IP Library › Granted Patent US 12,472,248
Granted Patent B2
US 12,472,248 · App. 17/661,160 · Granted Nov 18, 2025

Antibodies against fentanyl and fentanyl analogs

Inventors: Gary R. Matyas (Olney, MD); Rodell C. Barrientos (Rockville, MD); Oscar B. Torres (Rockville, MD); Connor Whalen (Cranberry Township, PA); Therese Oertel (Silver Spring, MD); Kenner C. Rice (Bethesda, MD); Arthur E. Jacobson (Rockville, MD); Eric W. Bow (Washington, DC); Agnieszka Sulima (Poolesville, MD)
Assignees: The Government of the United States, as represented by the Secretary of the Army; The United States of America, as represented by the Secretary, Department of Health Bethesda, MD
A61K39/385A61K39/0013A61K47/6415A61K47/646A61P25/36C07K16/44A61K2039/505A61K2039/55505A61K2039/55572A61K2039/6012A61K2039/6037C07K2317/24C07K2317/565C07K2317/76
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Quick Facts
Patent No.
US 12,472,248
App. No.
17/661,160
Granted
Nov 18, 2025
Kind
B2
Abstract

The present disclosure is directed to isolated recombinant antibodies, or antigen-binding fragments thereof, that bind to fentanyl or fentanyl analogs. The novel antibodies or antigen-binding fragments thereof can be used to detect, diagnose, treat, and/or prevent opioid use disorder.

Claims (16)

1 . An isolated recombinant monoclonal antibody, or an antigen-binding fragment thereof, that binds to fentanyl or a fentanyl analog, wherein said antibody comprises a heavy chain variable domain and a light chain variable domain,

(1) wherein the heavy chain variable domain comprises a complementarity determining region 1 (CDR1) comprising the amino acid sequence of SEQ ID NO: 3; a CDR2 comprising the amino acid sequence of SEQ ID NO:4; and a CDR3 comprising the amino acid sequence of SEQ ID NO:5; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:6; a CDR2 comprising the amino acid sequence of SEQ ID NO: 7; and a CDR3 comprising the amino acid sequence of SEQ ID NO:8; or

(2) wherein the heavy chain variable domain comprises a complementarity determining region 1 (CDR1) comprising the amino acid sequence of SEQ ID NO: 11; a CDR2 comprising the amino acid sequence of SEQ ID NO:12; and a CDR3 comprising the amino acid sequence of SEQ ID NO:13; and wherein the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:14; a CDR2 comprising the amino acid sequence of SEQ ID NO:15; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 16.

2 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of claim 1 , wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:3; a CDR2 comprising the amino acid sequence of SEQ ID NO:4; and a CDR3 comprising the amino acid sequence of SEQ ID NO:5; and the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:6; a CDR2 comprising the amino acid sequence of SEQ ID NO:7; and a CDR3 comprising the amino acid sequence of SEQ ID NO:8.

3 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of claim 2 , wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:1 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:2.

4 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of claim 1 , wherein the heavy chain variable domain comprises a CDR1 comprising the amino acid sequence of SEQ ID NO:11; a CDR2 comprising the amino acid sequence of SEQ ID NO:12; and a CDR3 comprising the amino acid sequence of SEQ ID NO:13; and the light chain variable domain comprises: a CDR1 comprising the amino acid sequence of SEQ ID NO:14; a CDR2 comprising the amino acid sequence of SEQ ID NO:15; and a CDR3 comprising the amino acid sequence of SEQ ID NO:16.

5 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of claim 4 , wherein the heavy chain variable domain comprises the amino acid sequence of SEQ ID NO:9 and the light chain variable domain comprises the amino acid sequence of SEQ ID NO:10.

6 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof of claim 1 , wherein said antibody binds specifically to fentanyl or fentanyl analog with a dissociation constant (Kd) equal to or less than 5 nM, and wherein the fentanyl analog is acryl fentanyl, cyclopropyl fentanyl, furanyl fentanyl, cis-3-methyl fentanyl, para-fluorofentanyl, or carfentanil.

7 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of any one of claims 1-6 , wherein the antibody is a chimeric antibody or a grafted antibody.

8 . The isolated recombinant monoclonal antibody, or antigen-binding fragment thereof, of claim 1 , further comprising a human constant region, wherein a source of the heavy chain variable domain and the light chain variable domain is different from a source of the human constant region.

9 . A composition comprising one or more of the isolated recombinant monoclonal antibodies, or antigen-binding fragments thereof, of claim 1 , and a pharmaceutically acceptable excipient.

10 . A method of detecting the presence of fentanyl or fentanyl analogs in a sample, wherein the method comprises contacting the isolated recombinant monoclonal antibody of claim 1 with the said sample and analyzing the sample to detect binding of the isolated recombinant monoclonal antibody to fentanyl or fentanyl analog, and wherein the fentanyl analogs is acryl fentanyl, cyclopropyl fentanyl, furanyl fentanyl, cis-3-methyl fentanyl, para-fluorofentanyl, or carfentanil.

11 . The method of claim 10 , wherein the sample comprises serum, urine, saliva, mucus, cerebrospinal fluid, blood, tissues, feces, soil, water, food products, or gas.

12 . A method of sequestering fentanyl or fentanyl analog in a subject in need thereof, comprising administering to the subject one or more of the recombinant monoclonal antibodies, or antigen-binding fragments thereof, of claim 1 in an amount effective to bind to the fentanyl or fentanyl analog in the subject in need.

13 . The method of claim 12 , wherein the subject is a human, and wherein the fentanyl analog is acryl fentanyl, cyclopropyl fentanyl, furanyl fentanyl, cis-3-methyl fentanyl, para-fluorofentanyl, or carfentanil.

14 . The method of claim 12 , wherein the subject in need is experiencing an opioid overdose.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 20, 2024
From: BARRIENTOS, RODELL C.
To: THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.
Reel/Frame 067459/0801 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 20, 2024
From: TORRES, OSCAR B.
To: THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE, INC.
Reel/Frame 067459/0865 →
CONFIRMATORY LICENSE Recorded Jan 30, 2024
From: HENRY M. JACKSON FDN FOR THE ADV MIL/MED
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 066286/0610 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 10, 2022
From: OERTEL, THERESE
To: THE GOVERNMENT OF THE UNITED STATES, AS REPRESENTED BY THE SECRETARY OF THE ARMY
Reel/Frame 059876/0979 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 10, 2022
From: WHALEN, CONNOR
To: THE GOVERNMENT OF THE UNITED STATES, AS REPRESENTED BY THE SECRETARY OF THE ARMY
Reel/Frame 059880/0223 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2022
From: MATYAS, GARY R.
To: THE GOVERNMENT OF THE UNITED STATES, AS REPRESENTED BY THE SECRETARY OF THE ARMY
Reel/Frame 059811/0152 →
Continuity (2)
Provisional Application 63181826 · Apr 29, 2021
Related Publication 20220362374A1 · Nov 17, 2022
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