# US 12,595,301 B2 · Anti-il-2 antibodies and compositions and uses thereof

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- Number: US 12,595,301 B2
- Document ID: US12595301B2
- Status: Granted
- Kind: B2
- Application number: 17/946,941
- Filed: 2022-09-16
- Published: 2023-10-26
- Granted: 2026-04-07
- Earliest claimed: 2015-10-23
- Assignees: Pfizer Inc.; The Regents of the University of California; The Board of Trustees of the Leland Stanford Junior University
- Applicants: Pfizer Inc.; The Regents of the University of California; The Board of Trustees of the Leland Stanford Junior University
- Inventors: Isaac J. Rondon; Natasha Crellin; Paul Bessette; Eleonora Trotta; Jeffrey A. Bluestone; Lauren K. Ely; Kenan C. Garcia
- Web page: https://patentgrep.com/patent/US12595301B2

## CPC

- C07K 16/246: {IL-2}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61K 2039/505: {comprising antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/51: Complete heavy chain or Fd fragment, i.e. VH + CH1
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

The present invention provides antibodies, or antigen-binding portions thereof, which specifically bind to IL-2 and reduce the affinity of IL-2 binding to IL-2Rα and IL-2Rβ. The invention further provides a method of obtaining such antibodies and nucleic acids encoding the same. The invention further relates to compositions and therapeutic methods for use of these antibodies for the treatment and/or prevention of autoimmune diseases, disorders or conditions and for immunosuppression, including, but not limited to, administering a complex comprising the antibody and IL-2.

## Claims

### Claim 1

A method for treating type 1 diabetes in a human subject, the method comprises administering to the subject an effective amount of an isolated antibody or antigen-binding portion thereof that specifically binds human IL-2, wherein the isolated antibody or antigen-binding portion thereof comprises:
a heavy chain complementarity determining region 1 (HCDR1) comprising SEQ ID NO: 208;
a heavy chain complementarity determining region 2 (HCDR2) comprising SEQ ID NO: 211;
a heavy chain complementarity determining region 3 (HCDR3) comprising SEQ ID NO: 213;
a light chain complementarity determining region 1 (LCDR1) comprising SEQ ID NO: 214;
a light chain complementarity determining region 2 (LCDR2) comprising SEQ ID NO: 215; and
a light chain complementarity determining region 3 (LCDR3) comprising SEQ ID NO: 216,
wherein the type 1 diabetes is caused by and/or associated with IL-2 activity; and
wherein the antibody is administered in complex with IL-2.

### Claim 2 (depends on 1)

The method of claim 1, wherein the antibody is an IgG antibody.

### Claim 3 (depends on 1)

The method of claim 1, wherein the antibody further comprises a heavy chain constant region comprising the amino acid sequence of SEQ ID NO: 33 with or without the C-terminal lysine.

### Claim 4 (depends on 1)

The method of claim 1, wherein the antibody further comprises a light chain constant region comprising the amino acid sequence of SEQ ID NO: 35.

### Claim 5 (depends on 1)

The method of claim 1, wherein the antibody comprises a heavy chain variable region comprising an amino acid sequence that is at least 95% identical to SEQ ID NO:31 and a light chain variable region comprising an amino acid sequence that is at least 95% identical to SEQ ID NO:32.

### Claim 6 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding portion is a monoclonal antibody.

### Claim 7 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding portion is a humanized antibody.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding portion is a human antibody.