IP Library Granted Patent US 12,466,895
Granted Patent B2
US 12,466,895 · App. 17/494,577 · Granted Nov 11, 2025

Antibodies against the MUC1-c/extracellular domain (MUC1-C/ECD)

Inventors: Donald W. Kufe (Wellesley, MA); Surender Kharbanda (Natick, MA)
Assignees: DANA-FARBER CANCER INSTITUTE, INC.; XYONE THERAPEUTICS, INC.
C07K16/3092A61K38/08A61K45/06A61K47/68031A61K47/6811A61K47/6849A61K47/6851A61K47/6855A61K47/6889C07K16/2809C07K16/3015C07K16/3023C07K16/3061C07K2317/24C07K2317/34C07K2317/565C07K2317/622C07K2317/73C07K2317/77C07K2319/00C07K2319/02C07K2319/03C07K2319/32C07K2319/33
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 12,466,895
App. No.
17/494,577
Granted
Nov 11, 2025
Kind
B2
Abstract

The present invention is directed to antibodies binding to MUC1-C/extracellular domain (MUC1-C/ECD) and methods of using such antibodies to treat cancers that express the MUC1 antigen.

Claims (29)

1 . A method of treating cancer comprising contacting a MUC1-positive cancer cell in a subject with an antibody comprising a variable heavy chain comprising CDR1, CDR2 and CDR3 regions according to SEQ ID NOS: 76, 77 and 78, and a variable light chain comprising CDR1, CDR2 and CDR3 regions according to SEQ ID NOS: 79, 80 and 81.

2 . The method of claim 1 , wherein said MUC1-positive cancer cell is a solid tumor cell.

3 . The method of claim 2 , wherein said solid tumor cell is a lung cancer cell, brain cancer cell, head & neck cancer cell, breast cancer cell, skin cancer cell, liver cancer cell, pancreatic cancer cell, stomach cancer cell, colon cancer cell, rectal cancer cell, uterine cancer cell, cervical cancer cell, ovarian cancer cell, testicular cancer cell, skin cancer cell, or esophageal cancer cell.

4 . The method of claim 1 , wherein said MUC1-positive cancer cell is a leukemia or myeloma.

5 . The method of claim 4 , wherein said leukemia or myeloma is acute myeloid leukemia, chronic myelogenous leukemia or multiple myeloma.

6 . The method of claim 1 , further comprising contacting said MUC1-positive cancer cell with a second anti-cancer agent or treatment.

7 . The method of claim 6 , wherein said second anti-cancer agent or treatment is selected from chemotherapy, radiotherapy, immunotherapy, hormonal therapy, or toxin therapy.

8 . The method of claim 6 , wherein said second anti-cancer agent or treatment inhibits an intracellular MUC1 function.

9 . The method of claim 6 , wherein said second anti-cancer agent or treatment is given at the same time as said first agent.

10 . The method of claim 6 , wherein said second anti-cancer agent or treatment is given before and/or after said first agent.

11 . The method of claim 1 , wherein said MUC1-positive cancer cell is a metastatic cancer cell, a multiply drug resistant cancer cell or a recurrent cancer cell.

12 . The method of claim 1 , wherein said antibody is a single chain antibody.

13 . The method of claim 1 , wherein said antibody is a chimeric antibody.

14 . The method of claim 1 , wherein said antibody a Fab fragment.

15 . The method of claim 1 , wherein said antibody is a recombinant antibody having specificity for the MUC1-C/ECD and a distinct cancer cell surface antigen.

16 . The method of claim 1 , wherein said antibody is a murine antibody.

17 . The method of claim 16 , wherein said murine antibody is an IgG.

18 . The method of claim 1 , wherein antibody is a humanized antibody.

19 . The method of claim 18 , wherein said humanized antibody is an IgG.

20 . The method of claim 1 , wherein said antibody further comprises an antitumor drug linked thereto.

21 . The method of claim 20 , wherein said antitumor drug is linked to said antibody through a photolabile linker.

22 . The method of claim 20 , wherein said antitumor drug is linked to said antibody through an enzymatically-cleaved linker.

23 . The method of claim 20 , wherein said antitumor drug is a toxin, a radioisotope, a cytokine, or an enzyme.

24 . The method of claim 1 , wherein said antibody further comprises a label.

25 . The method of claim 24 , wherein said label is a peptide tag, an enzyme, a magnetic particle, a chromophore, a fluorescent molecule, a chemilluminescent molecule, or a dye.

26 . The method of claim 1 , wherein said heavy and light chains have 85%, 90%, 95% or 99% homology to SEQ ID NO: 73 and 75.

27 . The method of claim 1 , wherein said heavy and light chains are encoded by nucleic acids having 85%, 90%, 95% or 99% homology to SEQ ID NO: 72, and 74.

28 . The method of claim 1 , wherein said antibody is conjugated to a liposome or nanoparticle.

