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

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 1
Chunk 25
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oy20 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 six 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 (formerly known as BeiGene
Switzerland GmbH), to advance clinical evaluation of Decoy20 in combination with BeOne’s anti-PD-1 antibody, Tislelizumab, or
the BeOne Product, for the treatment of participants with advanced solid tumors, or the Combination Study. This Combination Study
builds on preclinical results where Decoy20, combined with a PD-1 inhibitor, demonstrated tumor eradication. By November 2025, we
had enrolled six evaluable participants in the Combination Study, and we have seen one related serious adverse event of CRS in one
participant that has resolved within 72 hours. Following efficacy evaluations, we had three participants who experienced disease
progression and had to discontinue from the study, and we had evidence of stable disease at the first re-staging assessment in three
subjects. Of the three stable disease participants, one subject developed disease progression at the next restaging assessment
and has discontinued from the study; one subject continues dosing with Decoy20 alone with stable disease - this subject
developed an immune-related adverse event and has not been receiving tislelizumab since the emergence of that adverse
event; and the third subject continues dosing with both Decoy20 and tislelizumab with stable disease and is scheduled for further
re-staging assessments. The Safety Review Committee has reviewed all available safety data from this cohort and determined that
the Decoy20 and tislelizumab