Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer and Plans for FDA Alignment on Next-Stage Development

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10-02-2025

Company Poised to Enter Booming Bispecific Antibody Market Amid Growing Pharma Interest
Providence, RI, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical (NASDAQ: OCEA) today announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI), such as osimertinib that are used to treat non-small cell lung cancer (NSCLC). Specifically, they demonstrate that Ocean's immunotherapy candidates provide synergy with the TKI therapies (gefitinib and osimertinib) to suppress tumor growth and progression. In addition, the paper's findings demonstrate that its proprietary cancer immunotherapy candidates have a remarkable ability to restore treatment sensitivity following development of osimertinib resistance. This breakthrough offers a potential paradigm shift in the treatment of Epidermal Growth Factor Receptor (EGFR)-mutant NSCLC and could expand treatment options for patients whose tumors are no longer responding to tyrosine kinase inhibitors.
These findings, led by Ocean Biomedical's Scientific Co-founder Dr. Jack A. Elias in collaboration with researchers at Yale University and Brown University, were published in Translational Oncology and mark the first description of the role of chitinase 3-like-1 (CHi3L1) in EGFR-mutant cancers. The research underscores the ability of Ocean Biomedical's novel antibody to suppress CHi3L1 activity, leading to significant tumor reduction and, crucially, the reversal of drug resistance in preclinical models.
As part of its continued commitment to developing next-generation cancer therapeutics, Ocean Biomedical is initiating preclinical studies to advance its immunotherapy program and will engage with the FDA this year to align on a regulatory pathway for first-in-human trials.
Industry Momentum: Bispecific Antibodies Leading a 'Gold Rush' in Oncology
Ocean Biomedical's advancements come at a time when the oncology field is shifting its focus towards bispecific antibodies, an innovative therapeutic class designed to target multiple cancer mechanisms simultaneously. Bispecific antibodies that target PD-1/PD-L1 and VEGF have shown remarkable efficacy in recent clinical studies, with leading biotech and pharmaceutical companies rapidly investing in this space.
Merck's recent $588 million acquisition of LaNova's LM-299, a PD-1/VEGF bispecific antibody currently in early-stage clinical trials, underscores the high-value potential of this technology. Industry experts suggest that this wave of investments mirrors the early days of checkpoint inhibitors, highlighting the significant opportunity for Ocean Biomedical to position itself at the forefront of the next major oncology breakthrough.
Ocean has also developed bispecific antibodies that combine its anti-CHI3L1 antibody and anti-PD-1 or anti-CTLA4. Studies with these bispecific antibodies have highlighted their impressive efficacy in suppressing tumor growth and progression in preclinical models of NSCLC, malignant melanoma and glioblastoma.
Ocean's Board Chair and Co-Founder Statement on Market Potential and Investor Opportunity
'Our latest findings open an exciting new avenue in lung cancer treatment by demonstrating a potential solution to osimertinib resistance, a critical unmet need for patients worldwide,' said Dr. Chirinjeev Kathuria, Ocean's Board Chair and Co-Founder. 'With the industry shifting towards next-generation bispecific antibodies, Ocean Biomedical is strategically positioned to capitalize on this momentum in a variety of diseases including NSCLC, malignant melanoma and glioblastoma. The recent $588 million acquisition of LaNova's LM-299 validates the enormous market potential in this space, and we believe our innovative immunotherapy platform could drive significant value for both patients and investors.'
Expanding Therapeutic Applications
The company's lead oncology program is poised for multiple therapeutic applications:
As a standalone therapy for EGFR-mutant NSCLC,
In combination with existing TKIs to extend therapeutic response duration,
As a salvage therapy to restore treatment efficacy in resistant tumors.
Next Steps: FDA Alignment and Preclinical Advancements
With plans to initiate preclinical studies this year, Ocean Biomedical is actively preparing for discussions with the FDA to determine the regulatory pathway for clinical development. This milestone marks a significant step toward bringing its innovative cancer therapy to patients in need.
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 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. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company's management and 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.
The announced discoveries were 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 this treatment will prove safe or effective in humans, and that any clinical benefits of this 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 (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) risk that the Company may not be able to develop and maintain effective internal controls; (vii) 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; (viii) the ability to develop, license or acquire new therapeutics; (ix) 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; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company's business; (xii) the risk of cyber security or foreign exchange losses; (xiii) the risk that the Company is unable to secure or protect its intellectual property.
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, 2023 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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.
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Source: Ocean Biomedical, Inc.