Company: INDP
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001641172-25-023333
Chunk: 16

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 16
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 tumors where currently approved therapies have failed. In December 2022, we initiated an open label, multi-center,
dose escalation and expansion, single arm (monotherapy) Phase 1 study conducted in 2 parts. The Phase 1 study began with single dose
administration and has now been followed with continuous weekly dosing of Decoy20 in tumor-specific expansion cohorts. The study is enrolling
participants with any one of six 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, the optimal biologically active and recommended
Phase 2 dose, as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. The primary endpoints of the
study are 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 and duration of response.

In
August 2023, we evaluated the first four participants who received a single dose of 7 x 10^7 Decoy20 in Part 1 of the Phase 1 clinical
trial. All four participants who enrolled were evaluable in the first cohort. These participants experienced generally anticipated transient
adverse events including hemodynamic changes such as changes in pulse or blood pressure that resolved within 30 minutes and laboratory
abnormalities such as grade 1-3 elevations in transaminases (liver function tests) and grade 4 reductions in lymphocytes that generally
resolved within three days. One participant had a dose-limiting toxicity of grade 3 bradycardia (slow heart rate) and grade 2 hypotension
(low blood pressure) which resolved within approximately 90 minutes with i.v. fluids. Participants also experienced transient induction
of over 50 different biomarkers associated with innate and adaptive anti-tumor immune responses. After the end of infusion, Decoy20 was
cleared from the blood within 30 to 120 minutes. Peak cytokine and chemokine induction occurred within ~4 to 24 hours and most cytokine/chemokines
returned to the participant’s respective baseline by 24-72 hours. This rapid clearance and associated transient cytokine/chemok