The DOI matches its Crossref record; 46 of the 46 references it cites were found in a registry or an index.
Antibodies to watch in 2021
Open accessAbstract
annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. Of these 16 mAbs, 11 are possible treatments for non-cancer indications and 5 are potential treatments for cancer. Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021. In addition, 44 antibody therapeutics are in late-stage clinical studies for cancer indications. Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.
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Citations
Cites
Human neutralizing antibodies elicited by SARS-CoV-2 infection
Ju, B., Zhang, Q., Ge, J., Wang, R., Sun, J., Ge, X., Yu, J., Shan, S., Zhou, B., Song, S., et al. (2020) · Nature · doi:10.1038/s41586-020-2380-z · Cited by 1,667 · cited 1×
“LYCoV016 is a human anti-SARS-CoV-2 antibody with an Fc portion that was modified to include Leu234Ala and Leu235Ala (LALA) mutations, which disrupt effector functions.(20) The two antibodies bind complementary regions of the SARS-CoV-2 spike protein.”
BackgroundA Randomized, Controlled Trial of Ebola Virus Disease Therapeutics
Mulangu, S., Dodd, L. E., Davey, R. T., Tshiani Mbaya, O., Proschan, M., Mukadi, D., Lusakibanza Manzo, M., Nzolo, D., Tshomba Oloma, A., Ibanda, A., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1910993 · Cited by 1,605
Trial of Anifrolumab in Active Systemic Lupus Erythematosus
Morand, E. F., Furie, R., Tanaka, Y., Bruce, I. N., Askanase, A. D., Richez, C., Bae, S.-C., Brohawn, P. Z., Pineda, L., Berglind, A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1912196 · Cited by 1,379
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
Chen, P., Nirula, A., Heller, B., Gottlieb, R. L., Boscia, J., Morris, J., Huhn, G., Cardona, J., Mocherla, B., Stosor, V., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2029849 · Cited by 1,282
Lonial, S., Lee, H. C., Badros, A., Trudel, S., Nooka, A. K., Chari, A., Abdallah, A.-O., Callander, N., Lendvai, N., Sborov, D., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(19)30788-0 · Cited by 812
Evinacumab for Homozygous Familial Hypercholesterolemia
Raal, F. J., Rosenson, R. S., Reeskamp, L. F., Hovingh, G. K., Kastelein, J. J. P., Rubba, P., Ali, S., Banerjee, P., Chan, K.-C., Gipe, D. A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2004215 · Cited by 793
Cree, B. A. C., Bennett, J. L., Kim, H. J., Weinshenker, B. G., Pittock, S. J., Wingerchuk, D. M., Fujihara, K., Paul, F., Cutter, G. R., Marignier, R., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31817-3 · Cited by 756 · cited 1×
“The effectiveness of inebilizumab was demonstrated in the Phase 2/3 N-MOmentum trial (NCT02200770).(36) This study enrolled 230 patients with and without the AQP4-IgG antibody who were randomized 3:1 to receive either 2 doses of 300 mg of inebilizumab as a monotherapy or placebo at Day 1 and Day 15, and then followed…”
BackgroundTeprotumumab for the Treatment of Active Thyroid Eye Disease
Douglas, R. S., Kahaly, G. J., Patel, A., Sile, S., Thompson, E. H. Z., Perdok, R., Fleming, J. C., Fowler, B. T., Marcocci, C., Marinò, M., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1910434 · Cited by 752
Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder
Yamamura, T., Kleiter, I., Fujihara, K., Palace, J., Greenberg, B., Zakrzewska-Pniewska, B., Patti, F., Tsai, C.-P., Saiz, A., Yamazaki, H., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1901747 · Cited by 664
Wollenberg, A., Blauvelt, A., Guttman‐Yassky, E., Worm, M., Lynde, C., Lacour, J. ‐., Spelman, L., Katoh, N., Saeki, H., Poulin, Y., et al. (2021) · British Journal of Dermatology · doi:10.1111/bjd.19574 · Cited by 638
Cited by
Antibody drug conjugate: the “biological missile” for targeted cancer therapy
Fu, Z., Li, S., Han, S., Shi, C., & Zhang, Y. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-00947-7 · Cited by 1,643
Emerging new therapeutic antibody derivatives for cancer treatment
Jin, S., Sun, Y., Liang, X., Gu, X., Ning, J., Xu, Y., Chen, S., & Pan, L. (2022) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-021-00868-x · Cited by 459
Roles of tumor-associated macrophages in anti-PD-1/PD-L1 immunotherapy for solid cancers
Zhang, H., Liu, L., Liu, J., Dang, P., Hu, S., Yuan, W., Sun, Z., Liu, Y., & Wang, C. (2023) · Molecular Cancer · doi:10.1186/s12943-023-01725-x · Cited by 389
Kaplon, H., Chenoweth, A., Crescioli, S., & Reichert, J. M. (2022) · mAbs · doi:10.1080/19420862.2021.2014296 · Cited by 331
Self-citationOlsen, T. H., Boyles, F., & Deane, C. M. (2022) · Protein Science · doi:10.1002/pro.4205 · Cited by 319
Metadata
- Authors
- Kaplon, H., & Reichert, J. M.
- Venue
- mAbs
- Publisher
- Informa UK Limited
- Published
- 2021-01-01
- Volume
- 13
- Issue
- 1
- Pages
- 1860476-1860476
- ISSN
- 1942-0862 (ISSN-L)
- 1942-0870
- OpenAlex
- W3123681476
- Cited by
- 292
- References
- 46
- FWCI
- 32.55
- Type
- journal article
- Language
- en
- Open access
- gold
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