Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Decoy20, the Company’s Broad-Based, “Pulse-Prime” Immuno-Oncology Therapy for Advanced Solid Tumors
May 22 2024 - 8:00AM
Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage
biotechnology company dedicated to pioneering innovative cancer and
viral infection treatments, today announced the successful
advancement of its Phase 1 trial for Decoy20, an investigational
novel package of broad immune agonists for cancer immunotherapy
that has first-in-class potential across a diverse range of cancers
including liver, pancreatic, colorectal and non-small cell lung.
Following review by a Safety Review Committee
(SRC) of the company’s initial clinical data, which will be
presented at the annual meeting of the American Society of Clinical
Oncology (ASCO), the Company has successfully dosed the first
patient in the multi-dose portion of the trial with Decoy20. The
primary goal of this stage of the trial is to determine the safety
of Decoy20 when administered multiple times to the same patient,
and to begin to examine efficacy across multiple types of
cancer.
“Current immunotherapies usually target a few
immune system pathways and have low cure rates in advanced cancers.
Indaptus is investigating an incredibly exciting and differentiated
approach to fighting cancerous tumors that deviates from a focus on
targeted therapies in the field,” said Roger Waltzman, MD, Chief
Medical Officer of Indaptus. “The advancement of this trial is a
significant milestone that builds on strong evidence that Decoy20
successfully and broadly activates potent tumor-fighting cytokines
and chemokines in both the innate and adaptive immune systems, and
was administered systemically without intolerable adverse
events.”
Decoy20 is composed of attenuated and killed,
intact, non-pathogenic Gram-negative bacteria which are designed to
act as a “decoy,” tricking the body into activating a broad
antitumor response from both its innate and adaptive immune
systems. In preclinical studies, the treatment has been shown to
activate specialized immune receptors called TLRs, that facilitate
a potent defense against tumors, without inducing excessive
toxicity. The product candidate is designed to induce a strong and
broad pulse of immune activation, followed by rapid clearance from
the body.
“There is significant unmet medical need for
people living with advanced solid tumors and we are thrilled with
the successful completion of the first patient of the multi-dose
part of our Phase 1 clinical trial with Decoy20 and potential to
offer a disruptive, first-in-class innovation, with the successful
initiation of the multi-dosing part of our Phase 1 clinical trial
with Decoy20,” said Jeffrey Meckler, CEO of Indaptus. “As part of
our commitment to delivering innovative therapies to patients in
need, we look forward to advancing this research that has the
potential to treat patients who have limited options today.”
The company intends to progress Decoy20 into
combination studies with a checkpoint inhibitor, due to the
observation of tumor eradications by the Decoy platform in
combination with checkpoint therapy in pre-clinical studies.
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), Nucleotide oligomerization domain
(NOD)-like receptor (NLR) and Stimulator of interferon genes
(STING) agonist Decoy platform. The product candidates 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 product candidates 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, pancreatic 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 product candidates 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 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 product candidates 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 within 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 our Phase 1 clinical trial of
Decoy20, including the timing and design thereof; the anticipated
effects of our product candidates, including Decoy20; the plans and
objectives of management for future operations; our research and
development activities and costs; the sufficiency of our cash and
cash equivalents to fund our ongoing activities and our cash
management strategy; and our assessment of financing options to
support our corporate strategy. 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; conditions and events
that raise substantial doubt regarding our ability to continue as
going concern; 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 Quarterly Report on Form
10-Q for the quarter ended March 31, 2024 filed with the SEC on May
8, 2024, our most recent Annual Report on Form 10-K filed with the
SEC on March 13, 2024, 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
Media:Cuttlefish CommunicationsShira
Derasmoshira@cuttlefishpr.com 917-280-2497
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