Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3381

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3381
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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 in patients suffering from brain cancers, and we anticipate many of
our patients will likely already have one in place.

We
intend to model our Phase 1/2 clinical trial after the Phase 1/2 clinical trial of Johnson and Johnson’s Zarnestra sponsored by
M.D. Anderson Cancer Center (NCT00050986). The envisioned clinical trial plan involves a dose escalation SAD/multiple ascending dose,
or MAD, strategy followed by continued assessments of safety parameters and efficacy using six-month progression free survival as the
primary endpoint. We anticipate also monitoring tumor size during this trial using radiology techniques in the interest of acquiring
efficacy data more rapidly than the primary endpoint is likely to provide.

Our
Phase 3 clinical trial for OCX-909 is tent