5.8-8.2 months) with Stupp alone and had manageable toxicity with a continued encouraging trend in PFS. Long-term follow-up for durability of PFS and OS continue."

Clinical • P1 data • Brain Cancer • Cardiovascular • CNS Disorders • CNS Tumor • Fatigue • Glioblastoma • Hematological Disorders • Hepatology • Infectious Disease • Nephrology • Oncology • Otorhinolaryngology • Pain • Solid Tumor • Thrombosis • Ventriculomegaly • MGMT • NKG2D

INB-200 phase I study of gene modified autologous gamma-delta (γδ) T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ). (ASCO 2023) - P1 | "Data demonstrates that single, repeat doses of CRCT gamma delta T cells have manageable toxicity with continued encouraging trend in PFS and warrants further assessment. Clinical trial information: NCT04165941."

Clinical • P1 data • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Hematological Disorders • Hepatology • Oncology • Pain • Pulmonary Embolism • Solid Tumor • Thrombocytopenia • MGMT • NKG2D

INB-200/400: Final Phase 1/2 Study Results and A.I. based Deep Correlative Analysis of Gene-Modified Autologous Gamma-Delta (γδ) T Cell Therapy in Newly Diagnosed Glioblastoma (GBM) Patients (SNO 2026) - No abstract available

Clinical • P1/2 data • Brain Cancer • Glioblastoma • Solid Tumor

Upcoming Anticipated Milestones (GlobeNewswire) - "(i) Report initial preclinical animal data for INB-619 in the second half of 2026; (ii) Report on FDA discussions regarding the potential regulatory pathways for the DeltEx DRI GBM program; (iii) INB-100 program clinical update at a scientific meeting in late 2026; (iv) Provide additional clinical and translational updates from the DeltEx DRI GBM program."

Clinical data • FDA event • Preclinical • Glioblastoma • Oncology

INB-200: Phase I study and characterization of gene-modified autologous gamma delta (γδ) T cells in newly diagnosed glioblastoma multiforme (GBM). (ASCO 2026) - P1 | " DRI combines the polyclonal upregulation of stress-antigens with concurrent local delivery of MGMT-modified γδ T cells, engineered to resist temozolomide (TMZ) driven lymphodepletion. These findings demonstrate a manageable safety profile and a positive trend in PFS and OS from treatment with DRI cells."

IO biomarker • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • CCL2 • GZMB • IFNG • IL1B • IL6 • MGMT • NKG2D • PRF1 • TNFA

Challenging the Glioblastoma Status Quo: Could γδ T Cells Shift the Balance? (ASGCT 2026) - P1, P1/2 | "This investigational therapy consists of MGMT-modified γδ T cells engineered for temozolomide (TMZ) resistance, allowing concurrent administration with SOC maintenance TMZ. DeltEx DRI has been evaluated in newly diagnosed GBM patients in Phase 1 INB-200 (NCT04165941) and Phase 2 INB-400 (NCT05664243) trials...Conclusion DeltEx DRI shows encouraging clinical durability of response, sustained tumor infiltration by γδ T cells, and co-stimulation of adaptive immunity, supported by consistent manufacturing and a favorable safety profile. These early data suggest a promising novel strategy to combat frontline GBM, paving the way for Phase 2 studies to validate these findings."

IO biomarker • Brain Cancer • Glioblastoma • Infectious Disease • Solid Tumor • CD4 • CD8 • CXCR3 • MGMT

IN8bio Presents New Translational Data Demonstrating DeltEx DRI Reshapes the Immune Landscape in Glioblastoma (GlobeNewswire) - “The new analysis builds on previously reported clinical findings from IN8bio’s ongoing Phase 1 and 2 trials evaluating DeltEx DRI in newly diagnosed GBM patients. In patients receiving multiple doses, the company previously reported median progression-free survival (mPFS) of 13.0 months, compared to 6.6 months for standard-of-care (SOC) patients, representing a 97% improvement, with median overall survival (mOS) of greater than 17.2+ months compared to 13.2 months for SOC controls. The new mechanistic data now provides a potential biological rational for these outcomes.”

