Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting
31 Octobre 2023 - 2:01PM
Indaptus Therapeutics, Inc. (Nasdaq: INDP) announces it will be
presenting interim data from the first cohort of four patients in
the Phase 1 INDP-D101 trial of its lead compound, Decoy20. The
interim data, released today in abstract form, demonstrated that as
of August 31, 2023, each of the first cohort participants
experienced transient activation of biomarkers associated with
innate and/or adaptive immune responses, and generally expected
transient adverse events, both associated with predicted rapid
clearance of Decoy20. The data in full will be presented in a
poster at the Society for Immunotherapy of Cancer (SITC) on
November 4. The conference will be held from November 1-5, 2023 in
San Diego.
Michael J. Newman, Ph.D., Indaptus’ Founder and
Chief Scientific Officer noted, “Even in this early study, Decoy20
is exceeding our expectations from the perspective that we are
seeing activation of the immune system, based on transient
expression of multiple plasma cytokines and chemokines, with
expected transient adverse events. These results, in conjunction
with the desired and observed rapid clearance of Decoy20 from the
blood, are highly supportive of our “Pulse-Prime” hypothesis for
the Decoy20 mechanism of action.”
Roger Waltzman, M.D., Indaptus’ Chief Medical
Officer, added, “We are encouraged by the tolerability of Decoy20
and the notable evidence for broad immune biomarker activation at
this early stage. At one month following the single dose of
Decoy20, all four of the first cohort patients had stable disease.
We are following these patients as well as working on enrolling the
second cohort, which utilizes a lower dose. This lower dose is
based on the pharmacodynamic results seen with the first cohort and
plans to optimize Decoy20 for both weekly dosing and combination
approaches.”
The abstract/poster is titled, “Preliminary
results of an in progress, first-in-human Phase 1 study of Decoy20,
an intravenous, killed, multiple immune receptor agonist bacterial
product in patients with advanced solid tumors.” First
cohort patients received a single dose of 7x107 killed Decoy20
bacteria via a one-hour IV infusion. As of August 31, 2023,
treatment-related adverse events, potentially expected based upon
prior clinical studies with purified lipopolysaccharide, have
included, among other events, changes in hemodynamic parameters,
transaminase elevations, and lymphopenia; all resolved with or
without treatment within 30 minutes to 3 days. The Company believes
the short half-life of Decoy20 observed in blood coupled with the
marked, but transient, induction of multiple cytokines and
chemokines over approximately 24 hours supports the PK “pulse” and
PD “prime” hypothesis for the Decoy20 immune-oncology strategy.
About Indaptus
TherapeuticsIndaptus 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), Nucleotide oligomerization domain
(NOD)-like receptor (NLR) and Stimulator of interferon genes
(STING) agonist Decoy platform. The product candidates 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 product candidates 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 product candidates 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 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 product candidates 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
StatementsThis press release contains
forward-looking statements within 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
our Phase 1 clinical trial of Decoy20, including the timing and
design thereof, the timing of the enrollment of the second cohort
of patients in the Phase 1 trial, and our expectations regarding
the recommended Phase 2 doses for subsequent multi-dosing and
combination studies and related timing; the anticipated effects of
our product candidates, including Decoy20; and upcoming events and
presentations. 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; conditions and events that raise substantial doubt
regarding our ability to continue as going concern; 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 Quarterly Report on Form
10-Q for the quarter ended June 30, 2023 filed with the SEC
on August 14, 2023, 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
Media Contact:CORE
IRJules Abrahamjulesa@coreir.com917-885-7378
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