Immunovia (IMMNOV) Study Update summary

Study background and unmet need

• Pancreatic cancer is highly lethal with a 13% five-year survival rate, and only 1 in 5 are diagnosed early when surgery is an option.

• Early detection significantly improves survival, but current tools are inadequate for routine screening in average-risk populations and rely on imaging with mixed performance for early-stage disease.

• Surveillance is recommended for high-risk individuals, such as those with strong family history or genetic predisposition.

Current standard of care and limitations

• Imaging techniques like endoscopic ultrasound and MRI are standard but have limitations in sensitivity, specificity, cost, and patient burden.

• Endoscopic ultrasound is highly sensitive but only 80% specific, leading to false positives and patient anxiety.

• MRI has lower sensitivity (~50%) for early-stage cancer and is challenging for some patients.

Test development and validation process

• Discovery identified 41 proteins for early-stage pancreatic cancer detection, narrowed to five biomarkers for the final test.

• Analytical validation confirmed precise, accurate, and robust measurement of protein biomarkers, with average assay precision of 7.5%.

• Clinical validation (CLARITI study) was the largest of its kind, using 1,066 samples from high-risk populations, including 202 stage 1 & 2 cancer cases and 864 high-risk controls.