Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a
clinical-stage pharmaceutical company developing targeted
radiotherapeutics with advanced platform technologies for central
nervous system cancers, today announced it has expanded its supply
agreement with Biocept by acquiring an option to exclusively
license Biocept's CNSide, a CSF-based tumor cell capture and
enumeration platform, for patients receiving CNS radiotherapy. The
option ensures that Plus Therapeutics has ongoing expanded access
to the diagnostic CSF assay for patients with CNS cancers and can
further develop and improve the assay specifically for patients
with CNS cancers receiving radiotherapy.
“Thus far, in our ReSPECT-LM trial, we have had
a very positive experience with the CNSide assay and think it has
significant diagnostic potential,” said Marc H. Hedrick M.D.,
President and Chief Executive Officer of Plus Therapeutics. “The
announced agreement is an important building block to ensure Plus
Therapeutics remains at the forefront of CNS cancer therapy.”
Under the terms of the agreement, CNSide
developer, Biocept, has granted Plus Therapeutics a non-exclusive
license to its CNSide cell enumeration assay for Plus’
investigational therapy for leptomeningeal metastases (LM), rhenium
(186Re) obisbemeda, and an option for an exclusive license to the
assay. In exchange, Plus Therapeutics will provide $150,000 of its
common stock to Biocept. Prior to January 1, 2025, Plus
Therapeutics will have the option for exclusivity for the field of
radiotherapy in exchange for a $1.0 million payment, to be
exercised at Plus Therapeutics’ discretion.
“Use of the CNSide assay has the potential to
substantially improve the diagnostic paradigm for patients with
solid tumor leptomeningeal disease and could provide valuable
information for these patients who have limited treatment options
but where a targeted therapy may be beneficial,” said Priya U.
Kumthekar, M.D., Associate Professor of Neurology and Medicine at
Northwestern University’s Feinberg School of Medicine. “Paired with
novel investigational therapeutics such as Plus Therapeutics’
rhenium (186Re) obisbemeda, the overall clinical management of
these challenging patients could be transformed.”
CNSide is an assay based on proprietary
quantitative tumor cell capture method paired with advanced digital
imaging and molecular markers used to detect, characterize and
quantify tumor cells in CSF of patients with a variety of solid
organ carcinomas and suspected LM, particularly breast and lung
cancer and melanoma which are leading causes of LM. CNSide provides
a sensitive and specific quantitative method to evaluate tumor
status and response to treatment compared to conventional CSF
cytology or imaging monitoring.
In March 2023, Biocept initiated enrollment in
the FORESEE trial with CNSide. The FORESEE trial is a two-part,
multicenter, prospective clinical trial expected to enroll up to 40
patients with breast or non-small cell lung cancer who have
suspicious or confirmed LM. The goal of the FORESEE trial is to
evaluate the performance of CNSide in monitoring LM's response to
treatment and to assess the impact of CNSide on treatment decisions
made by physicians. The feasibility phase of the study is expected
to complete in the first half of 2024, which will be followed by a
validation phase that is estimated to include between 40 and 100
subjects.
About Leptomeningeal Metastases
(LM)LM is a rare complication of cancer in which the
primary cancer spreads to the cerebrospinal fluid (CSF) and
leptomeninges surrounding the brain and spinal cord. All
malignancies originating from solid tumors, primary brain tumors,
or hematological malignancies have this LM complication potential
with breast cancer as the most common cancer linked to LM, with
3-5% of breast cancer patients developing LM. Additionally, lung
cancer, GI cancers and melanoma can also spread to the CSF and
result in LM. LM occurs in approximately 5% of people with cancer
and is usually terminal with 1-year and 2-year survival of just 7%
and 3%, respectively. The incidence of LM is on the rise, partly
because cancer patients are living longer and partly because many
standard chemotherapies cannot reach sufficient concentrations in
the spinal fluid to kill the tumor cells, yet there are no
FDA-approved therapies specifically for LM patients, who often
succumb to this complication within weeks to several months, if
untreated.
