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Poster abstract highlights response across multiple indicators of immune activation with rapid clearance of Decoy20
NEW YORK, May 29, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces data from a poster being presented at the American Society of Clinical Oncology Annual Meeting 2024 on June 1. The conference will be held in Chicago at McCormick Place from May 31-June 4, 2024 where full data will be presented.
In the abstract, titled, “Preliminary results of a Phase 1 study of Decoy20, an intravenous, killed, multiple immune receptor agonist bacterial product in patients with advanced solid tumors,” investigators continued to provide validation from early results of the single dose cohort of its Phase 1 clinical trial. The data presented include the pharmacokinetics and immune response observed in both cohorts in the ongoing Phase 1 trial for Decoy20. A single i.v. dose of Decoy20 disappeared from blood within 30-120 minutes and produced transient induction in plasma of over 50 cytokines and chemokines, many of which have been associated with stimulation of innate and/or adaptive immune responses. These findings are important components of the “pulse-prime” hypothesis for Decoy20’s anti-tumor effect.
The study also showed that despite the presence of multiple immune agonists associated with intact bacteria, the safety profile of Decoy20 was largely as expected for administration of purified lipopolysaccharide (LPS), based on previously published clinical experience. Adverse effects were generally tolerable and resolved with or without treatment within 90 minutes to 3 days.
Roger Waltzman, Indaptus CMO commented, “We continue to receive important validation of the results of our Phase 1 study as they evolve, and presentation at the American Society for Clinical Oncology is an important event for the Company and for our compound. We continue the Phase 1 clinical trial with the first multi-dose cohort and expect to provide updates on progress throughout the year.”
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 single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy product candidates have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.