IN8bio Recognizes Achievement of 4-Years in Remission for Patient Treated with INB-200 in Glioblastoma Trial
NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, announced that Patient 009 in the Phase 1 trial of INB-200 for newly-diagnosed GBM has recently reached a significant clinical milestone. The patient, with a grade 4, IDH-mutant glioma, has been in remission and surviving for 4 years having been treated with INB-200. The patient is doing well, has returned to work and has a good quality of life post-treatment with INB-200. Patient 009's clinical progress and 4-year remission far surpasses progression-free outcomes observed in other clinical trials of IDH-mutant glioma patients.
'Surviving four years without progression in newly diagnosed astrocytoma WHO4 IDH mutated is a significant achievement demonstrating the potential activity of gamma-delta T cells,' said Dr. Burt Nabors, Principal Investigator of the INB-200 trial and Vice-Chair of Research of Neurology and Director for the UAB Division of Neuro-oncology. 'This outcome further highlights the potential impact of INB-200 in one of the most aggressive, difficult-to-treat and deadly cancers.'
IN8bio recently presented updated Phase 1 data from the INB-200 trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The results showed that repeated doses of INB-200 demonstrated an extended mPFS of 16.1 months, more than double the expected 6.9 months typically observed with the standard-of-care Stupp protocol in newly diagnosed GBM. INB-200 is the first genetically modified gamma-delta T cell therapy evaluated in GBM and has demonstrated a favorable safety profile and signals of long-term benefit.
'We are thrilled that our study participant has reached this incredible milestone,' said William Ho, CEO and co-founder, IN8bio. 'This type of long-term survival and life changing clinical impact is exactly what we strive to achieve at IN8bio. The current standard-of-care for newly diagnosed GBM has not advanced beyond an overall survival of 14-16 months in over two decades. This is a powerful testament to what's possible when we harness the unique biology of gamma-delta T cells.'
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell-based immunotherapies for cancer and autoimmune diseases. 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. The company's lead program, INB-100, is focused on acute myeloid leukemia evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, 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 ability of repeated intracranial dosing of INB-200 to extend mPFS and improve mOS in patients with GBM, including those with chemotherapy-resistant tumors; INB-200's ability to continue to be well-tolerated and show no serious toxicities beyond those typically observed with chemotherapy; INB-200's ability to improve patient outcomes and allow patients to return to work; the ability of IN8bio's DRI technology to offer a new way to treat newly-diagnosed GBM; gamma-delta T cells' ability to eliminate chemo-resistant cancer and stem cells that often survive SOC treatment; INB-200's potential as a novel direction in therapy for the treatment of solid tumor cancers like GBM; INB-200's ability to improve outcomes in ways that enhance effectiveness of treatments without adding toxicity; IN8bio's ability to achieve anticipated milestones, including the advancement of clinical development plans and receipt of regulatory approvals; and other statements that are not historical fact. 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 be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio's ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its γδ-TCE platform or DeltEx platform; the 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; the uncertainty of 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 IN8bio's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2025, 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.
Contacts:
IN8bio, Inc.Patrick McCall646.933.5603pfmccall@IN8bio.com
Media Contact:KKH AdvisorsKimberly Ha917.291.5744kimberly.ha@kkhadvisors.comSign in to access your portfolio
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Forward-Looking Statements We desire to take advantage of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). This news release contains various 'forward-looking statements' within the meaning of the PSLRA and other applicable securities laws. Such statements can be identified by the use of the forward-looking words 'anticipate,' 'estimate,' 'project,' 'believe,' 'intend,' 'plan,' 'expect,' 'hope' or similar words. These statements discuss future expectations; contain projections regarding future developments, operations or financial conditions; or state other forward-looking information. Such statements are based upon assumptions and assessments made by us in light of our experience and perception of historical trends, current conditions, expected future developments; and other factors we believe to be appropriate. These forward-looking statements involve various important risks, uncertainties and other factors, many of which are beyond our control, which could cause our actual results to differ materially from those expressed in the forward-looking statements. Some of the key factors that could cause actual results to differ materially from those expressed in the forward-looking statements include: efficiencies in plant operations and our overall supply chain network; price and product competition; the success and cost of new product development efforts; the lack of market acceptance of new products; changes in demand for our products, which may result from changes in consumer behavior or loss of brand reputation or customer goodwill; the impact of customer store brands on our branded retail volumes; the impact of any laws and regulatory matters affecting our food business, including any additional requirements imposed by the FDA or any state or local government; the extent to which good-fitting business acquisitions are identified, acceptably integrated, and achieve operational and financial performance objectives; inflationary pressures resulting in higher input costs; fluctuations in the cost and availability of ingredients and packaging; adverse changes in freight, energy or other costs of producing, distributing or transporting our products; the reaction of customers or consumers to pricing actions we take to offset inflationary costs; adverse changes in trade policies, including increased tariffs, retaliatory trade measures, or other trade restrictions; dependence on key personnel and changes in key personnel; adequate supply of labor for our manufacturing facilities; stability of labor relations; geopolitical events that could create unforeseen business disruptions and impact the cost or availability of raw materials and energy; dependence on a wide array of critical third parties to support our operations, including contract manufacturers, distributors, logistics providers and IT vendors; cyber-security incidents, information technology disruptions, and data breaches; the potential for loss of larger programs or key customer relationships; capacity constraints that may affect our ability to meet demand or may increase our costs; failure to maintain or renew license agreements; the possible occurrence of product recalls or other defective or mislabeled product costs; the effect of consolidation of customers within key market channels; maintenance of competitive position with respect to other manufacturers; the outcome of any litigation or arbitration; significant shifts in consumer demand and disruptions to our employees, communities, customers, supply chains, production planning, operations, and production processes resulting from the impacts of epidemics, pandemics or similar widespread public health concerns and disease outbreaks; changes in estimates in critical accounting judgments; and risks related to other factors described under 'Risk Factors' in other reports and statements filed by us with the Securities and Exchange Commission, including without limitation our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q (available at Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update such forward-looking statements, except as required by law. 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