Indaptus Therapeutics Presents Data Demonstrating Preclinical Efficacy of Decoy, its Bacteria-Based Immunotherapy Platform Technology

Indaptus Therapeutics, Inc. recently announces data presented in a poster at the American Association for Cancer Research (AACR) annual scientific conference on the company’s Decoy anti-tumor platform.

The poster, titled A systemically administered killed bacteria-based multiple immune receptor agonist for pulsed anti-tumor immunotherapy, authored by Michael J. Newman, PhD, the company’s Founder and Chief Scientific Officer, was presented Tuesday, April 18, 2023.

Highlights included:

• Decoy10 (a previous generation from the platform) is a novel, attenuated and stabilized multi-TLR, NLR and STING agonist bacteria-based immunotherapy that demonstrated 90% reduction of LPS-endotoxin activity and use of 100% killed, non-pathogenic bacteria
• Decoy10 inhibited tumor growth, metastasis, and induced tumor regressions as a single agent.  Regressions were also seen with Decoy10 in combination with a non-steroidal anti-inflammatory drug (NSAID), an anti-PD-1 checkpoint inhibitor, low-dose chemotherapy (LDC), and LDC plus a targeted antibody.  Regressions were durable and associated with immunological memory-mediated rejection of tumor rechallenge
• The data demonstrated that Decoy10 contains agonists of TLR2 (1/2 and 2/6), TLR4, TLR8, TLR9, NOD2 and STING, conferring the ability to activate both innate and adaptive immune pathways in tumors after a single safe i.v. dose of Decoy10 in combination with anti-PD-1 checkpoint therapy, an NSAID or both
• In vivo anti-tumor activity was seen with colorectal, breast, hepatocellular, pancreatic carcinomas, and non-Hodgkin’s lymphomas (mouse and human) in pre-clinical models

Dr. Michael Newman said “The data from this poster represent the culmination of the extensive pre-clinical work that we performed to bring us to our current position as a clinical-stage company.  Importantly, our results demonstrate the potential for activity in multiple solid tumor indications with high unmet need and the flexibility to be combined with a wide variety of synergy partners. The Decoy platform appears to be unique in its ability to deliver a package of TLR2,4,8,9, NOD2 and STING agonists systemically in pre-clinical models, resulting in priming or activation of innate and adaptive immune pathways in tumors, particularly in the combination setting.  We believe this represents a significant advance in the recruitment of the body’s own defenses in the fight against cancer, and we look forward to continuing to provide updates on both the INDP D-101 Phase 1 clinical trial and further research on the platform itself.”

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) agonist Decoy platform. The products 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 products 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 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 products 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 safe 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 products 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 https://indaptusrx.com/.