Indaptus to present interim data of first cohort in trial of INDP-D101

Indaptus Therapeutics 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 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 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.” 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 7×107 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.