Indaptus Therapeutics Receives Approval From Health Canada to Expand Clinical Trial of Decoy20

Indaptus Therapeutics, Inc. recently announced it has received Clinical Trial Authorization from Health Canada to initiate its clinical trial for its lead asset, Decoy20. This approval will allow the company to expand its ongoing US clinical trial, INDP-D101, to Canadian sites, broadening patient recruitment and enhancing its clinical research program. The trial will enroll patients in Canada under the current protocol, which involves weekly dosing of Decoy20. Indaptus also plans to submit an amendment to Health Canada to incorporate its upcoming combination trial, which pairs Decoy20 with Beigene’s PD-1 checkpoint inhibitor, tislelizumab.

Jeffrey Meckler, CEO of Indaptus, said “We are pleased to bring Canadian investigators and patients into our clinical efforts, creating a more diverse and robust data set. Health Canada’s approval followed a comprehensive review of our safety data and trial design. Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors.”

Roger Waltzman, Chief Medical Officer, added, “The addition of Canadian trial sites should allow us to accelerate the collection of valuable clinical data more efficiently, and from a broader, more diverse population. This expansion is critical as we continue to evaluate Decoy20’s unique ability to activate both the innate and adaptive immune systems, potentially addressing the challenges associated with solid tumors. By enhancing our trial infrastructure, we aim to accelerate our understanding of Decoy20’s full therapeutic potential, refine its dosing regimen, and improve treatment outcomes for patients facing difficult-to-treat cancers. We are confident this progress will pave the way for key insights that could bring us closer to meaningful advances in cancer treatment.”

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 (iv). 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 iv dose of Decoy product candidate, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated iv 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.