INB-400 / IN8bio - LARVOL DELTA

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

Highlights from the Clinical Data as of May 31, 2025: INB-400 (GlobeNewswire) - P1b/2 | N=4 | NCT05664243 | Sponsor: NCT05664243 | "Data from our Phase 2 clinical trial of INB-400 in patients with newly diagnosed GBM, including three additional clinical sites, also show encouraging preliminary results: current mPFS is at 10.8 months. Additional updates expected late 2025."

P2 data • Trial status • 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 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

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1/2 | N=4 | Active, not recruiting | Sponsor: In8bio Inc. | Recruiting ➔ Active, not recruiting | N=120 ➔ 4

Enrollment change • Enrollment closed • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

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

IN8bio to Present at International Society for Cell & Gene Therapy (ISCT) 2024 (GlobeNewswire) - "IN8bio, Inc...announced multiple presentations at the International Society for Cell & Gene Therapy 2024, to be held May 28th to June 1st in Vancouver, Canada."

Clinical • Oncology

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

IN8bio Doses First Patient in Phase 2 Clinical Trial of INB-400 in Newly Diagnosed Glioblastoma (GlobeNewswire) - "IN8bio...announced today 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....Arm A of the INB-400 trial is expected to enroll up to 40 patients....In Arm A of the trial, investigators will administer T cells to patients on the first day of each of six 28-day maintenance cycles concurrent with TMZ for up to six doses. The primary endpoint of the study is overall survival rate at 12 months."

Trial status • Glioblastoma

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

IN8bio Highlights Recent Company Accomplishments and Outlines 2024 Pipeline Goals (GlobeNewswire) - "INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at American Association for Cancer Research (AACR) 2024; INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for allogeneic Phase 1b in relapsed GBM in 2024."

IND • Preclinical • Trial status • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: In8bio Inc.

Combination therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: In8bio Inc. | Phase classification: P1b ➔ P1/2

Combination therapy • Phase classification • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

INB-400 Phase 1b/2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells in Combination With Maintenance Temozolomide Recurrent or Newly Diagnosed Glioblastoma (SNO 2023) - "INB-200, a Phase 1 trial, demonstrated the safety and efficacy of autologously (auto) derived genetically modified drug resistant immunotherapy (DRI) gd T cells combined with maintenance temozolomide (TMZ) to treat newly diagnosed (ND) patients with GBM. Allo arm patients must have a haploidentical donor. Fifteen US centers will conduct study."

Clinical • Combination therapy • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • NKG2D

IN8bio to Present Data Highlighting Potential of INB-200 and INB-400 to Treat Patients with Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 28th Annual Meeting (GlobeNewswire) - "IN8bio, Inc...announced that the Company will present two posters at the Society for Neuro-Oncology (SNO) 28th Annual Meeting, taking place November 15-19, 2023, in Vancouver, British Columbia.....The first poster is a TIPs poster detailing the study design for INB-400, the company-sponsored Phase 2 trial and the second will be a 'late-breaker' poster providing updated clinical data from the Phase 1 INB-200 trial."

P1 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma (GlobeNewswire) - "IN8bio, Inc...today announced the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme (GBM)....The Phase 2 clinical trial of INB-400...an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in 'Arm A' of the study. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP)."

Enrollment closed • Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Brain Cancer • Chronic Myeloid Leukemia • CNS Tumor • Glioblastoma • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1b | N=120 | Recruiting | Sponsor: In8bio Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2023 ➔ Sep 2023

Combination therapy • Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Reports Second Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "The Company is on track to complete INB-200 Phase 1 study enrollment in 2023 with updated data expected to be presented later this year....INB-400 on track to initiate enrollment in glioblastoma multiforme (GBM) in the second half of 2023. The Phase 2 trial (NCT05664243) will initially enroll newly diagnosed GBM patients in the autologous setting....Additional clinical and pipeline updates expected at a research and development (R&D) day on October 12, 2023 in New York City and at fall medical meetings with abstracts submitted for Society for Immunotherapy of Cancer (SITC), Society for Neuro-Oncology (SNO), and the American Society of Hematology (ASH) Annual Meetings in the fourth quarter of 2023."

Clinical data • P1 data • Pipeline update • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

IN8bio's DeltEx Gamma-Delta T Cells Show Promise in Targeting Ovarian Cancer (GlobeNewswire) - "IN8bio, Inc...announced positive preclinical data underscoring the potential of its DeltEx Gamma-Delta T cells to target and kill ovarian cancer. The data were featured in a poster presentation at the American Society of Cell & Gene Therapy (ASGCT) 26th Annual Meeting and showed that DeltEx Gamma-Delta T cells were able to target and kill ovarian cancer cells, even in platinum-resistant and treatment-resistant cell lines....The preclinical data demonstrates that temozolomide (TMZ), an alkylating agent that creates DNA double-stranded breaks, can work synergistically in combination with poly ADP-ribose polymerase inhibitors (PARPi) to significantly increase NKG2D ligand (NKG2D-L) expression....'We are encouraged by these results and look forward to evaluating the applicability of INB-400 in ovarian cancer and other solid tumor targets as soon as possible'."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

IN8bio Announces New Preclinical Data in Ovarian Cancer to be Presented at ASGCT 26th Annual Meeting (GlobeNewswire) - "IN8bio...will present preclinical data showcasing the potential of INB-400 to target ovarian cancer at the American Society of Cell & Gene Therapy (ASGCT) Annual Meeting, in Los Angeles from May 16-20, 2023....Preclinical data demonstrates that gamma-delta T cells have the ability to target other solid tumors such as ovarian cancer, supporting the development of these technologies outside of brain tumors. The data suggest that INB-400, a clinical stage genetically engineered gamma-delta T cell therapeutic candidate, has the potential to be developed as a novel therapy for ovarian cancer, offering hope for patients with this devastating disease."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

IN8bio Receives FDA Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma (GlobeNewswire) - "IN8bio, Inc...announces FDA orphan drug designation for INB-400 and INB-410, covering a broad range of malignant glioma treatments, including newly diagnosed GBM. As an industry leader in gamma-delta T cell development, this milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as 7-year market exclusivity....In December 2022, the FDA cleared IN8bio's investigational new drug application (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400. With Institutional Review Board (IRB) review and site initiation ongoing, patient enrollment is expected to begin in the second half of 2023."

Enrollment status • Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Pipeline Milestones and Events:...(i) INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM in the second half of 2023; (ii) INB-410: Submit a new IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM in late 2023."

Enrollment status • IND • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

IN8bio Provides INB-200 Clinical Update and Outlines 2023 Pipeline Goals (GlobeNewswire) - "Anticipated 2023 Pipeline Goals: INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM by Q3 2023. INB-410: Submit IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM. New solid tumor indications: Announce and present relevant data at a scientific conference in 1H 2023."

Enrollment status • IND • New indication • Glioblastoma • Oncology

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1b | N=120 | Not yet recruiting | Sponsor: In8bio Inc.

Combination therapy • New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

IN8bio Announces FDA Clearance to Initiate a Phase 2 Clinical Trial of INB-400 Gamma-Delta T Cells for Glioblastoma (GlobeNewswire) - "Phase 2 clinical trial initiation expected in 2023....IN8bio, Inc...announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed glioblastoma (GBM)....The Phase 2 clinical trial will commence with the enrollment of newly diagnosed GBM patients, with the initial arm assessing autologously derived MGMT-modified gamma-delta T cells. In line with recent FDA guidance, the Company is planning to expand the trial to include an allogeneic DeltEx DRI drug product in relapsed refractory GBM and potentially the frontline setting."

IND • New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor