Engineered anti-IL-2 antibodies
Inventors
AMIT, Inbar • Levin, Itay • NIMROD, Guy • FISCHMAN, Sharon • BARAK FUCHS, Reut • STRAJBL, Marek • WYANT, Timothy • ZHENIN, Michael • BLUVSHTEIN YERMOLAEV, Olga • SASSON, Yehezkel • GROSSMAN, Noam • LEVITIN, Natalia • OFRAN, Yanay
Assignees
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Publication Number
US-12275784-B2
Publication Date
2025-04-15
Expiration Date
Abstract
Described herein are engineered anti-IL-2 antibodies with modified amino acid sequences. The engineered antibodies would confer modified receptor binding specificity to an IL-2-anti-IL2 antibody complex, inhibiting the binding of IL-2 to CD25. The engineered anti-IL-2 antibodies would facilitate expansion of subsets of effector immune cells and decrease undesirable effects caused by IL-2. Thus, the engineered anti-IL-2 antibodies would be useful in treating disease such as cancer and infection.
Core Innovation
The invention relates to engineered anti-IL-2 antibodies and their use in combination therapy. The anti-IL-2 antibody comprises a heavy chain variable region (VH) and a light chain variable region (VL), wherein the complementarity determining regions have amino acid sequences defined by SEQ ID NOs. The antibody promotes differential growth of subsets of immune cells and decreases undesirable effects caused by IL-2.
The combination therapy includes an anti-IL-2 antibody, IL-2, and an immune checkpoint inhibitor, wherein the anti-IL-2 antibody, IL-2, and the immune checkpoint inhibitor are administered to a subject. The immune checkpoint inhibitor targets immune checkpoint molecules, including PD-L1, PD-1, and CTLA-4, and the therapy treats disease or a condition by treating cancer or a viral infection, and by addressing pulmonary edema or vascular leak syndrome.
The engineered antibodies are further defined by specific VH/VL CDR sequence options and, in embodiments, by pharmaceutical composition configurations. The disclosed polynucleotide sequences encode the heavy and/or light chain variable regions of the anti-IL-2 antibody with the defined SEQ ID NOs and CDR amino acid sequences.
Claims Coverage
The document includes three independent claims covering a combination-therapy treatment method, a combination-therapy composition, and isolated polynucleotide sequences encoding anti-IL-2 antibody variable regions. Across these claims, the coverage centers on three inventive features.
Combination therapy for treating a disease or condition with anti-IL-2, IL-2, and an immune checkpoint inhibitor
A method of treating a disease or condition in a subject comprising administering a combination therapy including an anti-IL-2 antibody, IL-2, and an immune checkpoint inhibitor, wherein the anti-IL-2 antibody comprises VH and VL with HCDRs and LCDRs having amino acid sequences of specified SEQ ID NOs, promotes differential growth of immune-cell subsets, and decreases undesirable effects caused by IL-2.
Anti-IL-2 combination therapy composition with defined VH/VL CDRs and pharmaceutically acceptable carrier
A combination therapy comprising an anti-IL-2 antibody, IL-2, and an immune checkpoint inhibitor, wherein the anti-IL-2 antibody comprises VH and VL with HCDRs and LCDRs having amino acid sequences of specified SEQ ID NOs, and the pharmaceutical composition(s) further comprise a pharmaceutically acceptable carrier.
Isolated polynucleotide sequences encoding anti-IL-2 VH/VL CDR-defined variable regions
An isolated polynucleotide sequence encoding the heavy chain variable region (VH) and/or the light chain variable region (VL) of an anti-IL-2 antibody, wherein the amino acid sequences are set forth in specified amino acid sequences (SEQ ID NOs) or wherein the variable region comprises HCDRs and/or LCDRs with amino acid sequences specified by SEQ ID NOs, and wherein the claim also covers an anti-IL-2 scFv with the polynucleotide sequence set forth in specified SEQ ID NOs.
Across the independent claims, the inventive content centers on an anti-IL-2 antibody defined by specified VH/VL CDR amino acid sequences, together with IL-2 and an immune checkpoint inhibitor, to treat disease or condition while decreasing undesirable effects caused by IL-2 and promoting differential growth of immune-cell subsets; the claims also define isolated polynucleotide sequences encoding the CDR-defined VH/VL and an scFv.
Stated Advantages
Promotes differential growth of subsets of immune cells.
Decreases undesirable effects caused by IL-2.
Treats cancer selected from melanoma and metastatic renal cell carcinoma.
Treats a viral infection selected from SARS-COV-2 virus.
Treats pulmonary edema or vascular leak syndrome.
Documented Applications
Treatment of cancer selected from melanoma and metastatic renal cell carcinoma.
Treatment of a viral infection selected from a SARS-COV-2 virus.
Treatment of a condition selected from pulmonary edema or vascular leak syndrome.
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