PROphet^® is a plasma-based proteomic pattern recognition system that predicts patient outcomes and assists in clinical drug development. It analyzes 7,000 proteins using aptamer-based assays and combines data collection with AI/ML models for patient selection, OS (overall survival)/PFS (progression-free survival) prediction, MoA (Mechanisms of Action) discovery, AE (adverse events) prediction, and response prediction. It is applicable in oncology, autoimmune diseases, inflammation, and inflammatory bowel disease.

Poly-proteomic modeling is a unique AI/ML approach that reduces the noise of real-world clinical data. It is reproducible across medical conditions, treatments, and plasma-protein detection platforms. It provides high reproducibility, response prediction, and overall survival (OS) prediction compared to single biomarker methods.

PROPHETIC (NCT04056247) is a global, multicenter trial with over 1,700 lung cancer patients and 250 melanoma patients recruited to date. The biorepository/database includes associated proteomic profiling and meta-clinical data.

The IcAR test and the PROphet^® irAE test.

The IcAR (Immuno-checkpoint Artificial Reporter) test measures the functionality of any immuno- modulator targets in medical oncology, allowing physicians to understand which patients will respond best to anti-PD-1 therapies and tailor treatments accordingly, while sparing non-responders from ineffective treatment.

A cell-based artificial reporter, IcAR mimics the interaction between the tumor and T-cell in-vitro, quantifying the functional binding of immune–cell ligands (PD-L1/PD-L2) from FFPE tissue. IcAR is a tissue-based test intended to measure the functionality of PD-L1 in the tumor and TME (tumor microenvironment).

IcAR boasts accuracy, sensitivity, and logistical simplicity, and enables the screening of substantial samples without requiring additional biopsies or biological material.

The PROphet-irAE^™ (immune-related adverse events) test predicts risk probability for developing severe immune-related adverse events and provides early prediction of irAEs. This may allow for a preferred treatment plan with reduced toxicity and helps in deciphering the biology associated with significant adverse events.

Existing capabilities and additional platforms currently under development may be relevant for such collaborative efforts:

PROphet^®/irAE Tests:

• Co-development of predictive biomarkers for specific medical conditions/treatments

IcAR Test:

• Co-development of the test for multiple checkpoint inhibitors
• Licensing of the IcAR test for specific IO treatments

Plasma liquid biopsy is non-invasive, not limited by tumor location, enables longitudinal sample collection, does not need to retain cell viability, and provides systemic data/insights.

Only 200 μL of plasma.

For new indications/treatments, a training set of at least 100 samples is required.

Shlomi Madar, Ph.D., VP Strategic Alliances: shlomim@oncohost.com