Indaptus Showcases Progress In INDP-D101 Trial With Multi-Pathway Decoy Immunotherapy

Indaptus Therapeutics, Inc., a clinical-stage biotech company developing therapies for cancer and viral infections, has shared recent updates on its INDP-D101 clinical trial. The company’s work builds on over a century of immunotherapy progress and is guided by the belief that effective treatment requires simultaneously activating both innate and adaptive immune responses safely through intravenous (IV) delivery.

“We currently have completed the monotherapy portion of our trial and have initiated seven patients in our initial cohort of combination therapy with tislelizumab, BeOne’s anti PD-1 monoclonal antibody. We are encouraged to report a patient in our monotherapy study who previously received an anti-PD-1 therapy had a clear reduction in size of liver metastases, consistent with a Partial Response. Unfortunately, there was evidence of disease progression at the next scheduled imaging, and the patient discontinued the study,” said Dr. Roger Waltzman, Chief Medical Officer. “However, the investigator believes the therapy provided clinical benefit for the patient over that 4-month period.

“Additionally, we have dosed 7 patients in the combination therapy initial safety cohort. Of the first three evaluable patients, one patient had stable disease at the first assessment, and the other two patients had disease progression. We continue to dose additional patients and will report their results in the coming weeks,” concluded Dr. Waltzman.

At the core of Indaptus’ strategy is its patented Decoy platform, which uses attenuated and killed non-pathogenic Gram-negative bacteria to stimulate multiple immune pathways, including TLR, NLR, and STING agonists. The platform is designed to minimize IV toxicity while maintaining the ability to engage key immune cells. Preclinical studies have shown the Decoy approach can trigger tumor eradication as a standalone therapy or in combination with checkpoint inhibitors, chemotherapy, NSAIDs, or targeted antibodies. Importantly, these combinations led to strong immune memory and shifted tumors from a “cold” to a “hot” immunological state after just a single IV dose.

Jeffrey Meckler, Indaptus Therapeutics Chief Executive Officer, commented, “We continue to progress our Decoy platform in the clinic to better understand this potential breakthrough therapy in combination with BeOne’s tislelizumab.

“On the financial front, we raised approximately $5.7 million in gross proceeds through the sale of convertible promissory notes and accompanying warrants. In July 2025, the notes were converted into common stock and pre-funded warrants, which strengthens our balance sheet. We remain focused on disciplined execution and look forward to sharing initial combination trial data later this year,” added Mr. Meckler.

Beyond oncology, the Decoy platform has demonstrated antiviral potential, producing meaningful activity against chronic hepatitis B and HIV in preclinical models. The approach also avoided sustained cytokine release syndrome biomarkers in animal studies, suggesting a favorable safety profile. With its antigen-agnostic design and ability to activate multiple immune pathways, Indaptus positions its Decoy candidates as a broad platform technology with promise across cancer and infectious disease indications.