Granted Patent
B2
US 12,410,261 · App. 18/618,414 · Granted Sep 9, 2025
Anti-HER2 antibody or antigen-binding fragment thereof, and chimeric antigen receptor comprising same
Inventors:
Jong Seo Lee (Yongin-si, KR); Kyu Tae Kim (Yongin-si, KR); Young Ha Lee (Yongin-si, KR); In Sik Hwang (Yongin-si, KR); Bong Kook Ko (Yongin-si, KR); Eunji Choi (Yongin-si, KR); You-Sun Kim (Yongin-si, KR); Jeongmin Kim (Yongin-si, KR); Miyoung Jung (Yongin-si, KR); Hoyong Lim (Yongin-si, KR); Sungyoo Cho (Yongin-si, KR)
Assignee:
GC Cell Corporation
C07K16/32A61K38/177A61K40/15A61K40/31A61K40/4205A61P35/00C07K14/705C12N5/0646A61K2239/31A61K2239/38A61K2239/49A61K2239/53C07K2317/565
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present disclosure relates to a novel anti-HER2 antibody or an antigen-binding fragment thereof used in the prevention or treatment of cancer, a chimeric antigen receptor including the same, and uses thereof. The antibody of the present disclosure is an antibody that specifically binds to HER2 which is highly expressed in cancer cells (particularly, breast cancer or gastric cancer cells), and binds to an epitope that is different from an epitope to which trastuzumab binds.
Claims (24)
1. A chimeric antigen receptor targeting human HER2, the chimeric antigen receptor comprising an amino acid sequence comprising:
an extracellular antigen binding domain comprising a heavy chain variable region comprising the amino acid sequences of SEQ ID NO: 7, SEQ ID NO: 8, and SEQ ID NO: 9, and a light chain variable region comprising the amino acid sequences of SEQ ID NO: 10, SEQ ID NO: 11, and SEQ ID NO: 12;
a hinge domain;
a transmembrane domain; and
an intracellular signaling domain comprising an OX40L intracellular signaling domain.
2. The chimeric antigen receptor of claim 1 , wherein the OX40L intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 127.
3. The chimeric antigen receptor of claim 2 , wherein the OX40L intracellular signaling domain comprises the amino acid sequence of SEQ ID NO: 127.
4. The chimeric antigen receptor of claim 1 , wherein the intracellular signaling domain further comprises a CD3z intracellular signaling domain.
5. The chimeric antigen receptor of claim 4 , wherein the CD3z intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 121.
6. The chimeric antigen receptor of claim 5 , wherein the CD3z intracellular signaling domain comprises the amino acid sequence of SEQ ID NO: 121.
7. The chimeric antigen receptor of claim 1 , wherein the intracellular signaling domain further comprises a CD28 intracellular signaling domain.
8. The chimeric antigen receptor of claim 7 , wherein the CD28 intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 125.
9. The chimeric antigen receptor of claim 8 , wherein the CD28 intracellular signaling domain comprises the amino acid sequence of SEQ ID NO: 125.
10. The chimeric antigen receptor of claim 1 , wherein the intracellular signaling domain further comprises a CD3z intracellular signaling domain and a CD28 intracellular signaling domain.
11. The chimeric antigen receptor of claim 10 , wherein the OX40L intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 127, the CD3z intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 121, and the CD28 intracellular signaling domain comprises an amino acid sequence having at least 90% sequence identity with SEQ ID NO: 125.
12. The chimeric antigen receptor of claim 11 , wherein the OX40L intracellular signaling domain comprises an amino acid sequence having the amino acid sequence of SEQ ID NO: 127, the CD3z intracellular signaling domain comprises an amino acid sequence having the amino acid sequence of SEQ ID NO: 121, and the CD28 intracellular signaling domain comprises an amino acid sequence having the amino acid sequence of SEQ ID NO: 125.
13. The chimeric antigen receptor of claim 1 , wherein the hinge domain is a CD8a hinge domain and the transmembrane domain is a CD28 transmembrane domain.
14. The chimeric antigen receptor of claim 12 , wherein the hinge domain is a CD8a hinge domain and the transmembrane domain is a CD28 transmembrane domain.
15. A nucleic acid encoding the chimeric antigen receptor of claim 1 .
16. A vector comprising the nucleic acid of claim 15 .
17. A cell expressing the chimeric antigen receptor of claim 1 .
18. The cell of claim 17 , wherein the cell is an immune cell.
19. The cell of claim 18 , wherein the cell is a natural killer cell.
20. A method of treating a HER2 positive cancer, the method comprising: administering to a subject in need thereof the cell of claim 19 .
Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 15, 2024
From: LEE, JONG SEO; KIM, KYU TAE; LEE, YOUNG HA; HWANG, IN SIK; KO, BONG KOOK; CHOI, EUNJI; KIM, YOU-SUN; KIM, JEONGMIN; JUNG, MIYOUNG; LIM, HOYONG; CHO, SUNGYOO
To: GREEN CROSS CELL CORPORATION
Reel/Frame 067112/0402 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 15, 2024
From: GC CELL CORPORATION
To: LEE, JONG SEO; KIM, KYU TAE; LEE, YOUNG HA; HWANG, IN SIK; KO, BONG KOOK
Reel/Frame 067112/0426 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 15, 2024
From: LEE, JONG SEO; KIM, KYU TAE; LEE, YOUNG HA; HWANG, IN SIK; KO, BONG KOOK
To: ABCLON, INC.
Reel/Frame 067112/0437 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 15, 2024
From: ABCLON, INC.
To: GC CELL CORPORATION
Reel/Frame 067112/0443 →
MERGER AND CHANGE OF NAME
Recorded Apr 15, 2024
From: GREEN CROSS LAB CELL CORPORATION; GC CELL CORPORATION
To: GREEN CROSS CELL CORPORATION
Reel/Frame 067127/0132 →
Priority Claims (1)
KR 10-2017-0151841
· Nov 14, 2017
· national
Continuity (4)
Continuation In Part
16764276
References Cited (400)
US 4554101A
· Hopp
· 1985
[cited by applicant]
US 5783186A
· Arakawa et al.
· 1998
[cited by applicant]
US 5821337A
· Carter et al.
· 1998
[cited by applicant]
US 7674460B2
· Serrero
· 2010
[cited by applicant]
US 7741465B1
· Eshhar et al.
· 2010
[cited by applicant]
US 8314213B2
· Bernett et al.
· 2012
[cited by applicant]
US 8404811B2
· Ye et al.
· 2013
[cited by applicant]
US 9079976B2
· Shirwan et al.
· 2015
[cited by applicant]
US 9394368B2
· Brogdon et al.
· 2016
[cited by applicant]
US 9624276B2
· Young et al.
· 2017
[cited by applicant]
US 9777064B2
· Wang et al.
· 2017
[cited by applicant]
US 9845362B2
· Mukherjee
· 2017
[cited by applicant]
US 20100183604A1
· Ohta et al.
· 2010
[cited by applicant]
US 20140255363A1
· Metelitsa et al.
· 2014
[cited by applicant]
US 20170107216A1
· Wu et al.
· 2017
[cited by applicant]
US 20170151281A1
· Wagner et al.
· 2017
[cited by applicant]
US 20170174679A1
· Lajkiewicz et al.
