Conducted by leading breast oncologists from
UCSF under a grant from the California Breast Cancer Research
Program and the University of California, San Francisco Brain
Spore, the study will analyze results from cerebrospinal fluid
using Biocept’s CNSide™ assay with results from blood
samples
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.
The Rationale for the Study
One of the most devastating complications of metastatic breast
cancer is the development of CNS disease, including brain
metastases and/or leptomeningeal disease. Among patients with
metastatic breast cancer, approximately 15-45% develop brain
metastases and approximately 5-10% develop leptomeningeal disease
during the course of their disease, resulting in significant
morbidity and mortality. As patient outcomes improve with better
systemic treatment options, control of CNS disease has become
increasingly important to reduce morbidity and prolong
survival.
Patients with leptomeningeal disease are often excluded from
clinical trials and there are few effective treatments. In order to
develop better tools for the diagnosis and treatment of metastatic
breast cancer with CNS disease, it is critical to better understand
the biology of this condition. Specifically, the profiling of the
cerebrospinal fluid tumor and immune microenvironment in patients
with brain metastases and/or leptomeningeal disease will enable a
better understanding of the characteristics that may contribute to
the development and progression of CNS disease.
About the California Breast Cancer Research Program
The mission of the California Breast Cancer Research Program
(CBCRP) is to prevent and eliminate breast cancer by leading
innovation in research, communication, and collaboration in the
California scientific and lay communities. CBCRP is the largest
state-funded breast cancer research effort in the nation and is
administered by the Research Grants Program Office within the
University of California Office of the President. The CBCRP funds
California investigators to solve questions in basic breast cancer
biology, causes and prevention of breast cancer, innovative
treatments and ways to live well following a breast cancer
diagnosis, and involves advocates and scientists in every aspect of
CBCRP decision-making, including program planning and grant
application review. Since 1994 the CBCRP has awarded more than $280
million in research funds to institutions across California, with
95% of its revenue going directly to funding research and education
efforts.
About CNSide
CNSide is based on Biocept’s proprietary quantitative tumor cell
capture and detection method, paired with assays to identify
actionable molecular treatment targets. Given the genetic changes
that can occur as metastatic cancer spreads to the central nervous
system, the evaluation of cerebrospinal fluid with CNSide provides
a unique opportunity to identify biomarkers such as HER2 and EGFR
in patients with metastatic carcinoma or melanoma to help guide
physicians in therapy selection. In addition, the quantitative
tumor cell count assay can be used in a serial fashion to monitor
the response to therapy more effectively than other current
methods.
About Biocept
Biocept, Inc. develops and commercializes molecular diagnostic
assays that provide physicians with clinically actionable
information for treating and monitoring patients diagnosed with a
variety of cancers. For more information, visit www.biocept.com.
Follow Biocept on Facebook, LinkedIn, Twitter, and Instagram.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements that are
based upon current expectations or beliefs, as well as a number of
assumptions about future events. Although we believe that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, we can give
no assurance that such expectations and assumptions will prove to
be correct. Forward-looking statements are generally identifiable
by the use of words like "may," "will," "should," "could,"
"expect," "anticipate," "estimate," "believe," "intend," “goal,” or
"project," or the negative of these words or other variations on
these words or comparable terminology. To the extent that
statements in this press release are not strictly historical,
including, without limitation, statements regarding the study
design and its potential results, benefits and other outcomes, our
hypotheses, the prognostic and therapeutic implications of the
ability to identify biomarkers that predict an elevated risk of CNS
disease progression, and the ability of CNSide to detect,
characterize and monitor disease progression in patients with
leptomeningeal disease, such statements are forward-looking, and
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. The reader is cautioned
not to put undue reliance on these forward-looking statements, as
these statements are subject to numerous risks and uncertainties,
including with the risk that the study described in this press
release does not provide clinically meaningful data, does not
confirm our hypothesis or otherwise does not demonstrate the
clinical value of our CNSide assay for the diagnosis and treatment
of the patients in the study, and the risk that our products and
services may not perform as expected. These and other factors are
described in greater detail under the "Risk Factors" heading of
Biocept’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2022, filed with the SEC on November 10, 2022. The effects of
such risks and uncertainties could cause actual results to differ
materially from the forward-looking statements contained in this
press release. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law. Readers are advised to review our filings with the SEC at
http://www.sec.gov/.
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Investor and Media Contact: Jody Cain, LHA Investor
Relations Jcain@lhai.com, 310-691-7100
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