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IN8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients
Globenewswire· 2025-02-11 13:00
Core Insights - IN8bio, Inc. announced promising clinical data for INB-100, an allogeneic gamma-delta T cell therapy for complex leukemias, particularly AML, showing potential for durable long-term remissions and improved survival [1][3][4] Clinical Trial Results - INB-100 demonstrated a 100% complete remission (CR) rate in AML patients across both original and expansion cohorts, with a median follow-up of 20.1 months [4][5] - The original cohort of AML patients achieved a median CR duration of 23.3 months, with some patients remaining in remission for over three years [5] - One-year progression-free survival (PFS) and overall survival (OS) rates for all patients treated with INB-100 were 90.9% and 100%, respectively, while AML patients had 100% PFS and OS at one year [5] Comparison with Historical Data - Historical controls showed a PFS of 67.8% and OS of 74.7% at one year from CIBMTR, and a PFS of 57.4% and OS of 66.7% at one year from KUCC, indicating INB-100's superior outcomes [5] Patient Demographics and Tolerability - The trial included older, high-risk patients (median age = 68) who had complex diseases or had failed multiple prior therapies, yet they achieved durable remissions with manageable side effects [5][6] - INB-100 therapy was well-tolerated, with no significant cytokine release syndrome (CRS) or neurotoxicity reported, and manageable graft-versus-host disease (GvHD) [5][6] Future Outlook - The company is committed to expanding the trial network and preparing for a potential registrational trial, aiming to provide broader patient access to INB-100 [6][9]
IN8bio to Present at Biotech Showcase 2025 in San Francisco
Globenewswire· 2025-01-06 12:00
Core Insights - IN8bio, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative gamma-delta T cell therapies for cancer treatment [3] - The company will participate in the Biotech Showcase 2025, with CEO William Ho presenting on January 14, 2025 [1][2] Company Overview - IN8bio specializes in gamma-delta T cell-based immunotherapies, which can differentiate between healthy and diseased tissues [3] - The lead program, INB-100, targets acute myeloid leukemia (AML) using haplo-matched allogeneic gamma-delta T cells post-hematopoietic stem cell transplant [3] - The company is also investigating autologous DeltEx DRI gamma-delta T cells for glioblastoma in combination with standard care [3] Event Participation - IN8bio will be present at the Biotech Showcase from January 13-15, 2025, and will also be available for meetings during the J.P. Morgan Health Care Conference from January 13-16, 2025 [2] - The panel discussion titled "The Battle Against Cancer: The Armamentarium Keeps Expanding" will take place on January 13, 2025 [2]
IN8bio Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
GlobeNewswire News Room· 2024-11-12 21:26
Reported 100% of Acute Myeloid Leukemia (AML) patients treated in INB-100 remain in complete remission (CR) at the 2024 European Hematology Association Congress and received FDA guidance for a future INB-100 registrational trialINB-100 trial currently expanding enrollment up to approximately 25 patients at the recommended Phase 2 dose (RP2D) along with the potential to add additional centers and a prospective parallel observational cohort as a controlClosed private placement for net proceeds of $11.6 Millio ...
IN8bio Announces Clinical Pipeline Prioritization to Focus on INB-100 for Acute Myeloid Leukemia
GlobeNewswire News Room· 2024-09-04 20:01
Core Insights - IN8bio is prioritizing its clinical program for INB-100 in acute myeloid leukemia (AML), reporting a 100% progression-free survival rate as of August 30, 2024 [1][8] - The company is suspending enrollment in the Phase 2 clinical trial of INB-400 for newly diagnosed glioblastoma (GBM) while continuing to monitor existing patients [2][4] - A workforce reduction of approximately 49% is being implemented to optimize resource allocation and preserve cash resources [2][10] Clinical Programs - INB-100 for AML is the primary focus, with plans to enroll approximately 25 additional patients in the expansion cohort, targeting completion in the first half of 2025 [6] - The company aims to affirm the positive clinical data for INB-100, which has shown a 100% relapse-free survival rate after a median follow-up of 18.7 months [8][7] - INB-200 has completed patient treatment, while enrollment in INB-400 is on hold as the company seeks partnership opportunities [4][9] Financial and Operational Strategy - The workforce reduction is expected to be completed in the third quarter of 2024, with one-time costs of approximately $0.3 million primarily related to severance [10] - The company is focusing on key milestones to generate near-term interest and value creation, particularly through the INB-100 program [5] - IN8bio had a Type B meeting with the FDA, receiving guidance on advancing INB-100 as a post-transplant maintenance therapy [7]
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 News Room· 2024-08-12 12:05
Received FDA guidance on the registrational path for INB-100 in acute myeloid leukemia (AML), an investigational allogeneic gamma-delta T cell therapy, with IND submission anticipated in Q1 2025. Early clinical data from investigator sponsored trials demonstrates prolonged relapse-free survival across both AML and glioblastoma (GBM) programs, compared to current standard-of-care, with both programs advancing to Phase 2 clinical development. Solidifying position as a leader in gamma-delta T cell therapy for ...
IN8bio to Present at the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference
GlobeNewswire News Room· 2024-06-24 12:00
NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today announced that William Ho, CEO and Co-founder, will participate in a fireside chat during the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference on Tuesday, June 25, 2024 at 2:30 p.m. ET. About IN8bio IN8bio has initiated a Phase 2 trial of INB-400 in GBM in the United States and has two ongoing Phase 1 trials in ...
IN8bio Presents Positive Data Demonstrating Durable 1-year Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100
Newsfilter· 2024-06-13 20:01
100% of treated leukemia patients (n=10/10) achieved durable complete remission (CR) at 1-year, including high-risk and relapsed acute myeloid leukemia (AML) patients who had previously failed multiple lines of therapy, including CAR-T. Data continue to show long-term in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration, demonstrating first-ever durable persistence and expansion of an allogeneic cellular therapy. The Company will host a conference ca ...
IN8bio Presents Positive Data Demonstrating Durable 1-year Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100
GlobeNewswire News Room· 2024-06-13 20:01
100% of treated leukemia patients (n=10/10) achieved durable complete remission (CR) at 1-year, including high-risk and relapsed acute myeloid leukemia (AML) patients who had previously failed multiple lines of therapy, including CAR-T. The Company will host a conference call at 4:15 pm ET. Use this link to participate. A listen-only version of the webcast is available here. NEW YORK, June 13, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovat ...
IN8bio Presents Progression-Free Survival Update from Phase 1 Study of INB-200 at 2024 American Society of Clinical Oncology Annual Meeting
GlobeNewswire News Room· 2024-06-03 10:05
92% of evaluable patients treated with INB-200 for glioblastoma exceeded a median progression-free survival (PFS) of seven months achieved with the standard-of-care regimen (Stupp regimen) Majority of fully dosed patients exceeded the expected median PFS based on age and tumor status; one patient from Cohort 2 remains alive and progression free at almost three years Radiologic evaluation indicative of "treatment effect" including changes in MRI enhancement and resolution of mid-line shift NEW YORK, June 03, ...
IN8bio Presents Progression-Free Survival Update from Phase 1 Study of INB-200 at 2024 American Society of Clinical Oncology Annual Meeting
Newsfilter· 2024-06-03 10:05
92% of evaluable patients treated with INB-200 for glioblastoma exceeded a median progression-free survival (PFS) of seven months achieved with the standard-of-care regimen (Stupp regimen) Majority of fully dosed patients exceeded the expected median PFS based on age and tumor status; one patient from Cohort 2 remains alive and progression free at almost three years Radiologic evaluation indicative of "treatment effect" including changes in MRI enhancement and resolution of mid-line shift The current standa ...