· 2017
[cited by applicant]
US 20170190786A1
· Fendly et al.
· 2017
[cited by applicant]
US 20170313759A1
· Batuwangala
· 2017
[cited by applicant]
US 20170335281A1
· Loew et al.
· 2017
[cited by applicant]
US 20170362253A1
· Xiao et al.
· 2017
[cited by applicant]
US 20180057486A1
· Wu et al.
· 2018
[cited by applicant]
US 20180079824A1
· Ahmed et al.
· 2018
[cited by applicant]
US 20190037831A1
· Hwang et al.
· 2019
[cited by applicant]
US 20190336533A1
· Hwang et al.
· 2019
[cited by applicant]
US 20200102366A1
· Cooper et al.
· 2020
[cited by applicant]
US 20210040216A1
· Chui et al.
· 2021
[cited by applicant]
US 20210060070A1
· Coughlin
· 2021
[cited by applicant]
US 20210147803A1
· Hwang et al.
· 2021
[cited by applicant]
US 20240366663A1
· Kim et al.
· 2024
[cited by applicant]
US 20240409665A1
· Lee et al.
· 2024
[cited by applicant]
US 20250073264A1
· Lim et al.
· 2025
[cited by applicant]
CA 2402930
· 2004
[cited by applicant]
CN 104177499
· 2014
[cited by applicant]
CN 105246504
· 2016
[cited by applicant]
CN 105925536
· 2016
[cited by applicant]
EP 3567049A2
· 2019
[cited by applicant]
JP 2010006705
· 2010
[cited by applicant]
JP 2013534809
· 2013
[cited by applicant]
JP 2016508725
· 2016
[cited by applicant]
JP 2016518368
· 2016
[cited by applicant]
KR 101453462
· 2014
[cited by applicant]
KR 1020150048783
· 2015
[cited by applicant]
KR 1020160015195
· 2016
[cited by applicant]
KR 1020160022857
· 2016
[cited by applicant]
KR 1020160062760
· 2016
[cited by applicant]
WO WO1994000136
· 1994
[cited by applicant]
WO WO2006033700
· 2006
[cited by applicant]
WO WO2011127297
· 2011
[cited by applicant]
WO WO2013094988
· 2013
[cited by applicant]
WO WO2014130657
· 2014
[cited by applicant]
WO WO2014185704
· 2014
[cited by applicant]
WO WO2015033299
· 2015
[cited by applicant]
WO WO2015033301
· 2015
[cited by applicant]
WO WO2015033303
· 2015
[cited by applicant]
WO WO2015034820
· 2015
[cited by applicant]
WO WO2015036927
· 2015
[cited by applicant]
WO WO2015044900
· 2015
[cited by applicant]
WO WO2015095895
· 2015
[cited by applicant]
WO WO2015160641
· 2015
[cited by applicant]
WO WO2015164594
· 2015
[cited by applicant]
WO WO2016039749
· 2016
[cited by applicant]
WO WO2016176639
· 2016
[cited by applicant]
WO WO2016077518
· 2016
[cited by applicant]
WO WO2016085248
· 2016
[cited by applicant]
WO WO2016090320
· 2016
[cited by applicant]
WO WO2016100608
· 2016
[cited by applicant]
WO WO2016120219
· 2016
[cited by applicant]
WO WO2016123333
· 2016
[cited by applicant]
WO WO2016126646
· 2016
[cited by applicant]
WO WO2016142833
· 2016
[cited by applicant]
WO WO2016142835
· 2016
[cited by applicant]
WO WO2016142852
· 2016
[cited by applicant]
WO WO2016142886
· 2016
[cited by applicant]
WO WO2016142894
· 2016
[cited by applicant]
WO WO2016154585
· 2016
[cited by applicant]
WO WO2016174652
· 2016
[cited by applicant]
WO WO2016191756
· 2016
[cited by applicant]
WO WO2017066227
· 2017
[cited by applicant]
WO WO2017070089
· 2017
[cited by applicant]
WO WO2017079694
· 2017
[cited by applicant]
WO WO2017079705
· 2017
[cited by applicant]
WO WO2017106634
· 2017
[cited by applicant]
WO WO2017118762
· 2017
[cited by applicant]
WO WO2017167967
· 2017
[cited by applicant]
WO WO2017176608
· 2017
[cited by applicant]
WO WO2017192961
· 2017
[cited by applicant]
WO WO2017202273
· 2017
[cited by applicant]
WO WO2017202275
· 2017
[cited by applicant]
WO WO2017202276
· 2017
[cited by applicant]
WO WO2017205464
· 2017
[cited by applicant]
WO WO2017222593
· 2017
[cited by applicant]
WO WO2018005374
· 2018
[cited by applicant]
WO WO2018006795
· 2018
[cited by applicant]
WO WO2018009505
· 2018
[cited by applicant]
WO WO2018013789
· 2018
[cited by applicant]
WO WO2018026971
· 2018
[cited by applicant]
WO WO2018044963
· 2018
[cited by applicant]
WO WO2018045142
· 2018
[cited by applicant]
WO WO2018051254
· 2018
[cited by applicant]
WO WO2018051255
· 2018
[cited by applicant]
WO WO2018140725
· 2018
[cited by applicant]
WO WO2019008152
· 2019
[cited by applicant]
WO WO2019008154
· 2019
[cited by applicant]
WO WO2019023575
· 2019
[cited by applicant]
WO WO2019030757
· 2019
[cited by applicant]
WO WO2019079564
· 2019
[cited by applicant]
WO WO2019098682
· 2019
[cited by applicant]
WO WO2019160501
· 2019
[cited by applicant]
WO WO2019160956
· 2019
[cited by applicant]
WO WO2019182392
· 2019
[cited by applicant]
WO WO2020055040
· 2020
[cited by applicant]
WO WO2020069409
· 2020
[cited by applicant]
WO WO2020096646
· 2020
[cited by applicant]
WO WO2020097346A1
· 2020
[cited by applicant]
WO WO2020101361
· 2020
[cited by applicant]
WO WO2021071962
· 2021
[cited by applicant]
WO WO2021218947
· 2021
[cited by applicant]
WO WO2022133056
· 2022
[cited by applicant]
WO WO2022133057
· 2022
[cited by applicant]
WO WO2022133061
· 2022
[cited by applicant]
WO WO2022204244
· 2022
[cited by applicant]
WO WO2022216144
· 2022
[cited by applicant]
WO WO2022216811
· 2022
[cited by applicant]
WO WO2022216813
· 2022
[cited by applicant]
WO WO2022216815
· 2022
[cited by applicant]
WO WO2022216826
· 2022
[cited by applicant]
WO WO2022216831
· 2022
[cited by applicant]
WO WO2022216837
· 2022
[cited by applicant]
WO WO2023080895
· 2023
[cited by applicant]
WO WO2023081317
· 2023
[cited by applicant]
WO WO2024040135
· 2024
[cited by applicant]
WO WO2024119126
· 2024
[cited by applicant]
WO WO2024238582A2
· 2024
[cited by applicant]
WO WO2024243058A1
· 2024
[cited by applicant]
WO WO2024254507A2
· 2024
[cited by applicant]
WO WO2024259070A2
· 2024
[cited by applicant]
Qin et al. (Incorporation of a hinge domain improves the expansion of chimeric antigen receptor T cells. J Hematol Oncol 10, 68, Mar. 2017). (Year: 2017).
[cited by examiner]
Sun et al. (Construction and evaluation of a novel humanized HER2-specific chimeric receptor. Breast Cancer Res 16, R61, 2014) (Year: 2014).
[cited by examiner]
U.S. Appl. No. 16/474,426, filed Jun. 27, 2019, Hwang et al.
[cited by applicant]
U.S. Appl. No. 16/764,276, filed Sep. 28, 2020, Lee et al.
[cited by applicant]
U.S. Appl. No. 16/881,650, filed May 22, 2020, Lee et al.
[cited by applicant]
U.S. Appl. No. 17/845,793, filed Jun. 21, 2022, Hwang et al.
[cited by applicant]
U.S. Appl. No. 18/285,631, filed Oct. 4, 2023, Hwang et al.
[cited by applicant]
U.S. Appl. No. 18/285,634, filed Oct. 4, 2023, Kim et al.
[cited by applicant]
U.S. Appl. No. 18/285,636, filed Oct. 4, 2023, Lim et al.
[cited by applicant]
U.S. Appl. No. 18/298,310, filed Apr. 10, 2023, Lee et al.
[cited by applicant]
Abate-Daga et al., “CAR models: next-generation CAR modifications for enhanced T-cell function,” Molecular Therapy—Oncolytics, Jan. 2016, 3(16014):1-7.
[cited by applicant]
Abou-Alfa et al., “Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma,” J. Hepatol., Aug. 2016, 65(2):289-95.
[cited by applicant]
Agus et al., “Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer,” J. Clin. Oncol., Apr. 10, 2005, 23(11):2534-43.
[cited by applicant]
Akiyama et al., “The product of the human c-erbB-2 gene: a 185-kilodalton glycoprotein with tyrosine kinase activity,” Science, Jun. 27, 1986, 232(4758):1644- 1646.
[cited by applicant]
Alizadeh et al., “IL15 Enhances CAR-T Cell Antitumor Activity by Reducing mTORC1 Activity and Preserving Their Stem Cell Memory Phenotype,” Cancer Immunology Research, May 2019, 7(5):759-772.
[cited by applicant]
Altschul et al., “Basic local alignment search tool,” J. Mol. Biol., Oct. 5, 1990, 215(3):403-410.
[cited by applicant]
Andre et al., “Anti-NKG2A mAb Is a Checkpoint Inhibitor that Promotes Anti-tumor Immunity by Unleashing Both T and NK Cells,” Cell. Dec. 13, 2018;175(7):1731-1743.
[cited by applicant]
Arteaga et al., “p185c-erbB-2 Signaling Enhances Cisplatin-induced Cytotoxicity in Human Breast Carcinoma Cells: Association between an Oncogenic Receptor Tyrosine Kinase and Drug-induced DNA Repair,” Cancer Research, J…
[cited by applicant]
Ataca et al., “Chimeric Antigen Receptor T Cell Therapy in Hematology,” Turk J Hematol., 2015, 32:285-294.
[cited by applicant]
Awada et al., “Abstract No. 2504: Results from a first-in-man, open label, safety and tolerability trial of CAN04 (nidanilimab), a fully humanized monoclonal antibody against the novel antitumor target, IL1RAP, in patie…
[cited by applicant]
Babic et al., “Pritumumab, the first therapeutic antibody for glioma patients,” Hum Antibodies, Feb. 5, 2018, 26(2):95-101.
[cited by applicant]
Bacigalupo et al., “Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab,” Bone Marrow Transplant, Aug. 2020, 55(8):1580-1587.
[cited by applicant]
Bacus et al., “Differentiation of cultured human breast cancer cells (AU-565 and MCF-7) associated with loss of cell surface HER-2/neu antigen,” Molecular Carcinogenesis, 1990, 3:350-362.
[cited by applicant]
Bacus et al., “Tumor-inhibitory Monoclonal Antibodies to the HER-2/Neu Receptor Induce Differentiation of Human Breast Cancer Cells,” Cancer Research, May 1992, 52:2580-2589.
[cited by applicant]
Bajaj et al., “Conatumumab: a novel monoclonal antibody against death receptor 5 for the treatment of advanced malignancies in adults,” Expert Opin. Biol. Ther., Nov. 2011, 11(11): 1519-1524.
[cited by applicant]
Baldo et al., “Amatuximab and novel agents targeting mesothelin for solid tumors,” Onco Targets Ther., Nov. 2017, 10:5337-5353.
[cited by applicant]
Bang et al., “First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors,” Ann. Oncol., Apr. 2017, 28(4):855-861.
[cited by applicant]
Bauman et al., “Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer.,” Cancers, Jun. 11, 2020, 12(6):1537.
[cited by applicant]
Bhati et al., “Efficacy and safety of an anti-CD 20 monoclonal antibody (Reditux™M) for the treatment of patients with moderate to severe rheumatoid arthritis following the failure of conventional synthetic disease-modi…
[cited by applicant]
Bilen et al. “Association of Neutrophil-to-Lymphocyte Ratio with Efficacy of First-Line Avelumab plus Axitinib vs. Sunitinib in Patients with Advanced Renal Cell Carcinoma Enrolled in the Phase 3 JAVELIN Renal 101 Trial…
[cited by applicant]
Bilusic et al., “Phase I trial of HuMax-IL8 (BMS-986253), an anti-IL-8 monoclonal antibody, in patients with metastatic or unresectable solid tumors,” J. Immunother. Cancer, Sep. 5, 2019, 7(1):240.
[cited by applicant]
Bobkov et al., “Antibodies targeting chemokine receptors CXCR4 and ACKR3,” Mol. Pharmacol., Dec. 2019, 96(6):753-764.
[cited by applicant]
Brunker et al., “RG7386, a novel tetravalent FAP-DR5 antibody, effectively triggers FAP-dependent, avidity-driven DR5 hyperclustering and tumor cell apoptosis,” Mol. Cancer Ther., May 2016, 15(5):946-57.
[cited by applicant]
Burge et al., “Pharmacokinetic and pharmacodynamic properties of TRU-015, a CD20-directed small modular immunopharmaceutical protein therapeutic, in patients with rheumatoid arthritis: a Phase I, open-label, dose-escala…
[cited by applicant]
Bussolati et al., “A modified Trastuzumab antibody for the immunohistochemical detection of HER-2 overexpression in breast cancer,” British Journal of Cancer, Apr. 5, 2005, 92:1261-1267.
[cited by applicant]
Carson et al., “A potential role for interleukin-15 in the regulation of human natural killer cell survival,” The Journal of Clinical Investigation, Mar. 1, 1997, 99(5):937-943.
[cited by applicant]
Casulo et al., “A phase I study of PRO131921, a novel anti-CD20 monoclonal antibody in patients with relapsed/refractory CD20+ indolent NHL: correlation between clinical responses and AUC pharmacokinetics,” Clin. Immuno…
[cited by applicant]
Catenacci et al., “Phase I escalation and expansion study of bemarituzumab (FPA144) in patients with advanced solid tumors and FGFR2b-selected gastroesophageal adenocarcinoma.,” J. Clin. Oncol., Jul. 20, 2020, 38(21):24…
[cited by applicant]
Cerutti et al., “Physicochemical and biological characterization of RTXM83, a new rituximab biosimilar,” BioDrugs, Jun. 2019, 33(3):307-319.
