UPDATE -- Indaptus Therapeutics Presents Data Demonstrating Preclinical Efficacy of Decoy, its Bacteria-Based Immunotherapy Platform Technology, at the American Association for Cancer Research Conference 2023
19 April 2023 - 11:28PM
Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the
Company”), a biotechnology company focused on discovering and
developing transformative therapeutics for patients, today
announces data presented in a poster at the American Association
for Cancer Research (AACR) annual scientific conference on the
Company’s Decoy anti-tumor platform.
The poster, titled, “A systemically administered killed
bacteria-based multiple immune receptor agonist for pulsed
anti-tumor immunotherapy,” authored by Michael J. Newman, Ph.D.,
the Company’s Founder and Chief Scientific Officer, was presented
Tuesday, April 18, 2023.
Highlights included:
- Decoy10 (a previous generation from
the platform) is a novel, attenuated and stabilized multi-TLR, NLR
and STING agonist bacteria-based immunotherapy that demonstrated
90% reduction of LPS-endotoxin activity and use of 100% killed,
non-pathogenic bacteria
- Decoy10 inhibited tumor growth,
metastasis, and induced tumor regressions as a single agent.
Regressions were also seen with Decoy10 in combination with a
non-steroidal anti-inflammatory drug (NSAID), an anti-PD-1
checkpoint inhibitor, low-dose chemotherapy (LDC), and LDC plus a
targeted antibody. Regressions were durable and associated with
immunological memory-mediated rejection of tumor rechallenge
- The data demonstrated that Decoy10
contains agonists of TLR2 (1/2 and 2/6), TLR4, TLR8, TLR9, NOD2 and
STING, conferring the ability to activate both innate and adaptive
immune pathways in tumors after a single safe i.v. dose of Decoy10
in combination with anti-PD-1 checkpoint therapy, an NSAID or
both
- In vivo anti-tumor activity was seen
with colorectal, breast, hepatocellular, pancreatic carcinomas, and
non-Hodgkin’s lymphomas (mouse and human) in pre-clinical
models
Michael Newman, Ph.D., Indaptus’ Chief Scientific Officer and
inventor of the Decoy platform, commented, “The data from this
poster represent the culmination of the extensive pre-clinical work
that we performed to bring us to our current position as a
clinical-stage company. Importantly, our results demonstrate the
potential for activity in multiple solid tumor indications with
high unmet need and the flexibility to be combined with a wide
variety of synergy partners. The Decoy platform appears to be
unique in its ability to deliver a package of TLR2,4,8,9, NOD2 and
STING agonists systemically in pre-clinical models, resulting in
priming or activation of innate and adaptive immune pathways in
tumors, particularly in the combination setting. We believe this
represents a significant advance in the recruitment of the body’s
own defenses in the fight against cancer, and we look forward to
continuing to provide updates on both the INDP D-101 Phase 1
clinical trial and further research on the platform itself.”
About the AACR Conference 2023The AACR Annual
Meeting is the focal point of the cancer research community, where
scientists, clinicians, other health care professionals, survivors,
patients, and advocates gather to share the latest advances in
cancer science and medicine. From population science and
prevention; to cancer biology, translational, and clinical studies;
to survivorship and advocacy; the AACR Annual Meeting highlights
the work of the best minds in cancer research from institutions all
over the world.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than
a century of immunotherapy advances. The Company’s novel approach
is based on the hypothesis that efficient activation of both innate
and adaptive immune cells and pathways and associated anti-tumor
and anti-viral immune responses will require a multi-targeted
package of immune system-activating signals that can be
administered safely intravenously (i.v.). Indaptus’ patented
technology is composed of single strains of attenuated and killed,
non-pathogenic, Gram-negative bacteria producing a multiple
Toll-like receptor (TLR) agonist Decoy platform. The products are
designed to have reduced i.v. toxicity, but largely uncompromised
ability to prime or activate many of the cells and pathways of
innate and adaptive immunity.
