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AR132805A1 - Immunostimulatory antigen-binding molecules that specifically bind to BCMA - Google Patents

Immunostimulatory antigen-binding molecules that specifically bind to BCMA

Info

Publication number
AR132805A1
AR132805A1 ARP240101357A ARP240101357A AR132805A1 AR 132805 A1 AR132805 A1 AR 132805A1 AR P240101357 A ARP240101357 A AR P240101357A AR P240101357 A ARP240101357 A AR P240101357A AR 132805 A1 AR132805 A1 AR 132805A1
Authority
AR
Argentina
Prior art keywords
seq
bcma
acid sequence
amino acid
cdr
Prior art date
Application number
ARP240101357A
Other languages
Spanish (es)
Inventor
Marlene Biehl
Alexander Christian Bujotzek
Gutierrez Cirlos Alejandro Carpy
Jan Eckmann
Tanja Fauti
Algirdas Grevys
Carina Hage
Christian Klein
Julia Krueger
Stefan Lorenz
Cline Marban-Doran
Pablo Umaa
Original Assignee
Hoffmann La Roche
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of AR132805A1 publication Critical patent/AR132805A1/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70575—NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

La presente invención se refiere a nuevos anticuerpos humanizados que se unen al antígeno de maduración de linfocitos B (BCMA), y a moléculas de unión al antígeno inmunoestimuladoras que comprometen estos anticuerpos BCMA, en particular a moléculas de unión al antígeno que contienen trímeros de 4-1BBL que se dirigen a BCMA, métodos para su producción, así como su uso en el tratamiento de cáncer. Reivindicación 1: Una molécula de unión al antígeno inmunoestimuladora que se une específicamente a un agente de maduración de linfocitos B (BCMA), que comprende (a) a una molécula Fab que comprende (i) una región variable de la cadena pesada (VH BCMA) que comprende una región determinante de la complementariedad de la cadena pesada CDR-H1 de SEQ ID Nº 1 (GYTFTNYWMH), una CDR-H2 de SEQ ID Nº 2 (IIHPNSGSTNYNEKFQG), y una CDR-H3 de SEQ ID Nº 3 (GIYDYPFAY), y (ii) una región variable de la cadena liviana (VL BCMA) seleccionada del grupo que consiste en (a) una VL que comprende una región determinante de la complementariedad de la cadena liviana CDR-L1 de SEQ ID Nº 4 (RASESVSIHGTHLMH), una CDR-L2 de SEQ ID Nº 5 (AASSLQS) y una CDRL3 de SEQ ID Nº 6 (QQSIEDPYT); y (b) una VL que comprende una región determinante de la complementariedad de la cadena liviana CDR-L1 de SEQ ID Nº 4 (RASESVSIHGTHLMH), una CDR-L2 de SEQ ID Nº 7 (AASNLES) y una CDRL3 de SEQ ID Nº 6 (QQSIEDPYT); y (c) una VL que comprende una región determinante de la complementariedad de la cadena liviana CDR-L1 de SEQ ID Nº 4 (RASESVSIHGTHLMH), una CDR-L2 de SEQ ID Nº 8 (AASNLQS) y una CDRL3 de SEQ ID Nº 6 (QQSIEDPYT), (b) un primer y segundo polipéptidos que están ligados entre sí mediante un enlace disulfuro, en donde la molécula de unión al antígeno se caracteriza por que el primer polipéptido comprende dos ectodominios de 4-1BBL, cada uno de los cuales comprende la secuencia de aminoácidos de SEQ ID Nº 9 o SEQ ID Nº 10 que están conectadas entre sí mediante un ligador peptídico, y por qué el segundo polipéptido comprende un ectodominio de 4-1BBL que comprende la secuencia de aminoácidos de SEQ ID Nº 9 o SEQ ID Nº 10, y (c) un dominio Fc de IgG. Reivindicación 25: Un anticuerpo que se une específicamente a BCMA, en donde el anticuerpo comprende (a) una VH BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 13 y una VL BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 15, o (b) una VH BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 13 y una VL BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 16. Reivindicación 26: Un anticuerpo que se une específicamente a BCMA, en donde el anticuerpo comprende (a) una VH BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 33 (VH2a) y una VL BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 34 (VL2a), o (b) una VH BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 35 (VH1b) y una VL BCMA que comprende una secuencia de aminoácidos de SEQ ID Nº 36 (VL1a). Reivindicación 27: Uno o más polinucleótidos aislados que codifican la molécula de unión al antígeno inmunoestimuladora de acuerdo con cualquiera de las reivindicaciones 1 a 26 o el anticuerpo de acuerdo con las reivindicaciones 25 o 26. Reivindicación 28: Uno o más vectores, particularmente vectores de expresión, que comprenden los polinucleótidos de acuerdo con la reivindicación 27. Reivindicación 29: Una célula huésped que comprende los polinucleótidos de acuerdo con la reivindicación 27 o los vectores de acuerdo con la reivindicación 28. Reivindicación 30: Un método para producir una molécula de unión al antígeno inmunoestimuladora que se une específicamente a BCMA, que comprende las etapas de a) cultivar la célula huésped de acuerdo con la reivindicación 28 en condiciones adecuadas para la expresión de la molécula de unión al antígeno inmunoestimuladora y opcionalmente