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NZ730442B2 - T cell activating bispecific antigen binding molecules agiant folr1 and cd3 - Google Patents
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NZ730442B2 - T cell activating bispecific antigen binding molecules agiant folr1 and cd3 - Google Patents

T cell activating bispecific antigen binding molecules agiant folr1 and cd3

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Publication number
NZ730442B2
NZ730442B2 NZ730442A NZ73044215A NZ730442B2 NZ 730442 B2 NZ730442 B2 NZ 730442B2 NZ 730442 A NZ730442 A NZ 730442A NZ 73044215 A NZ73044215 A NZ 73044215A NZ 730442 B2 NZ730442 B2 NZ 730442B2
Authority
NZ
New Zealand
Prior art keywords
antigen binding
seq
cell activating
activating bispecific
bispecific antigen
Prior art date
Application number
NZ730442A
Other versions
NZ730442A (en
Inventor
Marina Bacac
Peter Bruenker
Grundschober Anne Freimoser
Ralf Hosse
Christian Klein
Ekkehard Moessner
Pablo Umana
Tina Weinzierl
Original Assignee
F Hoffmann La Roche Ag
Filing date
Publication date
Application filed by F Hoffmann La Roche Ag filed Critical F Hoffmann La Roche Ag
Priority claimed from PCT/EP2015/076739 external-priority patent/WO2016079076A1/en
Publication of NZ730442A publication Critical patent/NZ730442A/en
Publication of NZ730442B2 publication Critical patent/NZ730442B2/en

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/2809—Immunoglobulins [IG], 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/35—Valency
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/66—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a swap of domains, e.g. CH3-CH2, VH-CL or VL-CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/74—Inducing cell proliferation
    • 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
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

The present invention generally relates to novel bispecific antigen binding molecules for T cell activation and re-direction to specific target cells. In addition, the present invention relates to polynucleotides encoding such bispecific antigen binding molecules, and vectors and host cells comprising such polynucleotides. The invention further relates to methods for producing the bispecific antigen binding molecules of the invention, and to methods of using these bispecific antigen binding molecules in the treatment of disease.

Claims (35)

