Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 2

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 2
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 June 2024, we enrolled two additional patients 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 patients 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 patients
at the 3 x 10^7 Decoy20 dose. As of March 12, 2025, we have enrolled more than 20 patients in the weekly dosing among the two Decoy20 dose levels
and we have observed early signs of potential benefits emerging with some patients with stable disease. We are working to increase the
number of trial sites to accelerate patient enrollment and data collection.

In
October 2024, we entered into a clinical supply agreement, or the Supply Agreement, with BeiGene Switzerland GmbH, or BeiGene, to advance
clinical evaluation of Decoy20 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, or the BeiGene Product, for the
treatment of patients with advanced solid tumors, or the Combination Study. This Combination Study builds on preclinical results where
Decoy20, combined with a PD-1 inhibitor, demonstrated high tumor eradication rates and established immunological memory. We intend to
seek approval from the FDA to initiate the Combination Study, which is anticipated to begin in 2025.

Under
the terms of the Supply Agreement, we will pay for all costs associated with the Combination Study (other than the cost of the BeiGene
Product), BeiGene will supply the BeiGene 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
BeiGene 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.

In
February 2025, we announced that we received clinical trial authorization from Health Canada to initiate a clinical trial for Decoy20
which allows us to expand our ongoing U.S. clinical trial to Canadian sites