Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2503

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2503
---
579, should allow for the filing of IND applications for both ODA-579 and ODA-611 within 18 months of raising sufficient
capital to fund such IND projects.

It
is our intention that the ODA-611 and ODA-579 Plasmodium falciparum therapeutic product candidates will initially follow the clinical
development example of Takeda and AbbVie’s DSM265 (ACTRN12613000522718 and ACTRN12613000527763). The Phase 1a portion of the trial
of ODA-611 will likely be a single-ascending dose, or SAD, trial based on the expected long half-life of this antibody, that is aimed
at evaluating safety and pharmacokinetics. The Phase 1a portion of ODA-579 will likely begin with a SAD study, and an additional MAD
may be added depending on the pharmacokinetics observed. Both drugs are expected to proceed into a Phase 1b trial that will likely consist
of a small number of volunteers testing the efficacy of the product candidates following a challenge with P. falciparum. This design
is intended to allow us to observe any early signs of efficacy on a preliminary basis that could help guide future development and further
refine the dosing strategy. The Phase 2 clinical trials of ODA-611 and ODA-579 are modeled after that of Novartis’ KAE607 (NCT03334747).
This trial design allows for assessment of the impact of different dose levels and treatment regimens of the molecules in the treatment
of P. falciparum infected patients in a region where malaria is endemic. The registration trials of ODA-611 and ODA-579 are aimed at
assessing the safety and efficacy of these treatments in combination with standard of care and are modeled after the National Institute
of Allergy and Infectious Diseases’, or NIAID, past work exploring combinations with chloroquine (NCT00379821). While the NIAID’s
chloroquine trial was primarily focused on children, we anticipate recruiting both adults and children because we believe this may maximize
the treatable population should our therapeutic candidate receive regulatory approval.

Intellectual
Property

We
seek to protect the intellectual property (“IP”) and proprietary technology that we consider important to our business, including
by pursuing patent applications that cover our product candidates and methods of using the same, as well as any other relevant inventions
and improvements that are