Indaptus Therapeutics Reports New Data Demonstrating Successful Broad Immune System Activation in Weekly Dosing Trial of Decoy20

Indaptus Therapeutics, Inc. recently provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20.

As announced in last week’s earnings release, the Company has now enrolled more than 20 patients in the weekly dosing cohort, marking a key milestone in the trial. Initial data indicate that Decoy20 at the 30 million cell dose was generally well-tolerated, with a favorable safety profile and promising early signs of clinical benefit, including some patients demonstrating stable disease. Additionally, Decoy20 triggered short-term increases in multiple key immune system biomarkers (cytokines and chemokines), which play a crucial role in activating the body’s natural defenses against cancer.

Today, Indaptus is reporting further insights showing that weekly Decoy20 treatment also leads to broad, blood-based immune cell trafficking. This immune cell movement, which includes transient weekly increases and decreases in the levels of major innate and adaptive immune cell types in the blood, is an important pharmacodynamic marker, indicating that immune cells are actively mobilizing from bone marrow and/or trafficking to tissues.

Michael Newman, Founder and Chief Scientific Officer of Indaptus, commented, “Immune cell movement – or trafficking to and from tissues, tumors and bone marrow – is critical for successful anti-tumor therapy. In our weekly dosing cohort, we have observed transient but broad movement of key immune cells that is consistent with the chemokine induction we previously reported. These findings further validate Decoy20’s ability to modulate the immune system in a controlled and potentially meaningful way. We are encouraged by the consistency of these pharmacodynamic effects with each week of Decoy20 dosing and look forward to continuing to assess their impact on potential tumor response.”

Decoy20 is designed to activate both the innate and adaptive sides of the immune system, with the goal of potentially enhancing the effectiveness of existing cancer treatments, including checkpoint inhibitors. The Company previously announced that it has initiated a new arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, which will focus on safety, dose optimization, and preliminary anti-tumor activity.

Indaptus remains committed to advancing innovative therapies that harness the body’s immune system to fight cancer and will continue to share updates as new data emerges.

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. For more information, visit www.indaptusrx.com