b) recuperar la molécula de unión al antígeno inmunoestimuladora. Reivindicación 31: Una molécula de unión al antígeno inmunoestimuladora que se une específicamente a BCMA producida mediante el método de acuerdo con la reivindicación 30. Reivindicación 32: Una composición farmacéutica que comprende la molécula de unión al antígeno inmunoestimuladora de acuerdo con cualquiera de las reivindicaciones 1 a 24 o 31 y al menos un excipiente farmacéuticamente aceptable.The present invention relates to novel humanized antibodies that bind to B-cell maturation antigen (BCMA), and to immunostimulatory antigen-binding molecules that engage these BCMA antibodies, in particular to antigen-binding molecules containing 4-1BBL trimers that target BCMA, methods for their production, as well as their use in the treatment of cancer. Claim 1: An immunostimulatory antigen-binding molecule that specifically binds to a B cell maturation agent (BCMA), comprising (a) a Fab molecule comprising (i) a heavy chain variable region (BCMA VH) comprising a heavy chain complementarity determining region CDR-H1 of SEQ ID NO: 1 (GYTFTNYWMH), a CDR-H2 of SEQ ID NO: 2 (IIHPNSGSTNYNEKFQG), and a CDR-H3 of SEQ ID NO: 3 (GIYDYPFAY), and (ii) a light chain variable region (BCMA VL) selected from the group consisting of (a) a VL comprising a light chain complementarity determining region CDR-L1 of SEQ ID NO: 4 (RASESVSIHGTHLMH), a CDR-L2 of SEQ ID NO: 5 (AASSLQS) and a CDRL3 of SEQ ID NO: 6 (QQSIEDPYT); and (b) a VL comprising a light chain complementarity determining region CDR-L1 of SEQ ID NO: 4 (RASESVSIHGTHLMH), a CDR-L2 of SEQ ID NO: 7 (AASNLES) and a CDRL3 of SEQ ID NO: 6 (QQSIEDPYT); and (c) a VL comprising a light chain complementarity determining region CDR-L1 of SEQ ID NO: 4 (RASESVSIHGTHLMH), a CDR-L2 of SEQ ID NO: 8 (AASNLQS), and a CDRL3 of SEQ ID NO: 6 (QQSIEDPYT), (b) first and second polypeptides that are linked together by a disulfide bond, wherein the antigen-binding molecule is characterized in that the first polypeptide comprises two 4-1BBL ectodomains, each of which comprises the amino acid sequence of SEQ ID NO: 9 or SEQ ID NO: 10 that are connected to each other by a peptide linker, and why the second polypeptide comprises a 4-1BBL ectodomain comprising the amino acid sequence of SEQ ID NO: 9 or SEQ ID NO: 10, and (c) an IgG Fc domain. Claim 25: An antibody that specifically binds to BCMA, wherein the antibody comprises (a) a BCMA VH comprising an amino acid sequence of SEQ ID NO: 13 and a BCMA VL comprising an amino acid sequence of SEQ ID NO: 15, or (b) a BCMA VH comprising an amino acid sequence of SEQ ID NO: 13 and a BCMA VL comprising an amino acid sequence of SEQ ID NO: 16. Claim 26: An antibody that specifically binds to BCMA, wherein the antibody comprises (a) a BCMA VH comprising an amino acid sequence of SEQ ID NO: 33 (VH2a) and a BCMA VL comprising an amino acid sequence of SEQ ID NO: 34 (VL2a), or (b) a BCMA VH comprising an amino acid sequence of SEQ ID NO: 35 (VH1b) and a BCMA VL comprising an amino acid sequence of SEQ ID NO: 36 (VH1c). amino acids of SEQ ID No. 36 (VL1a). Claim 27: One or more isolated polynucleotides encoding the immunostimulatory antigen binding molecule according to any one of claims 1 to 26 or the antibody according to claims 25 or 26. Claim 28: One or more vectors, particularly expression vectors, comprising the polynucleotides according to claim 27. Claim 29: A host cell comprising the polynucleotides according to claim 27 or the vectors according to claim 28. Claim 30: A method for producing an immunostimulatory antigen binding molecule that specifically binds to BCMA, comprising the steps of a) culturing the host cell according to claim 28 under conditions suitable for expression of the immunostimulatory antigen binding molecule and optionally b) recovering the immunostimulatory antigen binding molecule. Claim 31: An immunostimulatory antigen-binding molecule that specifically binds to BCMA produced by the method according to claim 30. Claim 32: A pharmaceutical composition comprising the immunostimulatory antigen-binding molecule according to any one of claims 1 to 24 or 31 and at least one pharmaceutically acceptable excipient.

ARP240101357A 2023-06-01 2024-05-29 Immunostimulatory antigen-binding molecules that specifically bind to BCMA AR132805A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23176584 2023-06-01
EP23189804 2023-08-04

Publications (1)

Publication Number Publication Date
AR132805A1 true AR132805A1 (en) 2025-07-30

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Country Status (4)

Country Link
CN (1) CN121219321A (en)
AR (1) AR132805A1 (en)
TW (1) TW202502811A (en)
WO (1) WO2024246086A1 (en)

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CN121219321A (en) 2025-12-26
TW202502811A (en) 2025-01-16
WO2024246086A1 (en) 2024-12-05

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