Granted Patent B2

US 12,497,443 · App. 17/363,798 · Granted Dec 16, 2025

Inventors: Jay Hooper (New Market, MD); Eddie Sullivan (Sioux Falls, SD); Hua Wu (Sioux Falls, SD)

Assignee: SAB, LLC

C07K16/1081A61K39/12C07K16/10A61K2039/505A61K2039/53A61K2039/54A61K2039/545A61K2039/575C07K2317/10C07K2317/21C07K2317/76C12N2760/12134C12N2760/14134C12N2770/24134C12N2770/36134

Abstract

Claims (24)

1 . A method for producing human antibodies against a DNA vaccine, comprising:

a) administering a transchromosomic ungulate with at least two DNA vaccines in at least two separate locations of the animal transchromosomic ungulate, the at least two DNA vaccines comprise:

i) a first DNA vaccine encoding a first antigen, and

ii) a second DNA vaccine encoding a second antigen, wherein the first antigen is injected at a first location and the second antigen is injected at a second location, wherein the first antigen and the second antigen are for the same disease target; and wherein the transchromosomic ungulate produces human IgG antibodies, wherein the transchromosomic ungulate is a knock-out for endogenous ungulate immunoglobulin genes, and comprises a human artificial chromosome (HAC) vector containing the full germ line sequence of human immunoglobulins;

b) collecting plasma from the transchromosomic ungulate; and

c) purifying polyclonal human IgG antibodies from the plasma.

2 . The method of claim 1 , wherein the disease target is a pathogen.

3 . The method of claim 2 , wherein the pathogen is selected from the group consisting of: Hantavirus, Ebola virus, Venezuelan Equine Encephalitis, and Zika virus.

4 . The method of claim 2 , wherein the first DNA vaccine and the second DNA vaccine are each derived from a distinct strain of the pathogen.

5 . The method of claim 4 , wherein the pathogen is Hantavirus and the two distinct strains are Sin Nombre Hantavirus and Andes Hantavirus.

6 . The method of claim 4 , wherein the pathogen is Ebola virus and the two distinct strains are Zaire Ebola virus and Sudan Ebola virus.

7 . The method of claim 1 , further comprising injecting the transchromosomic ungulate with an adjuvant in a location of the transchromosomic ungulate different from the at least two separate locations.

8 . The method of claim 7 , wherein the location of adjuvant injection is adjacent to one of the at least two separate locations of DNA vaccine injection.

9 . The method of claim 7 , further comprising repeating the DNA vaccine and adjuvant injection steps at an interval of about 21 days to about 28 days.

10 . The method of claim 1 , wherein each of the at least two separate locations is on a separate quarter of the transchromosomic ungulate.

11 . The method of claim 1 , wherein the at least two DNA vaccines are injected subcutaneously or subdermally, and an adjuvant is injected intramuscularly.

12 . The method of claim 1 , wherein the at least two DNA vaccines are administered at a dose of about 2 mg to about 40 mg per injection.

13 . The method of claim 12 , wherein the at least two DNA vaccines are administered at a dose of 12 mg per injection.

14 . The method of claim 1 , wherein plasma is collected from the transchromosomic ungulate between about 6 days to about 16 days after injection.

15 . The method of claim 1 , wherein the HAC vector comprises genes encoding:

a) one or more human antibody heavy chains, wherein each gene encoding an antibody heavy chain is operatively linked to a class switch regulatory element;

b) one or more human antibody light chains; and

c) one or more human antibody surrogate light chains, and/or an ungulate derived IgM heavy chain constant region; wherein at least one class switch regulatory element of the genes encoding the one or more human antibody heavy chains is replaced with an ungulate-derived class switch regulatory element.

16 . The method of claim 1 , wherein the purified polyclonal human IgG antibodies are similar to purified polyclonal antibodies produced by a human vaccinated with the DNA vaccine.

Assignments (1)

Continuity (3)

References Cited (85)