# US 12,215,156 B2 · HER-2 targeted bispecific compositions and methods for making and using the same

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- Number: US 12,215,156 B2
- Document ID: US12215156B2
- Status: Granted
- Kind: B2
- Application number: 18/494,007
- Filed: 2023-10-25
- Published: 2024-03-07
- Granted: 2025-02-04
- Earliest claimed: 2020-06-25
- Assignees: Amunix Pharmaceuticals, Inc.
- Applicants: Amunix Pharmaceuticals, Inc.
- Inventors: Volker Schellenberger; Eric Johansen; Angela Henkensiefken; Darragh Maccann; James McClory; Philipp Kuhn; Andre Frenzel; Bryan Irving; Mika Derynck
- Web page: https://patentgrep.com/patent/US12215156B2

## CPC

- C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex}
- A61P 35/00: Antineoplastic agents
- C07K 14/00: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 16/32: against translation products of oncogenes
- C12N 15/70: Vectors or expression systems specially adapted for E. coli
- 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 2039/505: {comprising antibodies}
- C07K 2317/31: multispecific
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- C07K 2319/00: Fusion polypeptide
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- C07K 2319/50: containing protease site
- C12N 2800/101: for bacteria
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)

## Abstract

Disclosed herein are polypeptides, and methods of making and using such polypeptides, that comprise a bispecific antibody construct covalently linked to an extended recombinant polypeptide comprising a barcode fragment releasable from said polypeptide upon digestion by a protease, and a Release Segment that can be proteolytically cleaved wherein said cleavage releases the bispecific antibody construct from the extended recombinant polypeptide.

## Claims

### Claim 1

A polypeptide comprising the amino acid sequence of SEQ ID NO: 34.

### Claim 2 (depends on 1)

The polypeptide of claim 1 consisting of the amino acid sequence of SEQ ID NO: 34.

### Claim 3 (depends on 1)

A pharmaceutical composition comprising a polypeptide of claim 1 and one or more pharmaceutically suitable excipients.

### Claim 4 (depends on 3)

A method of treating a HER2-expressing cancer in a subject, wherein the cancer is a solid tumor, the method comprising administering to said subject one or more therapeutically effective doses of a pharmaceutical composition of claim 3.

### Claim 5 (depends on 1)

A nucleic acid comprising (a) a polynucleotide sequence encoding a polypeptide of claim 1; or (b) a reverse complement of said polynucleotide sequence of (a).

### Claim 6 (depends on 5)

An expression vector comprising a polynucleotide sequence of claim 5 and a recombinant regulatory sequence operably linked to said polynucleotide sequence.

### Claim 7 (depends on 6)

A host cell, comprising an expression vector of claim 6.

### Claim 8 (depends on 4)

The method of claim 4, wherein the HER2-expressing cancer is selected from breast cancer, colorectal cancer, non-small cell lung cancer, and ovarian cancer.