Company: INDP
Filing Date: 2025-05-14
Form Type: 10-Q
Source: 0001641172-25-010099
Chunk: 42

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-05-14
Form: 10-Q
Item: Part I, Item 1
Chunk 42
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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. As of May 13, 2025, we have enrolled 13 participants on Decoy20 as a single
dose and 32 participants in the weekly dosing among the two Decoy20 dose levels and 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 4 participants
that have resolved within 24 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 March 2025,
we announced the initiation of the Phase 1 Combination Study of Decoy20 with Tislelizumab.

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