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2. DNA-delivered antibody cocktail exhibits improved pharmacokinetics and confers prophylactic protection against SARS-CoV-2

Author

Parzych, Elizabeth M., Du, Jianqiu, Ali, Ali R., Schultheis, Katherine, Frase, Drew, Smith, Trevor R. F., Cui, Jiayan, Chokkalingam, Neethu, Tursi, Nicholas J., Andrade, Viviane M., Warner, Bryce M., Gary, Ebony N., Li, Yue, Choi, Jihae, Eisenhauer, Jillian, Maricic, Igor, Kulkarni, Abhijeet, Chu, Jacqueline D., Villafana, Gabrielle, Rosenthal, Kim, Ren, Kuishu, Francica, Joseph R., Wootton, Sarah K., Tebas, Pablo, Kobasa, Darwyn, Broderick, Kate E., Boyer, Jean D., Esser, Mark T., Pallesen, Jesper, Kulp, Dan W., Patel, Ami, and Weiner, David B.

Published
2022
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3. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains

Author

Case, James Brett, Mackin, Samantha, Errico, John M., Chong, Zhenlu, Madden, Emily A., Whitener, Bradley, Guarino, Barbara, Schmid, Michael A., Rosenthal, Kim, Ren, Kuishu, Dang, Ha V., Snell, Gyorgy, Jung, Ana, Droit, Lindsay, Handley, Scott A., Halfmann, Peter J., Kawaoka, Yoshihiro, Crowe, Jr., James E., Fremont, Daved H., Virgin, Herbert W., Loo, Yueh-Ming, Esser, Mark T., Purcell, Lisa A., Corti, Davide, and Diamond, Michael S.

Published
2022
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4. The ChAdOx1 vectored vaccine, AZD2816, induces strong immunogenicity against SARS-CoV-2 beta (B.1.351) and other variants of concern in preclinical studies

Author

Spencer, Alexandra J, Morris, Susan, Ulaszewska, Marta, Powers, Claire, Kailath, Reshma, Bissett, Cameron, Truby, Adam, Thakur, Nazia, Newman, Joseph, Allen, Elizabeth R, Rudiansyah, Indra, Liu, Chang, Dejnirattisai, Wanwisa, Mongkolsapaya, Juthathip, Davies, Hannah, Donnellan, Francesca R, Pulido, David, Peacock, Thomas P., Barclay, Wendy S., Bright, Helen, Ren, Kuishu, Screaton, Gavin, McTamney, Patrick, Bailey, Dalan, Gilbert, Sarah C, and Lambe, Teresa

Published
2022
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5. AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults.

Author

Cai, Yingyun, Diallo, Seme, Rosenthal, Kim, Ren, Kuishu, Flores, Daniel J., Dippel, Andrew, Oganesyan, Vaheh, van Dyk, Nydia, Chen, Xiaoru, Cantu, Erin, Choudhary, Rakesh, Sulikowski, Michal, Adissu, Hibret, Chawla, Bhavna, Kar, Swagata, Liu, Chang, Dijokaite-Guraliuc, Aiste, Mongkolsapaya, Juthathip, Rajan, Saravanan, and Loo, Yueh-Ming

Subjects
SARS-CoV-2, CORONAVIRUS diseases, SARS-CoV-2 Omicron variant, COVID-19, HAMSTERS, GOLDEN hamster
Abstract

The evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in variants that can escape neutralization by therapeutic antibodies. Here, we describe AZD3152, a SARS-CoV-2–neutralizing monoclonal antibody designed to provide improved potency and coverage against emerging variants. AZD3152 binds to the back left shoulder of the SARS-CoV-2 spike protein receptor binding domain and prevents interaction with the human angiotensin-converting enzyme 2 receptor. AZD3152 potently neutralized a broad panel of pseudovirus variants, including the currently dominant Omicron variant JN.1 but has reduced potency against XBB subvariants containing F456L. In vitro studies confirmed F456L resistance and additionally identified T415I and K458E as escape mutations. In a Syrian hamster challenge model, prophylactic administration of AZD3152 protected hamsters from weight loss and inflammation-related lung pathologies and reduced lung viral load. In the phase 1 sentinel safety cohort of the ongoing SUPERNOVA study (ClinicalTrials.gov: NCT05648110), a single 600-mg intramuscular injection of AZD5156 (containing 300 mg each of AZD3152 and cilgavimab) was well tolerated in adults through day 91. Observed serum concentrations of AZD3152 through day 91 were similar to those observed with cilgavimab and consistent with predictions for AZD7442, a SARS-CoV-2–neutralizing antibody combination of cilgavimab and tixagevimab, in a population pharmacokinetic model. On the basis of its pharmacokinetic characteristics, AZD3152 is predicted to provide durable protection against symptomatic coronavirus disease 2019 caused by susceptible SARS-CoV-2 variants, such as JN.1, in humans. Editor's summary: Monoclonal antibody (mAb) therapies for SARS-CoV-2 were an essential component of the treatment toolbox for the first few years of the pandemic. Unfortunately, contemporary SARS-CoV-2 variants have evolved to escape these previously approved mAb therapies, leading to suspension of their use. For most individuals, this is acceptable, because we have our own antibodies generated by vaccination and prior infection. However, for immunocompromised individuals who were receiving mAb prophylaxis, this once again increases their risk of severe COVID-19. To address this gap in patient care, Cai et al. developed and tested AZD3152, a SARS-CoV-2 mAb capable of neutralizing contemporary strains of the virus. The authors found that prophylactic administration of AZD3152 was protective in a hamster model and had favorable pharmacokinetic profiles in humans. These data support further development of AZD3152 and next-generation SARS-CoV-2 mAbs. —Courtney Malo [ABSTRACT FROM AUTHOR]

Published
2024
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6. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-risk Individuals

Author

Francica, Joseph R, primary, Cai, Yingyun, additional, Diallo, Seme, additional, Rosenthal, Kim, additional, Ren, Kuishu, additional, Flores, Daniel J, additional, Dippel, Andrew, additional, Wu, Yuling, additional, Chen, Xiaoru, additional, Cantu, Erin, additional, Choudhary, Rakesh, additional, Sulikowski, Michal, additional, Adissu, Hibret, additional, Chawla, Bhavna, additional, Kar, Swagata, additional, van Dyk, Nydia, additional, Oganesyan, Vaheh, additional, Rajan, Saravanan, additional, Ryan, Patricia C, additional, Loo, Yueh-Ming, additional, Cohen, Taylor, additional, Esser, Mark T, additional, and Blair, Wade, additional

Published
2023
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7. Potently neutralizing and protective human antibodies against SARS-CoV-2

Author

Zost, Seth J., Gilchuk, Pavlo, Case, James Brett, Binshtein, Elad, Chen, Rita E., Nkolola, Joseph P., Schäfer, Alexandra, Reidy, Joseph X., Trivette, Andrew, Nargi, Rachel S., Sutton, Rachel E., Suryadevara, Naveenchandra, Martinez, David R., Williamson, Lauren E., Chen, Elaine C., Jones, Taylor, Day, Samuel, Myers, Luke, Hassan, Ahmed O., Kafai, Natasha M., Winkler, Emma S., Fox, Julie M., Shrihari, Swathi, Mueller, Benjamin K., Meiler, Jens, Chandrashekar, Abishek, Mercado, Noe B., Steinhardt, James J., Ren, Kuishu, Loo, Yueh-Ming, Kallewaard, Nicole L., McCune, Broc T., Keeler, Shamus P., Holtzman, Michael J., Barouch, Dan H., Gralinski, Lisa E., Baric, Ralph S., Thackray, Larissa B., Diamond, Michael S., Carnahan, Robert H., and Crowe, Jr, James E.

Published
2020
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11. Qualification of a Biolayer Interferometry Assay to Support AZD7442 Resistance Monitoring

Author

Brady, Tyler, primary, Zhang, Tianhui, additional, Tuffy, Kevin M., additional, Haskins, Nantaporn, additional, Du, Qun, additional, Lin, Jia, additional, Kaplan, Gilad, additional, Novick, Steven, additional, Roe, Tiffany L., additional, Ren, Kuishu, additional, Rosenthal, Kim, additional, McTamney, Patrick M., additional, Abram, Michael E., additional, Streicher, Katie, additional, and Kelly, Elizabeth J., additional

Published
2022
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13. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains

Author

Case, James Brett, primary, Mackin, Samantha, additional, Errico, John, additional, Chong, Zhenlu, additional, Madden, Emily A., additional, Guarino, Barbara, additional, Schmid, Michael A., additional, Rosenthal, Kim, additional, Ren, Kuishu, additional, Jung, Ana, additional, Droit, Lindsay, additional, Handley, Scott A., additional, Halfmann, Peter J., additional, Kawaoka, Yoshihiro, additional, Crowe, James E., additional, Fremont, Daved H., additional, Virgin, Herbert W., additional, Loo, Yueh-Ming, additional, Esser, Mark T., additional, Purcell, Lisa A., additional, Corti, Davide, additional, and Diamond, Michael S., additional

