Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer

Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer. The study will be led by Memorial Sloan Kettering Cancer Center (MSKCC), a top cancer treatment and research institution.

The primary objective of this multicenter randomized study is to evaluate the efficacy of HB-200, a novel intervention, for patients with HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse, defined as the presence of circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA without clinical or radiographic evidence of recurrence following definitive treatment. This will be the first MRD-treatment trial for this patient population.

NavDx®, Naveris' proprietary flagship blood test that detects TTMV-HPV DNA to diagnose disease recurrence or relapse in HPV-driven head and neck cancer, will be utilized to enroll patients to the trial, with requirements including detectable TTMV-HPV DNA by the NavDx assay three or more months after a patient received treatment for HPV16+ HNSCC. The NavDx test will be performed prior to, during, and following treatment.

"This study will propose a novel intervention for patients with MRD+ HPV-driven head and neck cancer and will assess the ability of NavDx to identify MRD in these patients," said Alan L. Ho, MD, PhD, Head and Neck Oncologist and Cellular Therapist, Memorial Sloan Kettering, and the primary principal investigator for the study. "The findings from this study will provide critical insights into the utility of treating patients identified at the early stage of molecular relapse."

NavDx is the first and only clinically validated circulating tumor HPV DNA blood test that provides a non-invasive and precise method for detecting disease recurrence or relapse in HPV-driven head and neck cancer before there is clinical or radiographic evidence of cancer recurrence.

"We are excited to announce the beginning of Phase II of our landmark trial, which marks the next step in our mission to bring innovative resources to viral-driven cancer surveillance," said Barry M. Berger, Chief Medical Officer of Naveris. "This trial is the first of its kind for this patient population and provides a promising look into the future of treatment paths, with NavDx being used to identify TTMV-HPV DNA and allowing for action earlier than ever before. We are grateful to the research team at Memorial Sloan Kettering Cancer Center for their collaboration and we look forward to presenting the results of this study when they are complete."

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Naveris is dedicated to improving outcomes for the millions of people at risk of developing viral-induced cancers by developing novel molecular diagnostics that enable earlier cancer detection. The company operates high-complexity testing clinical laboratories that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center, and are certified under CLIA. For more information on Naveris and the clinical impact of NavDx, please visit www.naveris.com and www.NavDx.com. NavDx has not been cleared or approved by the US Food and Drug Administration (FDA).