Full Press Release Details
IN8bio Announces Positive INB-200 Phase 1 Data Update in
Glioblastoma at the 2023 ASCO Annual Meeting
NEW YORK, June 5, 2023 (GLOBE NEWSWIRE) IN8bio, Inc. (Nasdaq: INAB), a
leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, announced updated data from the ongoing Phase 1 clinical trial of INB-200 in patients with newly diagnosed
glioblastoma multiforme (GBM). The data were featured as one-of-four oral presentations and the only Phase 1 study during the immunotherapy section of the Central
Nervous System Tumors session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago, Illinois.
The standard-of-care for GBM over the past twenty years falls short, with a median progression-free survival of just 4 to 7 months and overall survival of only 14 to 16 months. We
are thrilled to see that two patients who have received three doses of INB-200 remain progression-free, clinically asymptomatic and off treatment for a prolonged period of time, said Trishna Goswami,
M.D., Chief Medical Officer of IN8bio. Further, the use of multiple doses in later cohorts have not led to a change in the toxicity profile, which may enable patients to stay on treatment longer and, ultimately, improve outcomes.
The oral presentation at ASCO includes efficacy and safety data as of a data cutoff of April 30, 2023. Eight patients have been treated with INB-200: three in Cohort 1 (single dose), four in Cohort 2 (three doses) and one in Cohort 3 (six doses). As of May 19, 2023 key findings from the ongoing study include:
INB-200 has proven to be a safe and feasible method of delivering an innovative
cell-based immunotherapy for newly diagnosed glioblastoma patients, said Dr. Burt Nabors, director of the Division of Neuro-Oncology in the University of Alabama at Birmingham Marnix E. Heersink School of Medicine.
The Company expects to provide further clinical updates later this year as study enrollment continues. The ASCO presentation titled INB-200 Phase I Study of Gene Modified Autologous Gamma-Delta ( ) T Cells in Patients with Newly
Diagnosed Glioblastoma Multiforme (GBM) Receiving Maintenance Temozolomide (TMZ) (Abstract #2007) can be found at https://investors.in8bio.com.
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
is intended to enable 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.
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 hematological and 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 the timing of initiation, progress and scope of clinical trials for IN8bio s product candidates, including INB-100,
INB-200 and INB-400; and IN8bio s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in
its clinical trials, and advancement of clinical development plans. 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, presented by public health crises as well as rising inflation and regulatory developments;
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, which 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 May 12, 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.
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