OCEA Ocean Biomedical Inc

Ocean Biomedical (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, Jack A. Elias, MD, published new findings in the peer-reviewed journal Cancer Research that detail the mechanisms behind the role of chitinase 3-like-1 (Chi3L1) in the growth of glioblastoma tumors, providing further evidence of the potential impact of Ocean’s anti-Chi3L1 antibody in suppressing severe glioblastoma tumor growth.

Results of the research conducted at the Laboratory of Cancer Epigenetics and Plasticity at the Lifespan Health System and Brown University, showed that an independent team led by molecular neuroscientist Nikos Tapinos, MD, PhD, was able to uncover new data on the efficacy of Ocean Biomedical’s anti-Chi3L1 antibody in human glioblastoma implanted mouse models, resulting in clear reduction in glioblastoma tumor growth.

The paper also revealed groundbreaking insights into the mechanisms underlying stem cell differentiation in glioma stem cells, and how that differentiation process is altered by Ocean Biomedical’s cancer therapeutic candidate. In two different study approaches, treatment with anti-Chi3L1 antibody in vivo resulted in over 60% reduction of human glioblastoma growth, and significant survival benefit. This can be seen in the MRI evaluations of the human tumors in the brains of mice (which appear in red) and the quantitation of tumor volume from these scans (see figures). This represents a medical breakthrough in understanding how the most aggressive glioblastoma tumors are formed, and how patients diagnosed with this challenging disease might possibly be treated.

“This is a completely new way of thinking about how to treat this tumor. Glioblastoma is so challenging partly because the cells adapt to the environment constantly – but if you block Chi3L1 they can’t seem to acquire the more aggressive mesenchymal phenotype. It gives us a clear path forward to being able to address glioblastoma with this novel approach,” said Dr. Nikos Tapinos MD, PhD, Director of the Laboratory of Cancer Epigenetics and Plasticity, and last author on the paper.

This targeted research data builds on prior discovery work by Dr. Jack A. Elias, who is the former Dean of Medicine and Biology, and Senior Vice President for Health Affairs at Brown University and former Chair of Medicine and Chief of Pulmonology and Critical Care Medicine at Yale University and Yale-New Haven Hospital. Over the last year, Dr. Elias has published discoveries about the roles of CHI3L1 in the pathogenesis of a wide variety of cancers. He has also previously revealed discoveries that demonstrate that the metastasis of malignant melanoma cells can be inhibited by targeting immune checkpoint inhibitors (ICPI) such as PD-1 and CTLA-4 and their ligands. The novel approach to tumor suppression being advanced by Ocean Biomedical is focused on simultaneously impacting multiple cancer pathways including those mediated by PD-1, CTLA4 by controlling CHi3L1, PD-1, PD-L1, CTLA-4, other immune checkpoint inhibitors, and T-cell co-stimulators. It has been known for a long time that optimal antitumor responses frequently require the simultaneous administration of more than one therapy.

“We are excited that, step by step, we are gaining a deeper understanding of the multiple effects that CHi3L1 has in oncogenesis,” commented Dr. Elias, “This antibody is very effective – every time we put it into an appropriate modeling system we get exciting results such as the findings in these two human-mouse GBM studies. Glioblastoma is a major area of unmet medical need, and these new studies are highly encouraging because they open the door to a new way of treating this devastating cancer.”

“We are pleased to see our glioblastoma candidate being validated by Dr. Tapinos and his team, and we hope this will be another step in moving us towards filing an IND for Glioblastoma,” said Elizabeth Ng, CEO of Ocean Biomedical.

Ocean’s Chairman and co-founder, Dr. Chirinjeev Kathuria added, “There are so many challenges around finding effective treatments for glioblastoma, and we are working to advance this new approach that we believe can give hope to patients with glioblastoma, and can also be extended to potential therapeutics for non-small cell lung cancer, melanoma, and other forms of cancer.”

Prior research has established that elevated Chi3L1 levels are associated with many cancers, including glioblastoma, and may be targeted therapeutically. Recent studies from Ocean Biomedical have demonstrated that CHI3L1 is a critical regulator of a number of key cancer-causing pathways, highlighting its ability to inhibit tumor cell death (apoptosis), its inhibition of the expression of the tumor suppressors P53 and PTEN and its stimulation of the B-RAF protooncogene. Most recently Dr. Elias’s research team has discovered that CHI3L1 is a “master regulator” of ICPI, including key elements of the PD-1 and CTLA4 pathways. In accord with the importance of these pathways, Ocean has also generated antibodies: 1.) a monoclonal antibody against CHI3L1, 2.) bispecific antibodies that simultaneously target CHI3L1 and PD-1, and 3.) a new bispecific antibody that simultaneously targets CHI3L1 and CTLA4. The impressive ability of these bispecific antibodies to control primary and metastatic lung cancer in murine experimental modeling systems have been discussed in detail in an earlier article in the Journal of Clinical Investigation, and this expanded approach in Frontiers in Immunology.

Suren Ajjarapu, an Ocean Biomedical Director commented, “We’re proud to be collaborating with some of our nation’s top scientists to move these important programs forward, and we are confident that each advancement will add long term value for our shareholders and for the doctors and patients who need innovative new treatments.”

Discussing the future direction of his work Dr. Tapinos said, “Now we know which proteins are expressed in response to Chi3L1, which are different in different subpopulations of cells, with Chi3L1 common to all of them. They just receive it in different ways and upregulate different pathways. Knowing the drivers for this heterogeneity, this is the holy grail for glioblastoma.”

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. We do not undertake any obligation to update any forward-looking statements made by us. 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