Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2072

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2072
---

growth and survival. This type of treatment blocks the growth and spread of cancer cells and limits damage to healthy cells.

Immunotherapy
is designed to boost the body’s natural antitumor immune defenses. Lung cancers often contain genetic mutations that are seen as
“non-self” by the host’s immune system because they are not seen in normal cells and tissues. The human immune system
is designed to attack and eliminate cells and tissues that it detects as foreign or “non-self.” However, in many patients
with cancer these desired antitumor responses are suppressed by the tumor and surrounding cells. This is done by activating one of a
number of immune checkpoint inhibitor pathways, or ICPI pathways.

An
example of the multiple ICPI pathways that have been discovered that has received significant attention in lung cancer is the programmed
death-1/ PD-ligand 1, or PD-1/PD-L1, pathway. In many patients with lung cancer, the immune cells and nearby cells, such as macrophages
express, PD-1 and the tumor cells express its binding partner PD-L1. When PD-L1 binds PD-1, it activates pathways that suppress the host’s
antitumor immune response. On the other hand, therapeutics (usually antibodies) have been developed that prevent these PD-1/PD-L1 interactions.
These therapies boost the host’s antitumor responses which augments its ability to attack the tumor. Because there are multiple
ICPI pathways, assays that determine which pathway(s) is activated in a given tumor have been and are being developed. This allows the
therapeutic intervention to be directed to the ICPI pathway that is most important in a given individual.

Importantly,
immunotherapy has been generally regarded as revolutionizing the treatment of NSCLC, with immunotherapies targeting the PD-1/PD-L1 pathway
now emerging as standard-of-care in some settings. However, despite the advent of these new therapies for NSCLC, there continues to be
a need for other therapeutic options because only approximately 15% of patients respond to these interventions. In addition, among those
that initially improve, the responses are often not durable and diminish over time. In many cases, tumors evolve compensatory mechanisms
that circumvent the beneficial effects of an individual immunotherapy. Thus, a significant unmet medical need in NSCLC are treatment
options that either restore or complement, the efficacy of anti PD-1 / PD-L1 and other IC