IP Library › Granted Patent US 12,503,514
Granted Patent B2
US 12,503,514 · App. 18/344,391 · Granted Dec 23, 2025

Autoimmune suppressor and application thereof

Inventors: Bo Chen (Chengdu, CN); Gang Xu (Chengdu, CN); Juntao Yu (Chengdu, CN)
Assignee: Keymed Biosciences Co., Ltd.
C07K16/2866A61K39/395A61P37/06C07K2317/24C07K2317/522C07K2317/524C07K2317/526C07K2317/565C07K2317/567C07K2317/76C07K2317/92
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,503,514
App. No.
18/344,391
Granted
Dec 23, 2025
Kind
B2
Abstract

The present disclosure relates to a dual inhibiting antibody that targets human interleukin-4 and interleukin-13, a manufacturing method therefor and use thereof.

Claims (16)

1 . An antibody or a functional fragment thereof that specifically binds to IL-4Rα, comprising a heavy chain variable region (V H ) comprising V H CDR1, V H CDR2, and V H CDR3 that are identical to V H CDR1, V H CDR2, and V H CDR3 of SEQ ID NO: 176, and a light chain variable region (V L ) comprising V L CDR1, V L CDR2, and V L CDR3 that are identical to V L CDR1, V L CDR2, and V L CDR3 of SEQ ID NO: 221.

2 . The antibody or a functional fragment thereof according to claim 1 , wherein

the V H CDR1, V H CDR2, V H CDR3, V L CDR1, V L CDR2, and V L CDR3 are identical to amino acid sequences SEQ ID NOs: 177, 178, 179, 222, 223, and 224, respectively.

3 . A nucleic acid molecule encoding the antibody or a functional fragment thereof according to claim 1 .

4 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof the antibody or a functional fragment thereof according to claim 1 .

5 . The nucleic acid molecule according to claim 3 , wherein the nucleic acid molecule encoding the heavy chain variable region of the antibody or the functional fragment thereof comprises nucleic acid sequence SEQ ID NO: 180, and the nucleic acid molecule encoding the light chain variable region of the antibody or the functional fragment thereof comprises nucleic acid sequence SEQ ID NO: 225.

6 . A vector comprising a nucleic acid molecule encoding the antibody or functional fragment thereof according to claim 1 .

7 . A cell comprising a vector comprising a nucleic acid molecule encoding the antibody or functional fragment thereof according to claim 1 .

8 . A pharmaceutical composition comprising the antibody or functional fragment thereof according to claim 1 , and a pharmaceutically acceptable carrier.

9 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof a nucleic acid molecule encoding the antibody or functional fragment thereof according to claim 1 .

10 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof a vector comprising a nucleic acid molecule encoding the antibody or functional fragment thereof according to claim 1 .

11 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof a cell comprising a vector comprising a nucleic acid molecule encoding the antibody or functional fragment thereof according to claim 1 .

12 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof a pharmaceutical composition comprising the antibody or functional fragment thereof according to claim 1 , and a pharmaceutically acceptable carrier.

13 . The antibody or a functional fragment thereof according to claim 1 , wherein the heavy chain variable region comprises amino acid sequence SEQ ID NO: 176, and the light chain variable region comprises amino acid sequence SEQ ID NO: 221.

14 . A pharmaceutical composition comprising a nucleic acid encoding the antibody or functional fragment thereof according to claim 1 , and a pharmaceutically acceptable carrier.