[cited by applicant]
Chamie et al., “Adjuvant weekly girentuximab following nephrectomy for high-risk renal cell carcinoma: the ARISER randomized clinical trial,” JAMA Oncol., Jul. 2017, 3(7):913-920.
[cited by applicant]
Chen et al., “IGF-1R as an anti-cancer target—trials and tribulations,” Chinese Journal of Cancer, May 2013, 32(5):242-252.
[cited by applicant]
Cheney et al., “Ocaratuzumab, an Fc-engineered antibody demonstrates enhanced antibody-dependent cell-mediated cytotoxicity in chronic lymphocytic leukemia,” MAbs, May-Jun. 2014, 6(3):749-55.
[cited by applicant]
Cheng et al., “Safety and efficacy of tigatuzumab plus sorafenib as first-line therapy in subjects with advanced hepatocellular carcinoma: a phase 2 randomized study,” J. Hepatol., Oct. 2015, 63(4):896-904.
[cited by applicant]
Cho et al., “Antitumor activity of MEDI3726 (ADCT-401), a pyrrolobenzodiazepine antibody-drug conjugate targeting PSMA, in preclinical models of prostate cancer,” Mol Cancer Ther., Oct. 2018, 17(10):2176-2186.
[cited by applicant]
Choi et al., “Phase I Trial: Cirmtuzumab Inhibits ROR1 Signaling and Stemness Signatures in Patients with Chronic Lymphocytic Leukemia,” Cell Stem Cell, Jun. 2018, 22(6):951-959.
[cited by applicant]
ClinicalTrials.gov [online], “64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (CUPID),” NCT04726033, Nov. 28, 2022, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltria…
[cited by applicant]
ClinicalTrials.gov [online], “A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relaps…
[cited by applicant]
ClinicalTrials.gov [online], “A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects,” NCT01205737, Oct. 22, 2013, retrieved on Feb. 16, 2024, retrieved from URL: <ht…
[cited by applicant]
ClinicalTrials.gov [online], “A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanc…
[cited by applicant]
ClinicalTrials.gov [online], “A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors,” NCT01946789, Apr. 17, 2019, retrieved on Feb. 16, 2024, retrieved from URL: <http…
[cited by applicant]
ClinicalTrials.gov [online], “A Phase I Dose-Escalation Study of IMGN388 in Patients With Solid Tumors,” NCT00721669, Sep. 13, 2013, retrieved on Feb. 8, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT00…
[cited by applicant]
ClinicalTrials.gov [online], “A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111in Capromab Pendetide in Subjects With Metastatic Prostate Cancer,” NCT00992745, Oct. 12, 2011, retrieved on Feb. 8, 2024, retrieved …
[cited by applicant]
ClinicalTrials.gov [online], “A Phase I Study of Intravenous CO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma,” NCT03221348, Jan. 24, 2018, retrieved on Feb. 16, 2024, retrieved from URL: <https://clin…
[cited by applicant]
ClinicalTrials.gov [online], “A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma,” NCT02998047, Mar. 8, 2022, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/stu…
[cited by applicant]
ClinicalTrials.gov [online], “A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Pa…
[cited by applicant]
ClinicalTrials.gov [online], “A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors,” NCT03665285, Dec. 26, 2023, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinical…
[cited by applicant]
ClinicalTrials.gov [online], “A Study Comparing GB241 and Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma,” NCT03003039, Mar. 23, 2021, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.go…
[cited by applicant]
ClinicalTrials.gov [online], “A Study Evaluating the Safety and Pharmacokinetics of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer,” NCT02146313, Jun. 21, 2018, retrie…
[cited by applicant]
ClinicalTrials.gov [online], “A Study in Participants With Diabetic Kidney Disease,” NCT01113801, Sep. 17, 2019, retrieved on Feb. 8, 2024, retrieved from URL: <https://classic.clinicaltrials.gov/ct2/show/NCT01113801>, …
[cited by applicant]
ClinicalTrials.gov [online], “A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Health Subjects,” NCT04516564, Oct. 18, 2021, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors,” NCT04547205, Feb. 23, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT045472…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (AGAVE-201),” NCT04710576, Aug. 21, 2023, retrieved on Feb. 20, 2024, retrieved fro…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (Keynote-A04),” NCT04219254, Nov. 24, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <http…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of HLX06, a Humanized Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients With Advanced Solid Tumors,” NCT03494231, Jul. 30, 2019, retrieve…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of IGN002 for Refractory NHL,” NCT02847949, Mar. 11, 2022, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT02847949>, 21 pages.
[cited by applicant]
ClinicalTrials.gov [online], “A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma,” NCT04082936, Nov. 15, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors,” NCT03926013, Nov. 7, 2022, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT03…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of LY3076226 in Participants With Advanced or Metastatic Cancer,” NCT02529553, Apr. 17, 2020, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT02…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas,” NCT04103905, Jun. 16, 2021, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT04103905>,…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of MSB0254 Injection in Advanced Solid Tumors,” NCT04381325, Apr. 5, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT04381325>, 26 pages.
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors,” NCT04452955, Mar. 1, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/st…
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated (ELM-2),” NCT03888105, Apr. 20, 2023, ret…
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors,” NCT03760081, …
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B- Cell Lymphoma (DLBCL),” NCT03670901, Jan. 9, 2020, retrieved on…
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML),” NCT02864290, Oct. 29, 2021, retrieved on Feb. 16, 2024, retrie…
[cited by applicant]
ClinicalTrials.gov [online], “A Study to Evaluate Safety, Tolerability and Prelimianry Efficacy of FP-1305 in Cancer Patients (MATINS),” NCT03733990, Nov. 27, 2023, retrieved on Feb. 16, 2024, retrieved from URL: <https…
[cited by applicant]
ClinicalTrials.gov [online], “An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid Tumors,” NCT01466569, Jun. 23, 2015, retrieved on Feb. 16, 2024, retrieved from URL: …
[cited by applicant]
ClinicalTrials.gov [online], “An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy,” NCT03921528, Apr. 12, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinica…
[cited by applicant]
ClinicalTrials.gov [online], “An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynobial Giant Cell Tumor of the Knee,” NCT04731675, Oct. 6, 2022, retrieved on Feb. 20, 2024, retrieved from …
[cited by applicant]
ClinicalTrials.gov [online], “ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer (ARX517),” NCT04662580, Nov. 22, 2023, retrieved on Feb. 20, 2024, retriev…
[cited by applicant]
ClinicalTrials.gov [online], “Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants (Respond),” NCT00664716, Jan. 1, 2016, retrieved on Feb. 8, 2024, retrieved from URL: <https://clin…
[cited by applicant]
ClinicalTrials.gov [online], “B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma,” NCT03332121, Nov. 15, 2021, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT03332121…
[cited by applicant]
ClinicalTrials.gov [online], “Comparative Pharmacokinetic Trial of RGB-03 and MabThera,” NCT02371096, Feb. 25, 2015, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT02371096>, 15 pag…
[cited by applicant]
ClinicalTrials.gov [online], “Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis,” NCT04056897, Sep. 8, 2021, retrieved on Feb. 20, 2024, retrieved from URL: <ht…
[cited by applicant]
ClinicalTrials.gov [online], “First in Human Trial of TAS266 in Patients With Advanced Solid Tumors,” NCT01529307, Dec. 21, 2020, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT0152…
[cited by applicant]
ClinicalTrials.gov [online], “First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors,” NCT01881217, Sep. 14, 2017, retrieved on Feb. 16, 2024, retrieved from URL: <https://cl…
[cited by applicant]
Clinical Trials.gov [online], “Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer,” NCT02048150, Mar. 21, 2023, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov…
[cited by applicant]
ClinicalTrials.gov [online], “MabionCD20 Compared to MabThera in Lymphoma Patients (MADILYM),” NCT02617485, Oct. 25, 2023, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT02617485>, …
[cited by applicant]
ClinicalTrials.gov [online], “Nivolumab Combined With BMS-986253 in HCC Patients,” NCT04050462, Aug. 30, 2023, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT04050462>, 22 pages.