About Rhenium (186Re)
obisbemeda Rhenium (186Re) obisbemeda is a novel
injectable radiotherapy specifically formulated to deliver highly
targeted high dose radiation in CNS tumors in a safe, effective and
convenient manner to optimize patient outcomes. Rhenium (186Re)
obisbemeda has the potential to reduce risks and improve outcomes
for CNS cancer patients, versus currently approved therapies, with
a more targeted and potent radiation dose. Rhenium-186 is an ideal
radioisotope for CNS therapeutic applications due to its short
half-life, beta energy for destroying cancerous tissue and gamma
energy for live imaging. Rhenium (186Re) obisbemeda is being
evaluated for the treatment of recurrent glioblastoma and
leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM
clinical trials. ReSPECT-GBM is supported by an award from the
National Cancer Institute (NCI), part of the U.S. National
Institutes of Health (NIH), and ReSPECT-LM is funded by a
three-year $17.6M grant by the Cancer Prevention & Research
Institute of Texas (CPRIT).
About Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a robust supply chain through strategic
partnerships that enable the development, manufacturing and future
potential commercialization of its products. Plus Therapeutics is
led by an experienced and dedicated leadership team and has
operations in key cancer clinical development hubs including Austin
and San Antonio, Texas. For more information, visit
https://plustherapeutics.com/.
About Biocept, Inc.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. Biocept has developed and is commercializing the CNSide™
cerebrospinal fluid assay that detects cancer cells that have
metastasized to the central nervous system. Biocept’s patented
technology captures and quantitatively analyzes CSF tumor cells for
tumor-associated molecular markers. For more information, visit
www.biocept.com.
1The CNSide assay is not an FDA cleared or
approved assay. It is a Biocept lab developed test and its
performance characteristics were determined in Biocept’s
CLIA-certified, CAP-accredited laboratory.
Cautionary Statement Regarding
Forward-Looking StatementsThis press release contains
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws. All statements in this press
release other than statements of historical fact are
forward-looking statements. These forward-looking statements may be
identified by future verbs, as well as terms such as “designed to,”
“will,” “can,” “potential,” “focus,” “preparing,” “next steps,”
“possibly,” and similar expressions or the negatives thereof. Such
statements are based upon certain assumptions and assessments made
by management in light of their experience and their perception of
historical trends, current conditions, expected future developments
and other factors they believe to be appropriate. These statements
include, without limitation, statements regarding the following:
the potential promise of 186Re including the ability of 186Re to
safely and effectively deliver radiation directly to the tumor at
high doses; expectations as to the Company’s future performance
including the next steps in developing the Company’s current
assets; the Company’s clinical trials including statements
regarding the timing and characteristics of the ReSPECT-GBM and
ReSPECT-LM clinical trials; possible negative effects of 186Re; the
continued evaluation of 186Re including through evaluations in
additional patient cohorts; and the intended functions of the
Company’s platform and expected benefits from such functions.
The forward-looking statements included in this
press release are subject to a number of risks and uncertainties
that may cause actual results to differ materially from those
discussed in such forward-looking statements. These risks and
uncertainties include, but are not limited to: the Company’s actual
results may differ, including materially, from those anticipated in
these forward-looking statements as a result of various factors,
including, but not limited to, the following: the early stage of
the Company’s product candidates and therapies, the results of the
Company’s research and development activities, including
uncertainties relating to the clinical trials of its product
candidates and therapies; the Company’s liquidity and capital
resources and its ability to raise additional cash, the outcome of
the Company’s partnering/licensing efforts, risks associated with
laws or regulatory requirements applicable to it, market
conditions, product performance, litigation or potential
litigation, and competition within the cancer diagnostics and
therapeutics field, among others; and additional risks described
under the heading “Risk Factors” in the Company’s Securities and
Exchange Commission filings, including in the Company’s annual and
quarterly reports. There may be events in the future that the
Company is unable to predict, or over which it has no control, and
its business, financial condition, results of operations and
prospects may change in the future. The Company assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends or circumstances after the date they are
made unless the Company has an obligation under U.S. federal
securities laws to do so.
Investor ContactPeter VozzoICR Westwicke(443)
377-4767Peter.Vozzo@westwicke.com
Media ContactTerri ClevengerICR Westwicke(203)
856-4326Terri.Clevenger@westwicke.com
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