29 . The method of claim 1 , wherein said antibody results in the induction of cell death, such as by antibody-dependent cell cytotoxicity or complement-mediated cytoxicity.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2024
From: GENUS ONCOLOGY LLC
To: XYONE THERAPEUTICS, INC.
Reel/Frame 069610/0582 →
Continuity (4)
Division 16028662 · Jul 6, 2018
Division 15113956
Provisional Application 61933001 · Jan 29, 2014
Related Publication 20220049014A1 · Feb 17, 2022
References Cited (52)
US 7202346B2 · Payne et al. · 2007 [cited by applicant]
US 7897351B2 · Wreschner et al. · 2011 [cited by applicant]
US 8344113B2 · Bamdad · 2013 [cited by applicant]
US 20040057952A1 · Payne et al. · 2004 [cited by applicant]
US 20050042209A1 · Kufe · 2005 [cited by examiner]
JP 2004515472 · 2004 [cited by applicant]
JP 2006502110 · 2006 [cited by applicant]
JP 2012504961 · 2012 [cited by applicant]
JP 2017505625 · 2017 [cited by applicant]
WO WO1991016353 · 1991 [cited by applicant]
WO WO2002022685 · 2002 [cited by applicant]
WO WO2004005470 · 2004 [cited by applicant]
WO WO2010042562 · 2010 [cited by applicant]
Chames and Bay, “Bispecific antibodies for cancer therapy. The light at the end of the tunnel?” [cited by applicant]
English translation of Office Communication issued in Chinese Patent Application No. 201580011813.3, dated Feb. 26, 2019. [cited by applicant]
English translation of Office Communication issued in Chinese Patent Application No. 201580011813.3, dated Sep. 30, 2019. [cited by applicant]
English translation of Office Communication issued in Japanese Patent Application No. 2016-549460, dated Jan. 30, 2019. [cited by applicant]
English translation of Office Communication issued in Japanese Patent Application No. 2016-549460, dated Nov. 9, 2020. [cited by applicant]
English translation of Office Communication issued in Japanese Patent Application No. 2016-549460, dated Jun. 2, 2021. [cited by applicant]
English translation of Office Communication issued in Japanese Patent Application No. 2016-549460, dated Jan. 8, 2020. [cited by applicant]
English translation of Office Communication issued in Korean Patent Application No. 10-2016-7023436, dated Aug. 19, 2021. [cited by applicant]
Hartman et al., “MUC1 isoform specific monoclonal antibody 6E6/2 detects preferential expression of the novel MUCI/Y protein in breast and ovarian cancer,” [cited by applicant]
Hilkens et al., “Monoclonal antibodies against the nonmucin domain of MUC1/Episialin,” [cited by applicant]
Hust et al., “Single chain Fab (scFab) fragment,” [cited by applicant]
Kufe, “MUC1-C oncoprotein as a target in breast cancer: activation of signaling pathways and therapeutic approaches,” [cited by applicant]
Kurose et al., “Production of various antibodies and single chain Fv molecule against signal-transducing proteins,” [cited by applicant]
Mahanta et al., “A minimal fragment of MUC1 mediates growth of cancer cells,” [cited by applicant]
Maher and Wilkie, “CA Mechanics: Driving T cells into the MUC of cancer,” [cited by applicant]
Matsushita et al., “A straightforward protocol for the preparation of high performance microarray displaying synthetic MUC1 glycopeptides,” [cited by applicant]
Nath and Mukherjee, MUC1: a multifaceted oncoprotein with a key role in cancer progression, [cited by applicant]
Office Communication issued in Australian Patent Application No. 2015211034, dated Sep. 4, 2019. [cited by applicant]
Office Communication issued in Canadian Patent Application No. 2,938,111, dated Feb. 5, 2021. [cited by applicant]
Office Communication issued in European Patent Application No. 15703414.1, dated Jan. 2, 2018. [cited by applicant]
Office Communication issued in Indian Patent Application No. 201617026230, dated Nov. 5, 2020. [cited by applicant]
Office Communication issued in U.S. Appl. No. 15/113,956, dated Aug. 30, 2017. [cited by applicant]
Office Communication issued in U.S. Appl. No. 15/113,956, dated Feb. 12, 2018. [cited by applicant]
Office Communication issued in U.S. Appl. No. 16/028,662, dated Nov. 27, 2020. [cited by applicant]
Office Communication issued in U.S. Appl. No. 16/028,662, dated May 4, 2020. [cited by applicant]
Panchamoorthy et al., “Targeting the human MUC1-C oncoprotein with an antibody-drug conjugate,” [cited by applicant]
PCT International Search Report and Writen Opinion issued in International Application No. PCT/US2015/013410, dated Jul. 3, 2015. [cited by applicant]
PCT Invitation to Pay Additional Fees issued in International Application No. PCT/US2015/013410, dated Apr. 28, 2015. [cited by applicant]
Pichinuk et al., “Antibody targeting of cell-bound MUC1 Sea domain kills tumor cells,” [cited by applicant]
Ren et al., “Human MUC1 carcinoma-associated protein confers resistance to genotoxic anticancer agents,” [cited by applicant]
Rubinstein et al., “MUC1/X protein immunization enhances cDNA immunization in generating anti-MUC1 alpha/beta junction antibodies that target malignant cells,” [cited by applicant]
Stone et al., “A sensitivity scale for targeting T cells with chimeric antigen receptors (CARs) and bispecific T-cell engagers (BiTEs),” [cited by applicant]
Weiner et al., “Antibody-based immunotherapy of cancer,” [cited by applicant]
Wiens et al., “Somatic mutation in VH complementarity-determining region 2 and framework region 2: differential effects on antigen binding and Ig secretion,” [cited by applicant]
Wilkie et al., “Retargeting of human T cells to tumor-associated MUC1: the evolution of a chimeric antigen receptor,” [cited by applicant]
Office Communication issued in Canadian Patent Application No. 2,938,111, dated Nov. 9, 2021. [cited by applicant]
Sadelain et al., “The Basic Principles of Chimeric Antigen Receptor Design,” [cited by applicant]
Office Communication issued in Japanese Patent Application No. 2021-035405, dated Mar. 3, 2022. {English Translation}. [cited by applicant]
Office Communication issued in Korean Patent Application No. 10-20169-7023436, dated Feb. 25, 2022. {English Translation}. [cited by applicant]