NEW YORK – Cofactor Genomics said Tuesday that it has commenced the first multicenter clinical trial of its OncoPrism immunotherapy response prediction assay, an RNA-based test developed using the company's proprietary immune modeling technology.
Fifteen hospitals and healthcare networks including Mayo Clinic, MultiCare Institute for Research and Innovation, and Revive Research Institute, are currently enrolling patients in the PREDAPT (Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies) Trial, which is evaluating the use of OncoPrism, initially in patients with recurrent and metastatic head and neck cancers.
Curebase is participating as a CRO partner, providing trial support for the decentralized study, including a platform that allows individual investigators the ability to participate in the clinical trial even if their hospital is unable to participate as a traditional clinical site.
PREDAPT builds on preliminary retrospective results Cofactor has collected showing that its predictive immune modeling offers better discrimination of immunotherapy responders from non-responders than on-label PD-L1 immunohistochemistry (IHC) assays.
Cofactor will analyze specimens collected by the various study sites at its CAP/CLIA-accredited laboratory. According to Cofactor, participants will not be mandated to receive any additional visits or surgery outside of standard care based on their test results.
The company expects additional sites to join the trial before the end of 2021 and intends to expand to a broader patient population with trial protocols already in place for recruitment of patients with 10 additional tumor types.
"Physicians do not currently have adequate information to predict tumor response to immune checkpoint inhibitors, resulting in ineffective and inconsistent treatment. This is ultimately a heavy burden on both patients and the healthcare system that supports them; we intend to change that," Cofactor Chief Operating Officer David Messina said in a statement.
He added that the trial is the first of many that Cofactor intends to sponsor.