Indaptus Therapeutics announces opening of next cohort in trial of Decoy20

Indaptus Therapeutics 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 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. 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.