Indaptus Therapeutics Reports Positive Data from Phase 1 Trial of Decoy20

Indaptus Therapeutics has announced promising updates from its ongoing Phase 1 clinical trial of Decoy20, targeting patients with solid tumors. The findings were shared at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois. Dr. Roger Waltzman, Chief Medical Officer of Indaptus, highlighted that Decoy20 induces numerous cytokines and chemokines, crucial for immune responses, with associated side effects being generally mild and temporary. This is a notable improvement over traditional Toll-like receptor (TLR) and STING agonists. Given the limited treatment options for patients with relapsed advanced solid tumors, the data from Decoy20 offers potential new avenues for enhancing the immune system’s ability to combat cancer.

The ASCO presentation covered pharmacokinetic and safety data from two single-dose cohorts, involving 11 patients—four in the first cohort and seven in the second. Key results from the study include:

1. Manageable Side Effects: All adverse events were expected and manageable.
2. Rapid Clearance: Decoy20 was largely cleared from the bloodstream within 120 minutes post-administration.
3. Consistent Immune Response: Both lower and higher doses led to transient changes in blood immune cells, with a rapid increase in neutrophils and a decrease in other white blood cells, indicating effective temporary mobilization of these cells.
4. Immune Activation: Blood tests revealed brief activation of a broad range of immune responses in both dosage groups.
5. Support for “Pulse-Prime” Approach: The findings strengthen the hypothesis that Decoy20 can trigger the immune system in a short and broadly targeted manner.

The company's CEO, Jeffrey Meckler, expressed enthusiasm about these findings. He noted that the single-dose data offers confidence as the trial progresses to its multi-dosing phase, where consistent immune responses are anticipated, indicating potential anti-tumor activity. Further updates are expected later in the year.

Indaptus Therapeutics has a background rooted in over a century of immunotherapy advancements. Their unique approach is predicated on the notion that effective activation of both innate and adaptive immune cells, along with associated anti-tumor and anti-viral responses, necessitates a multi-targeted signal package that can be safely administered intravenously. The company's patented technology involves using single strains of attenuated and killed, non-pathogenic Gram-negative bacteria to produce a multi-TLR, NOD-like receptor (NLR), and STING agonist Decoy platform. These candidates are designed to reduce intravenous toxicity while maintaining the ability to activate various immune cells and pathways robustly.

Decoy product candidates have demonstrated significant single-agent efficacy against metastatic pancreatic and orthotopic colorectal carcinomas, as well as in combination therapies against hepatocellular carcinomas, pancreatic cancers, and non-Hodgkin’s lymphomas in preclinical models. These studies reported tumor eradication with Decoy candidates, particularly when combined with treatments like anti-PD-1 checkpoint therapy, low-dose chemotherapy, NSAIDs, or targeted antibodies. The accompanying immune responses included both innate and adaptive memory, achieved with just one intravenous dose, leading to a transformation from "cold" to "hot" tumor inflammation signatures.

Additionally, non-clinical toxicology studies have shown that intravenous administration of Decoy candidates does not cause sustained induction of biomarkers associated with cytokine release syndromes, potentially due to passive liver, spleen, and tumor targeting, followed by rapid elimination. Decoy candidates have also shown promising single-agent activity against chronic hepatitis B virus (HBV) and HIV infections in preclinical settings.

Indaptus Therapeutics continues to explore their innovative Decoy platform, aiming to advance cancer and viral infection treatments by leveraging the immune system's inherent capabilities. The company remains optimistic about the future potential of its therapeutic candidates, as indicated by the encouraging results from the ongoing clinical trials.

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