Biocept Signs CNSide™ Licensing Agreement with Plus Therapeutics
September 08 2023 - 8:00AM
Business Wire
Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular
diagnostic assays, products, and services, announces the signing of
a non-exclusive licensing agreement for CNSide™ with Plus
Therapeutics, Inc. (Nasdaq: PSTV) (Plus), which expands the
comprehensive laboratory services agreement between the two
companies that was announced in June 2022. Plus is using CNSide in
a clinical trial with their targeted radiotherapeutic to treat
patients with carcinomas and/or melanomas with suspected
leptomeningeal metastases (LM), which is cancer in the membranes
that surround the brain and spinal cord. CNSide is Biocept’s
proprietary cerebrospinal fluid (CSF)-based tumor cell capture and
enumeration platform used in detecting, quantifying, and monitoring
tumor status in LM.
This new agreement allows for Plus to perform CNSide testing
during its clinical trials and commercially, subject to regulatory
approval. Biocept will provide expertise, including consulting on
equipment and materials sourcing, as well as providing the
necessary technology and training to perform CNSide. Plus will pay
Biocept an upfront fee of $150,000 in stock, plus $6,000 per CSF
tumor cell enumeration analysis performed in Biocept’s
CLIA-certified and CAP-accredited laboratory prior to the
completion of the technology transfer. Once the technology transfer
is complete, Plus will pay Biocept $300,000 plus fees on a sliding
scale starting at $2,800 for each CNSide test they perform. The
license agreement also gives Plus the option to negotiate for
third-party exclusivity with a $1,000,000 payment to Biocept.
“We are gratified that Plus continues to recognize the value of
CNSide in leptomeningeal metastases disease management. We share
their commitment to improving the lives of patients suffering from
cancer of the central nervous system (CNS),” said Antonino Morales,
Biocept President and CEO. “We view this agreement as further
validation of the clinical utility of CNSide and the important role
it plays in diagnosing and monitoring patients with LM. It also
sets the stage for future agreements with other companies
developing treatments for cancer of the CNS and provides Biocept
with non-dilutive funding to support our goal of establishing
CNSide as standard of care under the National Comprehensive Cancer
Network® (NCCN®) guidelines.
“Importantly, Plus will reimburse Biocept for CNSide testing
performed prior to completion of the technology transfer at $6,000
per enumeration,” he added. “This amount more than covers our costs
and potentially sets the stage for reimbursement at a similar level
in future arrangements.”
Plus is using CNSide in its ReSPECT-LM Phase 1/2a
dose-escalation clinical trial of Rhenium 186 Obisbemeda for the
treatment of patients with LM. Plus recently announced completion
of Phase 1/Part A of the trial and presented favorable preliminary
safety and efficacy results. Plus has received U.S. Food and Drug
Administration (FDA) approval to move to Phase 1/Part B of the
ReSPECT-LM clinical trial. For more information on Plus, please
visit www.plustherapeutics.com.
“The CNSide test is the emerging gold standard for the
definitive diagnosis and follow up of patients with LM,” said Marc
H. Hedrick, M.D., President and CEO of Plus Therapeutics. “The
CNSide technology may, in the near future, supplement or replace
existing diagnostic technology for cerebrospinal fluid
malignancies. We view CNSide as an important complement to our
novel radiotherapeutic technology, Rhenium 186 Obisbemeda, now in
clinical development for leptomeningeal metastases in our actively
enrolling ReSPECT-LM trial.”
About CNSide
CNSide is a laboratory developed test (LDT) 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 CNS, the evaluation of cerebrospinal fluid
with CNSide provides a unique opportunity to identify biomarkers 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 is a molecular diagnostics company with commercialized
assays for patients with carcinomas or melanomas. Our experts have
spent years working to change the way physicians look at
cerebrospinal fluid in cancer patients. Biocept has developed a
unique, patented methodology to isolate cancer material that is
shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and
cell-free DNA (cfDNA). As such, Biocept is a leading commercial
provider of testing services designed to enable clinicians to
rapidly detect and monitor cancer biomarkers from a cerebrospinal
fluid sample. For more information, please visit
www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This news 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 "will," "expect," “goal,” “objective,”
"believe" or "intend" or the negative of these words or other
variations on these words or comparable terminology. To the extent
that statements in this news release are not strictly historical,
including, without limitation, statements regarding CNSide’s
clinical utility to support drug development, any exclusivity
payment, future agreements with biotech and biopharmaceutical
companies, monitoring patients on cancer therapies, adoption into
clinical care guidelines, and support reimbursements, our plan to
provide further evidence of CNSide’s clinical utility through our
FORESEE clinical trial, publications in peer-reviewed medical
journals, additional manuscripts to be submitted for peer review,
our cash runway, and other statements that are not historical fact,
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 that the results of the
FORESEE clinical trial may not support the inclusion of CNSide in
clinical care guidelines; Medicare and private payors may not
provide coverage and reimbursement or may breach, rescind or modify
their contracts or reimbursement policies or delay payments; risks
related to our need for additional capital; 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 in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023, filed with the Securities and Exchange Commission
(SEC) on May 10, 2023, and in our Quarterly Report on Form 10-Q for
the quarter ended June 30, 2023, filed with the SEC on August 14,
2023. The effects of such risks and uncertainties could cause
actual results to differ materially from the forward-looking
statements contained in this news 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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Contact: LHA Investor Relations Jody Cain Jcain@lhai.com
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