Antibody to programmed cell death 1 (PD-1) and use thereof
Inventors
Park, Jae Eun • Kim, Soo Young • Lee, Hyun Mi • LEE, Si Hyung • Lee, Hyun Kyung • Kim, Hye-Nan • Youn, Jin Chui • Park, Bum-Chan • Lim, Jung Chae • Cho, Young-Gyu • Park, Young Woo
Assignees
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Publication Number
US-11248048-B2
Publication Date
2022-02-15
Expiration Date
Abstract
Disclosed are an antibody to human programmed cell death 1 (PD-1) or an antigen-binding fragment thereof, a nucleic acid encoding the same, a vector including the nucleic acid, an isolated cell transformed with the vector, a method for producing the antibody or an antigen-binding fragment thereof, and a composition for preventing or treating cancer containing the same. The novel antibody binding to PD-1 or an antigen-binding fragment thereof can bind to PD-1 and inhibit the activity of PD-1, thus being useful for the development of immunotherapeutic agents for various diseases associated with PD-1.
Core Innovation
The patent describes a human antibody that binds programmed cell death 1 (PD-1) or an antigen-binding fragment thereof. The antibody is defined by specific heavy chain variable region and light chain variable region compositions that include heavy chain CDR1, CDR2, and CDR3, together with light chain CDR1, CDR2, and CDR3. The heavy chain and light chain CDR sequences are specified by sequence identifiers in the claim and are combined into multiple alternative heavy/light variable-region configurations that retain PD-1 binding.
The claimed PD-1 binding antibodies include sets of heavy chain variable region CDR combinations in which particular heavy chain CDR1, heavy chain CDR2, and heavy chain CDR3 sequences are paired with particular light chain CDR1, light chain CDR2, and light chain CDR3 sequences. The specification further extends to additional constraints in dependent claims by defining framework-region (FR1–FR4) selections as part of the heavy chain variable region. This framework-region selection is expressed as SEQ ID NO ranges.
The patent also ties the defined PD-1 binding antibodies to nucleic acid and production-related assets and to cancer therapy compositions. It discloses nucleic acids encoding the claimed antibody or antigen-binding fragment, expression vectors, and transformed cells, along with producing the antibody by culturing a cell and recovering the antibody or fragment from the cell culture. The document further describes the antibodies as active ingredients in a cancer prevention or cancer treating composition, with cancer selection from an enumerated group.
Claims Coverage
The claim set includes two independent claims, both directed to PD-1 binding antibodies or antigen-binding fragments defined by specific heavy-chain and light-chain variable-region CDR sequences. Across the independent claim(s), the coverage is anchored to exact CDR1/CDR2/CDR3 sequence definitions and enumerated alternative CDR combinations, with further narrowing in dependent claims via framework-region selection and specific formulation and cancer-type constraints.
Enumerated PD-1-binding heavy/light CDR variable-region combinations
An antibody binding to PD-1 or an antigen-binding fragment thereof comprising heavy chain variable region CDR1/CDR2/CDR3 sequences and light chain variable region CDR1/CDR2/CDR3 sequences arranged into specified alternative heavy/light variable-region configurations, including multiple listed CDR sequence combinations.
Specific PD-1-binding CDR sequence-defined antibody
An antibody binding to PD-1 or an antigen-binding fragment thereof comprising a heavy chain variable region with heavy chain CDR1 (SEQ ID NO: 17), heavy chain CDR2 (SEQ ID NO: 54), heavy chain CDR3 (SEQ ID NO: 58), and a light chain variable region with light chain CDR1 (SEQ ID NO: 205), light chain CDR2 (Thr Leu Ser), and light chain CDR3 (SEQ ID NO: 248).
Overall, the independent claims secure PD-1-binding antibody coverage through strict specification of heavy-chain and light-chain variable-region CDR sequence content, including either a set of enumerated alternative CDR combinations or one specific fixed CDR pairing. Dependent claims further narrow the antibodies using framework-region (FR1–FR4) selections and link the antibody to nucleic acid, vector, transformed cell, production, and cancer prevention/treatment composition use with an enumerated cancer list.
Stated Advantages
Provides antibodies or antigen-binding fragments that bind PD-1.
Enables use as an active ingredient in a cancer-preventing or cancer-treating composition.
Narrows therapeutic use to cancer selected from an enumerated group of cancer types.
Documented Applications
Cancer prevention or cancer treatment using a cancer-preventing or cancer-treating composition containing, as an active ingredient, the claimed PD-1-binding antibody or antigen-binding fragment.
Cancer type selection for the composition from an enumerated group including melanoma, lung cancer, liver cancer, gliocytoma, ovarian cancer, colon cancer, head and neck cancer, bladder cancer, kidney cancer, stomach cancer, breast cancer, metastatic cancer, and prostate cancer.
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