Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting

Poster to be presented at 38^th Annual Meeting of the Society for Immunotherapy of Cancer on November 4, 2023

NEW YORK, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) announces it will be presenting interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. The interim data, released today in abstract form, demonstrated that as of August 31, 2023, each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, both associated with predicted rapid clearance of Decoy20. The data in full will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) on November 4. The conference will be held from November 1-5, 2023 in San Diego.

Michael J. Newman, Ph.D., Indaptus’ Founder and Chief Scientific Officer noted, “Even in this early study, Decoy20 is exceeding our expectations from the perspective that we are seeing activation of the immune system, based on transient expression of multiple plasma cytokines and chemokines, with expected transient adverse events. These results, in conjunction with the desired and observed rapid clearance of Decoy20 from the blood, are highly supportive of our “Pulse-Prime” hypothesis for the Decoy20 mechanism of action.”

Roger Waltzman, M.D., Indaptus’ Chief Medical Officer, added, “We are encouraged by the tolerability of Decoy20 and the notable evidence for broad immune biomarker activation at this early stage. At one month following the single dose of Decoy20, all four of the first cohort patients had stable disease. We are following these patients as well as working on enrolling the second cohort, which utilizes a lower dose. This lower dose is based on the pharmacodynamic results seen with the first cohort and plans to optimize Decoy20 for both weekly dosing and combination approaches.”

The abstract/poster is titled, “Preliminary results of an in progress, first-in-human Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors.”   First cohort patients received a single dose of 7x10⁷ killed Decoy20 bacteria via a one-hour IV infusion. As of August 31, 2023, treatment-related adverse events, potentially expected based upon prior clinical studies with purified lipopolysaccharide, have included, among other events, changes in hemodynamic parameters, transaminase elevations, and lymphopenia; all resolved with or without treatment within 30 minutes to 3 days. The Company believes the short half-life of Decoy20 observed in blood coupled with the marked, but transient, induction of multiple cytokines and chemokines over approximately 24 hours supports the PK “pulse” and PD “prime” hypothesis for the Decoy20 immune-oncology strategy.