ANTIGENeering

Genetic Immunity's disease specific Antigen Selection and Construction (ANTIGENeering) technology employs state of art molecular biology to express most of the disesase specific antigens as immunogens from a single plasmid DNA.

Main features of Genetic Immunity's ANTIGENeering technology include:

single plasmid DNA to encode most of the disease specific antigens
regulation and optimization of different disease specific antigen expression to mimic the authentic antigen-presenting profile
safety is ensured by molecular specific modifications of the plasmid DNA
validated QC of antigen identity, quality, quantity and potency
cost-effective, reproducible, scalable manufacturing process
plasmid DNA can be formulated to pathogen-like, intelligent nanoparticles - Nanomedicine
dendritic cell targeting administration with DermaPrep topical delivery device

Case Study: ANTIGENeering of plasmid DNA for safe expression of HIV antigens

The Active Pharmaceutical Ingredient (API) in our lead product candidate - DermaVir Patch - is a single plasmid-DNA designed to authentically express most HIV antigens. A summary of our ANTIGENeering modifications are:

General features of ANTIGENeering	Specific features of DermaVir's pDNA

HIV-specific antigen expression	Gag, Protease, Reverse transcriptase, Env, Tat, Rev, Vif, Vpr

Virus-like particle release	Yes

Safety features	Integrase defective Reverse transcription impaired Nef truncated

Regulation of gene expression	HIV-1 LTR promoter

Testing	Sequencing, restriction digestion, physical and chemical characteristic, potency in human cells

Subtype-B HIV is the prevalent type in the USA, Europe, Australia and parts of Asia. Genetic Immunity's plasmid DNA, as utilized in the DermaVir Patch, encodes 90% of subtype-B HIV antigens. In addition to subtype-B, ANTIGENeering supports rapid development of DermaVir Patch varieties for personalized subtype-specific treatment. By replacing the plasmid DNA in DermaVir B with other subtype-optimized plasmid DNA other variants of DermaVir can be made that are suitable for inducing subtype-optimized immune responses.

In addition to our subtype-B HIV vaccine we are also actively engaged in developing plasmid DNA immunogens for the following subtypes:

DermaVir	Targeted epidemics	Infected population

Subtype C	Sub-Saharan Africa, South-Asia	22.5 million
Subtype B/C	China	3.3 million
Subtype B/F	South-America	1.6 million
Subtype A	East- & West-Africa, Middle-East	2.0 million
Subtype A/B	East-Europe	10,000

In order to manufacture different DermaVir Therapeutic Vaccines the subtype-optimized plasmid DNA is nanoformulated to pathogen-like intelligent nanoparticles (Nanomedicine) to improve its stability and immunogenicity. DermaVir is topically administered using DermaPrep to target lymph node dendritic cells.