Indaptus Therapeutics Activates Morristown Medical Center as Trial Site in INDP-D101, Its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors
February 07 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 the addition of Morristown Medical Center, part of the
Atlantic Health System, as 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. Patient screening at the Morristown, NJ hospital is
expected soon.
“The continued expansion of trial sites will help to facilitate
a potentially more rapid enrollment and get us to our 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 Morristown Medical Center, 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 will begin with a single dose escalation part
followed by an expansion part with continuous administration of
Decoy20. The study will enroll patients with advanced/metastatic
solid tumors, who have exhausted the other known treatment options.
More information can be found at www.clinicaltrials.gov.
Primary endpoint of the study is incidence, relatedness and
severity of adverse events and treatment-emergent adverse events
and determining 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 the 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. Indaptus’ patented technology is
composed of single strains of attenuated and killed,
non-pathogenic, Gram-negative bacteria to produce a multiple TLR
agonist Decoy platform, with expected reduced systemic toxicity,
and ability to prime or activate many of the cells and pathways of
innate and adaptive immunity. Decoy20 represents an
antigen-agnostic technology that has produced in pre-clinical
studies 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 with standard pre-clinical
models, including syngeneic mouse tumors and human tumor
xenografts. In those pre-clinical studies tumor eradication has
been observed with Decoy products in combination with anti-PD-1
checkpoint therapy, low-dose chemotherapy, non-steroidal
anti-inflammatory drug or an approved targeted antibody.
Combination-based tumor eradication produces innate and adaptive
immunological memory, involves activation of both innate and
adaptive immune cells and is 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 toxicology studies have
demonstrated safe i.v. administration, with no sustained induction
of hallmarks of cytokine release syndromes, possibly due to passive
targeting to liver, spleen and tumor, followed by rapid elimination
of the product. Indaptus 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 product development
efforts, business, financial condition, results of operations,
strategies, plans and prospects. 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. Forward-looking statements
relate to anticipated or expected events, activities, trends or
results as of the date they are made. 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 plans to develop and potentially commercialize its
technology, the timing and cost of our planned investigational new
drug application and any clinical trials, the completion and
receiving favorable results in any clinical trials, Indaptus’
ability to obtain and maintain regulatory approval of any product
candidate, our ability to protect and maintain its intellectual
property and licensing arrangements, our ability to develop,
manufacture and commercialize its product candidates, the risk of
product liability claims, the availability of reimbursement, the
influence of extensive and costly government regulation, and our
estimates regarding future revenue, expenses capital requirements
and the need for additional financing. More detailed information
about the risks and uncertainties affecting us is contained under
the heading “Risk Factors” included in our most recent Annual
Report on Form 10-K filed with the SEC on March 21, 2022, and in
other filings that we have made and may make with the Securities
and Exchange Commission in the future. 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 IRScott Birkby (investors)sbirkby@coreir.com
CORE IRJules Abraham (media)917-885-7378julesa@coreir.com
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