Indaptus Therapeutics Doses First Patient in Phase 1b/2 Combination Study of Decoy20 with PD-1 Checkpoint Inhibitor Tislelizumab

New trial arm to evaluate safety, dosing and preliminary anti-tumor activity of the combination therapy in advanced solid tumors

/EIN News/ -- NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab. This newly activated arm of the trial will assess safety, dose optimization, and early signs of anti-tumor activity in patients with advanced solid tumors, previously treated with a checkpoint inhibitor or with tumors typically unresponsive to a checkpoint inhibitor.

Jeffrey Meckler, Indaptus’ CEO commented, “This is an important milestone in our clinical development. We have long believed the Decoy platform has the potential to be a game-changing approach to treating solid tumors. Preclinical data consistently demonstrated that Decoy20 works synergistically with a checkpoint inhibitor. Now, for the first time, we are testing this combination in patients. Checkpoint inhibitors, like tislelizumab, have been one of the biggest breakthroughs in cancer therapy and have significantly improved outcomes in a variety of cancers. However, most patients still do not benefit. We believe the combination of Decoy20 plus a PD-1 inhibitor, such as tislelizumab, could enhance immune responses, potentially helping patients who have not responded or have tumors that classically do not respond to checkpoint inhibitor therapy.”

About the Combination Trial

• Over 25 patients have now received weekly doses of Decoy20 at 30 million cells and the treatment has been well tolerated. Most side effects were mild or moderate and were transient.
• Patients enrolled in the Decoy20 + tislelizumab combination arm will either have tumors that did not respond – or stopped responding – to prior checkpoint inhibitor therapy, or have tumor types that are typically unresponsive. This will allow the Company to determine that any observed benefit is likely due to the combination approach.

• Initially, patients will be enrolled sequentially onto combination treatment to closely monitor safety before expanding enrollment. 
  

About PD-1 Inhibitors
PD-1 inhibitors work by blocking the PD-1 (programmed death-1) receptor on T cells, preventing cancer cells from evading the immune system and restoring the body’s ability to fight cancer. Combining checkpoint inhibitors with immune system activators such as Decoy20 could provide a more powerful and sustained anti-tumor response.

Indaptus is committed to advancing innovative therapies that harness the immune system to fight cancer. With the launch of this combination trial, the Company is taking a major step towards realizing the full potential of its Decoy platform.

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.

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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 1b/2 of the combination study and the anticipated effects of our product candidates, including Decoy20. 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 most recent Annual Report on Form 10-K filed with the SEC on March 13, 2025, 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