IN8bio Announces Clinical Pipeline Prioritization to Focus on INB-100 for Acute Myeloid Leukemia
04 September 2024 - 10:01PM
IN8bio, Inc. (Nasdaq: INAB), a
leading clinical-stage biopharmaceutical company developing
innovative gamma-delta T cell therapies for cancer, today announced
a plan to optimize its resource allocation through a pipeline
prioritization and a workforce reduction of approximately 49%. The
Company will focus on generating robust clinical data from INB-100,
the ongoing investigator-sponsored Phase 1 clinical trial of acute
myeloid leukemia (AML), to further de-risk the registrational
pathway and affirm the 100% one-year progression-free survival
observed to date in this patient population.
The Company will suspend its glioblastoma (GBM)
development program while continuing to monitor patients in the
Phase 1 INB-200 clinical trial and those enrolled in the Phase 2
INB-400 clinical trial. INB-200 has completed patient treatment
with up to six repeat doses and further patient enrollment in the
INB-400 trial is on hold while the Company explores potential
partnership opportunities for the solid tumor program.
“The data across both of our INB-100 and INB-200
clinical programs remain positive and robust. We are committed to
building upon the data for INB-100 in AML, and we are making the
difficult decision to advance fewer pipeline programs, reduce our
spend and focus on key milestones that can help to generate
near-term interest and value creation,” said William Ho, Chief
Executive Officer and co-founder. “These are hard but necessary
steps to enable us to continue developing these novel cellular
immunotherapies that are demonstrating signs of clinical activity
in difficult cancer patients. We are excited to focus on INB-100 as
IN8bio and its investigators believe patient outcomes in its trial
to date are surpassing that of similar leukemia patients, including
those with AML undergoing haploidentical transplantation without
receiving INB-100. I want to express my gratitude to all our
employees, including those departing IN8bio today, for their
contributions towards our mission of Cancer Zero.”
Portfolio prioritization
INB-100 for AML
With additional funding, the INB-100 trial will
continue to enroll patients in the expansion cohort with a new
target total enrollment of approximately 25 patients at the
recommended Phase 2 dose. IN8bio expects to complete this
additional enrollment in the first half of 2025, with long-term
follow-up results anticipated in late 2025 and in 2026.
IN8bio had a Type B meeting with the FDA earlier
this summer where the Company received regulatory guidance on
advancing INB-100 for the treatment of AML as a post-transplant
maintenance therapy, with relapse-free survival as the primary
endpoint. To affirm the improvements in relapse free and overall
survival observed to date and to further de-risk a future
registrational randomized control trial, IN8bio will also seek to
add a control cohort to prospectively assess leukemia patients and
enable comparison between patients receiving INB-100 to those who
only receive standard haplotransplantation.
As of August 30, 2024, 100% of AML patients
remain relapse-free after receiving their dose of INB-100 after a
median follow-up of 18.7 months. The previously reported patients
with other leukemic diagnoses (ALL and MDS/MPN overlap with
concurrent TP53 mutations) who relapsed have since died of
progression. There have been no new relapses reported since
the last update.
INB-200 and INB-400
The Company has suspended patient enrollment in
the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it
explores partnership opportunities for the program. IN8bio will
continue to monitor patients previously treated in the fully
enrolled INB-200 clinical trial as well as any patients that have
been enrolled and are undergoing treatment in the INB-400 Phase 2
clinical trial.
Workforce Reduction
In conjunction with its pipeline prioritization,
IN8bio is implementing a workforce reduction of approximately 49%
of its current workforce, across all functional areas and at both
its New York City and Birmingham, Alabama sites, along with cash
compensation reductions implemented across the executive management
team and the Company’s board of directors. IN8bio expects to incur
one-time costs of approximately $0.3 million in connection with the
workforce reduction, of which nearly all are cash expenditures
related to severance. Such costs are expected to be incurred in the
third quarter of 2024.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical
company developing gamma-delta T cell-based immunotherapies for
cancer patients. 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. The company’s
lead program, INB-100, is focused on AML evaluating haplo-matched
allogenic gamma-delta T cells given to patients following a
hematopoietic stem cell transplant. The company is also evaluating
autologous DeltEx DRI gamma-delta T cells, in combination with
standard of care, for GBM. For more information about IN8bio, 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 INB-100 for AML to drive
significant value creation; IN8bio’s ability to preserve its cash
resources, achieve clinical cost savings and optimize its resource
allocation; the timing and impact of IN8bio’s workforce reduction;
IN8bio’s ability to find partnership opportunities for the GBM
clinical development program; the ability of IN8bio’s key
milestones to help to generate near-term interest and value
creation; IN8bio’s ability to continue developing novel gamma-delta
T cell therapies; IN8bio’s ability to receive additional funding;
the timing and success of IN8bio’s interactions with regulatory
agencies, including the FDA; and IN8bio’s ability to achieve
anticipated milestones, including expected presentations and data
readouts from its trials, enrollment of additional patients in its
clinical trials, 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; 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 be unable to raise additional capital and could be
forced to delay, further reduce or to explore other strategic
options for certain of our development programs, or even terminate
its operations; 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 August 8, 2024, 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,
Investor & Corporate
ContactGlenn Schulman, PharmD, MPHIN8bio,
Inc.203.494.7411gdschulman@IN8bio.com
Media ContactKimberly HaKKH
Advisors917.291.5744kimberly.ha@kkhadvisors.com
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