[cited by applicant]
ClinicalTrials.gov [online], “Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma,” NCT01950273, Sep. 5, 2018, retrieved on Feb.…
[cited by applicant]
ClinicalTrials.gov [online], “Pharmacokinetics, Efficacy and Safety of the 304 Injection,” NCT03980379, Jun. 10, 2019, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT03980379>, 22 p…
[cited by applicant]
ClinicalTrials.gov [online], “Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas,” NCT03715933, Feb. 15, 2024, retrieved on Feb. 16, 2024, retrieved from URL: <htt…
[cited by applicant]
ClinicalTrials.gov [online], “Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors,” NCT04084366, Jan. 5, 2024, retrieved on Feb. 20, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT04084366>…
[cited by applicant]
ClinicalTrials.gov [online], “Phase 2 Study to Evaluate Safety & Efficacy of VPI 2690B in Diabetic Nephropathy Patients,” NCT02251067, Mar. 28, 2017, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltria…
[cited by applicant]
ClinicalTrials.gov [online], “Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas,” NCT03153410, Jan. 29, 2024, retrieved on Feb. 16, 2…
[cited by applicant]
ClinicalTrials.gov [online], “Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck,” NCT03708224, Jan. 17, 2023, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrial…
[cited by applicant]
ClinicalTrials.gov [online], “RHCACD20MA (HS006) With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (Hi-CHOP),” NCT03485118, Apr. 2, 2018, retrieved on Feb. 16, 2024, retrieved from …
[cited by applicant]
ClinicalTrials.gov [online], “Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL),” NCT04746131, Sep. 26, 2022, retrieved on Feb. 20, 2…
[cited by applicant]
ClinicalTrials.gov [online], “Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma,” NCT02206308, Aug. 1, 2014, retrieved on …
[cited by applicant]
ClinicalTrials.gov [online], “SRK-181 Alone or in Combination With Anti-PD(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON),” NCT04291079, Jan. 11, 2024, retrieved on Feb. 20, 2…
[cited by applicant]
ClinicalTrials.gov [online], “Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029,” NCT00563810, Nov. 26, 2007, retrieved on Feb. 8, 2024, retrieved from URL: <https://clinicaltrials.gov/study…
[cited by applicant]
ClinicalTrials.gov [online], “Study of AVE1642 Anti-IGFIR Monoclonal Antibody in Patients With Advanced Multiple Myeloma,” NCT01233895, Nov. 3, 2010, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltria…
[cited by applicant]
ClinicalTrials.gov [online], “Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (daNIS-1),” NC…
[cited by applicant]
ClinicalTrials.gov [online], “Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia,” NCT02538614, Nov. 25, 2020, retrieved on Feb. 16, 2024, retrieved from URL: <https://cl…
[cited by applicant]
ClinicalTrials.gov [online], “Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors,” NCT04669899, Feb. 12, 2024, retrieved on Feb. 20, 2024,…
[cited by applicant]
ClinicalTrials.gov [online], “Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001),” NCT01370694, Mar. 15, 2019, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT0…
[cited by applicant]
ClinicalTrials.gov [online], “Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma,” NCT01459887, Oct. 26, 2011, retrieved on Feb. 16, 2024, retrieved from URL: <https:…
[cited by applicant]
ClinicalTrials.gov [online], “Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies,” NCT03424603, Dec. 14, 2022, retrieved on Feb. 16, 2024, retrieved from URL: <https:/…
[cited by applicant]
ClinicalTrials.gov [online], “Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL),” NCT03777085, May 30, 2019, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.go…
[cited by applicant]
ClinicalTrials. gov [online], “Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1033 (SAR391786),” NCT01720576, Sep. 12, 2013, retrieved on Feb. 16, 2024, retrieved from URL: <https://clini…
[cited by applicant]
ClinicalTrials.gov [online], “Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies,” NCT02924402, Dec. 20, 2023, retrieved on Feb. 16, 2024, retri…
[cited by applicant]
ClinicalTrials.gov [online], “This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors,” NCT03573544, Jul. 8, 2022, retrieved on Feb. 16, 2024, …
[cited by applicant]
ClinicalTrials.gov [online], “TREatment of degenerative and Neoplastic Diseases With Rituximab (TREND),” NCT01277172, Jan. 14, 2011, retrieved on Feb. 16, 2024, retrieved from URL: <https://clinicaltrials.gov/study/NCT0…
[cited by applicant]
ClinicalTrials.gov [online], “Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects,” NCT02310464, Oct. 3, 2022, retrieved on Feb. 16, 202…
[cited by applicant]
ClinicalTrials.gov [online], “A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer,” NCT00152477, Apr. 12, 2022, retrieved on Feb. 8, 2024, retrieved from URL: <https://classic.clinicalt…
[cited by applicant]
Coiffier, “Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10,” Expert Rev. Clin. Pharmacol., Sep. 2017, 10(9):923-933.
[cited by applicant]
Cooper et al., “Human natural killer cells: a unique innate immunoregulatory role for the CD56bright subset,” Immunobiology, May 15, 2001, 97 (10): 3146-3151.
[cited by applicant]
Corpet, “Multiple sequence alignment with hierarchical clustering,” Nuc. Acids Res., Nov. 25, 1988, 16(22):10881-10890.
[cited by applicant]
Croft et al., “Regulation of T Cell Immunity by OX40 and OX40L,” Madame Curie Bioscience Database, 2000-2013, retrieved on Jan. 12, 2022, retrieved from URL <“https://www.ncbi.nlm.nih.gov/books/NBK5990/”>, 12 pages.
[cited by applicant]
Crossland, “CD56-Specific T Cells; Using Genetically Engineered T Cells to Redirect Specificty to a T Cell Expressed Antigen” Dissertation for the degree of PhD, The University of Texas MD Anderson Cancer Center UTHealt…
[cited by applicant]
D' Angelo et al., “A phase 2 study of ontuxizumab, a monoclonal antibody targeting endosialin, in metastatic melanoma,” Invest. New Drugs, Feb. 2018, 36(1):103-113.
