UPDATE — Indaptus Therapeutics Presents Data Demonstrating Preclinical Efficacy of Decoy, its Bacteria-Based Immunotherapy Platform Technology, at the American Association for Cancer Research Conference 2023

Data presented were crucial to initiating its ongoing Phase 1 clinical trial with Decoy 20 in solid tumors

NEW YORK, April 19, 2023 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces data presented in a poster at the American Association for Cancer Research (AACR) annual scientific conference on the Company’s Decoy anti-tumor platform.

The poster, titled, “A systemically administered killed bacteria-based multiple immune receptor agonist for pulsed anti-tumor immunotherapy,” authored by Michael J. Newman, Ph.D., the Company’s Founder and Chief Scientific Officer, was presented Tuesday, April 18, 2023.

Highlights included:

• Decoy10 (a previous generation from the platform) is a novel, attenuated and stabilized multi-TLR, NLR and STING agonist bacteria-based immunotherapy that demonstrated 90% reduction of LPS-endotoxin activity and use of 100% killed, non-pathogenic bacteria
• Decoy10 inhibited tumor growth, metastasis, and induced tumor regressions as a single agent. Regressions were also seen with Decoy10 in combination with a non-steroidal anti-inflammatory drug (NSAID), an anti-PD-1 checkpoint inhibitor, low-dose chemotherapy (LDC), and LDC plus a targeted antibody. Regressions were durable and associated with immunological memory-mediated rejection of tumor rechallenge
• The data demonstrated that Decoy10 contains agonists of TLR2 (1/2 and 2/6), TLR4, TLR8, TLR9, NOD2 and STING, conferring the ability to activate both innate and adaptive immune pathways in tumors after a single safe i.v. dose of Decoy10 in combination with anti-PD-1 checkpoint therapy, an NSAID or both
• In vivo anti-tumor activity was seen with colorectal, breast, hepatocellular, pancreatic carcinomas, and non-Hodgkin’s lymphomas (mouse and human) in pre-clinical models

Michael Newman, Ph.D., Indaptus’ Chief Scientific Officer and inventor of the Decoy platform, commented, “The data from this poster represent the culmination of the extensive pre-clinical work that we performed to bring us to our current position as a clinical-stage company. Importantly, our results demonstrate the potential for activity in multiple solid tumor indications with high unmet need and the flexibility to be combined with a wide variety of synergy partners. The Decoy platform appears to be unique in its ability to deliver a package of TLR2,4,8,9, NOD2 and STING agonists systemically in pre-clinical models, resulting in priming or activation of innate and adaptive immune pathways in tumors, particularly in the combination setting. We believe this represents a significant advance in the recruitment of the body’s own defenses in the fight against cancer, and we look forward to continuing to provide updates on both the INDP D-101 Phase 1 clinical trial and further research on the platform itself.”

About the AACR Conference 2023
The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

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) agonist Decoy platform. The products 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 products 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 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 products 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 safe 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 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 expectations and plans regarding the Phase 1 clinical trial of Decoy20, including the timing and design thereof; the plans and objectives of management for future operations; our research and development activities; and our beliefs regarding the efficacy of our product candidates and the Decoy platform. 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; 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 17, 2023, 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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