# US 11,028,166 B2 · Albumin binding domain fusion proteins

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- Number: US 11,028,166 B2
- Document ID: US11028166B2
- Status: Granted
- Kind: B2
- Application number: 15/932,387
- Filed: 2018-02-20
- Published: 2019-01-17
- Granted: 2021-06-08
- Earliest claimed: 2017-02-16
- Assignees: Sonnet Bio Therapeutics
- Applicants: Sonnet Bio Therapeutics
- Inventors: John K. Cini; Haomin Huang
- Web page: https://patentgrep.com/patent/US11028166B2

## CPC

- C07K 16/244: {Interleukins [IL]}
- A61K 39/001138: {Tumor necrosis factors [TNF] or CD70}
- A61K 39/00114: {Interleukins [IL]}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 35/00: Antineoplastic agents
- C07K 14/7155: {for interleukins [IL]}
- C07K 16/18: against material from animals or humans
- C07K 16/22: against growth factors {; against growth regulators}
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/468: {Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 2039/6081: {Albumin; Keyhole limpet haemocyanin [KLH]}
- C07K 14/76: Albumins
- C07K 2317/31: multispecific
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2319/00: Fusion polypeptide
- C12N 15/62: DNA sequences coding for fusion proteins
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N 2510/00: Genetically modified cells
- C12N 2800/00: Nucleic acids vectors
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Compositions that include an albumin binding domain and a fusion partner (e.g., a cytokine or a binding moiety) are provided. Such therapeutics have increased serum half-life and find use in applications where one or more such therapeutics are needed, for example, in oncology applications.

## Claims

### Claim 1

A composition comprising an albumin binding domain (ABD), said ABD comprising:
a) a variable heavy chain comprising a vhCDR1, a vhCDR2 and a vhCDR3 of a variable heavy chain having SEQ ID NO: 25; and
b) a variable light chain comprising a vlCDR1, a vlCDR2 and a vlCDR3 of a variable light chain having SEQ ID NO: 29.

### Claim 2 (depends on 1)

The composition comprising an albumin binding domain according to claim 1, wherein said vhCDR1 comprises SEQ ID NO: 26, said vhCDR2 comprises SEQ ID NO: 27, said vhCDR3 comprises SEQ ID NO: 28, said vlCDR1 comprises SEQ ID NO: 30, said vlCDR2 comprises SEQ ID NO: 31, and said vlCDR3 comprises SEQ ID NO: 32.

### Claim 3 (depends on 1)

The composition according to claim 1, wherein said variable heavy chain of said ABD comprises SEQ ID NO: 25, and said variable light chain of said ABD comprises SEQ ID NO: 29.

### Claim 4

An albumin binding domain (ABD) fusion protein comprising an ABD attached to a fusion partner, wherein said ABD comprises a variable heavy chain comprising a vhCDR1, a vhCDR2 and a vhCDR3 of a variable heavy chain having SEQ ID NO: 25, and a variable light chain comprising a vlCDR1, a vlCDR2 and a vlCDR3 of variable light chain having SEQ ID NO: 29.

### Claim 5 (depends on 4)

The ABD fusion protein according to claim 4, wherein said vhCDR1 comprises SEQ ID NO: 26, said vhCDR2 comprises SEQ ID NO: 27, said vhCDR3 comprises SEQ ID NO: 28, said vlCDR1 comprises SEQ ID NO: 30, said vlCDR2 comprises SEQ ID NO: 31, and said vlCDR3 comprises SEQ ID NO: 32.

### Claim 6 (depends on 4)

The ABD fusion protein according to claim 4, wherein said variable heavy chain of said ABD comprises SEQ ID NO: 25 and said variable light chain of said ABD comprises SEQ ID NO: 29.

### Claim 7 (depends on 4)

The ABD fusion protein according to claim 4, wherein said fusion partner is a cytokine.

