Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Broad-Based, “Pulse-Prime” Immuno-Oncology Therapy for Advanced Solid Tumors

Indaptus Therapeutics, Inc. recently announced the successful advancement of its Phase 1 trial for Decoy20, an investigational novel package of broad immune agonists for cancer immunotherapy that has first-in-class potential across a diverse range of cancers including liver, pancreatic, colorectal and non-small cell lung.

Following review by a Safety Review Committee (SRC) of the company’s initial clinical data, which will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), the company has successfully dosed the first patient in the multi-dose portion of the trial with Decoy20. The primary goal of this stage of the trial is to determine the safety of Decoy20 when administered multiple times to the same patient, and to begin to examine efficacy across multiple types of cancer.

“Current immunotherapies usually target a few immune system pathways and have low cure rates in advanced cancers. Indaptus is investigating an incredibly exciting and differentiated approach to fighting cancerous tumors that deviates from a focus on targeted therapies in the field,” said Roger Waltzman, MD, Chief Medical Officer of Indaptus. “The advancement of this trial is a significant milestone that builds on strong evidence that Decoy20 successfully and broadly activates potent tumor-fighting cytokines and chemokines in both the innate and adaptive immune systems, and was administered systemically without intolerable adverse events.”

Decoy20 is composed of attenuated and killed, intact, non-pathogenic Gram-negative bacteria which are designed to act as a “decoy,” tricking the body into activating a broad antitumor response from both its innate and adaptive immune systems. In preclinical studies, the treatment has been shown to activate specialized immune receptors called TLRs, that facilitate a potent defense against tumors, without inducing excessive toxicity. The product candidate is designed to induce a strong and broad pulse of immune activation, followed by rapid clearance from the body.

“There is significant unmet medical need for people living with advanced solid tumors and we are thrilled with the successful completion of the first patient of the multi-dose part of our Phase 1 clinical trial with Decoy20 and potential to offer a disruptive, first-in-class innovation, with the successful initiation of the multi-dosing part of our Phase 1 clinical trial with Decoy20,” said Jeffrey Meckler, CEO of Indaptus. “As part of our commitment to delivering innovative therapies to patients in need, we look forward to advancing this research that has the potential to treat patients who have limited options today.”

The company intends to progress Decoy20 into combination studies with a checkpoint inhibitor, due to the observation of tumor eradications by the Decoy platform in combination with checkpoint therapy in pre-clinical studies.

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 iv dose of Decoy product, 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. 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.