Clinical data • Glioblastoma

IN8bio Announces Pricing of Private Placement of up to $40.2 Million to Advance Novel Gamma-Delta T Cell Engager (GlobeNewswire) - "IN8bio intends to use the net proceeds from the private placement to fund the IND enabling studies of INB-619, for use in oncology and autoimmune diseases. The Company expects to generate early animal model data for initial discussions with the U.S. Food and Drug Administration ('FDA') in 2026 with pivotal animal model data and potential IND submission in 2027. The Company also intends to use a portion of the net proceeds to fund the submission of data from the INB-200 and INB-400 Phase 1 and Phase 2 clinical programs in newly diagnosed glioblastoma to the FDA."

Financing • IND • Glioblastoma • Immunology

INB-200: Phase 1 Study and Characterization of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (SNO 2025) - "Expression patterns were consistent, underscoring manufacturing robustness and reproducibility. These Phase I findings demonstrate safety, manufacturing consistency, and encouraging durability of both the infused cells and clinical response."

Clinical • IO biomarker • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • GZMB • IFNG • MGMT • PRF1

INB-200: Phase 1 Study and Characterization of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (SNO 2025) - "Expression patterns were consistent, underscoring manufacturing robustness and reproducibility. These Phase I findings demonstrate safety, manufacturing consistency, and encouraging durability of both the infused cells and clinical response."

Clinical • IO biomarker • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • GZMB • IFNG • MGMT • PRF1

INB-200: Phase 1 Study and Characterization of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (WFNOS 2025) - "Expression patterns were consistent, underscoring manufacturing robustness and reproducibility. These Phase I findings demonstrate safety, manufacturing consistency, and encouraging durability of both the infused cells and clinical response."

Clinical • IO biomarker • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • GZMB • IFNG • MGMT • PRF1

INB-200: Phase 1 Study and Characterization of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (WFNOS 2025) - "Expression patterns were consistent, underscoring manufacturing robustness and reproducibility. These Phase I findings demonstrate safety, manufacturing consistency, and encouraging durability of both the infused cells and clinical response."

Clinical • IO biomarker • P1 data • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Solid Tumor • GZMB • IFNG • MGMT • PRF1

Upcoming Anticipated Pipeline Milestones and Events (GlobeNewswire) - "Updated Phase 1 and 2 data from the INB-200/400 program in newly diagnosed GBM to be presented at the SNO Annual Meeting, November 19-23, 2025."

Clinical data • Glioblastoma

IN8bio Recognizes Achievement of 4-Years in Remission for Patient Treated with INB-200 in Glioblastoma Trial (The Manila Times) - P1 | N=22 | NCT04165941 | "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. The patient, with a grade 4, IDH-mutant glioma, has been in remission and surviving for 4 years having been treated with INB-200. The patient is doing well, has returned to work and has a good quality of life post-treatment with INB-200. Patient 009’s clinical progress and 4-year remission far surpasses progression-free outcomes observed in other clinical trials of IDH-mutant glioma patients."

P1 data • Glioma

INB-200: Phase 1 study of gene-modified autologous gamma-delta (γδ) t cells in newly diagnosed glioblastoma multiforme (GBM) patients receiving maintenance temozolomide (TMZ). (ASCO 2025) - P1 | "To date all patients had manageable toxicity with outpatient treatment and a continued encouraging trend in longer PFS from treatment with DRI γδ T cells."

Clinical • IO biomarker • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT • NKG2D

IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival (GlobeNewswire) - P1 | N=22 | NCT04165941 | "Repeated doses of INB-200 demonstrate extended median progression-free survival (mPFS) of 16.1 months, more than double the expected 6.9 months typically observed with the standard-of-care (SOC) Stupp protocol; INB-200 is well-tolerated, showing no serious toxicities beyond those typically observed with chemotherapy. Importantly no cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed; Median PFS in patients receiving multiple doses of INB-200 exceeds the historical median overall survival (mOS) of 14.6 months with the SOC Stupp protocol; notably, four patients remain alive and progression free for a median of over two years."

