Indaptus Therapeutics Initiates Unrestricted Enrollment of Patients on Decoy20 Weekly Dosing Based on Encouraging Safety Data

Indaptus Therapeutics, Inc. recently provided an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20. The Safety Review Committee examined weekly administration data at the lower Decoy20 dose and cleared unrestricted enrollment of patients at this dose. The safety profile observed to date remains aligned with Decoy20’s expected mechanism of action. The most clinically relevant treatment-related adverse events include Grade 2 Infusion Related Reaction and Grade 2 Hypotension, both of transient duration.

“Unrestricted enrollment of patients at the lower Decoy20 dose will enable us to gather more safety and efficacy data, which is crucial for assessing the full potential of Decoy20. The data will guide how we initiate combination therapy next year, a critical phase in advancing Decoy20,” said Dr. Roger Waltzman, Indaptus Chief Medical Officer.

Jeffrey Meckler, Chief Executive Officer, added “We continue to gather robust data on Decoy20, which remains consistent with our expectations from preclinical studies. We believe the continuation of this trial, and the eventual initiation of combination therapy studies presents an important opportunity to have a potentially significant impact on cancer immunotherapy. We look forward to sharing these results in the coming months.”

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 iv 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 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.