Indaptus Therapeutics Activates Emory Winship Cancer Institute as Trial Site in INDP-D101, Its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors
March 13 2023 - 8:05AM
Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the
Company”), a biotechnology company focused on discovering and
developing transformative therapeutics for patients, today
announces that Atlanta, Ga.-based Emory Winship Cancer Institute
(“Emory”) has become a new clinical trial site for 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. Emory has begun screening patients.
“Emory joining the INDP-D101 trial is both
validation of the scientific concepts behind Decoy20 in early
testing, as well as acknowledgement of the remaining unmet medical
need, and the need for additional hope for patients with advanced
solid tumors. Emory is a well renowned center, and we are grateful
to include it among the other influential centers we have activated
thus far. We hope to continue the pace at which we are activating
trial sites in order to more rapidly advance the trial toward
initial data points, which, in turn will continue to facilitate the
development of what we believe is a potentially important
innovation in the treatment of solid tumors,” said Jeffrey Meckler,
Indaptus Therapeutics’ CEO. “We look forward to collaborating
closely with the investigators at Emory, and all of clinical trial
sites, which we hope to be opening in succession in the coming
weeks.”
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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