Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working
to accelerate the development and commercialization of
scientifically compelling assets from research universities and
medical centers, announced today that its Scientific Co-founder Dr.
Jack A. Elias, received a Notice of Allowance from the United
States Patent and Trademark Office (“USPTO”) for his U.S. patent
application covering a therapeutic molecule that Ocean Biomedical
is working to advance into the clinic for patients suffering from
pulmonary fibrosis. Discoveries in recent years by Ocean
Biomedical’s Scientific Co-founder, Dr. Jack A. Elias, and his
colleagues at Brown University, have revealed a new target and a
new pathway for treating pulmonary tissue damage in Idiopathic
Pulmonary Fibrosis (IPF). This patent allowance covers pulmonary
fibrosis caused by
multiple conditions
including: idiopathic pulmonary fibrosis
(IPF), genetic pulmonary fibrosis such as
Hermansky-Pudlak Syndrome (HPS),
chemotherapy and radiation-induced pulmonary fibrosis, and
exposure-induced interstitial lung diseases including asbestosis
and silicosis.
A Notice of Allowance is issued after the USPTO
examines a patent application and determines that the applicant
should be granted a patent from the application. Ocean Biomedical
anticipates that a patent will be issued by the USPTO from Dr.
Elias’ application in the coming months.
Ocean Biomedical’s novel approach to treating
pulmonary fibrosis – a condition with no disease modifying agents
currently available – is focused on inhibiting Chitinase 1 (Chit1)
with patented “OCF-203.” Chit1 is also a critical biomarker in
Scleroderma-associated interstitial lung disease (SSc-ILD) and
plays a role in bleomycin- and IL-13-induced pulmonary fibrosis. In
four pulmonary fibrosis animal models, Ocean Biomedical’s OCF-203
has shown an 85% – 90% reduction in collagen
accumulation. The results of this antifibrotic (termed
molecule X: SMX) in the bleomycin model can be seen in the diagram
below. Results also showed efficacy in the pale-ear mouse model of
HPS, including impressive reductions in fibrosis. As a result,
efforts are now moving towards IND-enabling studies.
Ocean Biomedical’s anti-fibrosis platform seeks
to address major unmet needs for IPF and HPS, and has shown
potential for expanded application into fibrotic diseases in other
organs, such as scleroderma, alcoholic liver disease, NASH, and
kidney failure (see below). This unique approach has been developed
by a research team led by Dr. Jack A. Elias, who is the former Dean
of Medicine and Biology at Brown University, and former Chair of
Medicine and Chief of Pulmonology and Critical Care Medicine at
Yale University and Yale-New Haven Hospital.
IPF is a devastating lung condition that
currently affects about 100,000 people per year in the United
States, and about 15 per 100,000 people worldwide, with a much
higher prevalence in males over 50 years old. The median survival
rate ranges from 2 – 5 years. Current standard-of-care therapeutics
have limited efficacy and significant side effects such that
patients choose to forgo drug therapy. There are no therapies
currently available that can reverse loss of lung function.
“It is difficult to see the limited treatment
options that are currently available for patients with pulmonary
fibrosis conditions. We are working to change that, and we’re
excited about the broad therapeutic potential for this unique
treatment pathway,” commented Dr. Elias.
“We are confident in the results being generated
in our anti-fibrosis platform, and we are proud to be moving them
forward, especially with the potential application for these
pulmonary fibrotic conditions that do not currently have effective
treatment options,” said Elizabeth Ng, CEO of Ocean Biomedical.
Suren Ajjarapu, a director of Ocean, commented,
“The range of pulmonary fibrosis conditions that can be impacted by
this patent allowance is impressive and has potential to generate
positive returns for our shareholders in multiple ways.”
“This company was founded by
physician-researchers to find solutions for large, unmet medical
needs and we are pleased with the possibility of extending the
anti-fibrosis platform into a broad range of hard-to-treat
conditions,” said Dr. Chirinjeev Kathuria, Ocean’s co-founder and
Executive Chairman.
About Ocean Biomedical
Ocean Biomedical, Inc. (“Ocean Biomedical” or
the “Company”) 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 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:
the expected timing and success of investigational new drug (“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. Ocean Biomedical 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 any clinical
benefit 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. Important factors,
among others, that may affect actual results or outcomes include
but are not limited to: recently transitioning to operating as a
NASDAQ-listed public company with a limited operating history; our
ability to successfully complete our pre-clinical trials and for
those trials to produce positive results; our ability to timely
file and obtain approval of INDs from the FDA in the future; the
timing of the initiation, progress and potential results of our
planned pre-clinical studies and clinical trials and our research
programs; our ability to access additional product candidates from
research universities and medical centers; the timing or likelihood
of regulatory filings and approvals; the commercializing of our
product candidates, if approved; our product development and
marketing strategy; our ability and the potential to successfully
manufacture and supply our product candidates for clinical trials
and for commercial use, if approved; future strategic arrangements
and/or collaborations and partnerships, and the potential benefits
of such arrangements; our assessment that the early observations
from our pre-clinical studies are encouraging; the potential for
IND-enabling studies and future clinical trial results to differ
from initial results or from our pre-clinical studies; regulatory
developments in the United States and other countries; difficulties
in managing our growth; our estimates regarding expenses, future
revenue, capital requirements and needs for financing and our
ability to obtain capital; the sufficiency of our existing and
anticipated capital to fund our planned operating expenses; our
ability to retain the continued service of our key personnel and to
identify, hire and retain additional qualified professionals; the
implementation of our business model and strategic plans for our
business and product candidates; the scope of protection we are
able to establish and maintain for intellectual property rights,
product candidates and our pipeline; our ability to contract with
third-party suppliers and manufacturers and their ability to
perform adequately; the pricing, coverage and reimbursement of our
product candidates, if approved; developments relating to our
competitors and our industry, including competing product
candidates and therapies; changes in the markets in which the
Company competes, including with respect to its competitive
landscape, technology evolution, or regulatory changes; changes in
domestic and global general economic and market conditions; risks
related to the ongoing COVID-19 pandemic and response, including
supply chain disruptions; the risk that the Company may fail to
keep pace with rapid technological developments to provide new and
innovative products and services or make substantial investments in
unsuccessful new products and services; the outcome of any legal
proceedings that may be instituted against the Company; the risk of
product liability or regulatory lawsuits or proceedings relating to
the Company’s business; the risk of cyber security or foreign
exchange losses; the risk that the Company is unable to secure or
protect its intellectual property; the risk that the Company may
not be able to develop and maintain effective internal controls;
the ability to develop, license, or acquire new therapeutics; the
risk that the Company will need to raise additional capital to
execute its business plan, which may not be available on acceptable
terms or at all; and those factors discussed in the Company’s
filings with the SEC.
The foregoing list of factors is not exhaustive.
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 which
are described in the “Risk Factors” section of the Company’s
definitive proxy statement filed by the Company on January 12,
2023, and other documents to be filed by the Company from time to
time with the SEC and which are and will be 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. Readers are cautioned not to put undue reliance on
forward-looking statements. 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.
Ocean Biomedical Investor RelationsOCEANIR@westwicke.com
Ocean Biomedical Media RelationsOCEANPR@westwicke.com
Kevin KertscherCommunications Director
Ocean Biomedical (NASDAQ:OCEA)
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