Indaptus Therapeutics Doses First Patient in Second Cohort of Single Dose Ranging Study of Decoy20
19 Setembro 2023 - 9:00AM
Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”) announces dosing of the first patient in the second
cohort of patients to receive a single dose of Decoy20 in the
INDP-D101 trial. This cohort dose is a dose reduction from the
previous cohort based on the significant pharmacodynamic effect
seen with the first cohort and anticipated optimal Decoy20 safety
profile for both weekly dosing and combination approaches.
“This cohort is important to the development of
Decoy20 as it may provide sufficient data for us to move Decoy20 to
a multi-dosing regimen,” said Dr. Roger Waltzman, Indaptus’ Chief
Medical Officer. “To date, we have seen positive signs of an immune
response with an anticipated adverse effect profile, and we look
forward to seeing whether this lower dose provides similar evidence
of increased cytokines that can trigger both innate and adaptive
immune responses.”
“We continue to be encouraged by the initial
results of the first cohort and look forward to progressing into
the multi-dosing regimen as soon as we have enough data,” said
Jeffrey Meckler, Chief Executive Officer. The study’s objectives
are to assess the safety and tolerability of Decoy20, to determine
the maximum tolerated dose (MTD) and recommended phase 2 dose
(RP2D), as well as to assess Decoy20 pharmacokinetics (PK),
pharmacodynamics and clinical activity. More information can be
found at www.clinicaltrials.gov.
The Phase 1 study was initiated with a single dose escalation,
which is planned to be followed by an expansion with continuous
weekly administration of Decoy20. The study is enrolling patients
with advanced/metastatic solid tumors, who have exhausted approved
treatment options.
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 Phase 1 clinical trial of
Decoy20, including the timing and design thereof, 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;
the plans and objectives of management for future operations; our
research and development activities and costs; the sufficiency of
our cash, cash equivalents and marketable securities to fund our
going activities and our cash management strategy; and our
assessment of financing options to support our corporate strategy.
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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