Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed

Ocean Biomedical, Inc. recently announced its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations. These research findings, which may be the most important Ocean Biomedical has announced to date, generated by Ocean’s Scientific Co-founder Dr. Jack A. Elias and colleagues from Yale University and Brown University, and first published as a preprint last week in bioRxiv, are the first to uncover the role of Chitinase 3-like-1 (CHI3L1) in the pathogenesis of EGFR-mutant cancers, with potential applications not just in NSCLC, but in all EGFR-mutant cancers, including glioblastoma and colon cancer.

The studies demonstrate the ability of Ocean Biomedical’s cancer-targeting immunotherapeutic antibody to control the growth of human tumor cells with EGFR mutations by suppressing CHI3L1 activity. Additionally, the findings demonstrate a stunning ability to restore therapeutic sensitivity to current tyrosine kinase inhibitor (TKI) therapies after resistance sets in, including the third-generation TKI, Osimertinib (marketed as Tagrisso by AstraZeneca). In mouse model testing in combination with Osimertinib (and also earlier TKI Gefitinib), Ocean’s antibody was shown to stop human tumor progression by inducing tumor cell death and stimulating tumor suppressor genes. In 2022, AstraZeneca’s top pharmaceutical product by revenue was Tagrisso, a medication used in the treatment of non-small-cell lung carcinomas. During that year, Tagrisso generated 5.44 billion U.S. dollars in revenue for the company.

EGFR-Mutant Lung Cancer: Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer deaths globally, accounting for 85% of all lung cancers. The EGFR-mutant lung cancer is found in 30%-50% of NSCLC patients with Asian heritage and 10%-20% of patients with Caucasian backgrounds. This lung cancer can be effectively treated with current third-generation tyrosine kinase inhibitor (TKI) therapies for about 9-18 months, but virtually all patients eventually develop therapeutic resistance.

In these findings, the role of CHI3L1 in EGFR-mutant lung cancer is described for the first time. Ocean Biomedical’s cancer immunotherapy candidate demonstrates potential use in EGFR-mutant cancer immunotherapy in multiple ways:

1) as a stand-alone therapy

2) as a combination therapy with current TKI inhibitors, and

3) as a “salvage therapy” in combination with TKI inhibitors like Osimertinib—potentially extending their therapeutic life.

“We are very excited to see the effectiveness of our anti-CHI3L1 antibody in suppressing and reversing tumor growth in studies of EGFR-mutant lung cancer cells,” said Dr. Elias. “We are even more amazed to see how it works in combination with current treatments like Osimertinib, especially its ability to restore therapeutic effectiveness in cells that have developed Osimertinib resistance.”

In multiple testing combinations, Ocean Biomedical’s patented anti-CHI3L1 antibody demonstrated effective tumor reduction. A TUNEL assay revealed roughly 20% tumor cell death via the folate receptor gamma (FRG) protein on its own, and roughly 40% tumor cell death via FRG in combination with Osimertinib. In mouse lung model testing with TKI inhibitors Gefitinib and Osimertinib, Ocean’s antibody demonstrated reduction of lung tumor metastasis by more than 50%.

CHI3L1 and Cancer: Advancing efforts to understand the underlying pathways driving tumor activation via CHI3L1, Ocean Biomedical’s scientific co-founder Dr. Jack A. Elias has revealed a series of novel discoveries around the roles of CHI3L1. These discoveries have shown CHI3L1 operating in multiple oncogenic pathways, some operating simultaneously. This current paper expands Dr. Elias’ team’s understanding of the role of CHI3L1 in NSCLC and in conjunction with genetic mutations that are often key drivers of tumor creation in some of the most aggressive cancers. With these novel discoveries, Dr. Elias’ team is broadening their understanding of the ways in which CHI3L1 interacts with EGFR mutations to drive the cancer.

“We are excited to expand our understanding of the role of CHI3L1 in driving tumor formation, and to discover this potential role for application in combination with current state-of-the-art therapies, especially in EGFR-mutant NSCLC, which is devastating for so many families and disproportionally affects Asian heritage populations,” said Elizabeth Ng, Chief Executive Officer of Ocean Biomedical.

“This new data that demonstrates tumor suppression and potential salvage therapy application in EGFR-mutation lung cancers could save thousands of lives,” added Ocean’s Executive Chairman and founder, Dr. Chirinjeev Kathuria. “We are proud of this pioneering work by Dr. Elias and his colleagues at Yale and Brown.”

“The range of potential therapeutic applications in our cancer platform continues to grow, and we look forward to growing the benefits for all of Ocean’s stakeholders,” commented one of Ocean’s directors, Suren Ajjarapu.

Dr. Jack A. Elias is a leader in pulmonary research and care. He is the former Chair of Yale’s Department of Internal Medicine, Dean Emeritus of Medicine and Biological Sciences at Brown University, and current Professor of Translational Science in the Departments of Medicine and Molecular Microbiology and Immunology at The Warren Alpert Medical School of Brown University. He is a leading pulmonary care specialist and research pioneer. In 2019, Dr. Elias co-founded Ocean Biomedical with several Brown University colleagues, alums, and experienced pharma business leaders to help address major unmet medical needs by accelerating more discovery science into needed therapeutics.

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. For more information, visit www.oceanbiomedical.com.