Indaptus Therapeutics Announces Opening of Next Cohort in Single Dose Ranging Study of Decoy20

• Cohort 1 patients exhibited a significant immune response consistent with the mechanism of action
  
• Safety Review Committee approved continuation to the next cohort of patients

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) today announced completion of the first cohort of patients who received a single dose in Part 1 of its INDP-D101 trial of Decoy20 and the initiation of a new cohort following review of data by the Safety Review Committee as prescribed by the clinical trial protocol.

Four patients were enrolled and evaluable in this cohort. Overall, patients experienced symptoms or adverse events (AEs) that were short-lived and consistent with the mechanism of action of Decoy20. These symptoms included temperature elevation, nausea and chills. Additional transient effects included changes in heart rate and blood pressure.

“The safety profile exhibited among the first cohort of patients in our Phase 1 dose ranging study was consistent with the Decoy20 mechanism of action. We expect the enrollment of the next cohort will bring us closer to determination of the recommended phase 2 dose for the multi-dosing part of the trial. We are pleased that the safety and immune activation data support continued dosing,” said Jeffrey Meckler, Indaptus’s CEO.

Three of the patients in the first cohort have completed the 28-day safety review period with two of the patients having also completed post-study tumor re-staging. One clinically relevant dose limiting toxicity of grade 3 bradycardia occurred and was reversible in under 30 minutes following a bolus of normal saline; grade 3 malaise in the same patient resolved overnight. Two patients experienced a grade 3 AST increase which resolved within 1 day. Other Adverse Events including chills, fatigue, vomiting, and fever were of grade 1-2 severity, resolved quickly, and were to be expected following exposure to the TLR4 agonist lipopolysaccharide (LPS), which is a major active ingredient of Decoy20 and a facilitator of innate and adaptive immune responses.

Evidence of immune activation was observed, based on transient expression of multiple plasma cytokines and chemokines associated with activation of innate and adaptive immune pathways, including several not expected with LPS exposure. “The presence of multiple, additional immune activating molecules in Decoy20 appears to have stimulated production of potential anti-tumor cytokines and chemokines beyond what would be expected for LPS alone, without significantly altering the safety profile,” said Dr. Michael Newman, Indaptus’s Founder and CSO. “The results to date are consistent with our hypothesis that Decoy20 represents a short-acting “pulse-prime” approach, capable of priming or activating innate and adaptive immune pathways without requirement for continuous exposure, which may reduce the potential for sustained or long-term adverse events.”