# US 11,078,264 B2 · Inhibiting granulocyte macrophage-colony stimulating factor (GM-CSF) prevents preterm birth

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- Number: US 11,078,264 B2
- Document ID: US11078264B2
- Status: Granted
- Kind: B2
- Application number: 16/655,733
- Filed: 2019-10-17
- Published: 2020-04-23
- Granted: 2021-08-03
- Earliest claimed: 2018-10-17
- Assignees: University of Connecticut
- Applicants: University of Connecticut
- Inventors: Christopher Nold; Anthony Vella
- Web page: https://patentgrep.com/patent/US11078264B2

## CPC

- C07K 16/243: {Colony Stimulating Factors}
- A61K 38/16: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof {(enzyme inhibitors A61K38/005)}
- A61P 15/06: Antiabortive agents; Labour repressants
- C12N 15/1136: {against growth factors, growth regulators, cytokines, lymphokines or hormones}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- 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

A method of treating a pregnant female subject includes administering to the pregnant female subject an effective amount of a Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) inhibitor, wherein the effective amount of the GM-CSF inhibitor is effective to reduce, prevent or delay preterm birth.

## Claims

### Claim 1

A method of treating a pregnant female subject, comprising administering to the pregnant female subject an effective amount of a Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) inhibitor, wherein the effective amount of the GM-CSF inhibitor is effective to reduce, prevent or delay preterm birth, and wherein the GM-CSF inhibitor is an anti-GM-CSF human monoclonal antibody.

### Claim 2 (depends on 1)

The method of claim 1, wherein preterm birth is spontaneous preterm birth.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pregnant human female presents to labor and delivery with symptoms of preterm birth.

### Claim 4 (depends on 1)

The method of claim 1, wherein the female subject is a pregnant human at 20 to 37 weeks of gestation.

### Claim 5 (depends on 4)

The method of claim 4, wherein the pregnant human female subject is at risk of preterm birth.

### Claim 6 (depends on 5)

The method of claim 5, wherein the pregnant human female subject at risk of preterm birth has a short cervical length, an infection, a placental anomaly, has had a prior cesarean delivery, has or had uterine fibroids, a connective tissue disorder, is pregnant from in vitro fertilization, diabetes, blood clotting problems, high blood pressure, vaginal bleeding, a personal history of preterm birth, a family history of preterm birth, a previous pregnancy with 18 months of the current pregnancy, a current multi-fetal pregnancy, a uterine abnormality, a cervical abnormality, is overweight before or during pregnancy, is underweight before or during pregnancy, or is carrying a fetus with known birth defects.

### Claim 7 (depends on 5)

The method of claim 5, wherein the pregnant human female subject at risk of preterm birth is a human woman under the age of 20 or over the age of 35.

### Claim 8 (depends on 5)

The method of claim 5, wherein the pregnant human female subject at risk of preterm birth is a human woman engaging in smoking, engaging in drinking alcohol, using illegal drugs, with limited or no healthcare during pregnancy, subject to stress, subject to long working hours with long periods of standing, or exposed to environmental pollutants.

### Claim 9 (depends on 1)

The method of claim 1, further comprising checking the female subject for signs of preterm labor.

### Claim 10 (depends on 9)

The method of claim 9, wherein checking the female subject for signs of preterm labor comprises a cervical exam, a transvaginal ultrasound exam, testing for amniotic fluid, or testing for fetal fibronectin.

### Claim 11 (depends on 1)

The method of claim 1, further comprising administering tocolytic medicines, administering corticosteroids, performing cervical cerclage, and administering antibiotics.

### Claim 12 (depends on 1)

The method of claim 1, wherein the human anti-GM-CSF antibody comprises mavrilimumab, otilimab, TJM2, lenzilumab, namilumab, gimsilumab, or PD-0360324.
