Company: INDP
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001493152-25-021759
Chunk: 75

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 2
Chunk 75
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 blood pressure that resolved within 30 minutes and laboratory
abnormalities such as grade 1-3 elevations in transaminases (liver function tests) and grade 4 reductions in lymphocytes that generally
resolved within three days. One participant had a dose-limiting toxicity of grade 3 bradycardia (slow heart rate) and grade 2 hypotension
(low blood pressure) which resolved within approximately 90 minutes with i.v. fluids. Participants also experienced transient induction
of over 50 different biomarkers associated with innate and adaptive anti-tumor immune responses. After the end of infusion, Decoy20 was
cleared from the blood within 30 to 120 minutes. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most cytokine/chemokines
returned to the participant’s respective baseline by 24-72 hours. This rapid clearance and associated transient cytokine/chemokine
induction are desired to avoid prolonged toxicity, often associated with longer term cytokine exposure.

In
September 2023, we began the second cohort of the Phase 1 clinical trial after receiving authorization from the Safety Review Committee.
The second cohort dose was a reduction from 7 x 10^7 Decoy20 dose to 3 x 10^7 Decoy20. In March 2024, we completed the second cohort
of participants who received a single dose of 3 x 10^7 Decoy20 in Part 1 of the clinical trial. Participants on the second (lower dose)
cohort experienced adverse events similar in frequency and severity to the higher dose cohort with one dose-limiting toxicity of grade
3 ALT elevation that required one week to resolve. Pharmacodynamic effects included transient induction of multiple biomarkers. Clearance
of Decoy20 was similarly rapid. Following authorization from the Safety Review Committee, we advanced into the weekly dosing part of
the trial.

In
May and June 2024, we enrolled two additional participants in the first cohort who received a single dose of 7 x 10^7 Decoy20, and in
August 2024 we received the authorization from the Safety Review Committee to initiate the weekly dosing with 7 x 10^7 Decoy20.

As
of October 2024, we completed one month of the weekly dosing part in the first six participants at the 3 x 10^7 Decoy20 dose and following
the review of the safety data by the