Thursday, January 28, 2021
OmniSeq®, an innovator in next generation sequencing in oncology, today announced its collaboration with the University of Pittsburgh Medical Center (UPMC) to employ its RNA sequencing (RNA-seq) gene expression profile assay for selecting immunotherapy combinations for patients in a Phase II clinical trial for patients with Recurrent/Metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The primary objective is to better select novel immunotherapeutic combinations by taking a more personalized approach to improve response rates and to further develop better predictive biomarkers of efficacy.
Currently, there is a large need for better therapeutics for patients with HNSCC and other solid tumors after failure of response to anti-PD-1 mAb immunotherapy. This Phase II trial will investigate personalized immunotherapy in R/M HNSCC, by evaluating a patient's tumor microenvironment via immune gene expression by RNA-seq to select the agent (Ipilimumab or Relatlimab) to add to Nivolumab in patients with R/M HNSCC patients that have failed prior immunotherapy.
"We are excited for this collaboration and to be able to offer the gene expression profile technology to R/M HNSCC patients who have failed prior immunotherapy," said Dr. Dan Zandberg, principal investigator and medical oncology co-leader of the Head & Neck Program at UPMC Hillman Cancer Center. "This trial represents an important first step towards taking a personalized approach to each patient to determine the best combination immunotherapy regimen to use."
The primary objective to be determined through the Phase II trial is the probability of response to treatment when combination immunotherapy treatment is selected based on immune gene expression in R/M HNSCC patients who have progressed on prior anti-PD-1 mAb immunotherapy.
"OmniSeq is pleased that our RNA-seq gene expression assay will be leveraged in Dr. Zandberg's Phase II trial for patient stratification," said Jeffrey Conroy, OmniSeq's Chief Scientific Officer. "Our RNA-seq platform allows data-driven matching of HNSCC patients to the appropriate investigational combination therapy based on the immunological tumor landscape."
Patients who meet eligibility criteria will have tumor tissue obtained and analysis will include OmniSeq's immune gene expression to determine which drug (either Relatlimab or Ipilimumab) will be combined with Nivolumab for treatment.
OmniSeq utilizes a comprehensive immune profiling assay that provides for simultaneous measurement of known and novel immune biomarkers (proteins, RNA, DNA) in solid tumor tissue specimens to support correlative studies, drug development and combination immunotherapy clinical trials. OmniSeq's gene expression profile is a component of its OmniSeq Advance® assay, a genomic and immune profiling assay, approved for clinical use by New York State Clinical Laboratory Evaluation Program (NYS CLEP). OmniSeq, Inc. is licensed by CLIA, CAP and the NYS CLEP to perform high-complexity molecular diagnostic testing.
More information about this trial (NCT04326257) is available at www.clinicaltrials.gov.