Company: INDP
Filing Date: 2025-09-02
Form Type: S-1
Source: 0001493152-25-012531
Chunk: 9

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-09-02
Form: S-1
Chunk 9
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 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 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.

| 2 |

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 dos