[cited by applicant]
Dalili et al., “A Review of Sorting, Separation and Isolation of Cells and Microbeads for Biomedical Applications: Microfluidic Approaches,” Analyst, 2019, 144:87-113.
[cited by applicant]
Damjanov et al., “Safety and efficacy of SBI-087, a subcutaneous agent for B cell depletion, in patients with active rheumatoid arthritis: results from a phase II randomized, double-blind, placebo-controlled study,” J. …
[cited by applicant]
De Bono et al., “Phase I trial of a murine antibody to MUC1 in patients with metastatic cancer: evidence for the activation of humoral and cellular antitumor immunity,” Ann Oncol., Dec. 2004, 15(12):1825-33.
[cited by applicant]
De Weers et al., “Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors,” J. Immunol., Feb. 2011, 186(3):1840-1848.
[cited by applicant]
Dotti et al., “Design and Development of Therapies using Chimeric Antigen Receptor-Expressing T cells,” Immunol Rev., Jan. 2014, 257(1)1-35.
[cited by applicant]
Du et al., “Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment,” Autoimmunity Highlights, Dec. 2017, 8(1):1-2.
[cited by applicant]
European Search Report in European Application No. 21809551.1, dated May 29, 2024, 11 pages.
[cited by applicant]
Extended European Search Report in European Patent Appln No. 18878132.2, dated Jul. 14, 2021, 10 pages.
[cited by applicant]
Forero et al., “First-in-human study of the antibody DR5 agonist DS-8273a in patients with advanced solid tumors,” Invest New Drugs, Jan. 3, 2017, 35(3):298-306.
[cited by applicant]
Fox et al., “A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis,” Mult. Scler., Mar. 2021, 27(3):420-429.
[cited by applicant]
Fulciniti et al., “Anti-DKK1 mAb (BHQ880) as a potential therapeutic agent for multiple myeloma,” Blood, Jul. 9, 2009, 114(2):371-9.
[cited by applicant]
Gacerez et al., “How chimeric antigen receptor design affects adoptive T cell therapy” J. Cell Physiol., Dec. 2016, 231(12):2590-2598.
[cited by applicant]
Gagez et al., “Obinutuzumab: a new class of anti-CD20 monoclonal antibody,” Curr. Opin. Oncol., Sep. 2014, 26(5):484-491.
[cited by applicant]
Garcia et al., “Bevacizumab (Avastin®) in cancer treatment: A review of 15 years of clinical experience and future outlook,” Cancer Treat Rev., Jun. 2020, 86:102017.
[cited by applicant]
GenBank Accession No. AB590584.1, “Synthetic construct DNA, clone: pFN21AE1768,
[cited by applicant]
GenBank Accession No. AF461811.1, “
[cited by applicant]
GenBank Accession No. N_000734.3, “
[cited by applicant]
GenBank Accession No. NM_001561.5, “
[cited by applicant]
GenBank Accession No. NM_001768.6, “
[cited by applicant]
GenBank Accession No. NM_003326.4, “
[cited by applicant]
GenBank Accession No. NM_006139.3, “
[cited by applicant]
GenBank Accession No. X52645.1 “Human Fc-gamma RIII-2 cDNA for Fc-gamma receptor III-2 (CD16),” Oct. 7, 2008, 2 pages.
[cited by applicant]
Genovese et al., “Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study,” Arthritis Rheu…
[cited by applicant]
Geoghegan et al., “Inhibition of CD73 Amp hydrolysis by a therapeutic antibody with a dual, non-competitive mechanism of action,” MAbs, Apr. 2, 2016, 8(3):454-67.
[cited by applicant]
Gibson et al., “Randomized Phase III Trial Results of Panitumumab, a Fully Human Anti-Epidermal Growth Factor Receptor Monoclonal Antibody, in Metastatic Colorectal Cancer,” Clin Colorectal Cancer, May 1, 2006, 6(1):29-…
[cited by applicant]
Gilbert et al., “Effect of CC chemokine receptor 2 CCR2 blockade on serum C-reactive protein in individuals at atherosclerotic risk and with a single nucleotide polymorphism of the monocyte chemoattractant protein-1 pro…
[cited by applicant]
Glazyrin et al., “Direct Detection of Herceptin/Transtuzumab Binding on Breast Tissue Sections,” J Histology & Cytochemistry, 2007, 55(1):25-33.
[cited by applicant]
Golan et al., “LY2495655, an antimyostatin antibody, in pancreatic cancer: a randomized, phase 2 trial,” J. Cachexia Sarcopenia Muscle, Oct. 2018, 9(5):871-879.
[cited by applicant]
Gold et al., “Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin,” Molecular Cancer, Dec. 2013, 12(143):1-8.
[cited by applicant]
Goldenberg et al., “Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects,” Leuk. Lymphoma, May 2010, 51(5):747-755.
[cited by applicant]
Goldenberg, “Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer,” Clin. Ther., Feb. 1999, 21(2):309-18.
[cited by applicant]
Gross et al., “Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial,” JAMA Ophthalmol., Oct. 2018, 136(10):1138-1148.
[cited by applicant]
Gupta et al., “Targeting CA 19-9 with a humanized monoclonal antibody at the time of surgery may decrease recurrence rates for patients undergoing resections for pancreatic cancer, cholangiocarcinoma and metastatic colo…
[cited by applicant]
Hammer et al., “Preclinical Efficacy of a PSMA-Targeted Thorium-227 Conjugate (PSMA-TTC), a Targeted Alpha Therapy for Prostate Cancer,” Clin. Cancer Res., Apr. 15, 2020, 26(8):1985-1996.
[cited by applicant]
Hancock et al., “A Monoclonal Antibody against the c-erbB-2 Protein Enhances the Cytotoxicity of cis-Diamminedichloroplatinum against Human Breast and Ovarian Tumor Cell Lines,” Cancer Res., Sep. 1, 1991, 51:4575-4580.
[cited by applicant]
Harwerth et al., “Monoclonal Antibodies against the Extracellular Domain of erbB-2 Receptor Function as Partial Ligand Agonists,” J Biol. Chem., Jul. 25, 1992, 267(21):15160-15167.
[cited by applicant]
Hashimoto et al., “A novel HER3-targeting antibody-drug conjugate, U3-1402, exhibits potent therapeutic efficacy through the delivery of cytotoxic payload by efficient internalization,” Clin. Cancer Res., Dec. 2019, 25(…
[cited by applicant]
Hassan et al., “First-in-human, multicenter, phase I dose-escalation and expansion study of anti-mesothelin antibody-drug conjugate anetumab ravtansine in advanced or metastatic solid tumors,” J. Clin. Oncol., Jun. 6, 2…
[cited by applicant]
Hassan et al., “Mesothelin immunotherapy for cancer: ready for prime time?,” J. Clin. Oncol., Dec. 12, 2016, 34(34):4171-4179.
[cited by applicant]
Hensel et al., “Early development of PAT-SM6 for the treatment of melanoma,” Melanoma Res., Aug. 2013, 23(4):264-75.
[cited by applicant]
Hernandez-Hoyos et al., “MOR209/ES414, a novel bispecific antibody targeting PSMA for the treatment of metastatic castration-resistant prostate cancer,” Mol. Cancer Ther., Sep. 2016, 15(9):2155-2165.
