IN8bio’s INB-200 Demonstrates Extended Progression-Free Survival in Patients with Newly Diagnosed Glioblastoma
20 Noviembre 2023 - 6:00AM
IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage
biopharmaceutical company developing innovative gamma-delta (γδ) T
cell therapies, presented data demonstrating that all patients
treated with INB-200 who completed mandated doses have exceeded a
progression-free survival (PFS) of seven months to date. This
survival data shows the potential of IN8bio’s DeltEx Drug Resistant
Immunotherapy (DRI) - genetically modified and
chemotherapy-resistant gamma-delta T cells to treat patients with
newly diagnosed glioblastoma (GBM). The poster highlighting the
updated clinical data from the Phase 1 INB-200 trial was presented
at the Society for Neuro-Oncology (SNO) 28th Annual Meeting in
Vancouver, British Columbia on November 17, 2023.
“Every patient in the Phase 1 trial that completed the mandated
doses has exceeded the standard-of-care median progression-free
survival of four to seven months, with one patient in Cohort 2
remaining alive and progression free past 28.5 months following
three doses,” said Trishna Goswami, MD, Chief Medical Officer at
IN8bio. “We are excited by the safety and efficacy results across
cohorts in this study and look forward to dosing additional
patients with the added hope of improving their treatment outcomes.
Following up on our oral presentation at this year’s ASCO Annual
Meeting, these encouraging results demonstrate the early promise of
IN8bio’s DeltEx DRI gamma-delta T cells for treating GBM patients
and potentially other solid tumor cancers.”
The current standard-of-care regimen for newly diagnosed GBM
consists of primary resection, six weeks of chemoradiation therapy
followed by six cycles of maintenance monthly temozolomide therapy,
which achieves a median PFS of 7 months and an overall survival
(OS) of approximately 14 to 16 months. The Phase 1 trial assesses
the safety and preliminary efficacy of the addition of DeltEx DRI
gamma-delta T cells to standard-of-care maintenance therapy. The
trial assesses three different dosing regimens from a single dose
delivered on cycle 1 day 1 in Cohort 1, to three doses delivered on
day 1 of cycles 1-3 in Cohort 2, to finally six doses delivered on
day 1 of cycles 1-6 in Cohort 3. All patients receive 1x107 cells
per dose, however the number of doses varies depending on the
cohort of enrollment.
The poster presentation at SNO included efficacy and safety data
as of the data cutoff on October 20, 2023. Ten patients have been
treated with INB-200: three in Cohort 1 (1 dose), four in Cohort 2
(3 doses) and three in Cohort 3 (6 doses). Key findings from the
ongoing study include:
- All patients who
completed mandated doses surpassed a PFS of seven months, with most
also exceeding the expected PFS based on their age and tumor
status.
- One patient (009)
with an IDH-mutant glioma remains alive and progression free at
28.5+ months; comparative data published in the New England Journal
of Medicine (NEJM) in August 2023 demonstrate that IDH-mutant
patients in the control arm of a clinical trial demonstrated a
median PFS of 11.1 months.
- No treatment-related
serious adverse events (SAEs), dose-limiting toxicities (DLTs),
cytokine release syndrome (CRS), infusion reactions, or immune
effector cell-associated neurotoxicity syndrome (ICANS) have been
reported in any cohort.
- The most common
treatment-emergent adverse events (TEAEs) were mostly Grade 1-2
toxicities consisting of white blood cell and platelet count
decreases related to standard-of-care temozolomide.
- Preserved
gamma-delta T cells found in relapsed tumor 148 days after initial
DRI infusion, pointing to durability of gamma-delta T cells in
treating cancer.
- The poster is
available on the Company’s website here.
About INB-200INB-200 is a genetically modified
autologous 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 IN8bioIN8bio 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 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 StatementsThis 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 INB-200 to treat patients with newly diagnosed GBM, including
future outcomes of the INB-200 program; the ability of the DeltEx
platform to effectively identify and eradicate tumor cells; the
development and continued progress and success of our preclinical
and clinical trials and programs and product candidates; 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 November 9, 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
Investors & Media:Argot
PartnersIN8bio@argotpartners.com
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