Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation and Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors
December 13 2022 - 7:30AM
Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the
Company”), a biotechnology company focused on discovering and
developing transformative therapeutics for patients, today
announces the initiation of INDP-D101, its 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. The USC Norris Cancer Center in
Los Angeles, California is the first activated clinical trial site
that has been opened for patient enrollment, and patient screening
is expected soon.
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 initiation of the dose-escalation part of our
first-in-human Phase 1 trial of Decoy20 marks an important
milestone in our early efforts to identify and study novel drugs
for patients with solid tumors who have exhausted known
life-prolonging treatment options and are thus facing poor
prognosis. Based on the substantial preclinical data demonstrating
safety and activity of Decoy20 alone and in combination with other
oncology drugs, we are encouraged by the potential Decoy20 holds
for those patients. In addition, evaluating Decoy20 in patients
with advanced and metastatic solid tumors is an important initial
step in our efforts to understand the potential of this
investigational medicine to treat a broad range of cancers. We look
forward to advancing to the expansion portion of the trial once the
appropriate dose is identified,” said Boyan Litchev, M.D., Chief
Medical Officer, Indaptus.
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.
“We believe the Decoy approach to immuno-oncology is an
innovative and we are very proud of our rapid journey from our IND
application to initiation of the study. We have designed a very
flexible and comprehensive initial human trial for the compound,
and we look forward to reporting initial cohort results in 2023. In
the meantime, we wish to thank Dr. Michael Newman, the inventor of
Decoy and our Chief Science Officer, Dr. Boyan Litchev, M.D. our
Chief Medical Officer, the entire science and clinical development
team, our talented investigators, and our participating centers for
their dedication and collaboration toward initiating this trial,”
added Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive
Officer.
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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