IN8bio Presents Biologic Correlative Data from the INB-200 Phase 1 Trial in Newly Diagnosed Glioblastoma at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting

• Data demonstrate the ability of single and repeat doses of INB-200, DeltEx drug-resistant immunotherapy (DRI) gamma-delta T cell therapy, to induce T cell persistence and a sustained immune response.
  
• A treated patient, with paired tissue biopsies, demonstrated infiltration of gamma-delta T cells 148 days following a single administration in Cohort 1.
  
• Updated patient, survival and enrollment data from the ongoing INB-200 study to be presented at the Society for Neuro-Oncology (SNO) Annual Meeting on November 17, 2023 from 7:30 PM – 9:30 PM PT (Abstract Number: CTIM-42).
  

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, today presented new biological correlative data from the ongoing Phase 1 clinical trial of INB-200 targeting newly diagnosed glioblastoma multiforme (GBM) in a poster presentation at the Society for Immunotherapy of Cancer’s (SITC) 38^th Annual Meeting.

Chemotherapy has remained a mainstay of solid tumor treatment. Alkylating agents such as temozolomide (TMZ) can directly kill chemotherapy-sensitive GBM cells but can also sensitize chemotherapy resistant tumor cells to immune recognition by upregulating stress-associated NKG2D ligands (NKG2DL) to drive immunogenicity. Unfortunately, the lymphodepleting effects of chemotherapy, such as TMZ, also kills T cells, and prevents an effective immune response to these stress targets. IN8bio’s DeltEx DRI gamma-delta T cells are designed to be resistant to chemotherapy, allowing them to remain functional and be used in combinations to create a strong synergistic tumor cell killing impact.

“Gamma-delta T cells are important in immune responses and their high levels are known to correlate with improved survival outcomes. Efficient immune reconstitution is pivotal for favorable outcomes in cancer patients. This new analysis sheds light on how our DeltEx DRI gamma-delta T cell approach may induce durable persistence and immune responses,” said William Ho, Co-founder and CEO. “These important insights will help inform the ongoing development of our DeltEx DRI therapies across a variety of solid and hematological tumors.

These data demonstrate that the lymphodepleting effects of chemotherapy results in a globally suppressed immune system where the DeltEx DRI gamma-delta T cells can strengthen the immune response and potentially broadly eliminate cancer cells. Furthermore, conventional standard-of-care can act as a long-term lymphodepleting agent, an important component for the development of allogeneic and potentially ‘off-the-shelf’ cellular therapies. In June 2023, IN8bio presented positive data from the Phase 1 study of INB-200 in an oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting. The Company will present updated patient, survival and enrollment data from the study at the Society for Neuro-Oncology (SNO) Annual Meeting taking place November 15-19, 2023.

About INB-200
INB-200 is a genetically modified autologous drug resistant immunotherapy (DRI) product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.

INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.

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 glioblastoma (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 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-100 and INB-400; the success of gamma delta T cells as a treatment option for patients with both solid and hematological cancers; IN8bio’s progress towards and achievement of its goal of “Cancer Zero”; 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 August 10, 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

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