INB-200 / IN8bio - LARVOL DELTA

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

INB-200 and INB-400 (GlobeNewswire) - "The Company has suspended patient enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it explores partnership opportunities for the program. IN8bio will continue to monitor patients previously treated in the fully enrolled INB-200 clinical trial as well as any patients that have been enrolled and are undergoing treatment in the INB-400 Phase 2 clinical trial."

Enrollment status • Brain Cancer • Glioblastoma • Oncology

INB-200 for GBM (GlobeNewswire) - P1 | N=21 | NCT04165941 | "Initial data points to a potential dose response across the three cohorts with dose-escalation ranging from a single dose in cohort 1, three doses in cohort 2, and up to six repeat doses in cohort 3. All patients in cohort 1 eventually relapsed. There have been no new relapses with a range of remission from 9.5 to 37.9 months in cohorts 2 and 3 to date. Multiple patients in these higher repeat dose cohorts have now exceeded the overall survival expected with standard-of-care alone relative to historical data....Several patients in this group, who are typically poor responders and generally unresponsive to chemotherapy, have remained in remission longer than expected. Notably, one patient who received six doses of INB-200 has been in remission for over a year. Updated clinical data from this trial is expected to be presented in Q4 2024."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

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) (EHA 2024) - "The majority of dosed patients who received DRI exceeded the expected median PFS of 7 months (5. 8-8. 2months) with Stupp alone and had manageable toxicity with a continued encouraging trend in PFS."

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

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

IN8bio Presents Progression-Free Survival Update from Phase 1 Study of INB-200 at 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - P1 | N=21 | NCT04165941 | "Key findings from the ongoing Phase 1 study: All patients who completed all protocol mandated doses surpassed a median standard-of-care PFS of 7 months, with a majority also exceeding the expected PFS based on their age and MGMT status of their tumors. 92% of evaluable patients treated with INB-200 for GBM exceeded a median PFS of 7 months achieved with the standard-of-care regimen (Stupp regimen). One patient with an IDH-mutant glioma remains alive and progression free at 34.9+ months; IDH-mutant patients in a recently published clinical trial of an IDH inhibitor demonstrated a median PFS of 11.1 months in the control arm and 28.5 months in the experimental arm."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Announces INB-200 Phase 1 Study Data in Newly Diagnosed Glioblastoma to be Presented at the 2024 ASCO Annual Meeting (GlobeNewswire) - P1 | N=21 | NCT04165941 | "IN8bio, Inc...announced an upcoming presentation of updated results from its fully enrolled Phase 1 study of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 31st - June 4th in Chicago, Illinois. INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delta T cells as a potential first-line treatment for patients with newly diagnosed glioblastoma multiforme (GBM)...The majority of patients dosed exceeded the expected median PFS of 7 months with Stupp therapy alone, demonstrating a continued encouraging trend in PFS. Long-term follow-up for durability of PFS and OS continue....The Phase 1 study results reported no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity."

Cytokine release syndrome • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Demonstrates Robust and Reproducible Gamma-Delta T Cell Therapy Manufacturing in Oral Presentation at ASGCT 2024 (GlobeNewswire) - P1 | N=21 | NCT04165941 | "The study evaluated T cell receptor repertoire and gene-expression changes from apheresis starting material through to final manufactured gamma-delta T cell products, from healthy donors and glioblastoma (GBM) patients enrolled in the INB-200 Phase 1 clinical trial (NCT04165941)....The gamma-delta T cell products demonstrated significant increases in markers of cellular activation and cytotoxicity, with enhanced expression of immune trafficking and stimulation markers, suggesting the potential for potent killing, tissue trafficking and immune cell recruitment in vivo. The data also revealed highly similar gene expression profiles between gamma-delta T cell products manufactured from healthy volunteers and GBM patients, demonstrating the robustness and reproducibility of the manufacturing process across different donor populations."

P1 data • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Reports First Quarter 2024 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Upcoming Anticipated Pipeline Milestones...INB-100: Report updated interim results from the ongoing Phase 1 investigator-sponsored trial at the 2024 EHA Annual Meeting, held June 13-16 in Madrid, Spain. In addition, we will potentially submit an IND application for a Phase 2 registrational trial in 2024 in the AML and myelodysplastic syndrome (MDS) patient setting; INB-200: Report interim Phase 1 long-term follow up results in GBM at multiple medical meetings in 2024 including at the 2024 ASCO Annual Meeting; INB-400: Initiated patient dosing in the Phase 2 autologous arm of INB-400 in newly diagnosed GBM. IN8bio expects to treat up to a total of 40 patients in arm A at multiple sites across the United States....R&D expenses were $4.9 million...due to (i) increased personnel-related costs, including salaries and stock-based compensation due to increased headcount and (ii) direct clinical costs for INB-100, INB-200 and INB-400."

Commercial • IND • P1 data • Trial status • Acute Myelogenous Leukemia • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor

Adoptive cell therapy for high grade gliomas using simultaneous temozolomide and intracranial mgmt-modified γδ t cells following standard post-resection chemotherapy and radiotherapy: current strategy and future directions. (PubMed, Front Immunol) - P1 | "We then validated a therapeutic system that we termed Drug Resistance Immunotherapy (DRI) that combines a standard regimen of TMZ concomitantly with simultaneous intracranial infusion of TMZ-resistant γδ T cells in a first-in-human Phase I clinical trial (NCT04165941). This manuscript will discuss DRI as a rational therapeutic approach to newly diagnosed GBM and the importance of repeated administration of DRI in combination with the standard-of-care Stupp regimen in patients with stable minimal residual disease."

IO biomarker • Journal • Brain Cancer • CNS Tumor • Gene Therapies • Glioblastoma • Glioma • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • NKG2D

IN8bio Announces Publication on Novel Gamma-Delta T Cell Therapy for Glioblastoma in Frontiers in Immunology (GlobeNewswire) - "IN8bio, Inc...announced a publication in Frontiers in Immunology that reviews IN8bio’s novel approach for solid tumors, such as glioblastoma (GBM), an aggressive form of brain cancer. Cellular therapies, particularly chimeric antigen receptor T cell therapies (CAR-T), have shown promise in hematologic malignancies but have faced significant challenges when applied to solid tumors like GBM. These obstacles include rapid tumor growth, antigen heterogeneity, and limited response to current therapies....IN8bio is also conducting a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed GBM."

Preclinical • Glioblastoma • Oncology • Solid Tumor

Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1 | N=21 | Active, not recruiting | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Active, not recruiting | N=12 ➔ 21 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Enrollment change • Enrollment closed • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

IN8bio Highlights Recent Company Accomplishments and Outlines 2024 Pipeline Goals (GlobeNewswire) - "INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit IND for Phase 3 randomized control trial in 2024; INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024."

IND • P1 data • Trial status • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • CNS Tumor • Glioblastoma • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor

IN8bio’s INB-200 Demonstrates Extended Progression-Free Survival in Patients with Newly Diagnosed Glioblastoma (GlobeNewswire) - P1 | N=12 | NCT04165941 | "IN8bio, Inc...presented data demonstrating that all patients treated with INB-200 who completed mandated doses have exceeded a progression-free survival (PFS) of seven months to date....All patients who completed mandated doses surpassed a PFS of seven months, with most also exceeding the expected PFS based on their age and tumor status. One patient (009) with an IDH-mutant glioma remains alive and progression free at 28.5+ months; comparative data published in the New England Journal of Medicine (NEJM) in August 2023 demonstrate that IDH-mutant patients in the control arm of a clinical trial demonstrated a median PFS of 11.1 months."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor