INB-100 / IN8bio - LARVOL DELTA

Inb-100: A Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-Delta T Cell (EAGD) Infusion Following Haploidentical Hematopoietic Stem Cell Transplantation and Post-Transplant Cyclophosphamide (PTCy) (ASH 2023) - P1 | "Post-BMT infusion of donor-derived, EAGD cells has demonstrated manageable safety with no infusional toxicity or ≥G3 acute GvHD or extensive chronic GvHD. Durable relapse free survival at a maximum of >3 years in subjects with poor risk cytogenetics and adverse clinical risk factors combined with ongoing homeostatic reconstitution of increasing gd T cell effectors post-BMT suggests this therapy may be an effective measure in mitigating relapse after HaploBMT. NCT03533816"

Post-transplantation • Preclinical • Acute Graft versus Host Disease • Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD27 • IL15 • IL6 • PTPRC

Expanded INB-100 Clinical Trial to Multiple Sites (GlobeNewswire) - "IN8bio expanded the Phase 1 trial of INB-100 to include The Ohio State University (OSU), diversifying centers and accelerating patient enrollment."

Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Myelodysplastic Syndrome

IN8bio Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Anticipated Pipeline Milestones and Important Events: INB-100: Accelerating patient enrollment in expansion cohort of ongoing Phase 1 clinical trial including the inclusion of an additional investigational center; Aim to complete enrollment into the expansion cohort in 2025; Expect to present updated clinical data in the second half of 2025; Advancing preparations for potential registrational Phase 2 trial with possible IND submission anticipated in 2026 based on receipt of additional funding."

IND • New P2 trial • P1 data • Trial status • Acute Myelogenous Leukemia

IN8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients (GlobeNewswire) - P1 | N=38 | NCT03533816 | "The data will be presented at the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, hosted in Honolulu, HI...100% of AML patients remain relapse-free...The original cohort of AML patients has reached a median CR of 23.3 months, with several patients in remission for over three years. The median duration across all treated AML patients (N=9) is 20.1 months...INB-100: All patients - 90.9% PFS and OS of 100% at one-year; and; AML patients - 100% PFS and OS of 100% at one-year...Results demonstrate activity even with older, high-risk patients receiving reduced intensity conditioning (RIC)....No cytokine release syndrome (CRS) or neurotoxicity; (ICANs); Tolerable graft-versus-host disease (GvHD) in-line with historical data that is managed with steroids; and Limited, mild infections."

Cytokine release syndrome • P1 data • Acute Myelogenous Leukemia

Inb-100: Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-Delta T Cell Infusion Followinghaploidentical Hematopoietic Stem-Cell Transplantation and Post-Transplant Cyclophosphamide (TCT-ASTCT-CIBMTR 2025) - P1 | "Of the initial 14 subjects enrolled, 10 were treated; 4 at dose level (DL)1 of 1x10 6 cells/kg and 6 at DL2 of 3x10 6 cells/kg. An expansion cohort at DL2, the RP2D is underway. Subjects were 60% male, median age 68, 80% AML in CR1."

Post-transplantation • Preclinical • Anemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Neutropenia • Oncology • Respiratory Diseases • Thrombocytopenia • Transplantation • FLT3 • TP53

IN8bio Reports Continued Progression-Free Survival in Phase 1 Investigator-Sponsored Trial of INB-100 Allogeneic Gamma-Delta T Cells for Leukemias at the 2024 American Society of Hematology Annual Meeting (GlobeNewswire) - P1 | N=38 | NCT03533816 | "In a poster presentation, IN8bio reported that there have been no newly reported deaths or relapses as of September 30, 2024. As of that cutoff date, median CR was at 16.4 months following a median of 19.2 months of follow-up. As previously reported, all patients (n=10) remained alive, progression-free, and in durable CR through one-year. 100% of AML patients remain in CR after a median 19.7 months of follow-up with three patients with high-risk cytogenetic AML and receiving no maintenance therapy remaining in mCR for greater than three years....In addition to the reported complete responses, INB-100 continued to demonstrate a well-tolerated safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) observed and limited mild infections....Enrollment of additional patients into the expansion cohort is on-going and updated data, are expected to be reported in the first half of 2025."

P1 data • Acute Myelogenous Leukemia

IN8bio Announces Upcoming Presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - "Title: INB-100: Pilot Study of Donor Derived, ex-vivo Expanded/Activated Gamma-Delta T cell Infusion Following Haploidentical Hematopoietic Stem-Cell Transplantation and Post-Transplant Cyclophosphamide"

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Chronic Myeloid Leukemia • Myelodysplastic Syndrome

IN8bio Announces Pricing of $12.4 Million Private Placement (GlobeNewswire) - "IN8bio, Inc...announced that it has entered into a definitive securities purchase agreement with accredited investors for a private placement that is expected to result in gross proceeds of approximately $12.4 million to IN8bio, before deducting placement agent fees and other offering expenses. The net proceeds from this financing are expected to fund the Company’s current operating plan into 2026....IN8bio intends to use the net proceeds from the private placement to fund the clinical development of INB-100 and future product candidates and for working capital and other general corporate purposes. The proceeds will support the continued enrollment of patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026."

