Indaptus Therapeutics Previews Positive Mechanism of Action Data to be Presented at the American Association for Cancer Research Annual Meeting

Data demonstrates that Company’s Decoy platform successfully induces or activates multiple immune cell
types involved in anti-tumor responses

New data shows activity in M1 macrophages, natural killer cells, dendritic cells, Th1 CD4, and CD8 T cells

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces that Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus, will present a poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday morning, April 10^th. An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research. The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy.

Dr. Newman commented, “These new data demonstrate that our patented single agent Decoy bacteria were able to induce or activate multiple human innate and adaptive immune cell types involved in anti-tumor responses, including M1 macrophages, natural killer cells, dendritic cells, Th1 CD4, and CD8 T cells. The activity was associated with induction of human tumor cell killing by Decoy bacteria in the presence of immune cells. Potentially unacceptable toxicity from this breadth of immune activation is avoided by using systemically administered killed bacteria as a delivery vehicle. Bacteria have been shown to be cleared very quickly by immune organs, and our clinical data have demonstrated broad immune activation with clearance of the product within approximately two hours, validating our ‘pulse-prime’ hypothesis. This burst of immune system activation exhibited by Decoy has the potential to reduce the chance for toxicities associated with continuous drug exposure.”  

Jeffrey Meckler, Indaptus’ Chief Executive Officer, added, “We are looking forward to expanding on this abstract in a poster session at the AACR conference. It confirms our hypothesis that our Decoy platform, in this case our research compound Decoy10,   activates multiple innate and adaptive immune cell types known to be critical for effective anti-tumor immune responses. The data are significant as they are highly supportive of the clinical data we have generated to date with Decoy20, which is currently in a multi-dose cohort of a Phase 1 clinical trial. It is also highly consistent with our clinical observation that single agent Decoy20 produces transient induction of dozens of cytokines and chemokines that are critical activators and effectors of both the innate and adaptive immune systems. We are looking forward to advancing our technology and demonstrating its utility for the treatment of solid tumors.

“I want to personally highlight the contributions Dr. Newman has made as the inventor of this technology and congratulate him on these very important findings,” Mr. Meckler added.

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: expectations regarding the impact of the data to be discussed at AACR; expectations regarding reduction in toxicity; advancing our technology and demonstrating its utility; 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; the plans and objectives of management for future operations; and our research and development activities. 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, 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.

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