IN8bio Announces New Preclinical Data for Gamma-Delta nsCAR-T Cell Therapy Platform at AACR 2024
April 09 2024 - 3:30PM
IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical
company developing innovative gamma-delta T cell therapies, today
announced new preclinical data from its non-signaling gamma-delta T
cell based Chimeric Antigen Receptor-T cell (nsCAR) platform, known
as INB-300, that demonstrated improved selectivity to target
leukemia cells while preserving healthy ones. The data support the
potential for nsCAR to have a wider therapeutic window and to be
used to prevent on-target off-tumor killing of healthy tissue that
may express the CAR-T target. The data was presented in a poster
session at the American Association for Cancer Research (AACR)
Annual Meeting 2024 on April 9, 2024.
IN8bio's nsCAR platform is based on the natural
ability of gamma-delta T cells to distinguish between healthy and
malignant tissue. By using a Chimeric Antigen Receptor (CAR) that
lacks a signaling domain, IN8bio believes it has created a
technology that enables these cells to differentiate between tumor
and healthy tissue, even when both express the CAR-targeted
antigen.
Approved CAR-T therapies have shown remarkable
efficacy against B cell malignancies, offering hope to patients
with limited treatment options. However, extending this therapy to
myeloid malignancies and solid tumors has proven challenging since
the antigens they target are also often found on the surface of
healthy blood cells and tissues. This unintended targeting of
healthy cells and tissues has led to many of the toxicities,
including patient deaths, observed in prior CAR-T therapies and has
limited their utility. Unlike traditional CAR-T therapy, IN8Bio’s
nsCAR is designed to direct the gamma delta T cell to its target
while maintaining their unique gamma-delta T cell receptors,
allowing them to identify and specifically eliminate heterogeneous
tumor cells through recognition of tumor-associated stress
antigens.
The new data presented at AACR included results
from proprietary constructs targeting CD33 and/or CD123 for in
vitro evaluation against various types of leukemia, including acute
myeloid leukemia (AML) and chronic myeloid leukemia (CML). The
study results demonstrated notable differences between cells
expressing traditional signaling CARs and those expressing the
nsCAR constructs, which include a reduction in activation-induced
cell death with nsCAR constructs.
The nsIL3-33mb15 CAR (CD123+CD33+IL-15)
enhancement of the gamma delta T cells against leukemia cells
demonstrated an average 1.8x increase in tumor killing capability
across three AML cell lines (HL-60, KG-1a and MOLM-13), compared to
unmodified gamma-delta T cells as measured by a 24-hour
cytotoxicity assay. Importantly, the nsCAR cells did not lead to
significant killing of healthy cells expressing the CD33 or CD123
target, demonstrating the selectivity of the nsCAR platform.
Results were run in triplicate and on average the selectivity was
increased by 5.5x. Across all runs, killing by the nsIL3-33mb15
construct against healthy CD34+ HPCs was below that of
un-transduced control gamma-delta T cells.
“INB-300 can selectively target leukemia cells
while preserving healthy tissue. We are now conducting further
optimization to improve the integration of membrane-bound IL-15
co-expression to potentially enhance both the efficacy and safety
of next-generation adoptive cell therapies against a wider spectrum
of cancers,” said Lawrence Lamb, Ph.D., co-founder and Chief
Scientific Officer of IN8bio. “These results can potentially
improve INB-300, as we advance towards IND enabling studies of our
next-generation gamma-delta T cell therapies to treat cancers.”
About INB-300
INB-300 is an nsCAR gamma-delta T cell platform
with several preclinical product candidates, including the INB-330
program against AML targets, that combine our expertise in
gamma-delta T cells and genetic engineering. These nsCAR constructs
lack signaling domains in order to take advantage of the unique
properties of gamma-delta T cells to differentiate between healthy
and tumor tissues. IN8bio is advancing new nsCAR constructs against
multiple targets to treat both solid and liquid tumors.
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-400, is in a Phase 2 trial in glioblastoma
multiforme (GBM). Additional programs include Phase 1 trials in
solid and hematologic tumors, including INB-200 for GBM and INB-100
for patients with hematologic malignancies undergoing
transplantation. 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 IN8bio’s nsCAR platform to (i)
selectively target and eradicate cancer cells while preserving
healthy tissue through recognition of tumor-associated stress
antigens and (ii) have a wider therapeutic window and to be used to
prevent on-target off-tumor killing of healthy tissue that may
express the CAR-T target; IN8bio’s ability to enhance both the
efficacy and safety of next-generation adoptive cell therapies
against a wider spectrum of cancers; and IN8bio’s ability to
advance its pipeline of novel gamma-delta CAR-T therapies to treat
additional cancers, including both solid and liquid tumors. 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 our 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 Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on March 14, 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
InvestorsMeru AdvisorsLee M. Sternlstern@meruadvisors.com
Media ContactKimberly HaKKH
Advisors917.291.5744kimberly.ha@kkhadvisors.com
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