Published
2022
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14. The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans

Author

Loo, Yueh-Ming, primary, McTamney, Patrick M., additional, Arends, Rosalinda H., additional, Abram, Michael E., additional, Aksyuk, Anastasia A., additional, Diallo, Seme, additional, Flores, Daniel J., additional, Kelly, Elizabeth J., additional, Ren, Kuishu, additional, Roque, Richard, additional, Rosenthal, Kim, additional, Streicher, Katie, additional, Tuffy, Kevin M., additional, Bond, Nicholas J., additional, Cornwell, Owen, additional, Bouquet, Jerome, additional, Cheng, Lily I., additional, Dunyak, James, additional, Huang, Yue, additional, Rosenbaum, Anton I., additional, Pilla Reddy, Venkatesh, additional, Andersen, Hanne, additional, Carnahan, Robert H., additional, Crowe, James E., additional, Kuehne, Ana I., additional, Herbert, Andrew S., additional, Dye, John M., additional, Bright, Helen, additional, Kallewaard, Nicole L., additional, Pangalos, Menelas N., additional, and Esser, Mark T., additional

Published
2022
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15. AZD7442 demonstrates prophylactic and therapeutic efficacy in non-human primates and extended half-life in humans

Author

Loo, Yueh-Ming, primary, McTamney, Patrick M., additional, Arends, Rosalinda H., additional, Gasser, Robert A., additional, Abram, Michael E., additional, Aksyuk, Anastasia, additional, Diallo, Seme, additional, Flores, Daniel J., additional, Kelly, Elizabeth J., additional, Ren, Kuishu, additional, Roque, Richard, additional, Rosenthal, Kim, additional, Streicher, Katie, additional, Tuffy, Kevin M., additional, Bond, Nicholas J., additional, Cornwell, Owen, additional, Bouquet, Jerome, additional, Cheng, Lily I., additional, Dunyak, James, additional, Huang, Yue, additional, Rosenbaum, Anton I., additional, Andersen, Hanne, additional, Carnahan, Robert H., additional, Crowe, James E., additional, Kuehne, Ana I., additional, Herbert, Andrew S., additional, Dye, John M., additional, Bright, Helen, additional, Kallewaard, Nicole L., additional, Pangalos, Menelas N., additional, and Esser, Mark T., additional

Published
2021
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16. The ChAdOx1 vectored vaccine, AZD2816, induces strong immunogenicity against SARS-CoV-2 Beta (B.1.351) and other variants of concern in preclinical studies

Author

Spencer, Alexandra J, primary, Morris, Susan, additional, Ulaszewska, Marta, additional, Powers, Claire, additional, Kailath, Reshma, additional, Bissett, Cameron, additional, Truby, Adam, additional, Thakur, Nazia, additional, Newman, Joseph, additional, Allen, Elizabeth R, additional, Rudiansyah, Indra, additional, Liu, Chang, additional, Dejnirattisai, Wanwisa, additional, Mongkolsapaya, Juthathip, additional, Davies, Hannah, additional, Donnellan, Francesca R, additional, Pulido, David, additional, Peacock, Thomas P., additional, Barclay, Wendy S., additional, Bright, Helen, additional, Ren, Kuishu, additional, Screaton, Gavin, additional, McTamney, Patrick, additional, Bailey, Dalan, additional, Gilbert, Sarah C, additional, and Lambe, Teresa, additional

Published
2021
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17. Development of a Parallel Reaction Monitoring Mass Spectrometry Assay for the Detection of SARS-CoV-2 Spike Glycoprotein and Nucleoprotein

Author

Cazares, Lisa H., primary, Chaerkady, Raghothama, additional, Samuel Weng, Shao Huan, additional, Boo, Chelsea C., additional, Cimbro, Raffaello, additional, Hsu, Hsiang-En, additional, Rajan, Sarav, additional, Dall’Acqua, William, additional, Clarke, Lori, additional, Ren, Kuishu, additional, McTamney, Patrick, additional, Kallewaard-LeLay, Nicole, additional, Ghaedi, Mahboobe, additional, Ikeda, Yasuhiro, additional, and Hess, Sonja, additional

Published
2020
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18. Potently neutralizing human antibodies that block SARS-CoV-2 receptor binding and protect animals

