Antibodies against the MUC1-c/extracellular domain (MUC1-C/ECD)
Inventors
Kufe, Donald W. • Kharbanda, Surender
Assignees
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Publication Number
US-12466895-B2
Publication Date
2025-11-11
Expiration Date
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.
Core Innovation
The invention relates to antibodies that bind selectively to the MUC1-C/extracellular domain (MUC1-C/ECD) epitope defined by SEQ ID NO:2. The antibodies comprise a variable heavy chain and a variable light chain having CDR1, CDR2 and CDR3 regions as defined by SEQ ID sequences, including engineered IgG formats and variants.
The invention provides methods for treating cancer by contacting a MUC1-positive cancer cell in a subject with the specified antibody. The antibodies are used in cancer treatment, including MUC1-positive cancers, and can be provided in different formats and functional configurations.
The disclosure also describes antibody-drug conjugates with linkers such as photolabile or enzymatically cleaved linkers, and conjugates to nanoparticles and liposomes. Related immunotherapies include CAR constructs targeting MUC1-C/ECD and fusion proteins with a second anti-T/B cell binder, positioned within immunotherapy approaches for MUC1-positive cancers.
Claims Coverage
The document includes an independent method claim directed to treating cancer by contacting a MUC1-positive cancer cell with an antibody defined by specific variable heavy-chain and variable light-chain CDR regions, with dependent refinements adding sequence constraints, therapeutic format/carrier conjugation, and cytotoxic mechanisms. Overall, the inventive features center on MUC1-C/ECD-targeting antibodies defined by CDR1/2/3 sequence identifiers and applied to cancer treatment through the contacting step.
MUC1-positive cancer treatment with defined CDR heavy and light chains
Treating cancer by contacting a MUC1-positive cancer cell in a subject with an antibody comprising a variable heavy chain with CDR1, CDR2 and CDR3 regions according to SEQ ID NOS:76, 77 and 78, and a variable light chain with CDR1, CDR2 and CDR3 regions according to SEQ ID NOS:79, 80 and 81.
Sequence homology constraints to specified SEQ IDs for antibody chains
Wherein the heavy and light chains each have 85%, 90%, 95% or 99% homology to SEQ ID NO:73 and SEQ ID NO:75.
Conjugation to liposome or nanoparticle
Wherein the antibody is conjugated to a liposome or nanoparticle.
Photolabile linker for antibody-drug conjugate linkage
Wherein the antitumor drug is linked to the antibody using a photolabile linker.
Cell death via antibody-dependent cytotoxicity or complement-mediated cytotoxicity
Wherein the antibody induces cell death, including antibody-dependent cell cytotoxicity or complement-mediated cytotoxicity.
Application to specific solid tumor cell types
Wherein the solid tumor cell is one of: lung, brain, head & neck, breast, skin, liver, pancreatic, stomach, colon, rectal, uterine, cervical, ovarian, testicular, or esophageal cancer cell.
Claim coverage focuses on a cancer-treatment contacting method using an antibody that targets MUC1-positive cancer cells through defined CDR1/2/3 regions, with dependent refinements that add chain homology thresholds, specify conjugation carriers, define ADC linker type, and limit the therapeutic outcome to cell death via ADCC and/or complement-mediated cytotoxicity, including application across enumerated solid tumor cell types.
Stated Advantages
Inhibits cancer cell growth.
Induces cancer cell death.
Documented Applications
Treating MUC1-positive cancers by contacting a MUC1-positive cancer cell in a subject with the specified antibody.
Use of the antibody in antibody-dependent cytotoxicity (ADCC) and complement-mediated cytotoxicity contexts for cancer treatment.
Use of MUC1-C/ECD-targeting CAR constructs and fusion proteins with a second anti-T/B cell binder as immunotherapies for MUC1-positive cancers.
Application of treatment to multiple solid tumor cell types including lung, brain, head & neck, breast, skin, liver, pancreatic, stomach, colon, rectal, uterine, cervical, ovarian, testicular, and esophageal cancers.
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