Breakthrough status for Tocagen glioma candidate

The US Food and Drug Administration has granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG).

Toca 511 & Toca FC, US clinical stage gene therapy company Tocagen’s lead immuno-oncology product, is currently under evaluation in an international, randomized Phase II/III clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment in the Phase 2 portion of the trial has completed and top-line results are anticipated in the first half of 2018.

The Breakthrough Therapy Designation application was based on data from three Phase 1, ascending-dose clinical trials involving 126 patients with recurrent brain cancer. The clinical data includes results published in Science Translational Medicine, including safety data, patient survival data and durable, complete or partial tumor shrinkage determined by independent radiology review. In addition, preclinical information was provided supporting a novel immunological mechanism of action involving the depletion of immune-suppressive myeloid cells in the tumor microenvironment. The FDA previously granted Fast Track designation to Toca 511 & Toca FC for the treatment of recurrent HGG.