IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage
biopharmaceutical company developing innovative gamma-delta T cell
therapies, today announced a publication in Frontiers in Immunology
that reviews IN8bio’s novel approach for solid tumors, such as
glioblastoma (GBM), an aggressive form of brain cancer.
Cellular therapies, particularly chimeric
antigen receptor T cell therapies (CAR-T), have shown promise in
hematologic malignancies but have faced significant challenges when
applied to solid tumors like GBM. These obstacles include rapid
tumor growth, antigen heterogeneity, and limited response to
current therapies.
The publication, titled: “Adoptive cell therapy
for high grade gliomas using simultaneous temozolomide and
intracranial mgmt-modified γδ t cells following standard
post-resection chemotherapy and radiotherapy: current strategy and
future directions,” explains the mechanism of action behind
IN8bio’s novel therapeutic approach called DeltEx Drug Resistance
Immunotherapy (DRI) and the current strategy and future directions
for this treatment.
The INB-200 and INB-400 studies by IN8bio
addresses the challenges towards targeting solid tumors by
harnessing the innate immune functions of gamma-delta T cells. GBM
cells constitutively express stress-associated NKG2D ligands
(NKG2DL), which can be further upregulated through the DNA damage
response (DDR) pathway triggered by alkylating agents like
temozolomide (TMZ).
“We believe our results to date represent a
significant advancement in the treatment of GBM. By combining
standard chemotherapy with gamma-delta T cells genetically
engineered to resist the lymphodepleting effects of chemotherapy,
we are creating a synergistic effect that enhances the immune
response against GBM while minimizing toxicity to healthy tissues,”
said Lawrence Lamb, Ph.D., Chief Scientific Officer and Co-Founder
of IN8bio. “This new treatment may improve the survival and quality
of life of patients with GBM by preventing tumor recurrence and
enhancing the immune response to eliminate residual cancer
cells.”
The current standard of care for newly diagnosed
GBM typically involves primary tumor resection followed by six
weeks of chemoradiation therapy, succeeded by six cycles of monthly
maintenance therapy with TMZ. This regimen typically yields a
median progression-free survival (PFS) of 6 to 7 months and an
overall survival (OS) ranging from 14 to 16 months. IN8bio‘s Phase
1 trial (INB-200) assessing the safety and efficacy of intracranial
infusions of autologously derived DeltEx DRI gamma-delta T cells in
addition to standard-of-care maintenance therapy suggests that the
therapy is manageable with a possible improvement in PFS.
In the Phase 1 study, cells from the patient are
isolated, expanded and modified prior to being delivered
intracranially to the tumor cavity every month in combination with
maintenance TMZ. 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 six
doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients
receive 1x107 cells per dose. The trial aims to improve PFS by
targeting residual cancer cells. Of the eight patients who have
completed scheduled dosing, all have exceeded the median PFS
expected with standard-of-care therapy alone.
IN8bio is also conducting a Phase 2 clinical
trial of a genetically modified autologous gamma-delta T cell
therapy (INB-400) targeting newly diagnosed GBM. The study will
assess the safety, efficacy and tolerability of genetically
modified DeltEx DRI cells at leading medical centers across the
United States.
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 INB-400INB-400 is
IN8bio’s DeltEx autologous and allogeneic DRI technology.
Allogeneic INB-400 will expand the application of DRI gamma-delta T
cells into other solid tumor types through the development of
allogeneic DeltEx DRI technology.
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 allogenic, 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 hematologic 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 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 CAR-T cellular therapies to treat hematologic
malignancies and GBM; the ability of the INB-200 study (i) to
present a significant advancement in the treatment of GBM, (ii)
create a synergistic effect that enhances the immune response
against GBM while minimizing toxicity to healthy tissues and (iii)
improve the survival and quality of life of patients with GBM by
preventing tumor recurrence and enhancing the immune response to
eliminate residual cancer cells; the ability of IN8bio’s Phase 1
trial in INB-200 to improve PFS by targeting residual cancer cells;
and extending IN8bio’s cash runway into 2025; IN8bio’s ability to
extend runway upon receipt of additional capital from the December
2023 private placement; IN8bio’s ability to raise additional
capital from the December 2023 private placement; IN8bio’s ability
to advance its work in other solid tumor indications; the potential
for INB-400 to treat GBM; the timing of initiation, progress and
scope of clinical trials for IN8bio’s product candidates, including
INB-100, INB-200 , INB-300 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, 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 ContactIN8bio, Inc.Patrick McCall+1
646.600.6GDT (6438)info@IN8bio.com
Investors Argot
PartnersIN8bio@argotpartners.com
Media ContactKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
IN8bio (NASDAQ:INAB)
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