RadiGene

T-cell therapies offer groundbreaking treatments for cancer and genetic diseases but face low success rates (10-30%) due to challenges in targeting, persistence, and off-target effects. Current methods like tumor PET scans and blood analysis fail to predict response or assess safety adequately. With ~300 novel CAR-T trials enrolling 20,000 patients annually, tools that support early safety and efficacy assessment are crucial to mitigate development risks.

Radigene’s patented imaging platform uses a universal gene tag and a radioactive tracer to track engineered T cells non-invasively. This technology provides real-time insights into therapy biodistribution, detects on-target off-tumor related toxicities and predicts patient responses in trials, reducing failure rates and improving clinical decision-making.

The platform integrates a surface-exposed gene tag and a high-affinity peptide tracer for precise PET imaging. Preclinical studies confirm high specificity, minimal non-specific uptake, rapid tracer clearance, and unaltered CAR-T cell efficacy. The small gene size (0.78 Kb) enables seamless integration with lentiviral vectors, CRISPR/Cas based knock-in, and mRNA expression systems.

Radigene excels in specificity, quantification, and scalability compared to competitors. Compatible with GMP standards and existing workflows, it targets integration into phase 0/1 trials and future T-cell therapies.