15 . A method of treating an allergy, asthma, or chronic obstructive pulmonary disease, comprising administering to a mammalian patient in need thereof a pharmaceutical composition comprising a nucleic acid encoding the antibody or functional fragment thereof according to claim 1 , and a pharmaceutically acceptable carrier.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2023
From: CHEN, BO; XU, GANG; YU, JUNTAO
To: KEYMED BIOSCIENCES CO., LTD.
Reel/Frame 064669/0483 →
Priority Claims (1)
CN 201810528489.8 · May 29, 2018 · national
Continuity (2)
Continuation 16971774
Related Publication 20240092920A1 · Mar 21, 2024
References Cited (75)
US 3773919A · Boswell et al. · 1973 [cited by applicant]
US 4522811A · Eppstein et al. · 1985 [cited by applicant]
US 7229619B1 · Young et al. · 2007 [cited by applicant]
US 11725057B2 · Chen · 2023 [cited by examiner]
US 20050112694A1 · Carter et al. · 2005 [cited by applicant]
US 20070041976A1 · Pluenneke · 2007 [cited by applicant]
US 20120135010A1 · Stevens et al. · 2012 [cited by applicant]
US 20170281769A1 · Eriksson et al. · 2017 [cited by applicant]
AU 2009329348A1 · 2011 [cited by applicant]
CA 3026568A1 · 2017 [cited by applicant]
CN 1076966A · 1993 [cited by applicant]
CN 103739711A · 2014 [cited by applicant]
CN 104487453 · 2015 [cited by applicant]
CN 104718223 · 2015 [cited by applicant]
CN 107474134A · 2017 [cited by applicant]
CN 109071657 · 2018 [cited by applicant]
CN 111647082 · 2020 [cited by applicant]
CN 113101364A · 2021 [cited by applicant]
CN 114634567 · 2022 [cited by applicant]
JP 2010505418A · 2010 [cited by applicant]
JP 2012507294A · 2012 [cited by applicant]
RU 2539774C2 · 2015 [cited by applicant]
WO WO2000064944A1 · 2000 [cited by applicant]
WO WO2003035847A2 · 2003 [cited by applicant]
WO WO2003038041A2 · 2003 [cited by applicant]
WO WO2003092610A2 · 2003 [cited by applicant]
WO WO2005062967A2 · 2005 [cited by applicant]
WO WO2005076990A2 · 2005 [cited by applicant]
WO WO2008151819A2 · 2008 [cited by applicant]
WO WO2010053751A1 · 2010 [cited by applicant]
WO WO2010070346 · 2010 [cited by applicant]
WO WO2010070346A2 · 2010 [cited by applicant]
WO WO2015006571 · 2015 [cited by applicant]
WO WO2017114694A1 · 2017 [cited by applicant]
WO WO2017211319A1 · 2017 [cited by applicant]
Brighlling et al., (2014). “Benralizumab for Chronic Obstructive Pulmonary Disease and Sputum Eosinphilia: A Randdomized, Double-Blind, Placebo-controlled Phase 2a Study,” Lance Respir Med, 2(11):891-901. [cited by applicant]
Cai et al., (2016). “Bioanalytical Challenges and Improved Detection of Circulating Levels of IL-13,” Bioanalysis 8(4):323-332. [cited by applicant]
Carrillo et al., (1988). “The Multiple Sequence Alignment Problem in Biology,” Siam J Appl. Math, 48:5. [cited by applicant]
Chothia et al., (1987). “Canonical Structures for the Hypervariable Regions of Immunoglobulins,” J Mol. Biol., 196:901-917. [cited by applicant]
De Pascalis et al., (2002). “Grafting of abbreviated complementarity determining regions containing specificity determining residues essential for ligand contact to engineer a less immunogenic humanzied monoclonal antib… [cited by applicant]
Englebienne, (1998). “Use of Colloidal Gold Surface Pasmon Resonance Peak Shill to Inter Affinity Constants form the Intemationsl Between Proten Antigens an Antibodies Specific for Single or Multiple Epitopes,” Analyst,… [cited by applicant]
English Translation of the Written Opinion of the International Searching Authority of PCT/CN2019/089031 (Sep. 2, 2020). [cited by applicant]
Fahy, (2015). “Type 2 Inflammation in Asthma—Present in Most, Absent in Many,” Nat Rev Immunol, 15:57-65. [cited by applicant]
Goel et al., (2004). “Plasticity within the Antigen-Combining Site May Manifest as Molecular Mimicry in the Humoral Immune Response,” J. Immunol., 173(12):7358-7367. [cited by applicant]
Griffin, (1994). “Computer Analysis of Sequence Data,” Methods in Molecular Biology, 24:1-8. [cited by applicant]
Hanania et al., (2015). “Lebrikizumab in Moderate-to-Severe Asthma: Pooled Data From Two Randomised Placebo-Controlled Studies,” Thorax, 70(8):748-56. [cited by applicant]
