Company: INDP
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001641172-25-023333
Chunk: 17

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 17
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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 10^7 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 Safety Review Committee we received the authorization to initiate unrestricted enrollment of participants
at the 3 x 10^7 Decoy20 dose. By May 2025, we had enrolled 13 participants on Decoy20 as a single dose and 32 participants in the weekly
dosing among the two Decoy20 dose levels. In May 2025, we decided to conclude enrollment in the weekly dosing and focus on the combination
study of Decoy20 with Tislelizumab, as further described below. We have observed early signs of potential benefits emerging with some
participants with stable disease. As expected with the mechanism of action of Decoy20, we have seen adverse events of cytokine release
syndrome (CRS) in 6 participants that have resolved within 24-72 hours.

In
October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeOne Medicines