IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage
biopharmaceutical company developing innovative gamma-delta T cell
therapies, today announced positive updated data from its Phase 1
investigator-sponsored trial of INB-100 in patients with
hematologic malignancies. The data, which will be presented in a
poster presentation at the 65th ASH Annual Meeting & Exposition
this evening, demonstrated that 100% of evaluable leukemia patients
(n=10) treated remained alive, progression-free, and in durable
complete remission (CR) as of November 3, 2023. The Company
believes this data indicate the curative potential of INB-100 to
provide durable relapse free periods for high-risk or relapsed AML
and other hematologic malignancies undergoing hematopoietic stem
cell transplantation (HSCT). The CRs to date, combined with
INB-100’s benefit/risk profile are encouraging for the treatment of
hematological malignancies and the trial is being expanded by ten
patients at Dose Level (DL) 2, the recommended Phase 2 dose (RP2D).
Additional expansion patient enrollment is on-going and updated
data is expected to be presented at medical meetings in 2024.
“With more patients and a longer observation
period, we are excited to report that 100% of evaluable dosed
patients continue to remain in morphological complete remission,
with six patients remaining alive and relapse free beyond one
year,” said Trishna Goswami, MD, Chief Medical Officer at IN8bio.
“Leukemic relapse is the leading cause of death in patients
undergoing HSCT and prevention of relapse remains a high unmet
need. In this trial, the first three patients were high-risk or
relapsed AML patients with complex cytogenetics. We are happy to
report two of the patients remain alive and relapse free for over
three years, and the third is now past two years. Furthermore,
INB-100 has demonstrated for the first time, the in-vivo expansion
and persistence of an allogeneic, or donor-derived, cellular
therapy at 365 days with blood levels of gamma-delta T cells
surpassing levels previously observed to be associated with greater
survival.”
“Our team is excited by the potential safety,
efficacy and durability of this novel cellular therapy and the
possibility to improve the likelihood of cure for patients with
blood cancers undergoing stem cell transplantation,” said Dr.
Joseph McGuirk, the Schutte-Speas Professor of Hematology-Oncology,
Division Director of Hematological Malignancies and Cellular
Therapeutics and Medical Director, Blood and Marrow Transplant at
The University of Kansas Cancer Center and the Principal
Investigator on the study. “Relapse post stem cell transplant
remains the primary cause of treatment failure and mortality. The
results of this clinical trial are very encouraging and hold great
promise that a novel cellular therapy using donor-derived
gamma-delta T cells may prevent relapse, resulting in improved
relapse free survival for patients with hematologic
malignancies.”
Summary of Data Presented at
ASH
The latest INB-100 trial data on immune
reconstitution showed significant allogeneic gamma-delta T cell
expansion and persistence in patients through the first 365 days
post-treatment.
Patients who received INB-100 treatment at DL 2
exhibited gamma-delta T cell levels:
- An average of 48.9x greater at 60
days compared with patients undergoing haploidentical HSCT without
INB-100 therapy.
- An average of 7.6x greater than
those achieved in DL 1, which continues to demonstrate a
dose-response related to the gamma-delta T cell infusion.
- An average of 2.7x greater at 365
days than levels found in DL 1, which is above levels previously
associated with improved survival outcomes.
Other observations:
- Elevations in CD4+, CD8+ T cells,
NK cells and B cells have also been observed, indicating a broad
positive immune response and stable reconstitution of the immune
system post-transplant.
- New cytokine data following
gamma-delta T cell infusion demonstrate peripheral increases in
pro-inflammatory cytokines in the plasma, such as interferon-gamma,
IL-6 and IL-15 early post-infusion, demonstrating broad immune
activation.
Updated safety data includes three additional
patients since in April 2023 (as of November 3, 2023):
- Low grade (1-2) acute graft versus
host disease (GvHD) observed in 60% of patients treated. Cases were
all steroid responsive.
- No dose limiting toxicities (DLTs)
have been observed.
- All evaluable patients across DL 1
and DL 2 remained on study and in CR, with two patients now
remaining progression free for over 3 years.
- Treated patients have remained
progression free for 42.7, 40.3, 28.6, 14.3, 12.2, 12.0, 9.0, 5.6,
5.3 and 4.9 months, respectively.
Conference Call DetailsIN8bio
will host a conference call and webcast tomorrow, Tuesday, December
12, 2023, at 8:30 am ET to review the updated clinical data from
the ASH presentation. The webcast can be accessed by clicking this
link and can also be accessed on the Events & Presentations
page of the Company’s website. To participate in the live call,
please register using this link. It is recommended that
participants register at least 15 minutes in advance of the call.
Once registered, participants will be informed of the dial-in
number and will be provided a unique PIN.
About the INB-100 Phase 1
TrialThe Phase 1 clinical trial (NCT03533816) is an
investigator-sponsored dose-escalation trial of allogeneic derived,
gamma-delta T cells from matched related donors that have been
expanded and activated ex vivo and administered systemically to
patients with leukemia following HSCT. The single-institution
clinical trial is currently being conducted at The University of
Kansas Cancer Center (KUCC). The primary endpoints of this trial
are safety and tolerability, and secondary endpoints include rates
of GvHD, relapse rate and overall survival.
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 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 ability of INB-100 to continue to prevent relapse in evaluable
patients; the continued ability of INB-100 to help patients remain
alive, progression-free, and in durable CR; the potential of
INB-100 to provide durable, relapse free periods for high-risk or
relapsed AML and other hematologic malignancies undergoing HSCT;
the timing of initiation, progress and scope of clinical trials for
IN8bio’s product candidates, including INB-100; 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 Contact:IN8bio, Inc.Patrick McCall+ 1
646.600.6GDT (6438)info@IN8bio.com
Investors & Media:Argot
PartnersIN8bio@argotpartners.com
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