IP Library Granted Patent US 11,078,286
Granted Patent B2
US 11,078,286 · App. 15/761,398 · Granted Aug 3, 2021

Monoclonal antibodies specific for fibroblast growth factor receptor 4 (FGFR4) and methods of their use

Inventors: Javed Khan (Derwood, MD); Sivasubramanian Baskar (Ellicott City, MD); Rimas J. Orentas (Seattle, WA); Dimiter S. Dimitrov (Frederick, MD); Zhongyu Zhu (Frederick, MD); Tai Chi Cheuk (Germantown, MD)
Assignee: The United States of America, as represented by the Secretary, Department of Health and Human Services
C07K16/2863A61K39/39558A61K47/6803A61K47/6849A61K47/6911A61P35/00C07K2317/622C07K2317/77C07K2317/92
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Quick Facts
Patent No.
US 11,078,286
App. No.
15/761,398
Granted
Aug 3, 2021
Kind
B2
Abstract

Monoclonal antibodies selected from immunized mice, immunized rabbits and a human scFv library that specifically bind fibroblast growth factor receptor 4 (FGFR4) are described. Chimeric antigen receptors, antibody-drug conjugates, immunoconjugates, bispecific antibodies and immunoliposomes comprising the disclosed FGFR4-specific antibodies are also described. The antibody compositions can be used to diagnose or treat a FGFR4-positive cancer, such as rhabdomyosarcoma, lung cancer, liver cancer, breast cancer, pancreatic cancer or prostate cancer.

Claims (13)

1. An isolated monoclonal antibody that specifically binds fibroblast growth factor receptor 4 (FGFR4), or an antigen-binding fragment thereof, comprising a variable heavy (VH) domain and a variable light (VL) domain, wherein:

the amino acid sequence of the VH domain of the antibody comprises the complementarity determining region 1 (CDR1), CDR2 and CDR3 sequences of SEQ ID NO: 3, wherein the CDR1, CDR2, and CDR3 sequences respectively comprise residues 26-33, 52-59, and 98-111 of SEQ ID NO:3; and

the amino acid sequence of the VL domain of the antibody comprises the CDR1, CDR2 and CDR3 sequences of SEQ ID NO: 4, wherein the CDR1, CDR2, and CDR3 sequences respectively comprise residues 27-32, 50-52, and 88-98 of SEQ ID NO:4.

2. The monoclonal antibody or antigen-binding fragment of claim 1 , wherein:

the amino acid sequence of the VH domain is at least 90% identical to SEQ ID NO: 3 and the amino acid sequence of the VL domain is at least 90% identical to SEQ ID NO: 4.

3. The monoclonal antibody or antigen-binding fragment of claim 1 , wherein:

the amino acid sequence of the VH domain comprises SEQ ID NO: 3 and the amino acid sequence of the VL domain comprises SEQ ID NO: 4.

4. The antigen-binding fragment of claim 1 , wherein the antigen-binding fragment is an Fab fragment, an Fab′ fragment, an F(ab)′ 2 fragment, a single chain variable fragment (scFv) or a disulfide stabilized variable fragment (dsFv).

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

6. The monoclonal antibody or antigen-binding fragment of claim 1 , which is a fully human antibody or antigen-binding fragment.

7. The monoclonal antibody or antigen-binding fragment of claim 1 , which is a chimeric, synthetic, or humanized antibody or antigen-binding fragment.

8. A composition comprising the monoclonal antibody or antigen-binding fragment of claim 1 and a pharmaceutically acceptable carrier.

9. The antigen-binding fragment of claim 4 , wherein the fragment is a scFv comprising the amino acid sequence of SEQ ID NO: 38.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2021
From: CHEUK, TAI CHI
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 055931/0112 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 28, 2018
From: KHAN, JAVED; BASKAR, SIVASUBRAMANIAN; ORENTAS, RIMAS J.; DIMITROV, DIMITER S.; ZHU, ZHONGYU
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 045379/0687 →
Continuity (2)
Provisional Application 62221045 · Sep 20, 2015
Related Publication 20180318440A1 · Nov 8, 2018