Indaptus Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Decoy20 in Solid Tumors
May 19 2022 - 6:00AM
Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the
"Company”), today announced that the U.S. Food and Drug
Administration (FDA) has cleared the Company’s Investigational New
Drug (IND) application for a Phase 1 clinical trial in patients
with advanced solid tumors where currently approved therapies have
failed. The Company plans to initiate the clinical trial in the
second half of 2022.
“We are excited to begin our first in human
study of Decoy20, as there is still a significant unmet medical
need for patients with advanced solid tumors. This is an important
milestone for Indaptus, which brings us one step closer to our goal
of demonstrating the utility of a multi-targeted and
antigen-agnostic, systemic immunotherapy that primes and activates
both innate and adaptive anti-tumor immune responses,” said Jeffrey
Meckler, Chief Executive Officer of Indaptus.
“Tumors remodel and inhibit systemic immune
responses and Indaptus’ Decoy technology is unique in its ability
to mobilize both innate and adaptive anti-tumor immune pathways
with systemic administration in pre-clinical tumor models, while at
the same time not inducing sustained hallmarks of cytokine release
syndromes in pre-clinical toxicology studies,” said Dr. Michael
Newman, Founder and Chief Scientific Officer of Indaptus.
“The trial is a Phase 1, open-label dose
escalation and expansion study evaluating the safety, tolerability
and preliminary efficacy of Decoy20 in patients with advanced solid
tumors. We look forward to demonstrating the safety profile of
Decoy20 and developing an effective, novel therapy for cancers
unresponsive to existing approved therapies,” continued Mr.
Meckler.
About the Phase 1 Study
The Phase 1 study is designed to evaluate the
safety, tolerability, and preliminary efficacy of Decoy 20 and will
follow a 3+3 design of dose-escalation cohorts. The study protocol
allows for exploration of additional dosing regimens, including
continuous weekly administration after initial safety has been
established. Decoy20 has the potential to treat a wide range of
solid tumors including hepatocellular, colorectal and pancreatic
carcinomas.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than
a century of immunotherapy advances. The Company’s approach is
based on the hypothesis that efficient activation of both innate
and adaptive immune cells 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. Indaptus’ patented technology is composed of single
strains of attenuated and killed, non-pathogenic, Gram-negative
bacteria, with reduced i.v. toxicity, but largely uncompromised
ability to prime or activate many of the cellular components of
innate and adaptive immunity. Decoy20 represents an
antigen-agnostic technology that has produced significant 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. Tumor eradication has been observed with Decoy products
in combination with anti-PD-1 checkpoint therapy, low-dose
chemotherapy 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.
Investor Contact:Will O'ConnorStern IR+1
212-362-1200 will@sternir.com
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