On December 11, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported positive updated data from its Phase 1 investigator-sponsored trial of INB-100 in patients with hematologic malignancies (Press release, In8bio, DEC 11, 2023, View Source [SID1234638424]). The data, which will be presented in a poster presentation at the 65th ASH (Free ASH Whitepaper) 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 Company believes this data indicate the curative potential of INB-100 to provide durable relapse free periods for high-risk or relapsed AML and other hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). 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.

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"With more patients and a longer observation period, we are excited to report that 100% of evaluable dosed patients continue to remain in morphological complete remission, with six patients remaining alive and relapse free beyond one year," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "Leukemic relapse is the leading cause of death in patients undergoing HSCT and prevention of relapse remains a high unmet need. In this trial, the first three patients were high-risk or relapsed AML patients with complex cytogenetics. We are happy to report two of the patients remain alive and relapse free for over three years, and the third is now past two years. Furthermore, INB-100 has demonstrated for the first time, the in-vivo expansion and persistence of an allogeneic, or donor-derived, cellular therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival."

"Our team is excited by the potential safety, efficacy and durability of this novel cellular therapy and the possibility to improve the likelihood of cure for patients with blood cancers undergoing stem cell transplantation," 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. "Relapse post stem cell transplant remains the primary cause of treatment failure and mortality. The results of this clinical trial are very encouraging and hold great promise that a novel cellular therapy using donor-derived gamma-delta T cells may prevent relapse, resulting in improved relapse free survival for patients with hematologic malignancies."

Summary of Data Presented at ASH (Free ASH Whitepaper)

The latest INB-100 trial data on immune reconstitution showed significant allogeneic gamma-delta T cell expansion and persistence in patients through the first 365 days post-treatment.

Patients who received INB-100 treatment at DL 2 exhibited gamma-delta T cell levels:

An average of 48.9x greater at 60 days compared with patients undergoing haploidentical HSCT without INB-100 therapy.
An average of 7.6x greater than those achieved in DL 1, which continues to demonstrate a dose-response related to the gamma-delta T cell infusion.
An average of 2.7x greater at 365 days than levels found in DL 1, which is above levels previously associated with improved survival outcomes.
Other observations:

Elevations in CD4+, CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response and stable reconstitution of the immune system post-transplant.
New cytokine data following gamma-delta T cell infusion demonstrate peripheral increases in pro-inflammatory cytokines in the plasma, such as interferon-gamma, IL-6 and IL-15 early post-infusion, demonstrating broad immune activation.
Updated safety data includes three additional patients since in April 2023 (as of November 3, 2023):

Low grade (1-2) acute graft versus host disease (GvHD) observed in 60% of patients treated. Cases were all steroid responsive.
No dose limiting toxicities (DLTs) have been observed.
All evaluable patients across DL 1 and DL 2 remained on study and in CR, with two patients now remaining progression free for over 3 years.
Treated patients have remained progression free for 42.7, 40.3, 28.6, 14.3, 12.2, 12.0, 9.0, 5.6, 5.3 and 4.9 months, respectively.
Conference Call Details
IN8bio will host a conference call and webcast tomorrow, Tuesday, December 12, 2023, at 8:30 am ET to review the updated clinical data from the ASH (Free ASH Whitepaper) presentation. The webcast can be accessed by clicking this link and can also be accessed on the Events & Presentations page of the Company’s website. To participate in the live call, please register using this link. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.

About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is an investigator-sponsored 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 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.