GigaGen Initiates Large-Scale Manufacturing of First-in-Class Recombinant Hyperimmune Drug for COVID-19, GIGA-2050
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) — GigaGen Inc., a biotechnology company advancing transformative antibody drugs for infectious diseases, transplant rejection and checkpoint resistant cancers, announced today the company has initiated large-scale manufacturing of its first-in-class recombinant hyperimmune drug for COVID-19, GIGA-2050, in collaboration with two partners for Good Manufacturing Practice (GMP), Waisman Biomanufacturing and Goodwin Biotechnology, Inc.
Large scale production of GIGA-2050 will support an Investigational New Drug application (IND) and Phase 1 studies in COVID-19 patients. The GMP product will be subjected to nonclinical GLP toxicology and pharmacokinetics studies in fall 2020 and the company expects to reach the clinic in early 2021.
Read the full press release.