Indaptus Therapeutics Announces Opening of Next Cohort in Single Dose Ranging Study of Decoy20
10 August 2023 - 10:45PM
Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”) today announced completion of the first cohort of
patients who received a single dose in Part 1 of its INDP-D101
trial of Decoy20 and the initiation of a new cohort following
review of data by the Safety Review Committee as prescribed by the
clinical trial protocol.
Four patients were enrolled and evaluable in this cohort.
Overall, patients experienced symptoms or adverse events (AEs) that
were short-lived and consistent with the mechanism of action of
Decoy20. These symptoms included temperature elevation, nausea and
chills. Additional transient effects included changes in heart rate
and blood pressure.
“The safety profile exhibited among the first cohort of patients
in our Phase 1 dose ranging study was consistent with the Decoy20
mechanism of action. We expect the enrollment of the next cohort
will bring us closer to determination of the recommended phase 2
dose for the multi-dosing part of the trial. We are pleased that
the safety and immune activation data support continued dosing,”
said Jeffrey Meckler, Indaptus’s CEO.
Three of the patients in the first cohort have completed the
28-day safety review period with two of the patients having also
completed post-study tumor re-staging. One clinically relevant dose
limiting toxicity of grade 3 bradycardia occurred and was
reversible in under 30 minutes following a bolus of normal saline;
grade 3 malaise in the same patient resolved overnight. Two
patients experienced a grade 3 AST increase which resolved within 1
day. Other Adverse Events including chills, fatigue, vomiting, and
fever were of grade 1-2 severity, resolved quickly, and were to be
expected following exposure to the TLR4 agonist lipopolysaccharide
(LPS), which is a major active ingredient of Decoy20 and a
facilitator of innate and adaptive immune responses.
Evidence of immune activation was observed, based on transient
expression of multiple plasma cytokines and chemokines associated
with activation of innate and adaptive immune pathways, including
several not expected with LPS exposure. “The presence of multiple,
additional immune activating molecules in Decoy20 appears to have
stimulated production of potential anti-tumor cytokines and
chemokines beyond what would be expected for LPS alone, without
significantly altering the safety profile,” said Dr. Michael
Newman, Indaptus’s Founder and CSO. “The results to date are
consistent with our hypothesis that Decoy20 represents a
short-acting “pulse-prime” approach, capable of priming or
activating innate and adaptive immune pathways without requirement
for continuous exposure, which may reduce the potential for
sustained or long-term adverse events.”
The Company continues to analyze the data generated. Further,
the Company anticipates that the data from the dose finding studies
will guide the selection for the Recommended Phase 2 dose for
subsequent multi-dosing and combination studies, which are planned
for 2024.
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), Nucleotide oligomerization domain
(Nod)-like receptor (NLR) and Stimulator of interferon genes
(STING) 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 timing and design of Phase 1 clinical trial of
Decoy20, including the timing of the enrollment of the second
cohort of patients; the anticipated effects of our product
candidates, including Decoy20; the expectation that the data
generated from the dose finding studies will guide the selection
for the Recommended Phase 2 dose for subsequent multi-dosing and
combination studies; and the expected timing of subsequent studies.
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 March 31, 2023 filed with the SEC on May
11, 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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