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

• Enrollment is now open in the company-sponsored Phase 2 clinical trial of INB-400 in patients with newly diagnosed glioblastoma multiforme (GBM).

• Enrollment completed in the dose escalation phase of the investigator-sponsored trial of INB-100 in leukemia patients with a clinical update expected at the American Society of Hematology (ASH) Annual Meeting.
  

• R&D Day held today, October 12, 2023 (9:00am-12:00pm EDT). Register online for webcast here.

NEW YORK, Oct. 12, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, 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).

“These important enrollment milestones reflect our continued pursuit to achieve Cancer Zero by leveraging the power of the immune system to develop therapies to eradicate cancer,” said William Ho, Co-founder and CEO. “Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs. We look forward to progressing the INB-400 and INB-100 trials to explore the full potential of gamma-delta T cells as a treatment option for patients with both solid and hematological cancers.”

Phase 1 Clinical Trial of INB-100 in Leukemia

Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation (HSCT). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS.

In April 2023, the Company presented data at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showing 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, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years. Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A clinical update with additional enrolled patients will be presented at the 65th ASH Annual Meeting being held December 9-12, 2023 in San Diego, CA.