Ocean Biomedical, Inc. (
NASDAQ: OCEA), a
biopharma company working to accelerate the development of
compelling discoveries from top research scientists, today
congratulates its JV partner Virion Therapeutics, LLC, a
clinical-stage biotechnology company developing
novel
T cell-based immunotherapies, on its
late breaker
presentation highlighting the
first-ever human
immunogenicity data from its novel checkpoint modifier
immunotherapy for HBV functional cure (VRON-0200), at the
EASL 2024 Congress (The European Association for
the Study of the Liver), taking place in Milan, Italy from June 5 -
8.
The late breaker Phase 1b data presented today,
(for more information, go to VirionTx.com), which
includes Virion’s first checkpoint modifier, glycoprotein D (gD),
demonstrated that VRON-0200 was not only safe and well tolerated,
but immunogenic in the majority of chronically HBV-infected
patients, following a single intramuscular injection. “Chronic HBV
infection severely impairs a patient’s ability to clear the virus.
A single low dose injection of VRON-0200 was able to stimulate T
cell responses in the majority of patients, most of whom had
little, to no, documented HBV immunity prior to treatment” said
Virion’s CEO, Dr. Andrew Luber. Luber added,
“VRON-0200 is our lead clinical program and these
clinical safety and immunogenicity data will further support our
proprietary platform technologies and other pipeline programs in
development, including VRON-0300, which is for patients with
advanced solid tumors.”
Unlike monoclonal antibody checkpoint inhibitors
which attempt to “rescue” already activated, but exhausted, CD8+ T
cells, Virion’s checkpoint modifiers alter T cell activation to
amplify and broaden a patient’s own immune response; this may
include regions of a tumor or infectious disease that are not
normally stimulated during a chronic disease, thereby potentially
producing a “new” immune response. Additionally, after it is
administered through an intramuscular injection, the checkpoint
modifiers act locally, at the injection site, and not throughout
the body, thereby limiting the risk for serious adverse events such
as those seen following the intravenous administration of
monoclonal antibody checkpoint inhibitors.
Ocean Biomedical co-founder and
Executive Chairman Dr. Chirinjeev Kathuria, commented: “We
congratulate Virion on these exciting data, as they continue to
advance VRON-0200, not only as a safe, well tolerated, and easy to
administer treatment, but also, now with positive clinical
immunogenity data, which is advancing their goal of an
interferon-sparing treatment option for the 300 million persons
worldwide infected with Chronic HBV. Treatments for chronic HBV are
in high demand and could capture an estimated global market
of $6.5+ billion by 2032. Ocean is
pleased to partner with Virion and we look forward to helping
accelerate this, and other programs, in development.”
About Chronic Hepatitis B
Despite a preventative vaccine, cases of chronic
hepatitis B (HBV) continue to rise, with an estimated 296
million persons infected worldwide and 820,000
deaths per year from HBV-related liver complications. This
includes almost 100 million persons in China who are affected by
this disease. Chronic HBV remains a global health issue with a high
unmet medical need since there is no cure available. The current
standard of care requires lifelong antiviral therapy to maintain
control of the virus.
About VRON-0200
VRON-0200 is a therapeutic immunotherapy,
administered by intramuscular injection, designed with the goal of
providing a functional cure for chronic HBV infection. While the
virus itself stimulates HBV-specific CD8+ T cells, for those
patients that can’t clear the initial infection, their T cells soon
become exhausted, placing limits on their ability to proliferate
and control the virus. Preclinical data support the hypothesis that
VRON-0200, through checkpoint modification, can amplify, broaden,
and enhance T cell responses which may include T cells that are not
normally activated during a chronic HBV infection, which results in
improved viral control.
About Virion Therapeutics (Virion)
Virion Therapeutics, LLC is a clinical-stage
company developing novel T cell-based immunotherapies to cure
cancer and chronic infectious diseases that utilize proprietary
genetically encoded checkpoint modifiers to enhance and broaden
CD8+ T cell responses to a tumor or chronic infection. Founded in
early 2018 to advance technology licensed from The Wistar
Institute, an international leader in biomedical research, Virion
has since developed a robust pipeline, including its lead VRON-0200
clinical program, and several additional IND-enabling programs,
including its VRON-0300 oncology program for advanced solid tumors,
leveraging its proprietary platform technologies. In early Fall
2023, Virion and Ocean Biomedical entered a joint venture to
accelerate and expand Virion’s pipeline of novel
immunotherapies.
