Indaptus Announces Promising Phase 1 Decoy20 Safety Data at SITC 2024

Indaptus Therapeutics, Inc., a clinical-stage biotech firm listed on Nasdaq under INDP, has unveiled promising safety, pharmacokinetics, and biomarker data on Decoy20, its lead compound, at the 2024 Society for Immunotherapy of Cancer (SITC) annual meeting. The data from their ongoing Phase 1 clinical trial includes results from two cohorts of patients administered Decoy20 once and another cohort receiving weekly doses.

Held in Houston from November 6-10, 2024, the SITC conference provided a platform for Indaptus to present data that indicated Decoy20's side effects were mostly mild to moderate and transient. Pharmacokinetic studies revealed that Decoy20 rapidly cleared from the bloodstream, which supports the company's "pulse" administration strategy. Notably, one patient with squamous cell carcinoma of the head and neck (SCCHN) and high PD-L1 levels experienced stable disease at their first scan, indicating no progression of cancer.

Dr. Roger Waltzman, Chief Medical Officer of Indaptus Therapeutics, expressed optimism about Decoy20's weekly administration safety profile, noting its ability to elicit broad innate and adaptive immune responses. He emphasized the potential effectiveness of combining Decoy20 with PD-1 inhibitors based on preclinical data.

Jeffrey Meckler, the Chief Executive Officer, highlighted the validation of their hypotheses through the new clinical data presented at SITC. He also mentioned that Indaptus is currently enrolling patients with six different tumor types for weekly dosing. Additionally, the company has partnered with BeiGene to explore a new trial cohort combining Decoy20 with BeiGene's PD-1 inhibitor, tislelizumab. Meckler expressed confidence in the Decoy platform's potential and excitement about future opportunities and results.

Indaptus Therapeutics, which has evolved from over a century of immunotherapy advancements, focuses on pioneering treatments for cancer and viral infections. The company's approach is based on the hypothesis that effective activation of both innate and adaptive immune cells and pathways, leading to anti-tumor and anti-viral responses, necessitates a multi-targeted package of immune system-activating signals that can be safely administered intravenously.

Their patented technology involves single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria that produce multiple immune system-activating signals. These signals target Toll-like receptors (TLR), Nucleotide oligomerization domain-like receptors (NLR), and Stimulator of interferon genes (STING). Decoy product candidates are designed to reduce intravenous toxicity while maintaining the ability to stimulate both innate and adaptive immunity.

Preclinical studies have shown that Decoy product candidates can act as single agents against metastatic pancreatic and colorectal cancers and in combination therapies to eradicate established tumors, such as hepatocellular carcinomas and non-Hodgkin’s lymphomas. These combinations involve anti-PD-1 checkpoint therapy, low-dose chemotherapy, non-steroidal anti-inflammatory drugs, or targeted antibodies. The observed tumor eradication was associated with immune memory and a transition from "cold" to "hot" tumor inflammation signatures after a single intravenous dose.

Nonclinical toxicology studies demonstrated that intravenous administration of Decoy candidates does not cause sustained cytokine release syndrome biomarker induction, likely due to rapid elimination from the body. Indaptus' Decoy products have also shown significant activity against chronic hepatitis B and HIV infections in preclinical models.

Indaptus Therapeutics continues to advance the clinical evaluation of Decoy20, intending to combine it with other treatments to enhance its efficacy against various cancers and viral infections. The company's focus remains on developing innovative therapeutic strategies that leverage the body's immune system for better health outcomes.