TEST:

NavDx®

P2, N=90, Recruiting, University of Virginia | Not yet recruiting --> Recruiting

"Naveris, Inc...announced that Blue Shield of California, an independent licensee of the Blue Cross Blue Shield Association, provides coverage as of July 1, 2024 for the NavDx® test, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA."

"Naveris, Inc...announced the presentation of new data at the 66th Annual Meeting of the American Society for Radiation Oncology (ASTRO), taking place September 29 – October 2, 2024, in Washington, D.C...These presentations will showcase the role of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test, in the management of HPV-driven oropharyngeal cancers, with a focus on integration into radiation oncology practices."

The primary objective is to assess the disease-free survival (DFS) for pts enrolled in the study receiving either HB-200 or placebo. The secondary objectives include overall survival, and safety.

P2; N=75 --> 145

"Naveris, Inc...announces the publication of a significant study, 'Utility of TTMV-HPV DNA in resolving indeterminate findings during oropharyngeal cancer surveillance', in Oral Oncology. The study highlights the crucial role of Naveris' flagship product, the NavDx test, in enhancing diagnostic precision and clinical decision-making in surveillance of HPV-associated oropharyngeal cancer. The NavDx test is the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test."

ctHPVDNA as a molecular surveillance tool reduced distress levels in HPV(+) OPC patients, with notably high patient confidence in the approach. Further investigation is warranted to judiciously incorporate this emerging modality in surveillance guidelines.

"Naveris, Inc...announced new data to be presented at The American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from May 31 – June 2, 2024. These presentations underscore Naveris’ continued innovation with the NavDx test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test aiding in the detection and management of HPV-driven cancers."

To our knowledge, this is the largest case series to date investigating TTMV HPV DNA in OPSCC patients with CUP. Our results suggest TTMV HPV DNA may be helpful in refining treatment algorithms for patients with CUP.

Naveris and collaborators have together successfully launched the NAVigate-HPV registry with the aim of creating a robust database linking tumor biomarker results from NavDx with clinical outcomes data for HPV-related cancers. The NAVigate-HPV database is expected to encompass more than 1,000 patients within 1 year and grow to > 5,000 patients within 5 years, serving as a powerful tool for precision cancer medicine in this patient cancer population. Establishing this registry will deepen insights into HPV-related cancers and advance diagnostic and therapeutic approaches to improve patient outcomes.

"Naveris, Inc...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."

"Naveris, Inc...announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for NavDx, the Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test that aids in the detection of HPV-driven cancer."

"Naveris, Inc...announced new data at EUROGIN International Multidisciplinary HPV Congress 2024, taking place in Stockholm on March 13-16...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."

At our institution, we are now routinely performing the ct-DNA assay for surveillance of treated HPV-oropharyngeal SCCa. Correlation between clinical, radiological, and biomarker findings are now part of routine discussions during the multidisciplinary tumor boards.ABBREVIATIONS: ct-DNA=circulating tumor deoxyribonucleic acid; HPV=Human Papilloma virus;OPC=Oropharyngeal SCCa=Squamous cell carcinomas; PCR= Polymerase chain reaction.

"Naveris, Inc...announced the launch of the NAVigate-HPV Registry. This innovative initiative will refine and expand the applications of the NavDx® test, the first and only clinically validated circulating Tumor Tissue Modified Viral (TTMV®)-HPV DNA blood test."

"Naveris, Inc...announced new data to be presented at The American Society for Radiation Oncology (ASTRO) Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Phoenix, AZ from February 29 – March 2, 2024....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."

"Naveris, Inc...today announced that Highmark Inc. (Highmark), an independent licensee of the Blue Cross Blue Shield Association, now offers coverage for NavDx, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV)-HPV DNA...NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. It provides a non-invasive and precise method for identifying HPV-driven cancers before there is clinical or radiographical evidence of disease....'Receiving coverage from a payor that serves millions of patients is a meaningful step forward as we work to further expand access to NavDx.'"

Our pilot study approach of using HPV ctDNA based selection of patients for post-operative active surveillance resulted in a high rate of gross disease recurrence and failed to meet our primary endpoint. Radiographic recurrence was not preceded by detectable TTMV-HPV DNA during 3 mo interval surveillance, and additional clinical factors are needed to select patients for active surveillance and initiation of delayed adjuvant therapy prior to recurrence.

This study demonstrates that circulating tumor-specific HPV DNA is a sensitive and specific marker for the detection of cervical cancer, with scores dynamically corresponding to treatment response. This biomarker has the potential to serve an unmet need in the management of these cancers. The current study is ongoing with additional patients enrolling and further HPV subtypes being analyzed.

