GeneCentric Therapeutics has entered the second phase of a diagnostic development collaboration with Jose Zevallos M.D., M.P.H., Chief of the Division of Head and Neck Oncologic Surgery in the Department of Otolaryngology at Washington University School of Medicine in St. Louis. The partnership is designed to develop a tumor subtyping, four-class molecular diagnostic test for patients with HPV-negative head and neck squamous cell carcinoma (HNSCC; pictured). [Sikora via Baylor College of Medicine]

GeneCentric Therapeutics said today it has entered the second phase of a diagnostic development collaboration with Jose Zevallos M.D., M.P.H., Chief of the Division of Head and Neck Oncologic Surgery in the Department of Otolaryngology at Washington University School of Medicine in St. Louis.

The partnership is designed to develop a tumor subtyping, four-class molecular diagnostic test for patients with HPV-negative head and neck squamous cell carcinoma (HNSCC), with the goal of guiding treatment decisions.

Following successful completion of Phase I development of a reduced gene-set signature, GeneCentric said it was poised to launch Phase II validation studies with Zevallos and his team. The last stage of the NCI grant, Phase III, will entail final confirmation of the HNSCC diagnostic test and commercialization.

“This research has the potential to impact treatment for a broad range of patients with head and neck cancer,” Zevallos said in a statement. “Our aim is to better identify cancers that are resistant to radiation therapy. We also hope the test will more accurately identify patients with occult lymph node metastasis and help surgeons make more informed decisions on when surgery to remove neck tumors should be offered to patients.”

The HPV-negative subtyper being developed is a modified version of GeneCentric’s Head and Neck Cancer Subtype Profiler (HNSP).

HNSP consists of five distinct subtypes, including one specific to HPV-related HNSCC, as determined through the company’s research. HNSP is based on GeneCentric’s Cancer Subtyping Platform (CSP), through which the company is working to develop universal drug response biomarkers intended to enable more effective and efficient drug development informed by high resolution, genomic-defined cancer subtypes.

According to GeneCentric, CSP-derived genomic profiles are designed to characterize tumor biology by combining gene expression data with disease-related molecular pathways and immune cell expression through advanced computational biology technologies. CSP leverages publicly-available gene expression datasets complemented by proprietary data and tools to develop discrete sets of key genes that define cancer subtypes.

The collaboration is funded by an R01 grant (1R01CA211939-01A1) of $615,138 awarded to Zevallos in August 2017 by the NIH’s National Cancer Institute. Zevallos has since been awarded $393,202 in FY 2018, and $376,150 in FY 2019 toward the research, titled “Development of a Four-Class, Molecular Subtyping Diagnostic for HPV-negative Head and Neck Cancer.”

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