• Company will present “late-breaker” poster detailing updated clinical data from Phase 1 trial of INB-200
• Company-sponsored Phase 2 trial of INB-400 to be showcased in Trials-in-Progress (TIPs) poster

NEW YORK, Nov. 10, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced that the Company will present two posters at the Society for Neuro-Oncology (SNO) 28^th Annual Meeting, taking place November 15-19, 2023, in Vancouver, British Columbia. The posters highlight the potential of IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI), genetically modified and chemotherapy-resistant gamma-delta T cells to treat patients with newly diagnosed glioblastoma multiforme (GBM). The first poster is a TIPs poster detailing the study design for INB-400, the company-sponsored Phase 2 trial and the second will be a “late-breaker” poster providing updated clinical data from the Phase 1 INB-200 trial.

“Having recently initiated enrollment in our Phase 2 trial, we are excited to share details on the study’s design and look forward to providing updates as the trial progresses,” said Trishna Goswami, MD, Chief Medical Officer at IN8bio. “We are encouraged by the safety and preliminary efficacy signal we have seen in our Phase 1 trial treating GBM patients with autologous, genetically modified gamma-delta T cells. Using this approach, we hope to provide a new treatment for patients living with this cancer who currently have few therapeutic options and limited survival.”

Details for the SNO 2023 presentations:

Abstract #: CTIM-42 (Late-breakers)
Title: INB-200: Phase 1 Study of Gene Modified Autologous Gamma-delta (γδ) T Cells in Newly Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving Maintenance Temozolomide (TMZ)

Presenter: Mina Lobbous, MD, MSPH, Cleveland Clinic, Case Western Reserve University
Session Name: Clinical Trials: Immunologic
Date and Time: Friday, November 17, 2023, 7:30 - 9:30 PM PT
Location: Exhibit Hall A/B

Abstract #: CTIM-35 (TIPs)
Title: INB-400 Phase 1b/2 Drug Resistant Immunotherapy with Activated, Gene Modified Allogeneic or Autologous γδ T Cells in Combination With Maintenance Temozolomide Recurrent or Newly Diagnosed Glioblastoma

Presenter: Burt Nabors, MD, Heersink School of Medicine, University of Alabama at Birmingham
Session Name: Clinical Trials: Immunologic
Date and Time: Friday, November 17, 2023, 7:30 - 9:30 PM PT
Location: Exhibit Hall A/B

Phase 2 Clinical Trial of INB-400 in GBM
The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in “Arm A” of the study. The primary endpoint of this arm is the 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.

INB-400 was granted Orphan Drug Designation (ODD) by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a disease with significant unmet need, with limited treatment options and poor associated outcomes. The treatment for this highly aggressive brain cancer, has remained largely unchanged for more than 18 years, with a median progression-free survival (PFS) of 6-7 months and median overall survival (OS) of only 14-16 months.

About INB-400
INB-400 is IN8bio’s DeltEx autologous and allogeneic drug-resistant immunotherapy (DRI) technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic DeltEx DRI technology.

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 has initiated a Phase 2 trial of INB-400 in GBM at multiple centers across the United States and has two ongoing Phase 1 trials in solid and hematological tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other hematological and solid tumor cancers. 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 potential of INB-400 and INB-200 to treat patients with newly diagnosed GBM; the development and continued progress and success of our preclinical and clinical trials and programs and product candidates; the timing of initiation, progress (including as to enrollment) and scope of clinical trials, including for INB-400 and INB-200; the ability of INB-400 to expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic DeltEx DRI technology; and IN8bio’s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and to develop new preclinical programs. 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, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements. These and other factors are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 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.
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