IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma
12 10월 2023 - 9:00PM
IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage
biopharmaceutical company focused on innovative gamma-delta T cell
therapies, today announced the completion of enrollment in the
Phase 1 study of INB-100 in leukemia patients and the initiation of
patient enrollment in the Phase 2 clinical trial evaluating INB-400
in newly diagnosed glioblastoma multiforme (GBM).
“These important enrollment milestones reflect
our continued pursuit to achieve Cancer Zero by leveraging the
power of the immune system to develop therapies to eradicate
cancer,” said William Ho, Co-founder and CEO. “Our novel,
synergistic immunotherapy approach has demonstrated promising early
clinical results in patients with unmet medical needs. We look
forward to progressing the INB-400 and INB-100 trials to explore
the full potential of gamma-delta T cells as a treatment option for
patients with both solid and hematological cancers.”
Phase 1 Clinical Trial of INB-100 in
Leukemia
Enrollment in the dose escalation phase of the
Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This
clinical trial assesses the safety of allogeneic gamma-delta T
cells from haploidentical related donors that have been expanded
and activated ex vivo and administered systemically to patients
with leukemia following hematopoietic stem cell transplantation
(HSCT). The primary endpoints of this trial are safety and
tolerability, and secondary endpoints include rates of graft versus
host disease (GvHD), relapse rate and OS.
In April 2023, the Company presented data at the
49th Annual Meeting of the European Society for Blood and Marrow
Transplantation (EBMT) showing that 100% of evaluable patients
(n=7) treated with INB-100 remained alive, progression-free, and in
durable complete remission (CR). As of April 21, 2023, all
evaluable patients across Dose Levels 1 and 2 remained on study and
in CR, with one patient remaining progression free for over 3
years. Additional treated patients have remained progression free
for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A
clinical update with additional enrolled patients will be presented
at the 65th ASH Annual Meeting being held December 9-12, 2023 in
San Diego, CA.
Phase 2 Clinical Trial of INB-400 in
GBM
The 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 the study is 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 by
the FDA in April 2023, marking the first genetically modified
gamma-delta T cell therapy to receive this regulatory designation.
GBM remains a significant unmet need, treatment options and
associated outcomes for GBM, a highly aggressive and
difficult-to-treat brain cancer, have remained largely unchanged
for more than 18 years, with a median progression-free survival of
6-7 months and overall survival of 14-16 months.
About INB-400INB-400 is
IN8bio’s DeltEx chemotherapy resistant 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 or
“off-the-shelf” DeltEx DRI technology.
About INB-100INB-100, IN8bio’s
DeltEx Allo, is an allogeneic product candidate, initially
developed for the treatment of patients with hematologic
malignancies undergoing hematopoietic bone marrow transplantation
(HSCT). It is currently being evaluated in a Phase 1 dose
escalation clinical trial, marking the first clinical trial of an
expanded and activated allogeneic gamma-delta T cell
immunotherapy.
About IN8bio
IN8bio 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 is currently conducting two
investigator-initiated Phase 1 clinical trials for its lead
gamma-delta T cell product candidates: INB-200 for the treatment of
newly diagnosed glioblastoma and INB-100 for the treatment of
patients with hematologic malignancies undergoing haploidentical
hematopoietic stem cell transplantation. IN8bio is initiating
enrollment for a company-sponsored multi-center Phase 2 clinical
trial of INB-400 in newly diagnosed glioblastoma, which received
IND clearance in late 2022. 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 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-100 and INB-400; the success of gamma delta T cells as a
treatment option for patients with both solid and hematological
cancers; IN8bio’s progress towards and achievement of its goal of
“Cancer Zero”; 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 August 10, 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,
CFO+ 1 646.600.6GDT (6438)info@IN8bio.com
Investors & Media Contact: Argot
PartnersIN8bio@argotpartners.com
IN8bio (NASDAQ:INAB)
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