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IN8bio Doses First Patient in Phase 2 Clinical Trial of INB-400 in Newly Diagnosed Glioblastoma
NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company advancing innovative gamma-delta T cell
About this update from In8bio, Inc.
[{"type":"text","content":"NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company advancing innovative gamma-delta T cell therapies, 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. INB-400 is the Company’s first autologous gamma-delta T cell therapy product candidate genetically engineered to survive chemotherapy and maintain the natural ability to recognize, engage and kill cancer cells when dosed along with current, standard-of-care treatments such as temozolomide (Temodar, or TMZ). Arm A of the INB-400 trial is expected to enroll up to 40 patients. INB-400 was granted Orphan Drug Designation by the FDA in 2023. “The initiation of patient dosing in our Phase 2 trial of INB-400 represents an important milestone for both IN8bio and patients with newly diagnosed GBM who have limited therapeutic options,” said William Ho, CEO and co-founder of IN8bio. “Our novel approach combines engineered, chemotherapy-resistant gamma-delta T cells with standard-of-care treatments to potentially drive deeper responses and improved patient outcomes in difficult-to-treat cancers. We look forward to advancing INB-400 at multiple leading medical centers across the United States for patients with GBM and sharing updates, including long-term follow up data from the Phase 1 INB-200 program, at medical meetings this year.” Gamma-delta T cells are naturally occurring immune cells with unique properties enabling them to naturally differentiate between healthy and cancerous tissues. They serve to bridge between the innate and adaptive immune system, contributing to direct tumor cell killing as well as immune memory, cell recruitment and activation to drive deeper immune responses. The Phase 2 study will evaluate the safety and tolerability of INB-400 in patients with newly diagnosed GBM in combination with TMZ. 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. Secondary endpoints include safety and tolerability, overall response rate, time to progression, and progressio...