Claims
1. A T cell activating bispecific antigen binding molecule comprising: (i) a first antigen binding moiety which is a Fab molecule capable of specific g to 5 CD3, and which comprises a complementarity ining region heavy chain (CDR-H) 1 comprising SEQ ID NO: 37, a CDR-H2 comprising SEQ ID NO: 38 and CDR-H3 comprising SEQ ID NO: 39 a complementarity determining region light chain (CDR-L) 1 comprising SEQ ID NO: 32, a CDR-L2 comprising SEQ ID NO: 33, and a CDR-L3 comprising SEQ ID NO: 34; and 10 (ii) a second antigen binding moiety capable of specific binding to Folate Receptor 1 (FolR1) comprising: a) a CDR-H1 comprising SEQ ID NO: 16, a CDR-H2 comprising SEQ ID NO: 17, a CDRH3 comprising SEQ ID NO:18, a CDR-L1 comprising SEQ ID NO: 32, a CDR-L2 comprising SEQ ID NO: 33, a CDR-L3 comprising SEQ ID NO:34; 15 b) a CDR-H1 comprising SEQ ID NO: 8, a CDR-H2 comprising SEQ ID NO: 56, a CDR-H3 comprising SEQ ID NO:57, a CDR-L1 comprising SEQ ID NO: 59, a CDRL2 sing SEQ ID NO: 60, and a CDR-L3 comprising SEQ ID NO:65; or c) a CDR-H1 comprising SEQ ID NO: 16, a CDR-H2 comprising SEQ ID NO: 275, a CDRH3 comprising SEQ ID NO:315, a CDR-L1 sing SEQ ID NO: 32, a CDR-L2 20 comprising SEQ ID NO: 33, and a CDR-L3 comprising SEQ ID NO:34.
2. The T cell activating bispecific antigen binding molecule of claim 1, n the first antigen binding moiety comprises a variable heavy chain comprising SEQ ID NO: 36 and a variable light chain comprising SEQ ID NO: 31.
3. The T cell activating bispecific n binding molecule of claims 1 or 2, additionally (iii) a third antigen binding moiety e of specific binding to FolR1. 30
4. The T cell activating ific antigen binding molecule of claim 3, wherein the second and third antigen binding moiety capable of specific binding to FolR1 comprise identical heavy chain complementarity determining region (CDR) and light chain CDR sequences.
5. The T cell activating bispecific antigen binding le of claims 3 or 4, wherein the third antigen binding moiety is identical to the second antigen binding moiety.
6. The T cell activating bispecific antigen binding molecule of any one of claims 3 to 5, 5 wherein at least one of the second and third antigen binding moiety is a Fab molecule.
7. The T cell activating bispecific antigen binding le of any one of claims 1 to 6, additionally comprising: (iv) an Fc domain composed of a first and a 5 second subunit capable of stable association.
8. The T cell activating bispecific antigen binding molecule of claim 7, n the first antigen binding moiety and the second antigen binding moiety are each ted at the Cterminus of the Fab heavy chain to the N-terminus of the first or second subunit of the Fc
9. The T cell activating bispecific antigen binding molecule of claims 7 or 8, wherein a third antigen binding moiety is connected at the C-terminus of the Fab heavy chain to the N terminus of the Fab heavy chain of the first antigen g moiety, optionally via a peptide linker.
10. The T cell activating bispecific antigen binding molecule of any one of claims 1 to 9, n the antigen binding moiety capable of specific binding to FolR1 comprises a variable heavy chain comprising SEQ ID NO: 15 and a variable light chain comprising SEQ ID NO: 31.
11. The T cell activating ific antigen binding molecule of any one of claims 1 to 9, wherein the n binding moiety capable of specific binding to FolR1 ses a variable heavy chain comprising SEQ ID NO: 55 and a variable light chain comprising SEQ ID NO: 64.
12. The T cell activating bispecific antigen binding molecule of any one of claims 1 to 9, wherein the antigen binding moiety capable of specific binding to FolR1 comprises a variable heavy chain comprising SEQ ID NO: 274 and a variable light chain comprising SEQ
13. ID NO: 31. 5 13. The T cell activating bispecific antigen binding molecule of any one claims 1 to 12 which binds to a human FolR1.
14. The T cell activating bispecific antigen binding le of any one of claims 1 to 13, which binds to a human FolR1 and a cynomolgus monkey FolR1.
15. The T cell activating bispecific antigen binding molecule of any one of claims 1 to 14, which binds to a human FolR1 and a cynomolgus monkey FolR1 and not a murine FolR1.
16. The T cell activating ific n binding molecule of claim 11, wherein the first 15 antigen binding moiety is a crossover Fab molecule wherein either the variable or the constant regions of the Fab light chain and the Fab heavy chain are exchanged.
17. The T cell activating bispecific antigen binding molecule of any one of claims 1 to 16, comprising not more than one antigen binding moiety 5 e of specific binding to CD3.
18. The T cell activating bispecific antigen binding molecule of any one of claims 7 to 17, wherein the first and the second antigen binding moiety and the Fc domain are part of an immunoglobulin molecule. 25
19. The T cell activating bispecific antigen binding le of claim 18, wherein the Fc domain is an IgG class immunoglobulin, optionally an IgG1 or IgG4, Fc domain.
20. The T cell activating bispecific n binding molecule of any one of claims 7 to 19, wherein the Fc domain is a human Fc domain.
21. The T cell activating bispecific antigen binding le of any one of claims 7 to 20, n the Fc domain comprises a modification promoting the association of the first and the second subunit of the Fc domain.
22. The T cell ting bispecific antigen binding molecule of claim 21, wherein, in the CH3 domain of the first subunit of the Fc domain, an amino acid residue is replaced with an amino acid residue having a larger side chain , thereby generating a protuberance 5 within the CH3 domain of the first subunit which is positionable in a cavity within the CH3 domain of the second subunit, and in the CH3 domain of the second subunit of the Fc domain an amino acid residue is replaced with an amino acid residue having a smaller side chain volume, thereby generating a cavity within the CH3 domain of the second subunit within which the protuberance within the CH3 domain of the first t is positionable.
23. The T cell activating bispecific antigen binding molecule of any one of claims 7 to 22, wherein the Fc domain comprises at least one amino acid substitution that reduces binding to an Fc receptor and/or effector function, as ed to a native IgG1 Fc domain. 15 24. The T cell activating bispecific antigen binding molecule of claim 23, wherein each subunit of the Fc domain comprises three amino acid substitutions that reduce binding to an activating Fc receptor and/or effector function, wherein said amino acid substitutions are
24. L234A, L235A and P329G (Kabat ing). 20 25. The T cell activating bispecific antigen binding molecule of claims 23 or 24, wherein the
25. Fc receptor is an Fcy or.
26. The T cell activating bispecific antigen binding molecule of any one of claims 23 to 25, n the effector function is dy-dependent cell-mediated cytotoxicity (ADCC).
27. A T cell activating bispecific antigen binding molecule comprising the amino acid sequence of SEQ ID NO:276, SEQ ID , and SEQ ID NO:35.
28. At least one ed polynucleotide encoding the T cell activating bispecific antigen 30 binding molecule of any one of claims 1 to 27.
29. At least one polypeptide encoded by the polynucleotide of claim 28.
30. At least one vector, optionally an expression vector, comprising at least one polynucleotide of claim 28.
31. A host cell comprising at least one polynucleotide of claim 28 or at least one vector of 5 claim 30, with the proviso that said host cell is not present in a human being.
32. A method of producing the T cell ting bispecific antigen binding molecule e of specific binding to CD3 and specifically binding to FolR1, sing the steps of a) culturing the host cell of claim 31 under conditions suitable for the expression of the T cell 10 activating bispecific antigen binding molecule and b) recovering the T cell activating bispecific antigen binding molecule.
33. A pharmaceutical composition comprising the T cell activating bispecific antigen binding molecule of any one of claims 1 to 27 or 32 and a pharmaceutically acceptable carrier.
34. Use of the T cell activating bispecific antigen binding le of any one of claims 1 to 27 or 32 in the cture of a medicament for treating cancer in an individual.
35. A T cell activating bispecific antigen g molecule of any one of claims 1 to 27, a 20 polynucleotide of claim 28, a polypeptide of claim 29, a vector of claim 30, a host cell of claim 31, a method of claim 32, a pharmaceutical composition of claim 33, or a use of claim 34, substantially as described herein and with reference to any example thereof.
NZ730442A 2015-11-17 T cell activating bispecific antigen binding molecules agiant folr1 and cd3 NZ730442B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14194147 2014-11-20
PCT/EP2015/076739 WO2016079076A1 (en) 2014-11-20 2015-11-17 T cell activating bispecific antigen binding molecules agiant folr1 and cd3

Publications (2)

Publication Number Publication Date
NZ730442A NZ730442A (en) 2024-04-26
NZ730442B2 true NZ730442B2 (en) 2024-07-30

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