[cited by applicant]
Hersey et al., “A randomized phase 2 study of etaracizumab, a monoclonal antibody against integrin alpha(v)beta(3), + or—dacarbazine in patients with stage IV metastatic melanoma,” Cancer, Mar. 15, 2010, 116(6):1526-153…
[cited by applicant]
Heublin et al., “Potential interplay of the gatipotuzumab epitope TA-MUC1 and estrogen receptors in ovarian cancer,” Int. J. Mol. Sci., Jan. 12, 2019, 20(2):295.
[cited by applicant]
Higgins et al., “CLUSTAL: a package for performing multiple sequence alignment on a microcomputer,” Gene, 1988, 73:237-244.
[cited by applicant]
Higgins et al., “Fast and sensitive multiple sequence alignments on a microcomputer,” Cabios Commuications, 1989, 5(2):151-153.
[cited by applicant]
Hosseini et al., “Mitigating the risk of cytokine release syndrome in a Phase I trial of CD20/CD3 bispecific antibody mosunetuzumab in NHL: impact of translational system modeling,” NPJ Syst. Biol. Appl., Aug. 28, 2020,…
[cited by applicant]
Hoy, “Dinutuximab: A Review in High-Risk Neuroblastoma,” Target Oncol., Apr. 2016, 11(2):247-53.
[cited by applicant]
Hoy, “Tafasitamab: first approval,” Drugs, Nov. 2020, 80(16):1731-1737.
[cited by applicant]
Hsu et al., “The Killer Cell Immunoglobulin-Like Receptor (KIR) Genomic Region: Gene-Order, Haplotypes and Allelic Polymorphism,” Immunological Review, Dec. 2002, 190:40-52.
[cited by applicant]
Hu et al., “Epitope mapping and structural analysis of an anti-ErbB2 antibody A21: Molecular basis for tumor inhibitory mechanism,” Proteins, Feb. 15, 2008, 70(3):938-949.
[cited by applicant]
Huang et al., “Parallelization of a local similarity algorithm,” Cabios, 1992, 8(2):155-165.
[cited by applicant]
Huang et al., “The CD20-specific engineered toxin antibody MT-3724 exhibits lethal effects against mantle cell lymphoma,” Blood Cancer J., Mar. 20, 2018, 8(3):33.
[cited by applicant]
Hudecek et al., “Going Non-Viral: the Sleeping Beauty Transposon System Breaks on Through to the Clinical Side,” Critical Reviews in Biochemistry and Molecular Biology, Jul. 4, 2017, 52(4):355-380.
[cited by applicant]
Hughes et al., “Have Clinical Trials Properly Assessed c-Met Inhibitors?,” Trends Cancer, Feb. 2018, 4(2):94-97.
[cited by applicant]
Hummel et al., “Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings,” Immunotherapy, Feb. 2021, 13(2):125-141.
[cited by applicant]
International Preliminary Report on Patentability in International Appln. No. PCT/KR2018/013928, dated May 19, 2020, 17 pages (with English Translation).
[cited by applicant]
International Preliminary Report on Patentability in International Appln. No. PCT/KR2021/006361, mailed on Dec. 1, 2022, 9 pages.
[cited by applicant]
International Search Report and Written Opinion in International Appln. No. PCT/KR2018/013928, dated Mar. 15, 2019, 25 pages (with English Translation).
[cited by applicant]
International Search Report and Written Opinion in International Appln. No. PCT/KR2021/006361, dated Nov. 25, 2021, 14 pages.
[cited by applicant]
Ishiguro et al., “An anti-glypican 3/CD3 bispecific T cell-redirecting antibody for treatment of solid tumors,” Sci. Transl. Med., Oct. 4, 2017, 9(410):eaal4291.
[cited by applicant]
Jiang et al., “Abituzumab targeting of αV-class integrins inhibits prostate cancer progression,” Mol. Cancer Res., Jul. 2017, 15(7):875-883.
[cited by applicant]
Jiang et al., “Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20+ B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study,” Sci. Rep., Jul. 15, 2020, 10(1):11676.
[cited by applicant]
Jonker et al., “Cetuximab for the treatment of colorectal cancer,” N. Engl. J. Med., Nov. 15, 2007,357(20):2040-2048.
[cited by applicant]
Kalaycio et al., “Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab: a phase I study in chronic lymphocytic leukemia,” Leuk. Lymphoma, 2016, 57(4):803-11.
[cited by applicant]
Kang et al., “Drozitumab, a human antibody to death receptor 5, has potent antitumor activity against rhabdomyosarcoma with the expression of caspase-8 predictive of response,” Clin. Cancer Res., May 15, 2011, 17(10):31…
[cited by applicant]
Kappos et al., “Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial,” Lancet., Nov. 19, 2011, 378(9805):1779-87.
[cited by applicant]
Kasprzyk et al., “Therapy of an Animal Model of Human Gastric Cancer Using a Combination of Anti-erbB-2 Monoclonal Antibodies,” Cancer Research, May 15, 1992, 52:2771-2776.
[cited by applicant]
Khan et al., “Ramucirumab for the treatment of gastric or gastro-esophageal junction cancer,” Expert Opin. Biol. Ther., Nov. 2019, 19(11):1135-1141.
[cited by applicant]
Kim et al., “First-in-Human Phase I Study of Aprutumab Ixadotin, a Fibroblast Growth Factor Receptor 2 Antibody-Drug Conjugate (BAY 1187982) in Patients with Advanced Cancer,” Target Oncol., Oct. 2019, 14(5):591-601.
[cited by applicant]
Kim et al., “Phase II study of ensituximab, a novel chimeric monoclonal antibody, in adults with unresectable, metastatic colorectal cancer,” Clin. Cancer Res., Jul. 15, 2020, 26(14):3557-3564.
[cited by applicant]
Klapper et al., “A subclass of tumor inhibitory monoclonal antibodies to ErbB-2/HER2 blocks crosstalk with growth factor receptors,” Oncogene, Jan. 1997, 14:2099-2109.
[cited by applicant]
Koene et al., “FcγRIIIa-158V/F Polymorphism Influences the Binding of IgG by Natural Killer Cell FcγRIIIa, Independently of the FcγRIIIa-48L/R/H Phenotype,” Blood, Aug. 1997, 90(3):1109-1114.
[cited by applicant]
Kruschinski et al., “Engineering antigen-specific primary human NK cells against HER-2 positive carcinomas,” Proceedings of the National Academy of Sciences, Nov. 11, 2008, 105(45):17481-17486.
[cited by applicant]
Kuenen et al., “A phase I pharmacologic study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody directed against EGFR in patients with advanced solid malignancies,” Clin. Cancer Res., Mar. 15, 2010, 16(6…
[cited by applicant]
Leary et al., “Abstract No. 2521: First-in-human first-in-class phase I trial of murlentamab, an anti-Mullerian-hormone receptor II (AMHRII) monoclonal antibody acting through tumor-associated macrophage (TAM) engagemen…
[cited by applicant]
Lee et al., “Preclinical pharmacokinetics, interspecies scaling, and pharmacokinetics of a Phase I clinical trial of TTAC-0001, a fully human monoclonal antibody against vascular endothelial growth factor 2,” Drug Des. …
[cited by applicant]
Lima et al., “Phase Ib study of drozitumab combined with first-line mFOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer,” Cancer Invest., Dec. 2012, 30(10):727-31.
