Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2486

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2486
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 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
OCX-909 program for GBM has the additional challenge of successfully delivering the protein therapeutic product candidate to the brain
where the Blood Brain Barrier or BBB has questionable permeability. The BBB is a stretch of less-permeable blood vasculature in the CNS,
as compared to the rest of the body. Its purpose is to carefully screen the entry and exit of molecules between the CNS and bloodstream.
The BBB is a difficult hurdle to cross using small molecules delivered to the periphery, and consistent peripheral delivery of protein-based
therapeutics, such as antibodies, to the brain has so far been elusive. Patients suffering from GBM may have a partially disrupted BBB
due to changes in the vasculature associated with the tumors or their recent surgery, but the inconsistency of these disruptions may
add considerable challenge to the development of a peripherally delivered medicament.

We
plan to bypass the BBB using a number of approaches, alone or in combination. The first approach is intracerebral-ventricular, or ICV,
delivery of OCX-909. We intend to make use of a port-reservoir system, such as an Ommaya reservoir, which is a small, plastic, coin-shaped
device placed under the scalp and connected to a catheter placed in one of the brain’s ventricles. This would allow direct delivery
of OCX-909 into the cerebral spinal fluid, or CSF, pool in the ventricles at the center of the brain. The size of the ICV space changes
throughout the day, particularly during sleep, effectively pumping CSF, and the drug it contains, throughout the brain. Though placement
of an Ommaya reservoir is somewhat invasive, it is frequently used