Full Press Release Details
IN8bio Reports Continued Durable Remissions in Phase 1 Trial of
INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting
NEW YORK, November 25, 2024 (GLOBE NEWSWIRE) IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company
developing innovative gamma-delta T cell therapies, presented results from the fully enrolled Phase 1 trial of INB-200 in a plenary oral presentation at the
29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX. The survival data along with histopathology and radiographic data are indicative of positive treatment effects, which
highlight the potential of IN8bio s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with solid
tumor cancers such as glioblastoma (GBM).
As the clinical trial data continues to mature, this novel immuno-cell therapy leveraging gamma-delta T
cells is highly feasible with a well-tolerated safety profile and biological evidence of improved immune surveillance in glioblastoma patients, said Burt Nabors, M.D., Division Director, Neuro-Oncology at the Heersink School of Medicine at the
University of Alabama at Birmingham
This novel treatment leverages the DNA damage induced by chemotherapy combined with genetically engineered
gamma-delta T cells and we believe it represents a significant advancement in the treatment of solid tumor cancers such as GBM, said William Ho, co-founder and CEO of IN8bio. Glioblastomas are
often classified as cold, immune desert tumors due to their limited immune cell infiltration. For the first time, we have confirmed the infiltration of gamma-delta T cells into these tumors through paired tissue biopsies following treatment with INB-200. We are encouraged by the patient follow-up with repeat dose patients demonstrating a 79% increase in median PFS as compared to 6.9 months as reported by the Stupp
regimen and an almost 50% increase in median PFS as compared to the 8.3 months in the three patients treated
with only a single dose of INB-200 in Cohort 1. The addition of IN8bio s DeltEx drug resistant immunotherapy (DRI) gamma-delta T cells show the
potential for extending PFS in this difficult-to-treat patient population when INB-200 was administered in combination with the
current standard-of-care used to treat newly diagnosed GBM patients.
The Phase 1 trial assessed the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to maintenance therapy with TMZ. The trial
assessed the administration of 1x107 cells per dose across three different dosing regimens increasing from a single dose in Cohort 1, three doses in Cohort 2, and six doses in Cohort 3. A total of
13 patients have been enrolled and treated with INB-200, including three patients in Cohort 1, four patients in Cohort 2 and six patients in Cohort 3.
Key findings from the INB-200 Phase 1 trial:
IN8bio is a clinical-stage
biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. 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 AML evaluating haplo-matched allogenic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company
is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma. 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 potential of IN8bio s genetically modified, chemotherapy-resistant gamma-delta T cells
as a potential first-in-class therapy for patients with solid tumor cancers such as GBM; the potential of IN8bio s DeltEx DRI gamma-delta T cells to extend PFS when
administered in combination with the current standard of care used to treat newly diagnosed GBM patients; IN8bio s ability to achieve anticipated milestones, including the advancement of clinical development plans; 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 our 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 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; 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, 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 12, 2024, 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.
Investor & Company Contacts:
Glenn Schulman, PharmD, MPH
Z3 BioCommunications, llc