Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2495

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2495
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 that is contained in our vaccine formulations. Based
on these data, we believe that vaccination with PfGARP and/or PfSEA-1 is unlikely to generate immunologic toxicity in humans and further
suggest that the parasite may likely not be able to mutate to escape the killing effect of the vaccine induced antibodies.

31

It
is important to note that, unlike the target of the RTS,S vaccine (circumsporozoite protein), PfSEA-1 and PfGARP antigens are expressed
in the host for 8 to 24 hours which allows sufficient time for them to be targeted by vaccine induced antibodies. This is in stark contrast
to the circumsporozoite protein, which is only expressed during the sporozoite stage of the P. falciparum lifecycle and thus only available
for intervention during the first five minutes of infection. Furthermore, P. falciparum disease progression is dependent upon repeated
rounds of schizont formation, merozoite egress, and infection of new erythrocytes (see lifecycle description above), and each time the
cycle repeats the parasite again becomes vulnerable to anti-PfSEA-1 or anti-PfGARP antibodies. In contrast, parasites that escape the
small window of intervention induced by the RTS,S vaccine are not prevented from further growth and replication. The subsequent unimpeded
progression through the parasite lifecycle is likely a primary contributor to the relatively low immunization success rate seen with
RTS,S.

We
are currently evaluating whether a vaccine targeting PfSEA-1, PfGARP or a combination of the two antigens would present the best opportunity
to protect patients from P. falciparum infection.

ODA-611—Anti-PfGARP
mAbs

We
produced a series of mAbs in mice that were immunized with laboratory generated recombinant PfGARP. Of the 16 mAbs that reacted with
PfGARP in an enzyme-linked immunosorbent assay, or ELISA, only one mAb killed parasites in culture (see Fig 12). We sequenced and expressed
the heavy-chain and light-chain variable regions (the genes that encode the mAb), and the resulting recombinant mAb had a dissociation
constant, or Kd, of 2.9 nM, (indicating strong binding of the monoclonal to its target PfGARP) and killed parasites in culture. A monovalent
antigen-binding