INDP Indaptus Therapeutics Inc

Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical biopharma company that utilizes a proprietary killed, non-pathogenic bacteria-based platform to generate a stabilized package of immune agonists to activate both innate (immediate) and adaptive (learned) cellular immune pathways, announces interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. A broad expression of cytokines and chemokines associated with innate and adaptive anti-tumor immune responses was observed, while adverse events were generally tolerable and resolved within 30 minutes to three days. Decoy20 is designed to “re-set” the immune system’s response to cancer. The poster was presented on November 4, 2023, at the Society for Immunotherapy of Cancer in San Diego.

“We are impressed that we saw short-term induction of more than 50 cytokines, chemokines and biomarkers and believe this is unprecedented with a single agent. These early data support our long-standing hypothesis that the Decoy platform may induce robust immune responses across multiple types of immune cells that we believe are important for the eradication of solid tumors,” commented Indaptus CEO Jeffrey Meckler.

“The relatively brief duration of exposure to Decoy20 supports our hypothesis of utilizing a “pulse-prime” approach, providing a short period of activation to avoid unwanted toxicities that may occur from prolonged immune activation,” commented Michael Newman, Ph.D., Indaptus Founder and Chief Scientific Officer.

As reported in the poster, trial subjects experienced transient induction of over 50 different biomarkers associated with immune responses, and generally anticipated transient adverse events.After the end of infusion, Decoy20 was cleared from the blood within 30 to 120 minutes. This rapid clearance and associated transient cytokine/chemokine induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure. In contrast, therapeutics that are designed to be continuously present over weeks, months, or even years, such as CAR-T, can induce this type of toxicity. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most returned to baseline by 24-48 hours. Lymphocyte cell populations were transiently reduced in the blood and then rebounded, suggesting that these critical immune cells were redistributing from the circulation to lymph nodes, immune organs or sites of tumor. This supports the hypothesis of an “immune resetting” proposed mechanism of action.

In addition, each of the subjects was observed to have stable disease four weeks after a single dose, with three of them having started the trial with progressive disease.

“We look forward to continuing the trial with the current cohort having a lower dose, given the broad potential immune activation we have observed,” added Roger Waltzman, M.D., Indaptus’ Chief Medical Officer. “We anticipate that in the next stage of the trial we will assess the effect of weekly dosing (as opposed to the single dose in these first two cohorts), while analyzing a host of biomarkers, immune and tumor cells in peripheral blood, and immune cell populations in the tumor microenvironment, coupled with standard radiographic measurements.”

The poster was titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.” First cohort patients received a single dose of 7x107 killed Decoy20 bacteria via a one-hour IV infusion.

About Indaptus TherapeuticsIndaptus 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 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 StatementsThis 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 timing of the enrollment of the second cohort of patients in the Phase 1 trial, and our expectations regarding the recommended Phase 2 doses for subsequent multi-dosing and combination studies and related timing; the anticipated effects of our product candidates, including Decoy20; and upcoming events and presentations. 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 June 30, 2023 filed with the SEC on August 14, 2023, 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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