The inherent heterogeneity in patient populations can often lead to variable drug response. We recently worked with a client who came to us after their Phase III clinical trial for a rare disease indication, consisting of several hundred participants, failed to reach its primary endpoint. We asked, can we identify a biomarker that indicates patients within the population that did in fact benefit from the therapeutic intervention?
In this case study, we share how Sapient used its rLC-MS technologies to assay tens of thousands of small molecule factors in the clinical trial samples to discover specific biomarkers in circulation that robustly change following exposure to therapy.
Watch the video to learn how a single pharmacodynamic (PD) biomarker was found to associate with significantly higher survival rates, and may be used to rescue the trial by stratifying the patient population into responders vs. non-responders.
Discovery of a PD Biomarker to Predict Drug Response
The inherent heterogeneity in patient populations can often lead to variable drug response. We recently worked with a client who came to us after their Phase III clinical trial for a rare disease indication, consisting of several hundred participants, failed to reach its primary endpoint. We asked, can we identify… Read More
Discovery of PD-1 Pathway Biomarkers of Target Engagement
The PD-1 pathway has transformed the development of immunotherapies as a means to reawaken the immune system to target cancer cells. Clinically, however, there is a great deal of heterogeneity in the response to PD-1 based therapeutics across cancer patients, irrespective of the underlying tumor. There… Read More
Discovery of an Early Diagnostic Biomarker for NASH
The incidence and prevalence of nonalcoholic fatty liver disease (NAFLD) continue to rise worldwide, estimated to affect over one-quarter of the global adult population today. A portion of NAFLD patients will progress to develop nonalcoholic steatohepatitis (NASH), which can cause liver inflammation and cirrhosis, but the… Read More
Discovery of Biomarker to Predict Immunotherapy Related Autoimmunity
Immunotherapy has transformed the treatment of solid organ cancers, rapidly becoming a first line therapy with transformative durable response. While immunotherapies have favorable toxicity profiles compared to traditional chemotherapies, immunotherapy is associated with the development of immune-related adverse events (irAEs), an autoimmune condition incited by activation of the immune system. Read More
