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

Ocean Biomedical recently 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 toward 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.

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.