To learn more, visit
www.VirionTx.com
About Ocean Biomedical
Ocean Biomedical, Inc. is a Providence, Rhode
Island-based biopharma company with an innovative business model
that accelerates the development and commercialization of
scientifically compelling assets from research universities and
medical centers. Ocean Biomedical deploys the funding and expertise
to move new therapeutic candidates efficiently from the laboratory
to the clinic to the world. Ocean Biomedical is currently
developing five promising discoveries that have the potential to
achieve life-changing outcomes in lung cancer, brain cancer,
pulmonary fibrosis, and the prevention and treatment of malaria.
The Ocean Biomedical team is working on solving some of the world’s
toughest problems, for the people who need it most.
To learn more,
visit www.oceanbiomedical.com.
Forward-Looking Statements
The information included herein and in any oral
statements made on behalf of Ocean Biomedical, Inc. (the “Company”)
or otherwise in connection herewith include “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the United States Private Securities Litigation Reform Act of 1995.
Forward-looking statements may be identified by the use of words
such as “estimate,” “plan,” “project,” “forecast,” “intend,”
“will,” “expect,” “anticipate,” “believe,” “seek,” “target,” or
other similar expressions that predict or indicate future events or
trends or that are not statements of historical matters, although
not all forward-looking statements contain such identifying words.
These forward-looking statements include, but are not limited to,
statements regarding estimates and forecasts of financial and
performance metrics and expectations; the expected timing and
success of IND filings for our initial product candidates;
statements regarding the expected timing of our IND-enabling
studies; the frequency and timing of filing additional INDs;
expectations regarding the availability and addition of future
assets to our pipeline; the advantages of any of our pipeline
assets and platforms; the potential benefits of our product
candidates; potential commercial opportunities; the timing of key
milestones for our programs; the future financial condition,
results of operations, business strategy and plans, and objectives
of management for future strategy and operations; and statements
about industry trends and other companies in the industry. These
forward-looking statements are based on various assumptions,
whether or not identified herein, and on the current expectations
of the Company’s management, and they are not predictions of actual
performance. These forward-looking statements are provided for
illustrative purposes only and are not intended to serve as and
must not be relied on by any investor as, a guarantee, an
assurance, a prediction, or a definitive statement of fact or
probability. Actual events and circumstances are difficult or
impossible to predict and will differ from assumptions.
Any discoveries announced by the Company are
based solely on laboratory and animal studies. The Company has not
conducted any studies that show similar efficacy or safety in
humans. There can be no assurances that any treatment tested by the
Company will prove safe or effective in humans, and that any
clinical benefits of any such treatment is subject to clinical
trials and ultimate approval of its use in patients by the FDA.
Such approval, if granted, could be years away.
Forward-looking statements are predictions,
projections, and other statements about future events that are
based on current expectations and assumptions and, as a result, are
subject to risks and uncertainties. These forward-looking
statements are not guarantees of future performance, conditions, or
results, and involve a number of known and unknown risks,
uncertainties, assumptions, and other important factors, many of
which are outside the control of the Company that could cause
actual results or outcomes to differ materially from those
discussed in the forward-looking statements. You should carefully
consider the foregoing factors and the other risks and
uncertainties that are described in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2022 and in the Company’s
subsequent Quarterly Reports on Form 10-Q and other documents filed
by the Company from time to time with the SEC and which are
available at www.sec.gov. These filings identify and address
other important risks and uncertainties that could cause actual
events and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. We do not undertake any obligation to
update any forward-looking statements made by us. These
forward-looking statements should not be relied upon as
representing the Company’s assessments as of any date subsequent to
the date of this release. Accordingly, undue reliance should not be
placed upon the forward-looking statements.
Contacts: Ocean Biomedical Investor
Relationsconnect@oceanbiomedical.comKevin KertscherCommunications
Director
Virion Therapeutics, LLC scurrie@viriontx.comDr. Sue
Currie Chief Operating Officer
Ocean Biomedical (NASDAQ:OCEA)
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