Drugs / GIGA-2050
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04883138 | May 2021 → Jan 2022 | COVID-19 | GigaGen, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-07-28 | Grifols Therapeutics LLC | Results GigaGen Publishes Research Showcasing First-Ever Clinical GMP Manufacturing and IND-Enabling Studies for its New Class of Drugs, Recombinant Polyclonal Antibodies grifols.com ↗
Through in vivo studies, GIGA-2050 was shown to be safe and protective against SARS-CoV-2 infection. |
| 2022-07-28 | GigaGen, Inc. | Results GigaGen Publishes Research Showcasing First-Ever Clinical GMP Manufacturing and IND-Enabling Studies for its New Class of Drugs, Recombinant Polyclonal Antibodies gigagen.com ↗
GIGA-2050 material produced at scales ranging from 3L to 250L had high product quality and consistent yield and potency. |
| 2021-04-15 | Grifols Therapeutics LLC | Results GigaGen Publishes Research on Company’s Recombinant Hyperimmunes in Nature Biotechnology grifols.com ↗
The data describes GigaGen’s proprietary technology for the production of a new class of antibody drug, “recombinant hyperimmune globulins,” which include its novel COVID-19 therapy, GIGA-2050. |
| 2020-08-12 | GigaGen, Inc. | Results BioCentury: GigaGen aims to overcome supply limits, boost potency with recombinant convalescent sera substitute gigagen.com ↗
GigaGen showed Monday in a bioRxiv publication that GIGA-2050 was 100 times more potent than convalescent sera. |
| 2020-08-10 | GigaGen, Inc. | Results Fierce Biotech: GigaGen’s polyclonal antibody against COVID-19 outperforms plasma in lab tests gigagen.com ↗
When tested against the SARS-CoV-2 live virus, GIGA-2050 was 100 times more protective than plasma from survivors, they reported on the journal preprint site bioRxiv. |
| 2020-08-10 | GigaGen, Inc. | Results BioSpace: GigaGen Publishes Data on New Recombinant Hyperimmune Drug Class as COVID-19 Therapy gigagen.com ↗
GIGA-2050, a new class of drug called a recombinant hyperimmune, offers 100-fold higher potency than convalescent serum therapy. |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GIGA-2050 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04883138 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Hyperimmune Polyclonal Antibody” NCT04883138 ↗ |
| Route | Intravenous | “Participants will receive a single intravenous (IV) infusion dose of GIGA-2050” NCT04883138 ↗ |