IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical
company developing innovative gamma-delta T cell therapies, today
announced that the Company will present two posters at the Society
for Neuro-Oncology (SNO) 28th Annual Meeting, taking place November
15-19, 2023, in Vancouver, British Columbia. The posters highlight
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
multiforme (GBM). The first poster is a TIPs poster detailing the
study design for INB-400, the company-sponsored Phase 2 trial and
the second will be a “late-breaker” poster providing updated
clinical data from the Phase 1 INB-200 trial.
“Having recently initiated enrollment in our
Phase 2 trial, we are excited to share details on the study’s
design and look forward to providing updates as the trial
progresses,” said Trishna Goswami, MD, Chief Medical Officer at
IN8bio. “We are encouraged by the safety and preliminary efficacy
signal we have seen in our Phase 1 trial treating GBM patients with
autologous, genetically modified gamma-delta T cells. Using this
approach, we hope to provide a new treatment for patients living
with this cancer who currently have few therapeutic options and
limited survival.”
Details for the SNO 2023 presentations:
Abstract #:
CTIM-42 (Late-breakers)Title: INB-200: Phase 1
Study of Gene Modified Autologous Gamma-delta (γδ) T Cells in Newly
Diagnosed Glioblastoma Multiforme (GBM) Patients Receiving
Maintenance Temozolomide (TMZ)
Presenter: Mina Lobbous, MD,
MSPH, Cleveland Clinic, Case Western Reserve
UniversitySession Name: Clinical Trials:
ImmunologicDate and Time: Friday, November 17,
2023, 7:30 - 9:30 PM PTLocation: Exhibit Hall
A/B
Abstract #:
CTIM-35 (TIPs)Title: INB-400 Phase 1b/2 Drug
Resistant Immunotherapy with Activated, Gene Modified Allogeneic or
Autologous γδ T Cells in Combination With Maintenance Temozolomide
Recurrent or Newly Diagnosed Glioblastoma
Presenter: Burt Nabors, MD,
Heersink School of Medicine, University of Alabama at
BirminghamSession Name: Clinical Trials:
ImmunologicDate and Time: Friday, November 17,
2023, 7:30 - 9:30 PM PTLocation: Exhibit Hall
A/B
Phase 2 Clinical Trial of INB-400 in
GBMThe Phase 2 clinical trial of INB-400 (NCT05664243), an
autologous, genetically engineered gamma-delta T cell therapy, is
open for enrollment and plans to enroll approximately 40 patients
in “Arm A” of the study. The primary endpoint of this arm is the
12-month overall survival (OS) rate, and key secondary endpoints
include tolerability, progression-free survival (PFS), overall
response rate (ORR) and time to progression (TTP). The University
of Louisville and The Cleveland Clinic are the first clinical sites
activated to enroll patients.
INB-400 was granted Orphan Drug Designation
(ODD) by the FDA in April 2023, marking the first genetically
modified gamma-delta T cell therapy to receive this regulatory
designation. GBM remains a disease with significant unmet need,
with limited treatment options and poor associated outcomes. The
treatment for this highly aggressive brain cancer, has remained
largely unchanged for more than 18 years, with a median
progression-free survival (PFS) of 6-7 months and median overall
survival (OS) of only 14-16 months.
About INB-400INB-400 is
IN8bio’s DeltEx autologous and allogeneic drug-resistant
immunotherapy (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 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
potential of INB-400 and INB-200 to treat patients with newly
diagnosed GBM; the development and continued progress and success
of our preclinical and clinical trials and programs and product
candidates; the timing of initiation, progress (including as to
enrollment) and scope of clinical trials, including for INB-400 and
INB-200; the ability of INB-400 to expand the application of DRI
gamma-delta T cells into other solid tumor types through the
development of allogeneic DeltEx DRI technology; 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
IN8bio (NASDAQ:INAB)
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