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New Anti-CD20 Monoclonals

Pr Guillaume CARTRON, MD Ph-D

Head of Hematology Department, UMR-CNRS 5235

CHRU Montpellier, University of Montpellier Conflicts of interest

 Active patents for new monoclonal antibodies – N° WO 03/035904, N° WO2005/118854, GB0822345.5 : Licensed to Clinical Data – PCT/EP2013/050787  With companies developping monoclonal antibodies – Takeda Millenium: Honorarium – Roche/Genentech: Honorarium/consultancy – GSK: Honoraires – Celgene: Honorarium/consultancy – Sanofi: Honorarium Aims of this talk

 To understand the different mechanisms of action of anti-CD20 mAbs

 To understand different ways to improve anti-CD20 mAbs activity

 To know differences between the « new anti-CD20 mAbs » (, and ) compared to Therapeutic antibodies: a very old story

 1891. Emil von Behring infused and cured a child with anti-diphteria sera

 1893. Paul Gibier « take the juice of tumor, infuse in a horse and then infuse the serum of the horse to the patient »  1895. Jules Héricourt and Charles Richet infused the first patient with sarcoma How rituximab works in vivo?

Apoptosis

Complement-dependent Antibody-dependent cytotoxicity (CDC) cellular cytotoxicity (ADCC

Targeted CR3 Death antigen signal C1qR FcR Effector C1q Effector cell cell Tumour cell

CR3 MAb Membrane attack complex

Phagocytosis

Lysis Cheson BD, Leonard JP. New Engl J Med 2008; 359: 613–626. Ways to improve rituximab efficacy

Complement

** FcgRs 142 C1q 184 Effector cells

CD20 219- 225 1 KISH FLKM ESLN FIRAH TPY IN IYN CEPA* N*P SEKN SPST QYCY homme TLSH FLKM RRLE LIQTS KPY VD IYDCEPS NS SEKN SPST QYCN souris Epitope/function Fc/function Type 1 or Type 2 mAb

Type I mAbs Type II mAbs Rituximab, Ofatumumab, , , Obinutuzumab Ublituximab Localize CD20 into lipid rafts Do not lo localize CD20 into lipid rafts  CDC  No CDC No homotypic adhesion Homotypic adhesion

ADCC

Phagocytosis Type 1 or Type 2 mAb

Type I mAbs Type II mAbs Rituximab, Ofatumumab, Veltuzumab, Tositumomab, Obinutuzumab Ublituximab Localize CD20 into lipid rafts Do not lo localize CD20 into lipid rafts  CDC  No CDC No homotypic adhesion Homotypic adhesion Caspase dependant cell death Non-caspase dependant cell death Bind CD20 molecules Bind half of CD20 molecules/type I CD20 modulation No CD20 modulation Trogocytosis ADCC

Phagocytosis CD20 structure and organisation

Large loops: Lipid raft Small loops: 142-184 monomer 72-80

219-225

Tetramer COOH NH2 Membran cell organisation Proteins associated with CD20: MHC I, MHC II, CD53, CD81, CD82, CD40, BCR,… CD20 migration into lipid rafts induces CDC

Phospholipids

Sphyngolipids

Cholesterol Translocation Lipid raft

Cbp CD20 CD20

Lyn Lyn P CD20 type I epitope

142 170 173 184

KISH FLKM ESLN FIRAH TPY IN IYN CEPA NP SEKN SPST QYCY S-S 167 183

NH2 COOH

Polyack MJ, et al. Blood 2002; 99:3256. Ofatumumab induces higher CDC

▼: ofatumumab ▼: ofatumumab ■: rituximab ■: rituximab ▲: 7D8▲: 7D8 ▲: 7D8 ●: 11B8●: 11B8

CDC CD20 binding

Teeling JL, et al. Blood 2004; 104: 1793-1800. Ofatumumab, a discontinuous epitope

Type I mAbs

142 170 173 184 Rituximab, 2H7, KISH FLKM ESLN FIRAH TPY IN IYN CEPA NP SEKN SPST QYCY LT20

142 159 166 184 Ofatumumab KISH FLKM ESLN FIRAH TPY IN IYN CEPA NP SEKN SPST QYCY 72 80 IPA GI YAPI

Teeling JL, et al. Blood 2006; 177: 362-371 Ofatumumab binding site

A ring of hydrophobic residues surrounding a deep positively charged pocket

Du J, et al. Mol Immunol 2009; 46: 2419-2423. Ofatumumab CD20 epitope

Du J, et al. Mol Immunol 2009; 46: 2419-2423. Ofatumumab exhibits higher CDC against CD20low cells

rituximab ofatumumab

CEM cells + anti-CD20 antibodies at 10µg/mL

Teeling JL, et al. J Immunol 2006; 177: 362-371. Ofatumumab concentration-effect relationship

ofatumumab ofatumumab

rituximab rituximab

Daudi + CMN DHL4 Daudi

Teeling JL, et al. Blood 2004; 104: 1793-1800.

