On December 12, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported updated results 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) (Press release, In8bio, DEC 12, 2022, View Source [SID1234625124]). The data, featured in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting and Exposition, demonstrate the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia (AML) and other hematologic malignancies.

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"While haploidentical stem cell transplantation provides a pathway towards leukemic cures, 50% of transplant patients relapse after one year, with many succumbing to the disease," said Dr. Joseph McGuirk, the Schutte-Speas Professor of Hematology-Oncology, Division Director of Hematological Malignancies and Cellular Therapeutics and Medical Director, Blood and Marrow Transplant at The University of Kansas Cancer Center and the Principal Investigator on the study. "The long-term durable responses, in conjunction with a manageable safety profile, observed in Cohort 1 are very meaningful and highlight the potential of INB-100 to increase the cure rates in patients with AML."

The poster presented at ASH (Free ASH Whitepaper) included efficacy and safety data from Cohort 1 of the ongoing study as of the data cutoff of November 11, 2022. As of December 9, 2022, four patients have received the first dose level (DL) of INB-100 (1 x 106 cells/kg) and remain on study and in remission. Three DL1 patients with at least approximately 18 months and one patient with 3.5 months of follow-up

all remain in morphologic complete remission (CR); two patients have remained progression free for more than two years, at 31.9 months and 29.5 months respectively, and a third for nearly a year and a half at 17.8 months. A fourth DL1 patient remains relapse free in CR at 3.5 months and continues to be monitored. Immune system reconstitution through the first 100-days post-treatment demonstrates continued normal function, including observed elevations in T cells, B cells, and gamma-delta T cells.

"These results are encouraging, and reinforce our conviction that INB-100, a one-time allogeneic gamma-delta T cell therapy, has the potential to provide meaningful clinical benefit to patients with AML who face a significant risk of relapse," said Trishna Goswami, M.D., Chief Medical Officer of IN8bio. "We are excited about the early signals of durable relapse-free survival observed in Cohort 1 in this high-risk patient population and look forward to gaining further insights as we enroll additional patients in Cohort 2 and evaluate INB-100 at a higher dose."

No DLTs, treatment-related ≥ grade 3 adverse events (AEs) or cytokine release syndrome (CRS) have been observed. Steroid-responsive cutaneous acute Grade 1/2 graft-versus-host disease (GvHD) has been observed in all patients, with one patient experiencing Grade 2 intestinal GvHD. The most common AEs were constipation, cytomegalovirus (CMV) reactivation, emesis, fatigue, and hypomagnesaemia, the majority of which were Grade 1/2.

Two patients have been enrolled and dosed in Cohort 2, evaluating INB-100 at a dose level of 3 x 106 cells/kg. The Company expects to share additional clinical updates from the Phase 1 study of INB-100 in 2Q 2023.

Conference Call Details

IN8bio will host a conference call and webcast today, December 12, 2022, at 8:30 a.m. ET to review the data from the ASH (Free ASH Whitepaper) presentation, as well as recent clinical updates. The webcast can be accessed by clicking the link: View Source and can also be accessed on the Events & Presentations page of the Company’s website.

About the INB-100 Phase 1 Trial

The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.