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Data further confirms Company’s “Pulse-Prime” hypothesis
NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces compelling safety, pharmacokinetics, and biomarker data on its lead compound, Decoy20, at the Society for Immunotherapy of Cancer (SITC) 2024 annual meeting. The data derive from two cohorts (13 patients) of Decoy20 single administration and one cohort (6 patients) of Decoy20 weekly administration in the Company’s ongoing Phase 1 clinical trial. The SITC conference is being held November 6-10, 2024 in Houston, Tex.
The data presented demonstrated that Decoy20 administered intravenously once weekly mainly showed side effects that were classified as mild or moderate and transient in duration. Further, pharmacokinetic analysis confirmed that Decoy20 quickly disappeared from the bloodstream after administration, supporting the Company’s “pulse” approach. One patient in the trial who has squamous cell carcinoma of the head and neck (SCCHN) with high levels of PD-L1, which is a protein that is associated with tumor response to certain immunotherapies, had “stable disease” — meaning the cancer had not progressed or worsened — at the time of their first imaging scan.
“We continue to be encouraged by the safety profile of Decoy20 when administered weekly,” said Dr. Roger Waltzman, Chief Medical Officer. “In addition, we see a broad innate and adaptive immune response. Based upon pre-clinical data, we expect Decoy20 combined with a PD-1 inhibitor to work together effectively to control tumors.”
Jeffrey Meckler, Chief Executive Officer, commented, “We’re pleased to present our latest clinical data at SITC because it further validates our hypotheses in this Phase 1 trial. We continue to confirm our “pulse-prime” approach, while observing an acceptable safety profile. Our trial is now enrolling patients with 6 tumor types for weekly dosing. Furthermore, we recently announced that we have engaged with BeiGene to embark on a new cohort where we will combine Decoy20 with BeiGene’s PD-1 inhibitor, tislelizumab. We have great confidence in our Decoy platform's potential and are excited to continue sharing positive results and pursuing new opportunities.”
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 candidate, 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 candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.