Patient Stratification and Clinical Testing

Patient Stratification and Clinical Testing for Immunotherapy Programs

Serametrix offers patient stratification and clinical testing for immunotherapy programs to support efficient clinical trials. In developing novel cancer therapeutics, clinical testing on a population that reflects the drug’s potential patients can lead to higher response rates. By understanding the eligible patient population, therapies can become more targeted and personalized while improving safety and effectiveness. Serametrix partners with drug developers by offering CLIA testing that aids in patient stratification, patient selection, and data reporting.

Patient Stratification

Baseline testing to enable allocation of enrolled patients into pre-determined cohorts; this allows end-of-study assessment of drug effects and efficacy in different patient populations.

“Did my drug work better in patients with Immune Profile X versus Y?”

Patient Selection

Pre-screening of patients to check eligibility for enrolment based on specified immune-based eligibility criteria; this allows a study design to test a drug in a biomarker-enriched cohort.
“Can I prove my drug works in a specified subset of cancer patients?”

Exploratory CLIA Data Reporting

Exploratory data secured under CLIA can carry more weight with investors and regulatory authorities and shorten the timeline from Discovery to Clinical Application, for example when reporting results to the FDA.

“Is it ok to use my exploratory biomarker data as a basis for future study design?”

CASE STUDY

Overcoming Resistance to I-O Treatment In MDSC-High Patients

Some patients respond poorly to PD-1 based therapies, likely due to an MDSC-mediated increase in immune suppression. Accordingly, the “MDSC-high” population may be considered a “difficult-to-treat” cohort. In this study, a P13k-gamma inhibitor with putative anti-MDSC activity (IPI-549) is being tested in combination with a PD-1 based treatment (nivolumab). Since this strategy is most suited to patients with elevated MDSC, Serametrix is providing pre-screen CLIA testing to check for the eligibility criterion of MDSC-high. Thresholding for such patient-selective biomarkers depends on available data from previous studies (clinical trials identifier NCT02637531).

To discuss ideas for your study or request a quote, click here.