Heinzmann et al., (2000). “Genetic Variants of IL-13 Signalling a Human Asthma and Atopy,” Hum Mol Genet, 9:549-559. [cited by applicant]
Hersey (2003). “IL-13 Receptors and Signaling Pathways: An Evolving Web,” J Allergy Clin Immunol, 111(4):677-90. [cited by applicant]
Khan et al., (2014). “Adjustable Locks and Flexible Keys: Plasticity of Epitope-Paratope Interactions in Germline Antibodies” J. Immunol., 192:5398-5405. [cited by applicant]
Maccallum et al., (1996). “Antibody-antigen interactions: contact analysis and binding site topography,” Journal of Molecular Biology, 262:732-745. [cited by applicant]
Mariuzza et al., (1987). “The Structural Basis of Antigen-Antibody Recognition,” Annu. Rev. Biophys. Biphys. Chem., 16:139-159. [cited by applicant]
Miller et al., (2003). “Design Construction, and In Vitro Analyses of Multivalent Antibodies,” J immunol, 170:4854-4861. [cited by applicant]
Nakamura et al., (2000). “Codon Usage Tabulated from International DNA Sequence Databases: Status for the year 2000,” Nucl. Acids Res, 28:292. [cited by applicant]
Noonan et al., (2013). “Dose-ranging Study of Lebrikizumab in Asthmatic Patients Not Receiving Inhaled Steroids,” J Allergy Clin Immunol, 132(3):567-574.e12. [cited by applicant]
Oh et al., (2010). “Investigational Therapeutics Targeting the IL-4/IL-13/STAT-6 Pathway for the Treatment of Asthma,” Eur Respir Rev, 19:46-54. [cited by applicant]
Poosarla et al., (2017). “Computational De Novo Design of Antibodies Binding to a Peptide With High Affinity,” Biotech Bioeng, 114(6):1331-1342. [cited by applicant]
Rich et al., (2000). “Advances in Surface Plasmon Resonance Biosensor Analysis,” Curr Opin Biotechnol, 11:54-61. [cited by applicant]
Rudikoff et al., (1982). “Single Amino Acid Substitution Altering Antigen-binding Specificity, Immunonlogy,” Proc. Natl. Acad. Sci. USA, 79:1979-1983. [cited by applicant]
Smith et al., (1994). “Bioinformatics and the Genome Projects, Biocomputing Informatics and Genome Projects,” Academic Press, 12, p. 427. [cited by applicant]
Smith et al., (2004). “Demystified Recombinant Antibodies,” J Clin Pathol, 57:912-917. [cited by applicant]
UniProtKb, (2020). “P05112 (IL4_Human),” available online at <https://www.uniprot.org/uniprotkb/P05112/entry>, 9 pages. [cited by applicant]
UniProtKb, (2020). “P2434 (IL4RA_Human),” available online at <https://www.uniprot.org/uniprot/P24394>, 18 pages. [cited by applicant]
UniProtKb, (2020). “P35225 (Il 13_Human),” available online at <https://www.uniprot.org/uniprotkb/P35225/entry>, 12 pages. [cited by applicant]
UniProtKb, (2020). “P78552 (113R1_Human),” available online at <https://www.uniprot.org/uniprotkb/P78552/entry>, 13 pages. [cited by applicant]
UniProtKb, (2020). “Q6JHZ9 (Q6JHZ9_MACFA),” available online at <https://www.uniprot.org/uniprotkb/Q6JHZ9/entry>, 4 pages. [cited by applicant]
Welschof et al., (2003). Recombinant Antibodies for Cancer Therapy Methods and Protocol, MIMB, 207, 3 pages. [cited by applicant]
Wynn et al., (2003). “IL-13 Effector Functions,” Annu. Ref. Immunol., 21:425-56. [cited by applicant]
Hua et al., (2017). “Generation and characterization of monoclonal antibodies against chicken IL-4 by plasmid immunization,” Chin J Vet Sci, 37(12):2270-2274. English abstract. [cited by applicant]
Liu et al., (2017). “IL-4R suppresses airway inflammation in bronchial asthma by inhibiting the IL-4/STAT6 pathway,” Pulmonary Pharma & Ther, 43:32-38. [cited by applicant]
Luo et al., “Effects of Blockage of IL-4Rα on the Early Cytokine Profiles in Hepatic Mononuclear Cells from Mice Infected with [cited by applicant]
Office Action (including translation) for BR112020009211-8, issued Jan. 17, 2024, pp. 1-6. [cited by applicant]
Oh et al., “Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma,” Eur Respir Rev 2010; 19: 115, 46-54. [cited by applicant]
Search Report (including translation) for CN2021103108037, issued Dec. 28, 2022, pp. 1-6. [cited by applicant]
Supplementary Search Report (including translation) for CN2021103108037, issued Sep. 27, 2023, pp. 1-4. [cited by applicant]
Wu et al., “Effect of prepared mIL-4Rα-EX-TT autovaccine on the asthma mice,” Chin Med Biotechnol, 2015, 10(5):398-404. [cited by applicant]