Enrollment status • Financing • Acute Myelogenous Leukemia

IN8bio Announces Clinical Pipeline Prioritization to Focus on INB-100 for Acute Myeloid Leukemia (GlobeNewswire) - "The Company will focus on generating robust clinical data from INB-100, the ongoing investigator-sponsored Phase 1 clinical trial of acute myeloid leukemia (AML), to further de-risk the registrational pathway and affirm the 100% one-year progression-free survival observed to date in this patient population....With additional funding, the INB-100 trial will continue to enroll patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026."

P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

IN8bio Solidifies Position as a Clinical Leader of Gamma-Delta T Cell Therapy in Oncology with 100% of Treated AML Patients in Complete Remission and Receives FDA Guidance for Registrational Trial of INB-100 (GlobeNewswire) - "Following a Type B meeting with the FDA earlier this summer, IN8bio received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint....IN8bio plans to submit an Investigational New Drug (IND) application to the FDA in Q1 2025. Pending clearance, the Company could initiate a registrational trial for AML in 2025."

FDA event • IND • New trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

IN8bio Solidifies Position as a Clinical Leader of Gamma-Delta T Cell Therapy in Oncology with 100% of Treated AML Patients in Complete Remission and Receives FDA Guidance for Registrational Trial of INB-100 (GlobeNewswire) - P1 | N=38 | NCT03533816 | "100% 1-year Relapse-Free Survival: All patients dosed in the Phase 1 investigator-sponsored trial continue to demonstrate relapse-free survival beyond one year....100% of AML patients remain relapse-free after receiving their dose of INB-100. There have been no new relapses reported since the last update with a data cut-off on May 15, 2024. The previously reported patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed are still alive....Full enrollment of the 10-patient expansion cohort is expected by the end of 2024, with long-term follow up results anticipated in 2025."

Enrollment status • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

INB-100: PILOT STUDY OF DONOR DERIVED, EX-VIVO EXPANDED/ACTIVATED GAMMA-DELTA T CELL INFUSION FOLLOWING HAPLOIDENTICAL HEMATOPOIETIC STEM-CELL TRANSPLANTATION AND POST-TRANSPLANT CYCLOPHOSPHAMIDE (EHA 2024) - P1 | "Transfusion of EAGD cells demonstrated manageable safety with no severe aGvHD. Durable RFS at or beyond 12mos in 7 subjects, 2 subjects with poor cytogenetics combined with ongoinghomeostatic increase of gd T cells post-HSCT suggests this therapy may be effective in mitigating relapse afterhaplo-PTCY HSCT and warranting on-going expansion."

IO biomarker • Post-transplantation • Preclinical • Acute Graft versus Host Disease • Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Immunology • Respiratory Diseases • Transplantation • CD27 • PTPRC

IN8bio Presents Positive Data Demonstrating Durable 1-year Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 (GlobeNewswire) - P1 | N=38 | NCT03533816 | "IN8bio...presents updated data from its Phase 1 trial of INB-100 at the European Hematology Association (EHA) 2024 Hybrid Congress. The data from INB-100 demonstrated that 100% of evaluable leukemia patients (n=10) remained alive, progression-free, and in durable CR through one year as of May 31, 2024....Two of the patients treated with INB-100 remain alive and relapse free for over three and a half years, and a third patient is now nearing three years....Enrollment and treatment of patients into the expansion cohort is ongoing, with updated data expected in late 2024 and 2025. IN8bio expects to discuss plans for a potential registrational trial for this indication with the U.S. Food and Drug Administration (FDA) in a Type B meeting this summer."

FDA event • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Myelodysplastic Syndrome

IN8bio Announces Upcoming Presentation at 2024 European Hematology Association Congress (GlobeNewswire) - "IN8bio, Inc...announced today a presentation at the European Hematology Association 2024 Congress, to be held June 13-16 in Madrid, Spain....'We’re excited to share the latest updated interim results from our Phase 1 trial evaluating our gamma-delta T cell therapy INB-100 after haploidentical stem cell transplantation for patients with leukemia at the upcoming EHA congress.'"

