Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2080

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2080
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 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 KEYNOTE-001 trial (NCT01295827).
This design is expected to allow for combined initial safety and efficacy endpoints using a single ascending dose, or SAD, strategy followed
by a repeat dose regimen to identify tumor responses through generally accepted Response Evaluation Criteria in Solid Tumors, or RECIST,
criteria and time to tumor progression. Using RECIST criteria as the primary endpoint of the initial clinical trial will measure whether
tumors shrink in response to treatment and allows for a relatively quick determination of whether our product candidates are likely to
provide benefit in a larger, more extensive pivotal trial. The time to the tumor progression endpoint will likely be a secondary endpoint
in these first trials but is the generally accepted primary endpoint for registrational trials in NSCLC.

GBM

The