Author

Zost, Seth J., primary, Gilchuk, Pavlo, additional, Case, James Brett, additional, Binshtein, Elad, additional, Chen, Rita E., additional, Reidy, Joseph X., additional, Trivette, Andrew, additional, Nargi, Rachel S., additional, Sutton, Rachel E., additional, Suryadevara, Naveenchandra, additional, Williamson, Lauren E., additional, Chen, Elaine C., additional, Jones, Taylor, additional, Day, Samuel, additional, Myers, Luke, additional, Hassan, Ahmed O., additional, Kafai, Natasha M., additional, Winkler, Emma S., additional, Fox, Julie M., additional, Steinhardt, James J., additional, Ren, Kuishu, additional, Loo, Yueh-Ming, additional, Kallewaard, Nicole L., additional, Martinez, David R., additional, Schäfer, Alexandra, additional, Gralinski, Lisa E., additional, Baric, Ralph S., additional, Thackray, Larissa B., additional, Diamond, Michael S., additional, Carnahan, Robert H., additional, and Crowe, James E., additional

Published
2020
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20. Inferior immunogenicity and efficacy of respiratory syncytial virus fusion protein-based subunit vaccine candidates in aged versus young mice

Author

Cayatte, Corinne, primary, Snell Bennett, Angie, additional, Rajani, Gaurav Manohar, additional, Hostetler, Leigh, additional, Maynard, Sean K., additional, Lazzaro, Michelle, additional, McTamney, Patrick, additional, Ren, Kuishu, additional, O’Day, Terrence, additional, McCarthy, Michael P., additional, and Schneider-Ohrum, Kirsten, additional

Published
2017
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21. Immunization with Low Doses of Recombinant Postfusion or Prefusion Respiratory Syncytial Virus F Primes for Vaccine-Enhanced Disease in the Cotton Rat Model Independently of the Presence of a Th1-Biasing (GLA-SE) or Th2-Biasing (Alum) Adjuvant

Author

Schneider-Ohrum, Kirsten, primary, Cayatte, Corinne, additional, Bennett, Angie Snell, additional, Rajani, Gaurav Manohar, additional, McTamney, Patrick, additional, Nacel, Krystal, additional, Hostetler, Leigh, additional, Cheng, Lily, additional, Ren, Kuishu, additional, O'Day, Terrence, additional, Prince, Gregory A., additional, and McCarthy, Michael P., additional

Published
2017
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23. Potently neutralizing human antibodies that block SARS-CoV-2 receptor binding and protect animals.

Author

Zost SJ, Gilchuk P, Case JB, Binshtein E, Chen RE, Reidy JX, Trivette A, Nargi RS, Sutton RE, Suryadevara N, Williamson LE, Chen EC, Jones T, Day S, Myers L, Hassan AO, Kafai NM, Winkler ES, Fox JM, Steinhardt JJ, Ren K, Loo YM, Kallewaard NL, Martinez DR, Schäfer A, Gralinski LE, Baric RS, Thackray LB, Diamond MS, Carnahan RH, and Crowe JE

Abstract

The COVID-19 pandemic is a major threat to global health for which there are only limited medical countermeasures, and we lack a thorough understanding of mechanisms of humoral immunity 1,2 . From a panel of monoclonal antibodies (mAbs) targeting the spike (S) glycoprotein isolated from the B cells of infected subjects, we identified several mAbs that exhibited potent neutralizing activity with IC 50 values as low as 0.9 or 15 ng/mL in pseudovirus or wild-type ( wt ) SARS-CoV-2 neutralization tests, respectively. The most potent mAbs fully block the receptor-binding domain of S (S RBD ) from interacting with human ACE2. Competition-binding, structural, and functional studies allowed clustering of the mAbs into defined classes recognizing distinct epitopes within major antigenic sites on the S RBD . Electron microscopy studies revealed that these mAbs recognize distinct conformational states of trimeric S protein. Potent neutralizing mAbs recognizing unique sites, COV2-2196 and COV2-2130, bound simultaneously to S and synergistically neutralized authentic SARS-CoV-2 virus. In two murine models of SARS-CoV-2 infection, passive transfer of either COV2-2916 or COV2-2130 alone or a combination of both mAbs protected mice from severe weight loss and reduced viral burden and inflammation in the lung. These results identify protective epitopes on the S RBD and provide a structure-based framework for rational vaccine design and the selection of robust immunotherapeutic cocktails.

Published
2020
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