Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 12

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 12
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11 mice by combination treatment as in the Figure above and then the mice were re-challenged with fresh HCC
tumor cells, without further treatment. All of the new tumors were rejected. Similar results have been obtained by combining our bacteria
with low-dose chemotherapy in a non-Hodgkin’s lymphoma model.

13

Clinical
Trial

In
May 2022, the FDA allowed us to proceed under our IND application for a Phase 1 clinical trial in patients with advanced solid tumors
where currently approved therapies have failed, and in December 2022, we initiated this Phase 1 clinical trial which is an open label,
multi-center, dose escalation and expansion, single arm (monotherapy) study conducted in 2 parts. The Phase 1 study has begun with a
single dose escalation, which is planned to be followed by an expansion part with continuous weekly administration of Decoy20. The study
is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options. The study’s objectives
are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose and recommended Phase 2 dose, as well as
to assess Decoy20 pharmacokinetics PK, pharmacodynamics and clinical activity. The primary endpoint of the study is incidence, relatedness
and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting
toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and
post-treatment, change in Decoy20 PK parameters over time, objective response rate in subjects with measurable disease and duration of
response.

In
August 2023, we completed the first cohort of patients who received a single dose in Part 1 of the Phase 1 clinical trial. Four patients
were enrolled and evaluable in the first cohort. Overall, patients experienced symptoms or adverse events (AEs) that were short-lived
and consistent with the mechanism of action of Decoy20. In September 2023, we advanced into the second cohort of the Phase 1 clinical
trial after receiving authorization from the Safety Review Committee. In early March 2024, we completed the second cohort of patients
who received a single dose in Part 1 of the Phase 1 clinical trial and, following authorization from the Safety Review Committee, advanced
into the multi-dosing cohort of the Phase 1 clinical trial. The second cohort dose was