# US 11,078,298 B2 · Antibodies to ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) and related methods

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- Number: US 11,078,298 B2
- Document ID: US11078298B2
- Status: Granted
- Kind: B2
- Application number: 16/345,562
- Filed: 2017-10-27
- Published: 2020-05-28
- Granted: 2021-08-03
- Earliest claimed: 2016-10-28
- Assignees: Banyan Biomarkers, Inc.
- Applicants: Banyan Biomarkers, Inc.
- Inventors: Michael Catania; Ronald L. Hayes
- Web page: https://patentgrep.com/patent/US11078298B2

## CPC

- C07K 16/40: against enzymes
- A61B 5/0042: {for the brain}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/501: {for diagnosis of the head, e.g. neuroimaging or craniography}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 21/04: for myasthenia gravis
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 31/22: for herpes viruses
- A61P 33/14: Ectoparasiticides, e.g. scabicides
- A61P 39/02: Antidotes
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 16/18: against material from animals or humans
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- C07K 2317/20: characterized by taxonomic origin
- C07K 2317/21: from primates, e.g. man
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/52: Constant or Fc region; Isotype
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The invention provides anti-UCH-L1 antibodies and anti-GFAP antibodies and their use in vitro detection of UCH-L1 and GFAP, respectively, in a sample from an individual, such as an individual known or suspected of having a brain injury or damage, for example, neurological damage such as mild traumatic brain injury. Also provided are methods, systems and kits for diagnosing brain injury or damage, such as neurological damage, in an individual with the aforementioned antibodies as well as compositions comprising the anti-UCH-L1 antibodies and anti-GFAP antibodies.

## Claims

### Claim 1

An antibody or antigen-binding fragment thereof that specifically binds to a human ubiquitin c-terminal hydrolase L I (UCH-L 1), wherein the antibody or antigen-binding fragment comprises a heavy chain variable region and a light chain variable region, wherein:
the heavy chain variable region comprises: (i) a CDR-HL comprising the amino acid sequence of SEQ ID NO:1; (ii) a CDR-H2 comprising the amino acid sequence of SEQ ID NO:9; and (iii) a CDR-H3 comprising the amino acid sequence of SEQ ID NO:20; and
wherein the light chain variable region comprises: (i) a CDR-LI comprising the amino acid sequence of SEQ ID NO:28; (ii) a CDR-L2 comprising the amino acid sequence of SEQ ID NO:37; and (iii) a CDR-L3 comprising the amino acid sequence of SEQ ID NO:45.

### Claim 2 (depends on 1)

A composition comprising the antibody or antigen-binding fragment of claim 1.