P1 data • Glioblastoma

INB-600: A Novel T Cell Engager Platform Specific for gamma-delta (γδ) T cells (ASGCT 2025) - P1, P1/2 | "To determine B cell depletion, γδ T cell expansion, and optimal dosing, incremental concentrations of the INB-619, along with a no-treatment (NT) control and zoledronate treatment (Zol), were cultured with peripheral blood mononuclear cells (PBMC) for up to 10 days from two healthy donors... In addition to its specific target binding and robust cytotoxicity, this novel γδ TCE promotes the expansion of both Vδ1+ and Vδ2+ γδ T cells, thereby sustaining its killing effect over time. This approach harnesses the advantages of Vδ2-mediated antigen processing and the long-term durability of Vδ1+ T cells. Should this approach be confirmed in autoimmune disease models, INB-619 could represent a promising off-the-shelf therapy for autoimmune diseases, potentially with fewer side-effects, mobilizing both circulating and tissue-resident γδ T cells to eliminate autoreactive B cells and reset B cell hematop Disease Focus of Abstract:Autoimmune Disorders"

IO biomarker • Hematological Malignancies • Immunology • Infertility • Oncology • Sexual Disorders • IFNG • IL17A • IL4 • IL6 • TNFA

IN8bio Reports First Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "American Society of Clinical Oncology (ASCO) 2025 Annual Meeting (May 30, 2025): Upcoming oral presentation: 'INB-200: Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)' will present updated clinical data from IN8bio’s Phase 1 trial of INB-200. The data will be featured in the Central Nervous System Tumors Oral Abstract Session."

P1 data • Glioblastoma

IN8bio to Present Clinical and Preclinical Data from Gamma-Delta T Cell Platform at Upcoming Scientific Conferences (GlobeNewswire) - "IN8bio, Inc...announced that it will present new clinical and preclinical data from its pipeline of gamma-delta T cell therapies at several upcoming scientific conferences."

Clinical data • Preclinical • Glioblastoma

Upcoming Anticipated Pipeline Milestones and Important Events: INB-200 and INB-400 (GlobeNewswire) - "Continue to evaluate early clinical data for signs of efficacy and durability; Report additional findings at upcoming medical meetings in 2025; Seek additional funding sources to advance allogeneic product for glioblastoma and other solid tumors."

Financing • Glioblastoma • Solid Tumor

IN8bio Reports Continued Durable Remissions in Phase 1 Trial of INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting (GlobeNewswire) - P1 | N=21 | NCT04165941 | "Key findings from the INB-200 Phase 1 trial: 92% of evaluable patients treated with INB-200 for GBM surpassed a median standard-of-care (Stupp regimen) PFS of 6.9 months, with a majority exceeding their expected PFS based on their age and the MGMT status of their tumors. One patient with an IDH-mutant glioma remains alive and progression free at over 40.5 months; IDH-mutant patients in a recently published clinical trial demonstrated a median PFS of 11.1 months in the control arm and 27.7 months in the experimental arm."

P1 data • Glioblastoma

IN8bio Announces Plenary Oral Presentation at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting (GlobeNewswire) - "IN8bio will provide longer-term follow-up and additional data demonstrating the activity of its DRI gamma-delta T cell approach in solid tumors from the Phase 1 trial of INB-200."

P1 data • Glioblastoma

INB-200: Fully Enrolled Phase 1 Study of Gene-Modified Autologous Gamma-Delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ) (SNO 2024) - "Subject with IDH mutant tumor remains progression free for > 35 months. Long-term follow-up for durability of PFS and OS continues."

Clinical • IO biomarker • P1 data • Brain Cancer • Cardiovascular • CNS Disorders • CNS Tumor • Fatigue • Glioblastoma • Hematological Disorders • Hepatology • Infectious Disease • Nephrology • Oncology • Otorhinolaryngology • Pain • Solid Tumor • Thrombosis • Ventriculomegaly • MGMT • NKG2D

IN8bio Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "IN8bio...will continue monitoring previously treated GBM patients in both the Phase 2 INB-400 and the Phase 1 INB-200 clinical trials to assess progression-free and overall survival. Updated data to be presented at future medical meetings."

P1 data • P2 data • Trial status • Glioblastoma

Temozolomide and the PARP Inhibitor Niraparib Enhance Expression of Natural Killer Group 2D Ligand ULBP1 and Gamma-Delta T Cell Cytotoxicity in Glioblastoma. (PubMed, Cancers (Basel)) - "Glioblastoma (GBM) is an immunologically cold tumor, but several immunotherapy-based strategies show promise, including the administration of ex vivo expanded and activated cytotoxic gamma delta T cells. Gamma delta T cell-mediated cytotoxicity at a 10:1 effector-to-target ratio was significantly increased upon pretreatment of cells derived from a GBM PDX with TMZ and niraparib in comparison to the control or either drug alone. Together, these data demonstrate that the combination of PARP inhibition, DNA alkylation, and gamma delta T cell therapy has the potential for the treatment of GBM."

IO biomarker • Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • ULBP1