Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2485

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2485
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lioblastoma Tumor Cells with OCX-909 Bi-Specific Anti-Chi3l1 / Anti-CTLA-4 Antibody.
**=p<0.01

Figure
3: Mechanism of Action of OCX-410

We
are planning to initially target checkpoint inhibitor positive NSCLC with OCX-410 and GBM with OCX-909 due to the previously published
importance of these checkpoint inhibitors for these tumor types as well as Dr. Elias’ supporting data in preclinical models of
these diseases. We intend to evaluate whether checkpoint inhibitor upregulation is critical for the activity of OCX-410 and OCX-909 in
humans, and we intend to evaluate the response seen in checkpoint inhibitor negative patients as well. The outcome of these studies may
help us to better identify our potential target patient population.

Oncology
Product Candidates Clinical Development Plan

All
three therapeutic antibody product candidates, OCX-253, OCX-410, and OCX-909, have been optimized against their respective targets, and
we are beginning efforts to develop, through the establishment of manufacturing and supply relationships with third parties, a production
system capable of supporting clinical use. A critical step in production is the creation of a master cell bank, or MCB, a depository
where genetically identical antibody-producing cells are stored, by a CMO. The MCB is critical for production of consistent therapeutics
through clinical development and, potentially, commercial production. We have collaborated on the first steps of MCB production for OCX-253
with Lonza Group AG, a global contract manufacturing organization and have completed development of 8 research cell lines that produce
OCX-253 in February 2021. Initial assessments indicate that any of these cell lines could possibly be used to generate clinical and commercial
grade OCX-253. Additional evaluations are under way to determine which of the 8 cell lines is preferred for the generation of the cGMP
MCB and the generation of clinical drug material. The OCX-410 and OCX-909 programs are expected to begin MCB generation in 2H 2023/1H
2024. We anticipate filing IND applications with the FDA for product candidates within 18 months of raising sufficient capital to fund
such IND projects.

23

We
intend to model our Phase 1/2 clinical trials of OCX-253 and OCX-410 after Merck’s pembrolizumab