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AR129995A1 - ANTI-STEAP1 ANTIGEN BINDING MOLECULES AND THEIR USES - Google Patents

ANTI-STEAP1 ANTIGEN BINDING MOLECULES AND THEIR USES

Info

Publication number
AR129995A1
AR129995A1 ARP230101920A ARP230101920A AR129995A1 AR 129995 A1 AR129995 A1 AR 129995A1 AR P230101920 A ARP230101920 A AR P230101920A AR P230101920 A ARP230101920 A AR P230101920A AR 129995 A1 AR129995 A1 AR 129995A1
Authority
AR
Argentina
Prior art keywords
cdr
seq
steap1
antigen
asp
Prior art date
Application number
ARP230101920A
Other languages
Spanish (es)
Inventor
Meredith Carroll Hazen
Isidro Hotzel
Julien Lafrance-Vanasse
Gabriele Maria Schaefer
Dhaya Seshasayee
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of AR129995A1 publication Critical patent/AR129995A1/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069Reproductive system, e.g. ovaria, uterus, testes, prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Cell Biology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Surgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención proporciona moléculas de unión al antígeno monoespecíficas y multiespecíficas y composiciones de estas. La invención también incluye métodos para tratar una enfermedad o trastorno, tal como cáncer, métodos para inhibir el crecimiento tumoral, kits para su uso con el uno o más métodos. Reivindicación 1: Una molécula de unión al antígeno multiespecífica que comprende: (A) un primer dominio de unión al antígeno que se une a STEAP1 y comprende una región variable de la cadena pesada (VH) anti-STEAP1 que comprende CDR-H1, CDR-H2 y CDR-H3 de una secuencia VH seleccionada de SEQ ID Nº 7, 17 - 25, 30 - 34, 38 y 68; y una región variable de la cadena liviana (VL) anti-STEAP1 que comprende CDR-L1, CDR-L2 y CDR-L3 de una secuencia VL seleccionada de SEQ ID Nº 8, 26 - 29, 39 y 69; y (B) un segundo dominio de unión al antígeno que se une a un receptor de linfocitos T. Reivindicación 2: Una molécula de unión al antígeno multiespecífica que comprende: (A) un primer dominio de unión al antígeno que se une a STEAP1 y comprende una región variable de la cadena pesada (VH) anti-STEAP1 que comprende CDR-H1, CDR-H2 y CDR-H3; y una región variable de la cadena liviana (VL) anti-STEAP1 que comprende CDR-L1, CDR-L2 y CDR-L3; en donde CDR-H1 comprende Xaa¹Xaa²YMA (SEQ ID Nº 35); en donde Xaa¹ es Asp (D) o Asn (N); y Xaa² es His (H), Tyr (Y) o Phe (F); CDR-H2 comprende YIXaa³YDGXaa⁴Xaa⁵TXaa⁶YGDSVKG (SEQ ID Nº 36); en donde Xaa³ es Asp (D) o Ser (S); Xaa⁴ es Gly (G), Asp (D) o Leu (L); Xaa⁵ es Ser (S), Asp (D) o Asn (N); y Xaa⁶ es Ser (S) o Tyr (Y); y CDR-H3 comprende RSGXaa⁷YHVGYAMXaa⁸Xaa⁹ (SEQ ID Nº 37); en donde Xaa⁷ es Phe (F) o Tyr (Y); Xaa⁸ es Asn (N) o Asp (D); y Xaa⁹ es Ala (A) o Gly (G); CDR-L1 comprende la secuencia de aminoácidos de SEQ ID Nº 4; CDR-L2 comprende la secuencia de aminoácidos de SEQ ID Nº 5; y CDR-L3 comprende la secuencia de aminoácidos de SEQ ID Nº 6; y (B) un segundo dominio de unión al antígeno que se une a un receptor de linfocitos T. Reivindicación 95: Un anticuerpo que comprende un primer dominio de unión al antígeno que se une a STEAP1 humano en uno o más residuos seleccionados de Ser101, His102, Gln103 y Lys281, en donde las posiciones de los residuos 101, 102, 103 y 281 corresponden a las posiciones 101, 102, 103 y 281 indicadas en SEQ ID Nº 65. Reivindicación 142: Uso de la molécula de unión al antígeno multiespecífica de acuerdo con cualquiera de las reivindicaciones 1 - 54, la molécula de unión al antígeno de acuerdo con cualquiera de las reivindicaciones 55 - 94, o el anticuerpo de acuerdo con cualquiera de las reivindicaciones 95 - 110 en la elaboración de un medicamento para el tratamiento o retraso de la progresión de cáncer que expresa STEAP1 