Biomarker Translational Approach

IDEAYA is employing a translational platform based on cutting-edge technologies for discovery, validation and clinical development of biomarkers in parallel with novel therapeutics. Biomarker-enabled translational approaches help enhance patient outcomes by identifying patients likely to respond to particular therapies and by providing clinical insights based on extent of target modulation.

A biomarker is a biological molecule found in tissue or bodily fluid that indicates a normal or abnormal process, or a condition or disease. Biomarkers can be DNA, RNA, protein, or metabolites, and examples include the presence of a genetic mutation and abnormal protein levels, among many others.

Diagnostic biomarkers include predictive, prognostic and resistance biomarkers. For a particular cancer indication, or potentially pan-indication, predictive biomarkers help select for patients most likely to benefit from a drug. Prognostic biomarkers provide information about a patient’s overall outcome, independent of a particular therapy. Resistance biomarkers enable clinical decisions for potential combinations and/ or next-line therapies.

Pharmacodynamic biomarkers are used both in pre-treatment and post-treatment testing to confirm and understand the extent of target modulation. In addition to providing biological proof-of-activity, such information can inform clinical decision making – e.g., dosing amounts and/or schedules.

Companion diagnostics (CDx) are diagnostic products intended for launch with a therapeutic drug. CDx products help support clinical decision-making as a diagnostic or pharmacodynamic biomarkers.

IDEAYA’s translational platform includes in-house capabilities coupled with strategic networks and partnerships for discovery, validation and clinical development of biomarkers. IDEAYA is applying its biomarker-enabled translational platform across several mechanistic approaches based on cancer biology, including targeted therapies that directly target tumor genomic susceptibilities and breakthrough synthetic lethality medicines for genetically defined patient populations.