PHILADELPHIA, Oct. 26,
2023 /PRNewswire/ -- Virion Therapeutics, LLC, a
clinical-stage biotechnology company developing novel T
cell-based immunotherapies, and its Joint Venture partner,
Ocean Biomedical, Inc. (NASDAQ: OCEA), today announced
that the first patients have been dosed in the Phase
1b clinical trial of its
investigational VRON-0200 immunotherapy, which is being
evaluated as a functional cure for patients with chronic
Hepatitis B virus (HBV) infection. VRON-0200, a
first-in-class treatment, using one of Virion's proprietary
checkpoint modifiers, was specifically designed to enhance and
broaden a patient's own immune response. This novel mechanism of
action may help overcome one of the key problems faced in treating
chronic HBV - immune exhaustion. The international, first-in-human
VRON-0200 Phase 1b study is currently
enrolling patients in Hong Kong
and New Zealand, with additional
sites planned in the United
States. Initial clinical data from this study are expected
in early 2024.
"The initiation and dosing of patients in this VRON-0200 study
is a critical first step in evaluating its impact on chronically
HBV-infected patient's immune responses to the virus, with the
ultimate goal of finding a cure for this insidious disease. The
mechanism by which VRON-0200 works is a totally new approach to
anything previously investigated or currently in development by
others – we are looking forward to evaluating the first clinical
data from this program, early next year," said Dr. Sue Currie, COO of Virion.
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 as there is no cure available. The
current standard of care requires lifelong antiviral therapy to
keep the virus in check.
Grace Wong, MD, Professor of
Medicine at the Chinese University at Hong
Kong (CUHK), and a principal investigator in the VRON-0200
study, commented, "Novel treatments that can control or
potentially cure chronic HBV infection, that are easy to
administer, and are well tolerated, alone, or in combination with
other treatments, are in high need." Wong added, "VRON-0200,
with its potential to expand a patient's own immune response to
control the infection, coupled with how it is given - as a single
(prime), or double (prime and boost) injection into the arm muscle,
has the potential to be an innovative therapy to address this high
global unmet medical need for patients with chronic HBV."
"The dosing of these first patients, in our lead VRON-0200
chronic HBV Phase 1b study,
represents a major milestone in Virion's mission of bringing
innovative immunotherapies to patients with cancer and chronic
infectious diseases," said Virion's CEO, Dr. Andrew Luber. "Targeting T cell activation,
via checkpoint modification, is unique to Virion. This first study,
using our first checkpoint modifier, gD, not only benefits patients
with chronic hepatitis B, but also, provides useful information for
our proprietary platform technologies and pipeline, including
VRON-0300, which is in development for patients with advanced solid
tumors," Luber added.
Ocean Biomedical co-founder and Executive Chairman Dr.
Chirinjeev Kathuria, commented: "This is another major clinical
and business value inflection point for our company. Treatments for
chronic HBV are in high demand and could capture an estimated
global market of $6.5+ billion by 2032. Companies at a
similar stage as our JV's VRON-0200 study, have seen large steps up
in value. For example, VIR Biotechnology's value increased by
over $3.6 billion dollars after
they reported their initial 8 patient Phase 1 data. Ocean is
pleased to partner with Virion in bringing this high-need,
high-value treatment – aiming for a functional cure - to patients
with chronic HBV around the world."
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 to 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 (CPMs) to enhance and broaden CD8+
T cell responses to a tumor or chronic infection. Founded in
early 2018, Virion has since developed a robust pipeline, including
its lead VRON-0200 clinical program, and several additional
IND-enabling programs, including VRON-0300 oncology program for
advanced solid tumors, leveraging its proprietary platform
technologies. In early Fall 2023, Virion and Ocean Biomedical
entered into 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 and 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 filing. Accordingly, undue reliance
should not be placed upon the forward-looking statements.
Contacts:
Virion Therapeutics, LLC
Dr. Sue Currie
Chief Operating Officer
scurrie@viriontx.com
Ocean Biomedical Investor Relations
connect@oceanbiomedical.com
Kevin Kertscher
Communications Director
View original content to download
multimedia:https://www.prnewswire.com/news-releases/virion-therapeutics-and-joint-venture-partner-ocean-biomedical-nasdaq-ocea-announce-first-patients-dosed-with-novel-immunotherapy-evaluating-a-functional-cure-for-chronic-hepatitis-b-virus-infection-301967728.html
SOURCE Virion Therapeutics, LLC