IN8bio to Present New Positive Clinical Data from Phase 1 Trial of INB-100 at EBMT 2023 Annual Meeting

Rhea-AI Summary

IN8bio, a clinical-stage biopharmaceutical company, has announced new data on its investigational drug INB-100, an allogeneic gamma-delta T cell therapy for leukemia patients undergoing haploidentical stem cell transplantation. The data, set for presentation at the European Society for Blood and Marrow Transplantation meeting, shows no dose-limiting toxicities, with four patients on the initial dose level achieving durable complete remission (CR). One patient has remained progression-free for nearly three years. The study, which has demonstrated robust immune system reconstitution, is ongoing and focuses on safety, tolerability, and secondary outcomes such as relapse rates.

Positive

• Four patients on dose level 1 of INB-100 remain in durable complete remission, with one patient progression-free for 32.2 months.
• No dose-limiting toxicities reported in the INB-100 trial.
• Robust immune system reconstitution observed in patients, including increases in T cells, NK cells, and gamma-delta T cells.

Negative

• None.

• Updated data on durability of responses and long-term complete responses (CRs) in leukemia patients treated with INB-100 will be presented; no dose-limiting toxicities have been observed
  
  
• New correlative data on immune reconstitution and gamma-delta T cell proliferation for Cohorts 1 and 2 will be presented
  

NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, today announced that new data 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), will be presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), being held in Paris, France April 23-26.

Four patients received dose level (DL) 1 of INB-100 (1 x 10⁶ cells/kg) and two patients received DL2 (3 x 10⁶ cells/kg) as of the abstract data cutoff of December 18, 2022. All four patients who received DL1 remain on study and in durable complete remission (CR), with one patient remaining progression free for nearly three years at 32.2 months and the others remaining progression free for 29.8, 18.1 and 3.8 months respectively. Immune system reconstitution through the first 100-days post-treatment was robust and durable, with observed elevations in T cells, NK cells, and gamma-delta T cells. Updated data from this Phase 1 study will be presented at the meeting on April 23^rd, 2023.

Details for the EBMT 2023 presentation are as follows:

Title: INB-100: Relapse Prophylaxis Post-Haploidentical Bone Marrow Transplantation and Cyclophosphamide (Haplo/Cy) by Infusion of Donor-Derived Expanded/Activated Gamma-Delta (γδ) T Cells: A Phase I Trial
Presenter: Joseph McGuirk, DO, The University of Kansas Cancer Center
Abstract #: P239
Date and time: Sunday, April 23, 8:30 a.m. CET
Session: ePoster Viewing

About the INB-100 Phase 1 Trial

The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic 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.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio is initiating INB-400, a company-sponsored Phase 2 clinical trial in newly diagnosed glioblastoma following IND clearance in late 2022. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: future positive results in clinical data relating to the INB-100 study, including results relating to durable CR and immune system reconstitution in patients in this study. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, which are described in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 30, 2023, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Company Contact:
IN8bio, Inc.
Patrick McCall
+ 1 646.600.6GDT (6438)
info@IN8bio.com

Investors & Media Contact:
Argot Partners
IN8bio@argotpartners.com

FAQ

What is the purpose of the INB-100 Phase 1 trial?

The trial evaluates the safety and efficacy of INB-100, an allogeneic gamma-delta T cell therapy, in leukemia patients undergoing haploidentical stem cell transplantation.

When will the updated data on INB-100 be presented?

The updated data will be presented on April 23, 2023, at the European Society for Blood and Marrow Transplantation meeting.

What are the results of the INB-100 trial so far?

As of the latest data, four patients on dose level 1 have achieved durable complete remission, with no dose-limiting toxicities reported.

What are the next steps for IN8bio regarding INB-100?

IN8bio will continue to monitor patients in the study and present further data at upcoming conferences.

What is the market potential for INB-100?

If successful, INB-100 could be a significant addition to treatment options for leukemia patients, particularly in the context of haploidentical stem cell transplantation.