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Indaptus Therapeutics Doses First Patient in Second Cohort of Single Dose Ranging Study of Decoy20

Following evidence of marked pharmacodynamic activity in first cohort, Cohort 2 has dose reduced while anticipating a similar effect NEW YORK, Sept. 19, 2023

articleIndaptus Therapeutics, Inc.September 19, 20234/company/indaptus-therapeutics-inc/news/indaptus-therapeutics-doses-first-patient-in-second-cohort-of-single-dose-ranging-study-of-decoy20
Indaptus Therapeutics Doses First Patient in Second Cohort of Single Dose Ranging Study of Decoy20

About this update from Indaptus Therapeutics, Inc.

[{"type":"text","content":"Following evidence of marked pharmacodynamic activity in first cohort, Cohort 2 has dose reduced while anticipating a similar effect\nNEW YORK, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) announces dosing of the first patient in the second cohort of patients to receive a single dose of Decoy20 in the INDP-D101 trial. This cohort dose is a dose reduction from the previous cohort based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both weekly dosing and combination approaches. “This cohort is important to the development of Decoy20 as it may provide sufficient data for us to move Decoy20 to a multi-dosing regimen,” said Dr. Roger Waltzman, Indaptus’ Chief Medical Officer. “To date, we have seen positive signs of an immune response with an anticipated adverse effect profile, and we look forward to seeing whether this lower dose provides similar evidence of increased cytokines that can trigger both innate and adaptive immune responses.” “We continue to be encouraged by the initial results of the first cohort and look forward to progressing into the multi-dosing regimen as soon as we have enough data,” said Jeffrey Meckler, Chief Executive Officer. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. More information can be found at www.clinicaltrials.gov. The Phase 1 study was initiated with a single dose escalation, which is planned to be followed by an expansion with continuous weekly administration of Decoy20. The study is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options. About Indaptus Therapeutics Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of s...

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