Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the
Company”), a biotechnology company focused on discovering and
developing transformative therapeutics for patients, today
announces the dosing of the first subject in INDP-D101. INDP-D101
is the Company’s first-in-human, open label, dose escalation and
expansion, multicenter Phase 1 clinical trial of its lead compound
Decoy20 in patients with advanced/metastatic solid tumors.
After Decoy20 dosing, the subject experienced expected and
manageable adverse events believed to be related to the immune
system activating components known to be in the product. A second
subject in the first three-subject cohort is expected to be
enrolled following final assessment of the safety and tolerability
associated with dosing of the first subject, per the study
protocol.
“Following dosing of our first subject in INDP-D101, we are
optimistic regarding our expectations for this part of the trial,”
said Michael Newman, Ph.D., the Company’s founder and chief
scientific officer. “Our hypothesis for the invention and
development of Decoy20 was based on attenuation and killing of
non-pathogenic bacteria to produce a product with a novel, less
toxic and potentially more effective ratio of immune stimulating
components. We are encouraged that the initial adverse event
profile exhibited by our first subject appears to be consistent
with this hypothesis.”
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.
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. More information can be found at
www.clinicaltrials.gov.
The primary endpoint of the study is incidence, relatedness and
severity of adverse events and treatment-emergent adverse events
and determination of the number of subjects per cohort with dose
limiting toxicity-based adverse events. Secondary endpoints include
the incidence of anti-drug antibodies and neutralizing antibodies
pre- and post-treatment, change in Decoy20 PK parameters over time,
objective response rate in subjects with measurable disease and
duration of response. More information can be found at
www.clinicaltrials.gov.
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. 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 21, 2022, 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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