From the public pipeline, it appears that the interest is in vascular anomalies
Hence the biomarker plan would be the following:
- PD Biomarker and longitudinal disease measurements: Create a sensitive ctDNA/ddPCR assay for mutant PIK3CA detection
- Target engagement panel for PI3K pathway inhibition: pAKT, pS6, insulin/glucose signaling markers, and inflammatory mediators in blood.
- Link PK and biomarker data: drug exposure, pathway suppression, and clinical improvement
- Imaging studies: Link biomarker changes to MRI-based lesion volume reduction or other objective measures
- Develop functional clinical biomarkers: Evaluate pain scores, bleeding events, swelling, mobility, and quality-of-life measures (PRO) to identify clinical indicators of treatment benefit.
- Explorations :a) Establish a longitudinal bio-repository b) Identify biomarkers associated with responders c) Confirm PIK3CA mutation subtype (H1047R, E542K, E545K, etc.) to determine whether mutation burden = disease severity or treatment response. d) Characterize enrolled patients from other studies
- ETC: Learn the current status of Translational medicine ( assays, biomarkers, sample collected etc) Personnel management, Operational (vendor contracts, negotiation) and plan for future
The website is : https://relaytx.com
