Therapeutic afucosylated monoclonal antibody and bispecific T-cell engagers for T-cell acute lymphoblastic leukemia.


Journal

Journal for immunotherapy of cancer
ISSN: 2051-1426
Titre abrégé: J Immunother Cancer
Pays: England
ID NLM: 101620585

Informations de publication

Date de publication:
02 2021
Historique:
accepted: 17 01 2021
entrez: 18 2 2021
pubmed: 19 2 2021
medline: 5 1 2022
Statut: ppublish

Résumé

T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive disease with a poor cure rate for relapsed/resistant patients. Due to the lack of T-cell restricted targetable antigens, effective immune-therapeutics are not presently available and the treatment of chemo-refractory T-ALL is still an unmet clinical need. To develop novel immune-therapy for T-ALL, we generated an afucosylated monoclonal antibody (mAb) (ahuUMG1) and two different bispecific T-cell engagers (BTCEs) against UMG1, a unique CD43-epitope highly and selectively expressed by T-ALL cells from pediatric and adult patients. UMG1 expression was assessed by immunohistochemistry (IHC) on a wide panel of normal tissue microarrays (TMAs), and by flow cytometry on healthy peripheral blood/bone marrow-derived cells, on 10 different T-ALL cell lines, and on 110 T-ALL primary patient-derived cells. CD43-UMG1 binding site was defined through a peptide microarray scanning. ahuUMG1 was generated by Genetic Glyco-Engineering technology from a novel humanized mAb directed against UMG1 (huUMG1). BTCEs were generated as IgG1-(scFv) Among 110 T-ALL patient-derived samples, 53 (48.1%) stained positive (24% of TI/TII, 82% of TIII and 42.8% of TIV). Importantly, no expression of UMG1-epitope was found in normal tissues/cells, excluding cortical thymocytes and a minority (<5%) of peripheral blood T lymphocytes. ahUMG1 induced strong ADCC and ADCP on T-ALL cells in vitro, which translated in antitumor activity in vivo and significantly extended survival of treated mice. Both UMG1-BTCEs demonstrated highly effective killing activity against T-ALL cells in vitro. We demonstrated that this effect was specifically exerted by engaged activated T cells. Moreover, UMG1-BTCEs effectively antagonized tumor growth at concentrations >2 log lower as compared with ahuUMG1, with significant mice survival advantage in different T-ALL models in vivo. Altogether our findings, including the safe UMG1-epitope expression profile, provide a framework for the clinical development of these innovative immune-therapeutics for this still orphan disease.

Sections du résumé

BACKGROUND
T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive disease with a poor cure rate for relapsed/resistant patients. Due to the lack of T-cell restricted targetable antigens, effective immune-therapeutics are not presently available and the treatment of chemo-refractory T-ALL is still an unmet clinical need. To develop novel immune-therapy for T-ALL, we generated an afucosylated monoclonal antibody (mAb) (ahuUMG1) and two different bispecific T-cell engagers (BTCEs) against UMG1, a unique CD43-epitope highly and selectively expressed by T-ALL cells from pediatric and adult patients.
METHODS
UMG1 expression was assessed by immunohistochemistry (IHC) on a wide panel of normal tissue microarrays (TMAs), and by flow cytometry on healthy peripheral blood/bone marrow-derived cells, on 10 different T-ALL cell lines, and on 110 T-ALL primary patient-derived cells. CD43-UMG1 binding site was defined through a peptide microarray scanning. ahuUMG1 was generated by Genetic Glyco-Engineering technology from a novel humanized mAb directed against UMG1 (huUMG1). BTCEs were generated as IgG1-(scFv)
RESULTS
Among 110 T-ALL patient-derived samples, 53 (48.1%) stained positive (24% of TI/TII, 82% of TIII and 42.8% of TIV). Importantly, no expression of UMG1-epitope was found in normal tissues/cells, excluding cortical thymocytes and a minority (<5%) of peripheral blood T lymphocytes. ahUMG1 induced strong ADCC and ADCP on T-ALL cells in vitro, which translated in antitumor activity in vivo and significantly extended survival of treated mice. Both UMG1-BTCEs demonstrated highly effective killing activity against T-ALL cells in vitro. We demonstrated that this effect was specifically exerted by engaged activated T cells. Moreover, UMG1-BTCEs effectively antagonized tumor growth at concentrations >2 log lower as compared with ahuUMG1, with significant mice survival advantage in different T-ALL models in vivo.
CONCLUSION
Altogether our findings, including the safe UMG1-epitope expression profile, provide a framework for the clinical development of these innovative immune-therapeutics for this still orphan disease.