en un sujeto que lo necesita, opcionalmente para el tratamiento o retraso de la progresión de cáncer de próstata o sarcoma de Ewing.The present invention provides monospecific and multispecific antigen binding molecules and compositions thereof. The invention also includes methods of treating a disease or disorder, such as cancer, methods of inhibiting tumor growth, kits for use with the one or more methods. Claim 1: A multispecific antigen binding molecule comprising: (A) a first antigen binding domain that binds STEAP1 and comprises an anti-STEAP1 heavy chain variable region (VH) comprising CDR-H1, CDR-H2 and CDR-H3 of a VH sequence selected from SEQ ID NOs: 7, 17-25, 30-34, 38 and 68; and an anti-STEAP1 light chain variable region (VL) comprising CDR-L1, CDR-L2 and CDR-L3 of a VL sequence selected from SEQ ID NO: 8, 26-29, 39 and 69; and (B) a second antigen-binding domain that binds to a T cell receptor. Claim 2: A multispecific antigen-binding molecule comprising: (A) a first antigen-binding domain that binds STEAP1 and comprises an anti-STEAP1 heavy chain variable region (VH) comprising CDR-H1, CDR-H2 and CDR-H3; and an anti-STEAP1 light chain variable region (VL) comprising CDR-L1, CDR-L2 and CDR-L3; wherein CDR-H1 comprises Xaa¹Xaa²YMA (SEQ ID NO: 35); where Xaa¹ is Asp (D) or Asn (N); and Xaa² is His (H), Tyr (Y) or Phe (F); CDR-H2 comprises YIXaa³YDGXaa⁴Xaa⁵TXaa⁶YGDSVKG (SEQ ID NO: 36); where Xaa³ is Asp (D) or Ser (S); Xaa⁴ is Gly (G), Asp (D) or Leu (L); Xaa⁵ is Ser (S), Asp (D) or Asn (N); and Xaa⁶ is Ser (S) or Tyr (Y); and CDR-H3 comprises RSGXaa⁷YHVGYAMXaa⁸Xaa⁹ (SEQ ID NO: 37); where Xaa⁷ is Phe (F) or Tyr (Y); Xaa⁸ is Asn (N) or Asp (D); and Xaa⁹ is Ala (A) or Gly (G); CDR-L1 comprises the amino acid sequence of SEQ ID No. 4; CDR-L2 comprises the amino acid sequence of SEQ ID No. 5; and CDR-L3 comprises the amino acid sequence of SEQ ID No. 6; and (B) a second antigen-binding domain that binds to a T cell receptor. Claim 95: An antibody comprising a first antigen-binding domain that binds human STEAP1 at one or more residues selected from Ser101, His102, Gln103 and Lys281, wherein the positions of residues 101, 102, 103 and 281 correspond to positions 101, 102, 103 and 281 indicated in SEQ ID NO: 65. Claim 142: Use of the multispecific antigen-binding molecule according to any of claims 1 - 54, the antigen-binding molecule according to any of claims 55 - 94, or the antibody according to any of claims 95 - 110 in the manufacture of a medicament for the treatment or delay of the progression of cancer expressing STEAP1 in a subject in need thereof, optionally for the treatment or delay of progression of prostate cancer or Ewing sarcoma.

ARP230101920A 2022-07-22 2023-07-21 ANTI-STEAP1 ANTIGEN BINDING MOLECULES AND THEIR USES AR129995A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202263391568P 2022-07-22 2022-07-22

Publications (1)

Publication Number Publication Date
AR129995A1 true AR129995A1 (en) 2024-10-23

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Country Status (16)

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EP (1) EP4558528A1 (en)
JP (1) JP2025523995A (en)
KR (1) KR20250041021A (en)
CN (1) CN119654349A (en)
AR (1) AR129995A1 (en)
AU (1) AU2023312051A1 (en)
CA (1) CA3261989A1 (en)
CL (1) CL2025000179A1 (en)
CO (1) CO2025000447A2 (en)
CR (1) CR20250056A (en)
IL (1) IL317637A (en)
MA (1) MA71559A (en)
MX (1) MX2025000637A (en)
PE (1) PE20250796A1 (en)
TW (1) TW202417504A (en)
WO (1) WO2024020564A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
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WO2026019990A1 (en) * 2024-07-18 2026-01-22 Genentech, Inc. Methods of treating cancer with anti-ccr8/anti-cd3 bispecific antibodies

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