Indaptus Therapeutics Receives Approval from Health Canada to Expand Clinical Trial of Decoy20

Rhea-AI Summary

Indaptus Therapeutics (NASDAQ: INDP) has received Clinical Trial Authorization from Health Canada to expand its ongoing U.S. clinical trial, INDP-D101, for its lead asset Decoy20. The expansion will allow patient enrollment in Canadian sites under the current protocol of weekly Decoy20 dosing.

The company plans to submit an amendment to Health Canada to incorporate its upcoming combination trial pairing Decoy20 with Beigene's PD-1 checkpoint inhibitor, tislelizumab. This expansion aims to create a more diverse and robust data set, following Health Canada's comprehensive review of safety data and trial design.

The addition of Canadian trial sites is expected to accelerate the collection of clinical data from a broader population, helping evaluate Decoy20's ability to activate both innate and adaptive immune systems in treating solid tumors.

Positive

• Received Clinical Trial Authorization from Health Canada
• Geographic expansion of clinical trial to Canadian sites
• Planned combination trial with Beigene's tislelizumab
• Potential for accelerated patient recruitment

Negative

• None.

Insights

Clinical Research Analyst

The Health Canada authorization for Decoy20's clinical trial expansion represents a strategic milestone for Indaptus Therapeutics' development program. Geographic expansion to Canada offers several key advantages: accelerated patient recruitment, potentially reduced trial costs and enhanced data diversity - critical factors for early-stage biotechnology companies with resources.

The planned combination trial with tislelizumab is particularly noteworthy. PD-1 inhibitors have shown significant success in various cancers, with the global market exceeding $40 billion. By combining Decoy20's dual innate-adaptive immune activation mechanism with PD-1 blockade, Indaptus is pursuing a scientifically rational strategy that could potentially overcome resistance mechanisms in solid tumors.

However, investors should note several critical factors:

• The trial remains in early stages, with significant clinical validation still required
• The immuno-oncology field is highly competitive, with numerous combination approaches being tested
• While geographic expansion is positive, it also increases operational complexity and costs
• The company's market capitalization and cash position may impact their ability to fully execute their clinical program

The expansion demonstrates operational progress and regulatory validation of the safety data, but substantial clinical and commercial uncertainties remain. The combination strategy with tislelizumab could potentially differentiate Decoy20 in the crowded immuno-oncology space, but success will depend on generating compelling efficacy data in upcoming trial readouts.

NEW YORK, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today announced the Company has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This approval will allow the Company to expand its ongoing U.S. clinical trial, INDP-D101, to Canadian sites, broadening patient recruitment and enhancing its clinical research program. The trial will enroll patients in Canada under the current protocol, which involves weekly dosing of Decoy20. Indaptus also plans to submit an amendment to Health Canada to incorporate its upcoming combination trial, which pairs Decoy20 with Beigene’s PD-1 checkpoint inhibitor, tislelizumab.

Jeffrey Meckler, CEO of Indaptus, commented, “We are pleased to bring Canadian investigators and patients into our clinical efforts, creating a more diverse and robust data set. Health Canada’s approval followed a comprehensive review of our safety data and trial design. Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors.”

Roger Waltzman, Chief Medical Officer, added, “The addition of Canadian trial sites should allow us to accelerate the collection of valuable clinical data more efficiently, and from a broader, more diverse population. This expansion is critical as we continue to evaluate Decoy20’s unique ability to activate both the innate and adaptive immune systems, potentially addressing the challenges associated with solid tumors. By enhancing our trial infrastructure, we aim to accelerate our understanding of Decoy20’s full therapeutic potential, refine its dosing regimen, and improve treatment outcomes for patients facing difficult-to-treat cancers. We are confident this progress will pave the way for key insights that could bring us closer to meaningful advances in cancer treatment."

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 candidate, 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 candidate. Indaptus’ Decoy product candidates have also produced meaningful 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 research and development plans and our plans to seek approval to initiate a combination trial. 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 September 30, 2024 filed with the SEC on November 12, 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 IR
Louie Toma
louie@coreir.com

FAQ

What is the significance of Health Canada's approval for Indaptus Therapeutics (INDP)?

Health Canada's approval allows Indaptus to expand its ongoing U.S. clinical trial INDP-D101 to Canadian sites, enabling broader patient recruitment and enhanced clinical research for Decoy20.

How will Decoy20 be administered in the INDP Canadian clinical trial?

Decoy20 will be administered through weekly dosing according to the current trial protocol.

What is the planned combination therapy for Decoy20 in the INDP trial?

Indaptus plans to combine Decoy20 with Beigene's PD-1 checkpoint inhibitor, tislelizumab, pending Health Canada amendment approval.

How does Decoy20 work in treating solid tumors?

Decoy20 works as a broad immune system activator, targeting both the innate and adaptive immune systems to potentially address challenges associated with solid tumors.

What are the expected benefits of expanding the INDP-D101 trial to Canada?

The expansion is expected to accelerate clinical data collection, provide a more diverse patient population, and help refine Decoy20's dosing regimen for improved treatment outcomes.