IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical
company developing innovative gamma-delta (γδ) T cell therapies,
presented encouraging preliminary clinical data of INB-200 at the
2024 American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago on June 1, 2024.
The preliminary data demonstrated that 92% of evaluable patients
treated with INB-200 exceeded a median PFS of 7 months (median
follow-up: 11.7 months) with concomitant temozolomide (TMZ), as of
a data cutoff date of May 30, 2024. The survival data along with
radiographic improvements are indicative of positive treatment
effects, which highlight the potential of IN8bio’s genetically
modified, chemotherapy-resistant gamma-delta T cells as a potential
first-in-class therapy for patients with newly diagnosed
glioblastoma (GBM).
The Phase 1 study assessed the safety and preliminary efficacy
of the addition of DeltEx DRI gamma-delta T cells to maintenance
therapy with TMZ. The trial assessed the administration of 1x107
cells per dose across three different dosing regimens increasing
from a single dose delivered on cycle 1 day 1 during maintenance 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.
Thirteen patients have been enrolled and treated with INB-200,
including three patients in Cohort 1 (1 dose), four patients in
Cohort 2 (3 doses) and six patients in Cohort 3 (6 doses).
“For far too long, there has been little advancement for
patients with GBM to improve their treatment outcomes,” said Burt
Nabors, M.D., Division Director, Neuro-oncology at the Heersink
School of Medicine at the University of Alabama at Birmingham. “The
addition of multiple intracranial injections of IN8bio’s DeltEx DRI
gamma-delta T cells shows the potential for extending
progression-free survival in this patient population when
administered in combination with the current standard of care used
to treat newly diagnosed glioblastoma patients.”
The current standard of care for newly diagnosed glioma patients
consists of primary resection, six weeks of daily chemoradiation
therapy followed by six cycles of monthly maintenance TMZ therapy
(Stupp regimen), which achieves a median PFS of 7 months and an
overall survival (OS) of approximately 14 to 16 months. All of the
patients in the Phase 1 study that received all of their protocol
defined treatments with INB-200 exceeded a median PFS of 7 months,
including one patient in Cohort 2 that remains alive and
progression free for nearly three years.
“The safety profile of gamma-delta T cells continues to be
strong across all three dose cohorts with no cell therapy-related
toxicities such as immune effector cell-associated neurotoxicity
syndrome or cytokine release syndrome reported in patients
receiving up to the maximum dose of six infusions of the therapy,”
said Trishna Goswami, M.D., Chief Medical Officer, IN8bio. “We are
now dosing newly diagnosed patients in Arm A of the Phase 2 study
with INB-400, evaluating up to six infusions of our autologous
gamma-delta T cells in combination with the Stupp protocol.”
The poster presentation at ASCO included promising activity and
safety data for the fully enrolled trial, as of the data cutoff
date of May 1, 2024.
Key findings from the ongoing Phase 1 study:
- All patients who
completed all protocol mandated doses surpassed a median
standard-of-care PFS of 7 months, with a majority also exceeding
the expected PFS based on their age and MGMT status of their
tumors.
- 92% of evaluable
patients treated with INB-200 for GBM exceeded a median PFS of 7
months achieved with the standard-of-care regimen (Stupp
regimen).
- One patient with an
IDH-mutant glioma remains alive and progression free at 34.9+
months; IDH-mutant patients in a recently published clinical trial
of an IDH inhibitor demonstrated a median PFS of 11.1 months in the
control arm and 28.5 months in the experimental arm.
- No treatment-related
serious adverse events, dose-limiting toxicities, cytokine release
syndrome, infusion reactions, or immune effector cell-associated
neurotoxicity syndrome have been reported in any cohort.
- The most common
treatment emergent adverse events were Grade 1-2 toxicities
consisting of white blood cell and platelet count decreases related
to standard-of-care TMZ.
- Preserved
gamma-delta T cells were found in relapsed tumor 148 days after
initial DRI infusion in one patient with paired biopsies, pointing
to durability of DRI gamma-delta T cells.
- Radiographic
evaluation pre- and post-treatment included resolution of midline
shift in one patient with evidence of changes in enhancement
attributed to treatment effect in multiple patients. One subject
was found to have a 36% decrease in a lesion attributed to positive
treatment effect.
“As these encouraging results from our ongoing INB-200 Phase 1
study continue to mature, we look forward to reporting additional
results from a long-term follow-up of cohort 3 at future medical
meetings,” said William Ho, CEO and co-founder, IN8bio.
Poster details:Abstract
#: 2042Title: INB-200: Fully
enrolled Phase 1 study of gene-modified autologous gamma-delta
(γδ) T cells in patients with newly diagnosed glioblastoma
multiforme (GBM) receiving maintenance temozolomide
(TMZ)Presenter: Mina Lobbous, MBChB, MD, MSPH,
University of Alabama at BirminghamSession Name:
Central Nervous System TumorsDate and Time:
Saturday, June 1, 2024 from 10:00 a.m. – 1:00 p.m.
EDTPoster Board: #341
The poster presentation is accessible on the Company’s website
here.
About INB-200INB-200 is a genetically modified
autologous DeltEx 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 investigational treatment
approach designed to enable 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 in an
initial indication of GBM.
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 the potential
of IN8bio’s product candidates' therapeutic potential; the
potential of DeltEx DRI to treat patients with newly diagnosed GBM;
the potential of multiple intracranial injections of IN8bio’s
DeltEx DRI gamma-delta T cells to extend PFS for newly diagnosed
GBM patients; the potential activity and safety data of IN8bio’s
product candidates; and the timing of IN8bio’s future presentations
and data readouts. 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: uncertainties inherent in the initiation and completion
of preclinical studies and clinical trials and clinical development
of IN8bio’s product candidates, including patient enrollment and
follow-up and IN8bio’s ability to meet anticipated deadlines and
milestones; 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;
uncertainties related to 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 actual results to differ from
those contained in the forward-looking statements, that 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 May 9, 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,
changed circumstances, or otherwise, except as otherwise required
by law.
Corporate Contact:IN8bio, Inc.Glenn Schulman,
PharmD, MPH203.494.7411gdschulman@IN8bio.com
Investors
Meru AdvisorsLee M. Sternlstern@meruadvisors.com
Media ContactKimberly HaKKH
Advisors917.291.5744kimberly.ha@kkhadvisors.com
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