Ocean Biomedical, Inc. announced that 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 deathand 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: as a stand-alone therapy, as a combination therapy with current TKI inhibitors, and as a ?salvage therapy? in combination with TKI inhibitors like Osimertinib?potentially extending their therapeutic life. 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.