Identifiants

pubmed: 33597219
pii: jitc-2020-002026
doi: 10.1136/jitc-2020-002026
pmc: PMC7893666
pii:
doi:

Substances chimiques

Antibodies, Bispecific 0
Antibodies, Monoclonal, Humanized 0
Antineoplastic Agents, Immunological 0
Epitopes 0
Leukosialin 0
SPN protein, human 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Références

Blood. 2007 Jun 1;109(11):4655-62
pubmed: 17311990
J Biol Chem. 2008 Aug 29;283(35):23627-35
pubmed: 18586676
Blood Adv. 2017 Aug 18;1(19):1551-1564
pubmed: 29296797
Leukemia. 1995 Oct;9(10):1783-6
pubmed: 7564526
J Exp Med. 1989 Jul 1;170(1):259-67
pubmed: 2787380
Infect Immun. 2006 Jul;74(7):4310-21
pubmed: 16790805
J Clin Invest. 2012 Oct;122(10):3398-406
pubmed: 23023710
Blood. 2011 Aug 25;118(8):2077-84
pubmed: 21719599
Immunology. 2016 Nov;149(3):280-296
pubmed: 27392084
Leukemia. 2018 Nov;32(11):2307-2315
pubmed: 30315238
Cancer Immunol Immunother. 2011 Dec;60(12):1697-706
pubmed: 21710258
Tissue Antigens. 1998 May;51(5):528-35
pubmed: 9672151
Exp Hematol. 1998 Dec;26(13):1209-14
pubmed: 9845376
J Clin Oncol. 2018 Oct 10;36(29):2926-2934
pubmed: 30138085
Biomed Res Int. 2014;2014:742831
pubmed: 24689054
Blood. 2018 Apr 5;131(14):1522-1531
pubmed: 29358182
Clin Lymphoma Myeloma. 2009;9 Suppl 3:S214-21
pubmed: 19778844
Blood. 2007 Jun 15;109(12):5136-42
pubmed: 17344466
MAbs. 2018 May/Jun;10(4):539-546
pubmed: 29485921
Eur J Immunol. 1995 Apr;25(4):1051-5
pubmed: 7537669
Blood. 2002 Feb 1;99(3):863-71
pubmed: 11806988
Immune Netw. 2014 Jun;14(3):164-70
pubmed: 24999313
Biol Blood Marrow Transplant. 2012 Dec;18(12):1897-904
pubmed: 22824185
J Immunol. 2020 Mar 15;204(6):1674-1688
pubmed: 32060138
Mol Cell Proteomics. 2011 May;10(5):M111.007898
pubmed: 21372249
Cancer Res. 2019 Jul 1;79(13):3372-3382
pubmed: 31064847
J Clin Invest. 1999 Mar 15;103(6):921
pubmed: 10079114
Leukemia. 2017 Oct;31(10):2037-2047
pubmed: 28074072
Nat Rev Cancer. 2019 Jul;19(7):369
pubmed: 31201391
Bone Marrow Transplant. 2017 Jan;52(1):20-27
pubmed: 27618682
Blood. 2003 Feb 1;101(3):949-54
pubmed: 12393572
Tissue Antigens. 1994 Aug;44(2):73-82
pubmed: 7817381
Cancer Res. 2003 Oct 1;63(19):6453-7
pubmed: 14559836
J Immunol. 2019 Feb 15;202(4):1137-1144
pubmed: 30651344
Oncotarget. 2017 Oct 23;8(63):106753-106763
pubmed: 29290986

Auteurs

Daniele Caracciolo (D)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Caterina Riillo (C)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Andrea Ballerini (A)

BiovelocITA srl, Milano, Italy.

