Favrille now intends to initiate a phase I/II clinical trial evaluating the safety and biologic activity of FAV-201 in patients with cutaneous T-cell lymphoma.
The trial will build upon preclinical data that suggest activity of an immunotherapy based on a T-cell receptor. The multi-center trial is expected to enroll approximately 30 patients.
“This new product candidate represents an extension of our platform and draws on our success to date in the development of our lead product candidate FavId for the treatment of B-cell non-Hodgkin’s lymphoma (NHL),” said Dr John Longenecker, president and CEO of Favrille.
FAV-201 is a recombinant, patient-specific, T-cell receptor-based immunotherapy designed to induce an active immune response against the unique protein found on the surface of T-cells that constitute a patient’s lymphoma. Favrille uses a similar approach with its lead product candidate FavId for the treatment of B-cell NHL.
In January the company completed enrollment in a pivotal phase III clinical trial of FavId following induction therapy with Rituxan, the current standard of care. Favrille has received fast track designation from the FDA for FavId.