Peer-Reviewed Publication
J Infect Dis2026July 14, 2026Journal Article
Randomized, Double-Blind, Placebo-Controlled First-in-Human Trial of a First-in-Class AI-Designed Monoclonal Antibody (GB-0669) Against the Conserved SARS-CoV-2 Spike S2 Stem Helix.
Francesco Borriello1, Gavin C K W Koh1, Iñaki F Troconiz1,2, Rounak Nassirpour1, Lovely Goyal1, Anvar Suyundikov1, Akber Safder3, Nicholas Robertson1, Anna Allen1, Andrew Robertson1, Stephanie Straley1, Pam Farmer4, Denise Murphy1, Eric Carlin1, Kimberly P Schmitt1, Amarendra Pegu1, Daria Hazuda1, Alexandra Snyder1, Dinesh P De Alwis1
1Generate Biomedicines, 101 South Street, Somerville, MA 02143, USA.
2Department of Pharmaceutical Sciences, School of Pharmacy and Nutrition, University of Navarra, Pamplona, Spain; IdisNA, Navarra Institute for Health Research, Pamplona, Spain; Institute of Data Science and Artificial Intelligence, DATAI, University of Navarra, Pamplona, Spain.
3PPD, 100 W Gore Street, Orlando, FL 32803, USA.
4Pharmacovigilance consultant, San Francisco, CA 94131, USA.
Abstract
BACKGROUND: Antibodies against the SARS-CoV-2 spike receptor-binding domain provided effective COVID-19 treatment until resistant variants emerged. GB-0669 is a half-life-extended monoclonal antibody optimized using artificial intelligence. It targets the conserved spike S2 stem helix, a region subject to limited selective pressure from antibody responses induced by natural infection or vaccinatio…
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