Health Canada Approves Expansion of Decoy20 Cancer Immunotherapy Trial
Key Insights
Indaptus Therapeutics receives Clinical Trial Authorization from Health Canada to expand its ongoing U.S. clinical trial INDP-D101 (search) for its lead cancer immunotherapy candidate Decoy20.
The company plans to submit an amendment for a combination trial pairing Decoy20 with Beigene (search)'s PD-1 checkpoint inhibitor tislelizumab, broadening the therapeutic approach.
Decoy20's unique mechanism activates both innate and adaptive immune responses through multiple pathways, showing promise in pre-clinical studies against various solid tumors.
Indaptus Therapeutics (Nasdaq: INDP) has secured approval from Health Canada to expand its clinical trial program for Decoy20, marking a significant advancement in its cancer immunotherapy development efforts. The Clinical Trial Authorization will enable the biotechnology company to extend its ongoing U.S. trial, INDP-D101 (search), into Canadian research sites.
The expansion maintains the current protocol of weekly Decoy20 dosing while broadening the patient recruitment base. This development comes as Indaptus prepares to explore combination therapy, planning an amendment to include studies pairing Decoy20 with tislelizumab, Beigene (search)'s PD-1 checkpoint inhibitor.
Novel Immune System Activation Approach
Decoy20 represents an innovative approach to cancer immunotherapy, utilizing attenuated and killed, non-pathogenic Gram-negative bacteria. The treatment is designed to activate multiple immune pathways simultaneously through Toll-like receptor (TLR), NOD-like receptor (NLR), and Stimulator of interferon genes (STING) agonist mechanisms.
"The addition of Canadian trial sites should allow us to accelerate the collection of valuable clinical data more efficiently, and from a broader, more diverse population," stated Roger Waltzman, Chief Medical Officer. "This expansion is critical as we continue to evaluate Decoy20's unique ability to activate both the innate and adaptive immune systems."
Promising Pre-clinical Results
Pre-clinical studies have demonstrated Decoy20's potential across multiple cancer types. The therapy has shown significant activity against:
- Metastatic pancreatic carcinomas
- Orthotopic colorectal carcinomas
- Established breast carcinomas
- Hepatocellular carcinomas
- Non-Hodgkin's lymphomas
Notably, when combined with other treatments such as anti-PD-1 checkpoint therapy, low-dose chemotherapy, or targeted antibodies, Decoy20 demonstrated enhanced efficacy in pre-clinical models.
Safety Profile and Administration
The intravenous administration of Decoy20 has shown a favorable safety profile in IND-enabling studies, with no sustained induction of cytokine release syndrome (search) biomarkers. This characteristic is attributed to the therapy's passive targeting to liver, spleen, and tumor tissues, followed by rapid elimination.
"Health Canada's approval followed a comprehensive review of our safety data and trial design," noted Jeffrey Meckler, CEO of Indaptus. "Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors."
Future Directions
The expansion into Canadian research sites is expected to accelerate data collection and provide insights into Decoy20's therapeutic potential. The company aims to optimize dosing regimens and improve treatment outcomes for patients with difficult-to-treat cancers through this broader clinical program.