Naveris Announces New Data at EUROGIN International Multidisciplinary HPV Congress 2024

Data presented showcases clinical utility of NavDx for patients with HPV-driven anal cancer

WALTHAM, Mass.–(BUSINESS WIRE)–Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16.

NavDx is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer. The test provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease. Data supporting the clinical validity and utility of NavDx have been published in nearly 20 peer-reviewed publications, leading to recent positive Medicare and commercial insurance coverage policies.

“We are glad to be presenting our latest findings at EUROGIN, including the first study highlighting the utility of NavDx in the surveillance of patients, post-treatment, for recurrent anal cancer,” said Barry M. Berger, MD, Chief Medical Officer at Naveris. “The research we and our partners have the opportunity to share at this conference showcases the clinical significance of the NavDx test in the detection and surveillance of multiple types of HPV-driven cancers, building on the body of evidence supporting its use at every stage of these viral driven cancers.”

“Our study marks a significant advancement in the surveillance of anal squamous cell carcinoma, demonstrating that circulating TTMV-HPV DNA significantly enhances early detection of recurrence, giving patients battling HPV-driven cancers a chance for better outcomes,” said Shane Lloyd, MD, Associate Professor of Radiation Oncology at University of Utah School of Medicine and Huntsman Cancer Institute, and the presenting author for the study. “This precision medicine approach, leveraging advanced molecular diagnostics, could enable more prompt and individualized treatments.”

Following are oral presentations from Naveris and its partners at EUROGIN 2024 showcasing the clinical utility of NavDx for patients with HPV-driven anal cancer:

• FC 07-9: Detection of patients with recurrent HPV-driven anal cancer using circulating tumor HPV DNA

Presenting Author: Shane Lloyd, MD; University of Utah School of Medicine and Huntsman Cancer Institute

Session, Date/Time: Anus – Free Communications | March 13, 2024 | 1:45PM – 3:25PM CET

Results were presented from the first multi-institutional analysis of the NavDx test ordered during routine clinical practice for the post-treatment surveillance of patients with HPV-driven anal squamous cell carcinoma (ASCC). The test showed high positive and negative predictive values of 100% and 98.6%, respectively, when ordered through routine clinical use in this cohort of 33 patients, comparable to its use in HPV-driven oropharyngeal cancer. Positive NavDx test results successfully pinpointed patients with recurrences in all cases, highlighting the test’s utility as a potent surveillance tool in daily clinical practice for early detection of recurrence.

• FC 07-12: Circulating tumor tissue modified viral-human papillomavirus DNA (TTMV-HPV DNA) is a biomarker of response to pembrolizumab in anal cancer

Presenting Author: Brandon Huffman, MD; Dana-Farber Cancer Institute at Harvard Medical School

Session, Date/Time: Anus – Free Communications| March 13, 2024 | 1:45PM – 3:25PM CET

Results were presented from a phase II clinical trial involving 32 patients with advanced anal cancer treated with pembrolizumab. This study explored NavDx as a potential biomarker for monitoring disease response. Initial findings indicate baseline sensitivity and specificity of 95% and 100%, respectively. The study additionally found that pre-treatment NavDx levels were indicative of tumor burden in the recurrent and metastatic setting and that changes in these levels were significantly associated with clinical outcomes. Together this highlights the utility of NavDx as a dynamic tool for early assessment of therapeutic response.

Additional updates will be presented as part of the EUROGIN 2024 HPV and Head & Neck Cancer Forum:

• HN05-2: DART 2.0 (Mayo)

Presenting Author: Daniel Ma, MD; Mayo Clinic

Session, Date/Time: HN – HPV and Head & Neck Forum, Management | March 15, 2024 | 10:00AM – 11:30AM CET

Details of the trial design from the ongoing DART 2.0 trial will be shared (NCT05541016). The DART 2.0 trial evaluates the ability of NavDx to improve treatment intensity selection in patients with HPV-driven head and neck cancer to best balance the side effects of treatment with decreasing cancer recurrence. DART 2.0 builds upon the results of the previously reported phase III MC1675 DART clinical trial, where post-treatment detectability of NavDx was a significant risk factor for cancer recurrence in patients with head and neck cancer.

• HN 07-3: TTMV-HPV DNA for surveillance in the clinic

Presenting Author: Eleni Rettig, MD, FACS; Brigham and Women’s Hospital and Dana-Farber Cancer Institute at Harvard Medical School

Session, Date/Time: HN – HPV and Head & Neck Forum, Molecular Diagnosis and Surveillance |

March 15, 2024 | 2:30PM – 4:00PM CET

Early insights will be shared from the first prospective cohort study examining biomarker-led monitoring for early detection of recurrent HPV-positive oropharyngeal cancer (OPC) (NCT04965792). The study involved 150 patients, with NavDx tested pre-treatment and every three months post-treatment and patients followed for five years.

About Naveris

Naveris is a privately held, commercial stage, precision oncology diagnostics company with facilities in Massachusetts and North Carolina. Since its founding in 2017, Naveris has been committed to improving outcomes for the millions of people at risk of developing viral-induced cancers with 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).

Contacts

Megan Kernan

ICR Westwicke Healthcare PR

Tel: 646.677.1870

[email protected]