Indaptus Therapeutics' Decoy20 Demonstrated a Broad Immune Response of More than Fifty Cytokines and Chemokines in Patients Following a Single Dose in First Cohort of Ongoing Phase 1 Study

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- 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 ...

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