Company: INDP
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001641172-25-023333
Chunk: 73

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 73
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 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 (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. In June 2025 we
announced the dosing of the first participant in the Combination Study and by August 2025 we had enrolled 6 participants, and we
have seen one related serious adverse event of CRS in 1 participant that has resolved within 72 hours. The Combination Study will
assess safety, dose optimization, and early signs of anti-tumor activity in participants with advanced solid tumors, previously
treated with a checkpoint inhibitor or with tumors typically unresponsive to checkpoint inhibitors.

Under
the terms of the Supply Agreement, we will pay for all costs associated with the Combination Study (other than the cost of the BeOne
Product), BeOne will supply the BeOne Product to us for the purposes of the study, and we will supply Decoy20 for the purposes of the
Combination Study. The Supply Agreement will terminate upon the earlier of (i) the one-year anniversary of the date that we provide BeOne
with the Combination Study’s final clinical study report or (ii) the date of termination of the Combination Study, subject to early
termination in certain circumstances.

Impact
of Macroeconomic Conditions