Exploration of the antibody–drug conjugate clinical landscape
ABSTRACTThe antibody–drug conjugate (ADC) field has undergone a renaissance, with substantial recent developmental investment and subsequent drug approvals over the past 6 years. In November 2022, ElahereTM became the latest ADC to be approved by the US Food and Drug Administration (FDA). To date, o...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | mAbs |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2023.2229101 |
| _version_ | 1797356287012372480 |
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| author | Heather Maecker Vidya Jonnalagadda Sunil Bhakta Vasu Jammalamadaka Jagath R. Junutula |
| author_facet | Heather Maecker Vidya Jonnalagadda Sunil Bhakta Vasu Jammalamadaka Jagath R. Junutula |
| author_sort | Heather Maecker |
| collection | DOAJ |
| description | ABSTRACTThe antibody–drug conjugate (ADC) field has undergone a renaissance, with substantial recent developmental investment and subsequent drug approvals over the past 6 years. In November 2022, ElahereTM became the latest ADC to be approved by the US Food and Drug Administration (FDA). To date, over 260 ADCs have been tested in the clinic against various oncology indications. Here, we review the clinical landscape of ADCs that are currently FDA approved (11), agents currently in clinical trials but not yet approved (164), and candidates discontinued following clinical testing (92). These clinically tested ADCs are further analyzed by their targeting tumor antigen(s), linker, payload choices, and highest clinical stage achieved, highlighting limitations associated with the discontinued drug candidates. Lastly, we discuss biologic engineering modifications preclinically demonstrated to improve the therapeutic index that if incorporated may increase the proportion of molecules that successfully transition to regulatory approval. |
| first_indexed | 2024-03-08T14:24:27Z |
| format | Article |
| id | doaj.art-b29b260a7b5744b7a89579178ccb0b77 |
| institution | Directory Open Access Journal |
| issn | 1942-0862 1942-0870 |
| language | English |
| last_indexed | 2024-03-08T14:24:27Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj.art-b29b260a7b5744b7a89579178ccb0b772024-01-13T11:27:52ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2229101Exploration of the antibody–drug conjugate clinical landscapeHeather Maecker0Vidya Jonnalagadda1Sunil Bhakta2Vasu Jammalamadaka3Jagath R. Junutula4Aarvik Therapeutics, Inc, Hayward, CA, USAAarvik Therapeutics, Inc, Hayward, CA, USAAarvik Therapeutics, Inc, Hayward, CA, USAAarvik Therapeutics, Inc, Hayward, CA, USAAarvik Therapeutics, Inc, Hayward, CA, USAABSTRACTThe antibody–drug conjugate (ADC) field has undergone a renaissance, with substantial recent developmental investment and subsequent drug approvals over the past 6 years. In November 2022, ElahereTM became the latest ADC to be approved by the US Food and Drug Administration (FDA). To date, over 260 ADCs have been tested in the clinic against various oncology indications. Here, we review the clinical landscape of ADCs that are currently FDA approved (11), agents currently in clinical trials but not yet approved (164), and candidates discontinued following clinical testing (92). These clinically tested ADCs are further analyzed by their targeting tumor antigen(s), linker, payload choices, and highest clinical stage achieved, highlighting limitations associated with the discontinued drug candidates. Lastly, we discuss biologic engineering modifications preclinically demonstrated to improve the therapeutic index that if incorporated may increase the proportion of molecules that successfully transition to regulatory approval.https://www.tandfonline.com/doi/10.1080/19420862.2023.2229101Antibody–drug conjugateADCpayloadlinkerdrug-to-antibody ratiosite-directed conjugation |
| spellingShingle | Heather Maecker Vidya Jonnalagadda Sunil Bhakta Vasu Jammalamadaka Jagath R. Junutula Exploration of the antibody–drug conjugate clinical landscape mAbs Antibody–drug conjugate ADC payload linker drug-to-antibody ratio site-directed conjugation |
| title | Exploration of the antibody–drug conjugate clinical landscape |
| title_full | Exploration of the antibody–drug conjugate clinical landscape |
| title_fullStr | Exploration of the antibody–drug conjugate clinical landscape |
| title_full_unstemmed | Exploration of the antibody–drug conjugate clinical landscape |
| title_short | Exploration of the antibody–drug conjugate clinical landscape |
| title_sort | exploration of the antibody drug conjugate clinical landscape |
| topic | Antibody–drug conjugate ADC payload linker drug-to-antibody ratio site-directed conjugation |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2023.2229101 |
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