Phase II Study Launched for MRD+ Head and Neck Cancer

Naveris, a company at the forefront of precision oncology diagnostics for cancers caused by viruses, has initiated a Phase II clinical trial focusing on HPV16-positive head and neck squamous cell carcinoma (HNSCC). The trial is being conducted under the leadership of Memorial Sloan Kettering Cancer Center (MSKCC), a renowned institution in the field of cancer research and treatment.

The central aim of this multicenter, randomized trial is to assess the effectiveness of HB-200, a new therapeutic intervention, for individuals with HPV16+ HNSCC who have experienced a molecular relapse. Molecular relapse is characterized by the detection of circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA, even in the absence of clinical or radiographic signs of disease recurrence post-treatment. This marks the first trial to target minimal residual disease (MRD) in this specific patient group.

For patient enrollment, the study will employ NavDx®, Naveris’s proprietary blood test that detects TTMV-HPV DNA, which is instrumental in identifying disease recurrence or relapse in HPV-driven head and neck cancer. Eligible participants are those with detectable TTMV-HPV DNA three months post-treatment, and the NavDx test will be administered at various stages of the trial.

Dr. Alan L. Ho, a leading head and neck oncologist and cellular therapist at Memorial Sloan Kettering, who is spearheading the study, emphasized the significance of this intervention and the role of NavDx in identifying MRD in these patients. He stated that the study's results would offer valuable insights into the early treatment of molecular relapse.

NavDx stands out as the first clinically validated blood test that detects circulating tumor HPV DNA, providing a non-invasive and accurate means of identifying cancer recurrence before clinical or radiographic evidence emerges.

Barry M. Berger, Naveris’s Chief Medical Officer, expressed enthusiasm for the Phase II trial, highlighting its innovative approach to viral-driven cancer surveillance. He noted the trial's potential to shape future treatment strategies by enabling earlier intervention through the detection of TTMV-HPV DNA.

Naveris is a Massachusetts and North Carolina-based company focused on developing molecular diagnostics for early cancer detection, particularly for those at risk of viral-induced cancers. The company operates accredited clinical laboratories and is committed to enhancing outcomes for individuals affected by such diseases.