Decoy products represent an antigen-agnostic
technology that have produced single-agent activity against
metastatic pancreatic and orthotopic colorectal carcinomas, single
agent eradication of established antigen-expressing breast
carcinoma, as well as combination-mediated eradication of
established hepatocellular carcinomas and non-Hodgkin’s lymphomas
in standard pre-clinical models, including syngeneic mouse tumors
and human tumor xenografts. In pre-clinical studies tumor
eradication was observed with Decoy products in combination with
anti-PD-1 checkpoint therapy, low-dose chemotherapy, a
non-steroidal anti-inflammatory drug, or an approved, targeted
antibody. Combination-based tumor eradication in pre-clinical
models produced innate and adaptive immunological memory, involved
activation of both innate and adaptive immune cells, and was
associated with induction of innate and adaptive immune pathways in
tumors after only one i.v. dose of Decoy product, with associated
“cold” to “hot” tumor inflammation signature transition.
IND-enabling, nonclinical toxicology studies
demonstrated safe i.v. administration without sustained induction
of hallmark biomarkers of cytokine release syndromes, possibly due
to passive targeting to liver, spleen, and tumor, followed by rapid
elimination of the product. Indaptus’ Decoy products have also
produced significant single agent activity against chronic
hepatitis B virus (HBV) and chronic human immunodeficiency virus
(HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking
statements with the meaning of the Private Securities Litigation
Reform Act. These include statements regarding management’s
expectations, beliefs and intentions regarding, among other things,
our expectations and plans regarding the Phase 1 clinical trial of
Decoy20, including the timing and design thereof; the plans and
objectives of management for future operations; our research and
development activities; and our beliefs regarding the efficacy of
our product candidates and the Decoy platform. Forward-looking
statements can be identified by the use of forward-looking words
such as “believe”, “expect”, “intend”, “plan”, “may”, “should”,
“could”, “might”, “seek”, “target”, “will”, “project”, “forecast”,
“continue” or “anticipate” or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. Because
forward-looking statements relate to matters that have not yet
occurred, these statements are inherently subject to risks and
uncertainties that could cause our actual results to differ
materially from any future results expressed or implied by the
forward-looking statements. Many factors could cause actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to the following: our limited operating history; the
need for, and our ability to raise, additional capital given our
lack of current cash flow; our clinical and preclinical
development, which involves a lengthy and expensive process with an
uncertain outcome; our incurrence of significant research and
development expenses and other operating expenses, which may make
it difficult for us to attain profitability; our pursuit of a
limited number of research programs, product candidates and
specific indications and failure to capitalize on product
candidates or indications that may be more profitable or have a
greater likelihood of success; our ability to obtain and maintain
regulatory approval of any product candidate; the market acceptance
of our product candidates; our reliance on third parties to conduct
our preclinical studies and clinical trials and perform other
tasks; our reliance on third parties for the manufacture of our
product candidates during clinical development; our ability to
successfully commercialize Decoy20 or any future product
candidates; our ability to obtain or maintain coverage and adequate
reimbursement for our products; the impact of legislation and
healthcare reform measures on our ability to obtain marketing
approval for and commercialize Decoy20 and any future product
candidates; product candidates of our competitors that may be
approved faster, marketed more effectively, and better tolerated
than our product candidates; our ability to adequately protect our
proprietary or licensed technology in the marketplace; the impact
of, and costs of complying with healthcare laws and regulations,
and our failure to comply with such laws and regulations;
information technology system failures, cyberattacks or
deficiencies in our cybersecurity; and unfavorable global economic
conditions. These and other important factors discussed under the
caption “Risk Factors” included in our most recent Annual Report on
Form 10-K filed with the SEC on March 17, 2023, and our other
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. All forward-looking statements speak
only as of the date of this press release and are expressly
qualified in their entirety by the cautionary statements included
in this press release. We undertake no obligation to update or
revise forward-looking statements to reflect events or
circumstances that arise after the date made or to reflect the
occurrence of unanticipated events, except as required by
applicable law.
Contact: investors@indaptusrx.com
Investor Relations Contact:
CORE IRLouie Tomalouie@coreir.com
CORE IRJules Abraham (media)917-885-7378julesa@coreir.com
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