The investigational new drug application is held by GSK.
The Vivalis and GSK global collaboration and license agreement aims to develop cell-based manufacturing of seasonal and pandemic human influenza vaccines.
FDA’s acceptance will allow GSK to test its influenza vaccine produced in Vivalis’s duck stem cell line EB66 technology on humans in an early stage Phase I trial.
The corresponding Phase I clinical trial will be the first human trial of clinical material produced using the EB66 cell line.
Vivalis’ EB66 platform, which was used to develop the EB66 cell line, uses a technology to derive avian-based stem cells for vaccine production.