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 ?d 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 ?d T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI ?d T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and advancing novel ?d 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 ?d-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 McCall
646.933.5603
pfmccall@IN8bio.com
Media Contact:
KKH Advisors
Kimberly Ha
917.291.5744
kimberly.ha@kkhadvisors.com
