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Biocept Announces Participation In An Investigator-Initiated Study To Better Understand The Development And Progression Of Metastatic Breast Cancer To The Central Nervous System

Benzinga · 11/16/2022 08:10

Biocept, Inc. (NASDAQ:BIOC), a leading provider of molecular diagnostic assays, products and services, announces a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer.

The study is being conducted by breast oncologists Michelle E. Melisko, M.D. and Laura A. Huppert, M.D. at the University of California, San Francisco (UCSF) under a grant from the California Breast Cancer Research Program and the UCSF Brain Spore. Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions. In addition, Drs. Huppert and Melisko will work with Dr. Chris Im in the laboratory of Dr. Max Krummel at UCSF to examine the immune-cell microenvironment in a companion study, and the results will be analyzed together.

“We hypothesize that patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease will have tumor cells and cell-free tumor DNA (ctDNA) that can be detected in cerebrospinal fluid, and that higher concentrations of cerebrospinal fluid tumor cells and ctDNA will correlate with progression of brain metastases and/or development of leptomeningeal disease,” said Dr. Melisko. “The ability to identify cancer biomarkers that predict an elevated risk of CNS disease progression will have prognostic and therapeutic implications in treating these patients.”

“This collaborative study is designed to provide important information derived from cerebrospinal fluid samples that will better inform physicians treating patients with metastatic breast cancer involving the CNS, in particular those with leptomeningeal disease, who have a very poor prognosis if untreated,” said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. “CNSide will help these physicians determine the extent of involvement, potential targets for treatment and help them evaluate the response to treatment.”

“This study will also evaluate and compare the information derived from cerebrospinal fluid versus that of matched blood samples, where—based on our early experience—we believe cerebrospinal fluid could be more informative of intracranial response to treatment than related blood-based tests or radiologic changes routinely assessed by MRI,” he added.

The pilot study will collect cerebrospinal fluid and blood samples from 20 patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The samples will be analyzed for the presence, quantity and mutational profile of cerebrospinal fluid ctDNA and cerebrospinal fluid tumor cells, which will be paired with results from peripheral blood mononuclear cell samples. Exploratory analysis of changes in cerebrospinal fluid ctDNA, tumor cell, and immune cell characteristics will be performed over time in a limited number of serial samples. The cerebrospinal fluid findings will then be correlated with clinical outcomes, including CNS disease progression and survival.