Bleeker WK, et al. Br J Haematol 2008; 140: 303-312. Anti-CD20 mAbs induces homotypic adhesion differently

Type 2 Type 1

Bologna L, et al. J Immunol 2011; 186: 3762-3769. Homotypic adhesion induces peripheral localisation of actin and mitochondria

Raji cells expressing Ac-GFP-labelling actin + Tos

JC-1 labeled cells Ivanov A, et al. J Clin Invest 2009; 119: 2143-2159. Cell death induces by type II mAbs differs from apoptosis

Type 2 Type 1

Tos Apoptosis CtrlCtrl

Ivanov A, et al. J Clin Invest 2009; 119: 2143-2159. Involvment of lysosomes in type II mAbs cell death

Type II Type II Type II

Cathepsin B staining

Type II

LAMP-1Lysosomal associated membran protein Ivanov A, et al. J Clin Invest 2009; 119: 2143-2159. Type II mAbs bind half of CD20 molecules compared to type I mAbs

Cragg MS, et al. Blood 2003; 101: 2738-2743. Comparison of the obinutuzumab-CD20 epitope- binding with other CD20 mAbs

70°

90° Niederfellner G, et al. Blood 2011; 118:358. CD20 Type II epitope

Type I mAbs

142 170 173 184 Rituximab, 2H7, LT20 KISH FLKM ESLN FIRAH TPY IN IYN CEPA NP SEKN SPST QYCY

Type II mAbs

142 172 178 184 Obinutuzumab, tositumomab KISH FLKM ESLN FIRAH TPY IN IYN CEPA NP SEKN SPST QYCY

Niederfellner G, et al. Blood 2011; 118:358. Elbow hinge substitution

167°

140°

Niederfellner G, et al. Blood 2011; 118:358. Model of type I or type II mAbs-CD20 interactions

Type I - Inter tetramer binding

CD20 - More CD20 bound - Translocation into lipid rafts - CDC - « open » configuration of CD20 Lipid rafts - Caspase dependant cell-death

- Intra tetramer binding Type II - Half CD20 bound - No translocation into lipid rafts CD20 - No CDC - « closed » configuration of CD20 - No caspase dependant cell-death - Homotypic adhesion Ways to improve rituximab efficacy

Complement

** FcgRs 142 C1q 184 Effector cells

CD20 219- 225 1 KISH FLKM ESLN FIRAH TPY IN IYN CEPA* N*P SEKN SPST QYCY homme TLSH FLKM RRLE LIQTS KPY VD IYDCEPS NS SEKN SPST QYCN souris Epitope/function Fc/function Type I and type II mAbs exhibit similar Fc-mediated functions

Antibody FcgRs B-lymphoma cell

Antibody

FcgRs

CD20 NK cell

Granzyme Perforine Macrophage B-lymphoma cell ADCC. CD20 ADPC. FcgRs expression

FcgRI FcgRIIa FcgRIIb FcgRIIc FcgRIIIa FcgRIIIb

Monocytes/ + + + + macrophages

NK cells + +

Neutrophils +/- + +

B lymphocytes +

Dendritic cells + + + +

Mastocytes +/- + +

Platelets + FCGR3A polymorphism influences IgG1 binding to NK-cells

IgG1

IgG1

FcgRIIIa-158F FcgRIIIa-158V

NK NK Human IgG1 have a better affinity for FcgRIIIa-158VV NK-cells than FcgRIIIa-158FF NK cells

Koene HR, et al. Blood 1997: 90: 1109-1114. Dall’Ozzo S, et al. Cancer Research 2004; 64: 4664-4669. Amino acid 158 interacts with Fc arm FcgRIIIa-158VF influences rituximab response in human

100% 100 90% P = 0.03

80 67% P = 0.03

60 51%

40

20 Objective Response (%) Response Objective FCGR3A-158VV 0 FCGR3A-158F carriers M2 M12 Cartron G, et al. Blood 2002; 99:754–758. Is FcgRIIIa-158VF influences all IgG1 mAbs response?

Trastuzumab

Musolino A, et al. J Clin Oncol 2007; 26: 1789-1796. Ways to improve ADCC

Mutation Fc

Low fucose Effets of glycoengiennering and Fc mutations

Teneur en fucose : Teneur en fucose : Teneur en fucose : Target cells : WIL2-S

sFcγRIIIaV binding98 % sFcγRIIIa4 % F binding 98 % Cytotoxicité (%) Cytotoxicité

Cellules cible : Raji Unités de résonancedeUnités Unités de résonancedeUnités Temps (s) Temps (s) Okazaki A, et al. J Mol Biol 2004; 336: 1239-1249. Superior ADCC: The effect of glycoengineering

Obinutuzumab Rituximab Ofatumumab Ublituximab Rituximab Z138 (PBMC: V/V) 100

80

60 dependent dependent

- 40

killing (%) killing 20

Antibody 0

–20 0.064 0.32 1.6 8 40 200 1000 Antibody concentration (ng/mL)

PBMC: V/V = peripheral blood mononuclear cells expressing human FcγRIIIa V/V. Herter S, et al. ASH 2010. Abstract 3925 (Poster presentation) De Romeuf C et al. Br J Haematol 2008; 140: 635-643 Conclusion

ADCC

Direct ADPC effect

CDC Rituximab Ofatumumab Obinutuzumab Ublituximab

Arbitrary scale: Rituximab referenced with 3 for all in vitro activities New Anti-CD20 Monoclonals

Pr Guillaume CARTRON, MD Ph-D

Head of Hematology Department, UMR-CNRS 5235

CHRU Montpellier, University of Montpellier