P1 data • Hematological Malignancies • Leukemia • 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 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 Announces Positive Clinical Update Demonstrating Continued Durable Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 in Leukemia (GlobeNewswire) - P1 | N=38 | NCT03533816 | "The data, which will be presented in a poster presentation at the 65th ASH Annual Meeting & Exposition this evening, demonstrated that 100% of evaluable leukemia patients (n=10) treated remained alive, progression-free, and in durable complete remission (CR) as of November 3, 2023....The CRs to date, combined with INB-100’s benefit/risk profile are encouraging for the treatment of hematological malignancies and the trial is being expanded by ten patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D). Additional expansion patient enrollment is on-going and updated data is expected to be presented at medical meetings in 2024."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

IN8bio to Host Investor Call at 8:30 AM ET on Tuesday, December 12 to Discuss Updated Clinical Data from Phase 1 Trial of INB-100 in Patients with Leukemia (GlobeNewswire) - "IN8bio...announced the Company will host a conference call on Tuesday, December 12, 2023 at 8:30 am ET. The event will highlight data presented at the ASH 65th Annual Meeting in a poster presentation on December 11, 2023 starting at 6:00 pm PT. The Company’s INB-100 trial is focused on investigating the potential of harnessing donor-derived allogeneic gamma-delta T cells for the treatment of patients with hematological malignancies following hematopoietic bone marrow transplantation (HSCT)."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies

IN8bio to Present New Positive Data from Phase 1 Trial of INB-100 at 2023 American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - P1 | N=38 | NCT03533816 | "New data on the completed dose-escalation of this Phase 1 trial highlights promising efficacy of INB-100 in patients with hematologic malignancies; updated data on durability of responses and long-term complete responses (CRs) to be presented. INB-100 continues to demonstrate a favorable safety profile with no dose-limiting toxicities (DLTs) and evidence of robust gamma-delta T cell expansion using recommended Phase 2 dose (RP2D)."

P1 data • Hematological Malignancies • 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

IN8bio Presents Positive, New INB-100 Data Showing Long-term Complete Remissions and Elevated Gamma-Delta T Cells in 100% of Evaluable Treated Leukemia Patients at EBMT 2023 (GlobeNewswire) - P1 | N=38 | NCT03533816 | "IN8bio, Inc...announced new positive data from the Phase 1 investigator-sponsored trial of INB-100 in leukemia patients. The data presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showed that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR) as of April 21, 2023, indicating the curative potential of INB-100 for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT)....The latest data on immune reconstitution presented at EBMT showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 180 days post-treatment. Patients who received INB-100 treatment at Dose Level 2 exhibited an average of 82.9x greater gamma-delta T cell expansion at 60 days compared to patients undergoing haploidentical HSCT without INB-100 therapy."

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

IN8bio Presents Positive, New INB-100 Data Showing Long-term Complete Remissions and Elevated Gamma-Delta T Cells in 100% of Evaluable Treated Leukemia Patients at EBMT 2023 (GlobeNewswire) - "'The data that continue to emerge from this clinical trial are very encouraging and suggest that INB-100 may offer a new treatment option for this high-risk population,' said Dr. Joseph McGuirk....'While the data are early, it is encouraging that all evaluable treated patients have shown positive clinical outcomes and durable responses, particularly in light of the high-risk and complex cytogenetics of these patients.'"

Media quote

INB-100: RELAPSE PROPHYLAXIS POST-HAPLOIDENTICAL BONE MARROW TRANSPLANTATION AND CYCLOPHOSPHAMIDE (HAPLO/CY) BY INFUSION OF DONOR-DERIVED EXPANDED/ACTIVATED GAMMA-DELTA (ΓΔ) T CELLS: A PHASE I TRIAL (EBMT 2023) - P1 | "The preliminary results of this Phase 1 study of donor-derived, EAGD cells has demonstrated the therapy to have a robust safety profile, with no infusional toxicity, treatment associated SAEs, or grade 3-4 acute or extensive chronic GVHD. The absence of relapse suggest the possibility that this therapy will be an effective measure in mitigating relapse after HaploBMT."

IO biomarker • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Chronic Myeloid Leukemia • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation • CD27 • CD8 • FOXP3 • IFNG • IL2RA • PTPRC • TNFA

IN8bio to Present New Positive Clinical Data from Phase 1 Trial of INB-100 at EBMT 2023 Annual Meeting (GlobeNewswire) - P1 | N=38 | NCT03533816 | "IN8bio...announced that new data from the ongoing Phase 1 trial evaluating INB-100, an allogeneic, gamma-delta T cell therapy, in patients with hematologic malignancies undergoing haploidentical stem cell transplantation (HSCT), will be presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), being held in Paris, France April 23-26....All four patients who received DL1 remain on study and in durable complete remission (CR), with one patient remaining progression free for nearly three years at 32.2 months and the others remaining progression free for 29.8, 18.1 and 3.8 months respectively....Updated data from this Phase 1 study will be presented at the meeting on April 23rd, 2023."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

IN8bio Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Pipeline Milestones and Events: (i) INB-100: Report updated Phase 1 trial data from leukemia patients undergoing HSCT at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in April 2023; define recommended Phase 2 dose for INB-100; (ii) INB-200: Complete enrollment of Cohort 3 in the Phase 1 trial; report updated data and results with longer-term follow-up at medical meetings throughout 2023; (iii) INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform at the American Association of Cancer Research (AACR) Annual Meeting in April 2023."

P1 data • Preclinical • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Brain Cancer • Chronic Myeloid Leukemia • CNS Tumor • Glioblastoma • Glioma • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Solid Tumor