[cited by applicant]
Liu et al., “Driving better and safer HER2-specific CARs for cancer therapy,” Oncotarget, Sep. 5, 2017, 8(37):62730-62741.
[cited by applicant]
Liu et al., “Identification of PAM4 (clivatuzumab)-reactive epitope on MUC5AC: a promising biomarker and therapeutic target for pancreatic cancer,” Oncotarget., Feb. 28, 2015, 6(6):4274-85.
[cited by applicant]
Liu et al., “Phase I study of safety and pharmacokinetics of the anti-MUC16 antibody-drug conjugate DMUC5754A in patients with platinum-resistant ovarian cancer or unresectable pancreatic cancer,” Ann. Oncol., Nov. 2016…
[cited by applicant]
Liu et al., “Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors,” N. Engl. J. Med., Feb. 6, 2020, 382(6):545-553.
[cited by applicant]
Lonial et al., “Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma,” N. Engl. J. Med., Aug. 13, 2015, 373(7):621-631.
[cited by applicant]
Lord et al., “Structure-based engineering to restore high affinity binding of an isoform-selective anti-TGFβ1 antibody,” MAbs., Apr. 2018, 10(3):444-452.
[cited by applicant]
LoRusso et al., “Icrucumab, a fully human monoclonal antibody against the vascular endothelial growth factor receptor-1, in the treatment of patients with advanced solid malignancies: a Phase 1 study,” Invest. New. Drug…
[cited by applicant]
Mahalingham et al., “Phase I study of imalumab (BAX69), a fully human recombinant antioxidized macrophage migration inhibitory factor antibody in advanced solid tumours,” Br. J. Clin. Pharmacol., Sep. 2020, 86(9):1836-1…
[cited by applicant]
Maier et al., “Requirements for the Internalization of a Murine Monoclonal Antibody Directed against the HEER-2/neu Gene Product c-erbB-2,” Cancer Res., Oct. 1, 1991, 51:5361-5369.
[cited by applicant]
Marchio et al. “Evolving concepts in HER2 evaluation in breast cancer: Heterogeneity, HER2-low carcinomas and beyond,” Semin Cancer Biol, Feb. 26, 2020, 72:123-135.
[cited by applicant]
Marcus et al., “Obinutuzumab for the First-Line Treatment of Follicular Lymphoma,” N. Engl. J. Med., Oct. 5, 2017, 377(14):1331-1344.
[cited by applicant]
Markham, “Naxitamab: First Approval,” Drugs, Feb. 2021, 81(2):291-296.
[cited by applicant]
Martin et al., “Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma,” Blood Cancer J., Mar. 29, 2019, 9(4):41, 10 pages.
[cited by applicant]
Martinsson-Niskanen et al., “Monoclonal antibody TB-403: a first-in-human, Phase I, double-blind, dose escalation study directed against placental growth factor in healthy male subjects,” Clin. Ther., Sep. 2011, 33(9):1…
[cited by applicant]
Milone et al., “Clinical Use of Lentiviral Vectors,” Leukemia, Jul. 2018, 32(7):1529-41.
[cited by applicant]
Musolino et al., “Immunoglobulin G Fragment C Receptor Polymorphisms and Clinical Efficacy of Trastuzumab-Based Therapy in Patients with HER-2/neu-Positive Metastatic Breast Cancer,” J. Clin. Oncol., Apr. 10, 2008, 26(1…
[cited by applicant]
Nadafi et al., “Anti-CD19 Monoclonal Antibodies: a New Approach to Lymphoma Therapy,” Int. J. Mol. Cell Med., 2015, 4(3):143-151.
[cited by applicant]
Nahta et al., “The HER-2-Targeting Antibodies Transtuzumab and Pertuzumab Synergistically Inhibit the Survival of Breast Cancer Cells”, Cancer Research, Apr. 2004, 64(7): 2343-2346.
[cited by applicant]
Needleman et al., “A General Method Applicable to the Search for Similarities in the Amino Acid Sequence of Two Proteins,” J Mol. Biol., 1970, 48:443-453.
[cited by applicant]
Niederwieser et al., “Efficacy and Safety of ABP 798: Results from the Jasmine Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product,” Target Oncol., Oct. 2020, 15(5):599-611.
[cited by applicant]
O'Day et al., “A randomised, phase II study of intetumumab, an anti-αv-integrin mAb, alone and with dacarbazine in stage IV melanoma,” Br. J. Cancer, Jul. 26, 2011, 105(3):346-52.
[cited by applicant]
Office Action in Australian Appln. No. 2018370195, dated Jul. 6, 2021, 5 pages.
[cited by applicant]
Office Action in Chinese Appln. No. 201880074007.4, dated Feb. 25, 2023, 15 pages (with English translation).
[cited by applicant]
Office Action in Indian Appln. No. 202017023032, dated Oct. 31, 2022, 6 pages.
[cited by applicant]
Office Action in Japanese Appln. No. 2020-544730, dated Dec. 14, 2021, 11 pages (with English Translation).
[cited by applicant]
Office Action in Japanese Appln. No. 2020-544730, dated May 23, 2022, 4 pages (with English Translation).
[cited by applicant]
Office Action in Japanese Appln. No. 2020-544730, dated May 26, 2021, 12 pages (with English Translation).
[cited by applicant]
Office Action in Korean Application No. 10-2018-0140251, dated Apr. 25, 2024, 13 pages (with English Translation).
[cited by applicant]
Okamoto et al., “TAK-701, a humanized monoclonal antibody to hepatocyte growth factor, reverses gefitinib resistance induced by tumor-derived HGF in non-small cell lung cancer with an EGFR mutation,” Mol. Cancer Ther., …
[cited by applicant]
Overdijk et al., “Dual Epitope Targeting and Enhanced Hexamerization by DR5 Antibodies as a Novel Approach to Induce Potent Antitumor Activity Through DR5 Agonism,” Mol. Cancer Ther., Oct. 2020, 19(10):2126-2138.
[cited by applicant]
Petrylak et al., “PSMA ADC monotherapy in patients with progressive metastatic castration-resistant prostate cancer following abiraterone and/or enzalutamide: Efficacy and safety in open-label single-arm phase 2 study,”…
[cited by applicant]
Piloto et al., “IMC-EB10, an anti-FLT3 monoclonal antibody, prolongs survival and reduces nonobese diabetic/severe combined immunodeficient engraftment of some acute lymphoblastic leukemia cell lines and primary leukemi…
[cited by applicant]
Plummer et al., “Phase 1 and pharmacokinetic study of lexatumumab in patients with advanced cancers,” Clin. Cancer Res., Oct. 15, 2007, 13(20):6187-94.
[cited by applicant]
Poddubnaya et al., “Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial,” Hematol. Oncol., Feb. 2…
[cited by applicant]
Pognan et al., “Colony-stimulating factor-1 antibody lacnotuzumab in a phase 1 healthy volunteer study and mechanistic investigation of safety outcomes.,” J Pharmacol Exp Ther., Jun. 2019, 369(3):428-442.
[cited by applicant]