Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2478

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2478
---
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 ICPI-based therapies.

A
general overview of immunotherapy and antibodies is presented below under the caption “A Primer on Antibodies, Antigens and Targeted
Therapies.”

18

We
believe that OCX-253, our mono-specific mAb against Chi3l1, if approved, will likely be used individually or in combination with immunotherapies,
such as anti-PD-1 therapeutics. Our belief is based on the observation that OCX-253 modulates multiple oncogenic pathways, or signaling
networks used by cancer cells to control the growth and progression of tumors, in addition to its ability to modulate ICPI pathways.
Should OCX-253 become a marketed treatment, we would anticipate it being initially used primarily in later-stage cancers, as with most
recently approved oncology therapeutics. OCX-253 may progress towards being used for earlier stage cancers, and/or in combination with
other medications, as clinician and regulatory agency experience with the drug grows and as our understanding of the needs of individual
patients deepens.

OCX-410,
our bi-specific antibody, is designed to combine the mechanism of actions of OCX-253 and anti-PD-1 therapeutics. We believe this is a
promising combination because studies by Dr. Elias have demonstrated that this bi-specific antibody recruits immune cells, such as CD8+
cytotoxic T cells that kill tumor cells, and the physical interaction of these activated T cells to tumor cell membranes. If approved,
we anticipate that OCX-410 will likely enter the market as a second-line therapy in patients with stage III or IV lung cancer who have
failed anti PD-1/PD-L1 immunotherapies