P2; Initiation date: Sep 2023 --> Jan 2024

"Naveris, Inc...announced that Palmetto GBA, the Medicare Administrative Contractor that administers the Molecular Diagnostics Services program (MolDX®), established Medicare coverage for NavDx®, Naveris’ proprietary flagship blood test for Tumor Tissue Modified Viral (TTMV®)-HPV DNA. NavDx is the first and only clinically validated circulating TTMV-HPV DNA blood test. NavDx provides a non-invasive and precise method for monitoring minimal residual disease (MRD) in HPV-driven cancers before there is clinical or radiographical evidence of recurrence."

P2; N=77 --> 30 | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

"Naveris, Inc...announced the publication of two new peer-review studies in the journals Clinical Cancer Research (CCR) and JAMA Otolaryngology-Head & Neck Surgery (JAMA Head & Neck), which highlight the clinical utility of the company’s tumor tissue modified viral (TTMV®) DNA platform and add to a growing library of data supporting use of the company’s NavDx® blood test."

"Naveris, Inc...announced that the company will be attending The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) 2023 Annual Meeting in Nashville, Tenn., from September 30-October 4 and The American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting in San Diego, Calif., from October 1-4...Naveris will be exhibiting at both meetings, providing the latest information on NavDx®, Naveris’ proprietary flagship blood test for tumor tissue modified viral (TTMV®)-HPV DNA."

P2; N=90; Not yet recruiting; Sponsor:University of Virginia

"In a paper published in JAMA Otolaryngology–Head & Neck Surgery...a team led by researchers at the Icahn School of Medicine at Mount Sinai evaluated the accuracy of the DNA blood test, NavDx, which was developed by Naveris. The test quantifies fragments of circulating tumor tissue-modified viral (TTMV) HPV DNA that is shed into the blood by cancer cells."

"However, the sensitivity was 91.5% for the diagnosis cohort and 88.4% for the surveillance cohort, signifying that nearly 1 in 10 negative tests among patients with HPV-associated OPSCC was a false negative. Additional research is required to validate the assay's performance and, if validated, then further research into the implementation of this assay into standard clinical practice guidelines will be required."

Increased HPV16 signal detection using the CHAMP-16 assay suggests the potential for detection of recurrences significantly earlier than with conventional ddPCR assays in patients with HPV16+ OPSCC. Critically, this multi-probe approach maintains the cost-benefit advantage of ddPCR over next generation sequencing (NGS) approaches, supporting the cost-effectiveness of this assay for both large population screening and routine post-treatment surveillance.

P=N/A; Trial completion date: Mar 2028 --> Mar 2031 | Trial primary completion date: Mar 2028 --> Mar 2031

The commercially available NavDx TTMV-HPV DNA assay demonstrated 100% specificity, and therefore excellent positive predictive value, in both diagnosis and surveillance. However, the sensitivity was lower, 91.5% for the diagnosis cohort and 79.2% for the surveillance cohort, signifying that a negative value may require further work-up. Further studies will be required to determine the optimal timing of testing and how results should inform treatment decisions.

Implementing NavDx for HPV + OPSCC surveillance would benefit patients by reducing costs and unnecessary diagnostic testing.

P=N/A; N=600; Recruiting; Sponsor:Memorial Sloan Kettering Cancer Center

"Naveris, Inc...announced the launch of the DART 2.0 prospective clinical trial (NCT05541016) by Mayo Clinic. The DART 2.0 trial will evaluate the ability of NavDx, Naveris’ flagship blood test for tumor tissue modified viral (TTMV)-HPV DNA, to improve treatment selection in patients with HPV-driven head and neck cancer. NavDx provides a non-invasive and precise method for monitoring molecular residual disease (MRD) and recurrence by analyzing tumor-derived viral DNA in patients' blood samples."

Our findings further support the clinical potential of monitoring circulating TTMV-HPV DNA during post-treatment surveillance. We demonstrate a very high assay NPV correlated with physician-reported outcomes. TTMV-HPV DNA can be used to assist in surveillance and could inform imaging needs and future practice guidelines for HPV-driven head and neck cancer survivors.

Regression analysis revealed a high degree of correlation between expected and effective concentrations, demonstrating excellent linearity (R = 1) across a broad range of analyte concentrations. These results demonstrate that NavDx accurately and reproducibly detects circulating TTMV-HPV DNA, which has been shown to aid in the diagnosis and surveillance of HPV-driven cancers.

P2; Not yet recruiting --> Recruiting

P2; N=45 --> 77

P=N/A; N=100; Recruiting; Sponsor:Northwell Health

"Naveris, Inc...announced that the company and the principle investigator at Mayo Clinic will present its award-winning abstract at the American Society for Radiation Oncology (ASTRO) Annual Meeting held October 23-26, 2022. This presentation describes significant new data supporting the clinical value of NavDx®, the first and only clinically validated circulating tumor-tissue-modified HPV (TTMV®) DNA blood test, as a non-invasive blood test to assess the risk of disease recurrence after treatment in patients with human papilloma virus (HPV)-driven head and neck cancer."

"Naveris, Inc...announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society."

P2; N=320; Not yet recruiting; Sponsor:Mayo Clinic

P2; N=145 --> 75