“Stapling” scFv for multispecific biotherapeutics of superior properties

Single-chain fragment variable (scFv) domains play an important role in antibody-based therapeutic modalities, such as bispecifics, multispecifics and chimeric antigen receptor T cells or natural killer cells. However, scFv domains exhibit lower stability and increased risk of aggregation due to tra...

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Main Authors: Lauren E. Boucher, Elisabeth Geyer Prinslow, Michael Feldkamp, Fang Yi, Rupesh Nanjunda, Sheng-Jiun Wu, Tun Liu, Eilyn R. Lacy, Steven Jacobs, Natalia Kozlyuk, Brian Del Rosario, Bingyuan Wu, Patricia Aquino, Robert C. Davidson, Samantha Heyne, Nicholas Mazzanti, James Testa, Michael D. Diem, Elsa Gorre, Andrew Mahan, Hirsh Nanda, Harsha P. Gunawardena, Alexis Gervais, Anthony A. Armstrong, Alexey Teplyakov, Chichi Huang, Adam Zwolak, Partha Chowdhury, Wan Cheung Cheung, Jinquan Luo
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:mAbs
Subjects:
Online Access:https://www.tandfonline.com/doi/10.1080/19420862.2023.2195517
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author Lauren E. Boucher
Elisabeth Geyer Prinslow
Michael Feldkamp
Fang Yi
Rupesh Nanjunda
Sheng-Jiun Wu
Tun Liu
Eilyn R. Lacy
Steven Jacobs
Natalia Kozlyuk
Brian Del Rosario
Bingyuan Wu
Patricia Aquino
Robert C. Davidson
Samantha Heyne
Nicholas Mazzanti
James Testa
Michael D. Diem
Elsa Gorre
Andrew Mahan
Hirsh Nanda
Harsha P. Gunawardena
Alexis Gervais
Anthony A. Armstrong
Alexey Teplyakov
Chichi Huang
Adam Zwolak
Partha Chowdhury
Wan Cheung Cheung
Jinquan Luo
author_facet Lauren E. Boucher
Elisabeth Geyer Prinslow
Michael Feldkamp
Fang Yi
Rupesh Nanjunda
Sheng-Jiun Wu
Tun Liu
Eilyn R. Lacy
Steven Jacobs
Natalia Kozlyuk
Brian Del Rosario
Bingyuan Wu
Patricia Aquino
Robert C. Davidson
Samantha Heyne
Nicholas Mazzanti
James Testa
Michael D. Diem
Elsa Gorre
Andrew Mahan
Hirsh Nanda
Harsha P. Gunawardena
Alexis Gervais
Anthony A. Armstrong
Alexey Teplyakov
Chichi Huang
Adam Zwolak
Partha Chowdhury
Wan Cheung Cheung
Jinquan Luo
author_sort Lauren E. Boucher
collection DOAJ
description Single-chain fragment variable (scFv) domains play an important role in antibody-based therapeutic modalities, such as bispecifics, multispecifics and chimeric antigen receptor T cells or natural killer cells. However, scFv domains exhibit lower stability and increased risk of aggregation due to transient dissociation (“breathing”) and inter-molecular reassociation of the two domains (VL and VH). We designed a novel strategy, referred to as stapling, that introduces two disulfide bonds between the scFv linker and the two variable domains to minimize scFv breathing. We named the resulting molecules stapled scFv (spFv). Stapling increased thermal stability (Tm) by an average of 10°C. In multiple scFv/spFv multispecifics, the spFv molecules display significantly improved stability, minimal aggregation and superior product quality. These spFv multispecifics retain binding affinity and functionality. Our stapling design was compatible with all antibody variable regions we evaluated and may be widely applicable to stabilize scFv molecules for designing biotherapeutics with superior biophysical properties.
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1942-0870
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publishDate 2023-12-01
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spelling doaj-art-07a49e5767d741f0bc24b50e3af689e12025-08-20T03:51:54ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2195517“Stapling” scFv for multispecific biotherapeutics of superior propertiesLauren E. Boucher0Elisabeth Geyer PrinslowMichael Feldkamp1Fang Yi2Rupesh Nanjunda3Sheng-Jiun Wu4Tun Liu5Eilyn R. Lacy6Steven Jacobs7Natalia Kozlyuk8Brian Del Rosario9Bingyuan Wu10Patricia Aquino11Robert C. Davidson12Samantha Heyne13Nicholas Mazzanti14James Testa15Michael D. Diem16Elsa Gorre17Andrew Mahan18Hirsh Nanda19Harsha P. Gunawardena20Alexis Gervais21Anthony A. Armstrong22Alexey Teplyakov23Chichi Huang24Adam Zwolak25Partha Chowdhury26Wan Cheung Cheung27Jinquan Luo28AbbVie, 1 North Waukegan Rd, North Chicago, IL, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USABiologics Discovery, Janssen Research & Development, LLC, Spring House, PA, USASingle-chain fragment variable (scFv) domains play an important role in antibody-based therapeutic modalities, such as bispecifics, multispecifics and chimeric antigen receptor T cells or natural killer cells. However, scFv domains exhibit lower stability and increased risk of aggregation due to transient dissociation (“breathing”) and inter-molecular reassociation of the two domains (VL and VH). We designed a novel strategy, referred to as stapling, that introduces two disulfide bonds between the scFv linker and the two variable domains to minimize scFv breathing. We named the resulting molecules stapled scFv (spFv). Stapling increased thermal stability (Tm) by an average of 10°C. In multiple scFv/spFv multispecifics, the spFv molecules display significantly improved stability, minimal aggregation and superior product quality. These spFv multispecifics retain binding affinity and functionality. Our stapling design was compatible with all antibody variable regions we evaluated and may be widely applicable to stabilize scFv molecules for designing biotherapeutics with superior biophysical properties.https://www.tandfonline.com/doi/10.1080/19420862.2023.2195517Multi-specific antibodyScfvScfv stabilizationSingle chain fvSpfvStapled scfv
spellingShingle Lauren E. Boucher
Elisabeth Geyer Prinslow
Michael Feldkamp
Fang Yi
Rupesh Nanjunda
Sheng-Jiun Wu
Tun Liu
Eilyn R. Lacy
Steven Jacobs
Natalia Kozlyuk
Brian Del Rosario
Bingyuan Wu
Patricia Aquino
Robert C. Davidson
Samantha Heyne
Nicholas Mazzanti
James Testa
Michael D. Diem
Elsa Gorre
Andrew Mahan
Hirsh Nanda
Harsha P. Gunawardena
Alexis Gervais
Anthony A. Armstrong
Alexey Teplyakov
Chichi Huang
Adam Zwolak
Partha Chowdhury
Wan Cheung Cheung
Jinquan Luo
“Stapling” scFv for multispecific biotherapeutics of superior properties
mAbs
Multi-specific antibody
Scfv
Scfv stabilization
Single chain fv
Spfv
Stapled scfv
title “Stapling” scFv for multispecific biotherapeutics of superior properties
title_full “Stapling” scFv for multispecific biotherapeutics of superior properties
title_fullStr “Stapling” scFv for multispecific biotherapeutics of superior properties
title_full_unstemmed “Stapling” scFv for multispecific biotherapeutics of superior properties
title_short “Stapling” scFv for multispecific biotherapeutics of superior properties
title_sort stapling scfv for multispecific biotherapeutics of superior properties
topic Multi-specific antibody
Scfv
Scfv stabilization
Single chain fv
Spfv
Stapled scfv
url https://www.tandfonline.com/doi/10.1080/19420862.2023.2195517
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