Company: INDP
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001641172-25-010099
Chunk: 41

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-05-14
Form: 10-Q
Item: Part I, Item 1
Chunk 41
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 PK parameters over time, objective response rate and duration of response.

In
August 2023, we evaluated the first four participants who received a single dose of 7 x 10^7 Decoy20 in Part 1 of the Phase 1 clinical trial.
All four participants who enrolled were evaluable in the first cohort. These participants experienced generally anticipated transient adverse
events including hemodynamic changes such as changes in pulse or 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 patient 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
patient’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.

1

In
May and June 2024, we enrolled two additional participants in the first cohort who received a single dose of 7 x 10^