### Claim 8 (depends on 7)

The ABD fusion protein according to claim 7, wherein said cytokine is selected from the group consisting of: IL-2, IL-7, IL-12, IL-15, IL-18, IL-21, GM-CSF and IFN-α.

### Claim 9 (depends on 4)

The ABD fusion protein according to claim 4, wherein said fusion partner is an scFv comprising an scFv variable heavy chain and an scFv variable light chain.

### Claim 10 (depends on 9)

The ABD fusion protein according to claim 9, wherein said scFv is selected from the group consisting of an anti-TGFβ scFv, an anti-PD-L1 scFv, an anti-TNF scFv, an anti-IL-1 scFv, an anti-IL-6 scFv, an anti-IL-8 scFv, an anti-IL-17A scFv, an anti-IL-17B scFv, an anti-IL-17C scFv, an anti-IL-17D scFv, an anti-IL-17E scFv, an anti-IL-17F scFv, and an anti-IL-23 scFv.

### Claim 11

An ABD fusion protein according to the formula: (FP1)-L1-(ABD)-L2-(FP2),
wherein ABD is an albumin binding domain comprising a variable heavy chain and a variable light chain;
wherein FP1 and FP2 are a first fusion partner and a second fusion partner, respectively;
wherein L1 and L2 are a first and second linker, respectively;
where said variable heavy chain of said ABD comprises a vhCDR1, a vhCDR2 and a vhCDR3 of a variable heavy chain having SEQ ID NO: 25; and
where said variable light chain of said ABD comprises a vlCDR1, a vlCDR2 and a vlCDR3 of a variable light chain having SEQ ID NO: 29.

### Claim 12 (depends on 11)

The ABD fusion protein according to claim 11, wherein said vhCDR1 comprises SEQ ID NO: 26, said vhCDR2 comprises SEQ ID NO: 27, said vhCDR3 comprises SEQ ID NO: 28, said vlCDR1 comprises SEQ ID NO: 30, said vlCDR2 comprises SEQ ID NO: 31, and said vlCDR3 comprises SEQ ID NO: 32.

### Claim 13 (depends on 11)

The ABD fusion protein according to claim 11, wherein said variable heavy chain of said ABD and said variable light chain comprises SEQ ID NO: 25 and said variable light chain of said ABD comprises SEQ ID NO: 29.

### Claim 14 (depends on 11)

The ABD fusion protein according to claim 11, wherein said FP1 and said FP2 are a first cytokine and a second cytokine respectively.

### Claim 15 (depends on 14)

The ABD fusion protein according to claim 14, wherein said first cytokine and said second cytokine are selected from the group consisting of:
IL-2 and IL-12; IL-7 and IL-15; IL-15 and IL-12; IL-18 and GM-CSF; IL-21 and IL-15; GM-CSF and IL-12; GM-CSF and IL-21; and IFN-α and IL-15.

### Claim 16 (depends on 11)

The ABD fusion protein according to claim 11, wherein said FP1 and said FP2 are a first scFv and a second scFv, respectively.

### Claim 17 (depends on 11)

The ABD fusion protein according to claim 11, wherein said FP1 and said FP2 are selected from the group consisting of a TNF scFv and an IL-1 scFv; a TNF scFv and an IL-6 scFv; a TNF scFv and an IL-8 scFv; a TNF scFv and an anti-IL-17A, anti-IL-17B, anti-IL-17C, anti-IL-17D, anti-IL-17E, or anti-IL-17F scFv; a TNF scFv and an IL-23 scFv; a first TNF scFv and a second TNF scFv; an anti-PD-L1 scFv and an IL-12; an anti-PD-L1 scFv and an IL-15; an anti-PD-L1 scFv and an anti-TGFβ scFv; a first anti-PD-L1 scFv and a second PD-L1 scFv; an anti-TGFβ scFv and an IL-12; an anti-TGFβ scFv and an IL-15; an anti-TGFβ scFv and a PD-L1 scFv; and a first anti-TGFβ scFv and a second anti-TGFβ scFv.
