INOVIQ's CAR-NK Exosomes Demonstrate 61.5% Tumor Reduction in Triple-Negative Breast Cancer Study
核心洞察
INOVIQ (搜索)'s EGFR (搜索)-targeted CAR-NK exosomes (搜索) achieved 61.5% tumor burden reduction in a triple-negative breast cancer (搜索) mouse model, significantly outperforming unmodified NK-EVs at 24.5% reduction.
All mice treated with CAR-NK-EVs (搜索) survived the 28-day study period with 100% survival rate, compared to 83.3% for unmodified NK-EVs and 66.7% for vehicle controls.
The therapy demonstrated excellent safety profile with stable body weight, no adverse effects, and superior tumor targeting specificity with reduced liver accumulation.
INOVIQ (搜索) Limited has reported positive in vivo proof-of-concept data demonstrating the therapeutic potential of its proprietary Epidermal Growth Factor Receptor (搜索) (EGFR (搜索))-targeted chimeric antigen receptor (CAR)-Natural Killer (NK)-extracellular vesicles in a triple-negative breast cancer (搜索) mouse model. The results validate INOVIQ's EXO-ACE manufacturing platform for large-scale production of therapeutic EVs as next-generation, off-the-shelf, cell-free therapeutics for hard-to-treat solid tumors (搜索).
Significant Tumor Reduction and Survival Benefits
The in vivo study, conducted by accredited CRO GemPharmatech Co Ltd (搜索), evaluated the efficacy, safety and biodistribution of INOVIQ (搜索)'s CAR-NK-EV candidate compared with unmodified NK-EVs and vehicle controls, with six mice per group. Bioluminescence imaging over 28 days showed that CAR-NK-EVs (搜索) achieved excellent antitumor efficacy, reducing tumor burden by 61.5% compared to 24.5% for unmodified NK-EVs (p < 0.05).
The survival data proved equally compelling, with all mice treated with CAR-NK-EVs (搜索) surviving the 28-day study period (100%), versus 83.3% for unmodified NK-EVs and 66.7% for vehicle controls.
Superior Safety and Targeting Profile
CAR-NK-EV treatment was well tolerated, with stable body weight and no observable adverse effects, supporting a favorable preliminary safety profile for repeat dosing. Biodistribution analysis revealed significantly reduced non-specific liver accumulation of CAR-NK-EVs (搜索) compared to unmodified NK-EVs (p < 0.05), confirming superior tumor targeting specificity.
"This study provides robust proof-of-concept evidence supporting the therapeutic potential of our CAR-NK-EVs (搜索) for precise targeting of EGFR (搜索)-positive triple-negative breast cancer (搜索)," commented INOVIQ (搜索) CSO Professor Greg Rice. "Building on these findings, we will progress further preclinical work evaluating therapeutic dose, safety and manufacturing. These efforts are critical for clinical translation of our CAR-EV platform and advancing the field of exosome-based immunotherapy."
Rapid Cell Killing Demonstrated in Vitro
Earlier preclinical results validated at the Peter MacCallum Cancer Centre (搜索) demonstrated that INOVIQ (搜索)'s CAR-NK-exosomes eliminated more than 90% of TNBC (搜索) cells within just 10 hours of treatment. In comparison, untreated cells and those exposed to non-CAR-NK exosomes (搜索) showed minimal tumor cell death.
Professor Phillip Darcy, Co-leader of the Cancer Immunology Program at Peter Mac and a member of INOVIQ (搜索)'s Medical and Scientific Advisory Board, highlighted the therapeutic potential: "CAR-exosomes represent a next-generation, cell-free therapeutic with potential safety and efficacy advantages over autologous cell therapies for the treatment of solid tumors (搜索)."
Clinical Development Timeline and Platform Advantages
INOVIQ (搜索) CEO Dr Leearne Hinch outlined the company's development strategy: "These results validate our CAR-EV platform and demonstrate its potential to target and destroy solid tumors (搜索). The combination of potent anti-tumor activity, excellent safety, precision targeting and scalability positions our CAR-EV platform as a next-generation, off-the-shelf, cell-free therapeutic approach. We are accelerating preclinical and manufacturing development with additional data readouts expected in 2026, supporting our path toward first in human studies in 2028."
The company is positioning its CAR-NK-exosome platform as a safer, more scalable alternative to autologous CAR-T therapies, which can be limited by toxicity, manufacturing complexity, and reduced effectiveness in solid tumors (搜索). By contrast, exosome-based therapies could offer improved tumor penetration, reduced side effects, and broader accessibility.
Intellectual Property Protection
INOVIQ (搜索) has filed a new provisional patent application covering innovations in precision CAR-targeting and EV purification, further strengthening the company's intellectual property portfolio and protecting its core CAR-EV technology. The technology builds on peer-reviewed data published in the Journal of Visualized Experiments, showcasing proof-of-concept results demonstrating that INOVIQ's engineered CAR-T exosomes (搜索) can kill breast and blood cancer (搜索) cells in vitro.