Giuseppe Gaipa (G)

Centro Ricerca M. Tettamanti, Clinica Pediatrica Università Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.

Ludovic Lhermitte (L)

Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Paris, France.
Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.

Marco Rossi (M)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Cirino Botta (C)

Hematology Unit, Annunziata Hospital, Cosenza, Italy.

Eugénie Duroyon (E)

Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Paris, France.
Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.

Katia Grillone (K)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Maria Eugenia Gallo Cantafio (ME)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Chiara Buracchi (C)

Centro Ricerca M. Tettamanti, Clinica Pediatrica Università Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.

Greta Alampi (G)

Centro Ricerca M. Tettamanti, Clinica Pediatrica Università Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.

Alessandro Gulino (A)

Tumor Immunology Unit, Department of Health Sciences, Human Pathology Section, University of Palermo, Palermo, Italy.

Beatrice Belmonte (B)

Tumor Immunology Unit, Department of Health Sciences, Human Pathology Section, University of Palermo, Palermo, Italy.

Francesco Conforti (F)

Pathology Unit, Annunziata Hospital, Cosenza, Italy.

Gaetanina Golino (G)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Giada Juli (G)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Emanuela Altomare (E)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Nicoletta Polerà (N)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Francesca Scionti (F)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Mariamena Arbitrio (M)

IRIB-CNR, Catanzaro, Italy.

Michelangelo Iannone (M)

IRIB-CNR, Catanzaro, Italy.

Massimo Martino (M)

Stem Cell Transplant Program, Clinical Section, Department of Hemato-Oncology and Radiotherapy, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.

Pierpaolo Correale (P)

Medical Oncology Unit, "Bianchi-Melacrino-Morelli" Grand Metropolitan Hospital, Reggio Calabria, Italy.

Gabriella Talarico (G)

Immunotransfusion Service Unit, Pugliese-Ciaccio Hospital, Catanzaro, Italy.

Andrea Ghelli Luserna di Rorà (A)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Anna Ferrari (A)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Daniela Concolino (D)

Department of Medical and Surgical Sciences, Pediatric Unit, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.

Simona Sestito (S)

Department of Medical and Surgical Sciences, Pediatric Unit, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.

Licia Pensabene (L)

Department of Medical and Surgical Sciences, Pediatric Unit, University "Magna Graecia" of Catanzaro, Catanzaro, Italy.

Antonio Giordano (A)

Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, Pennsylvania, USA.

Markus Hildinger (M)

Evitria, Zurich, Switzerland.

Maria Teresa Di Martino (MT)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Giovanni Martinelli (G)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

Claudio Tripodo (C)

Tumor Immunology Unit, Department of Health Sciences, Human Pathology Section, University of Palermo, Palermo, Italy.

Vahid Asnafi (V)

Université de Paris, Institut Necker-Enfants Malades, Institut National de Recherche Médicale U1151, Paris, France.
Laboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.

Andrea Biondi (A)

Centro Ricerca M. Tettamanti, Clinica Pediatrica Università Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.

Pierosandro Tagliaferri (P)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Pierfrancesco Tassone (P)

Department of Experimental and Clinical Medicine, Magna Græcia University of Catanzaro, Catanzaro, Italy tassone@unicz.it.
Sbarro Institute for Cancer Research and Molecular Medicine, Center for Biotechnology, College of Science and Technology, Temple University, Philadelphia, Pennsylvania, USA.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH