Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 100

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 100
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 immune responses are prompted against recombinant antigens encoded by genetically engineered DNA plasmids.

The immune system is able to recognize these foreign
antigens generated by the host, resulting in a complete and adequate immunization. RNA-based vaccines invigorates the immunogen production
via induction of both cellular and humoral immune responses. These vaccines also act on DNA based vaccine’s principle with an exception
that there is no need of translocation to the nucleus for RNA transcription.

The display of viral proteins, such as the SARS-CoV-2
coat Spike protein, triggers humoral (neutralizing antibodies) and cellular responses that protect the recipient from the viral infection
as well as from future infections. Thus, this approach requires both efficient mRNA delivery into target cells and the identification
of suitable nucleic acid molecules that would trigger effective anti-viral immune response. BNT162b1, a lipid-soluble nanoparticles-based
formulation containing mRNA encoding the S protein RBD trimer, was produced by Pfizer and BioNTech.

Viral vector vaccines consist of an often attenuated
recombinant virus, designed to encode sequence of an antigen for host cell delivery for high level endogenous production of that antigen
and thus induces elevated levels of cellular and humoral immune responses. These vaccines grant increased capabilities of gene transduction
because of the natural host cell infection ability of the viruses and these are of replicating or non-replicating. They are constructed
to transmit one or many antigens, as well as the capacity to load a big genome suggest that a wider range of vaccines might be developed.

Whole virus and protein vaccines are well-established
platforms. Examples of whole virus, live attenuated vaccines are measles-mumps-rubella vaccine and rotavirus vaccine; inactivated vaccines:
hepatitis A and rabies; and protein vaccines: hepatitis B and acellular pertussis. Viral vector and nucleic acid (mRNA and DNA) vaccines
are more novel platforms. The only viral vector vaccine licensed for human use is the Ebola vaccine by Merck.

The tremendous success of the vaccines from Pfizer-BioNTech
(BNT162b2, also known as Comirnaty®) and Moderna (mRNA-1273, also known as Spikevax®) in combatting Coronavirus has demonstrated
the value and rapid translational potential of lipid nanoparticles.

The Coronavirus pandemic introduced many millions of people to mRNA
vaccines, saving many lives. These vaccines consist