The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tocagen’s Toca 511 and Toca FC for the treatment of recurrent high grade glioma (HGG), one of the most common and aggressive forms of primary brain cancers.

The Breakthrough Therapy designation was supported by safety, efficacy (durable, complete or partial tumor shrinkage) and patient survival data from three Phase 1 studies involving 126 patients with recurrent brain cancer. Additionally, the designation was also based on preclinical data supporting a novel immunological mechanism of action involving the depletion of immune-suppressive myeloid cells in the tumor microenvironment.

Tocagen is currently investigating Toca 511 and Toca FC in an international, randomized Phase 2/3 clinical trial in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Results of the Phase 2 study are anticipated in the first half of 2018.

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Toca 511 and Toca FC, an investigational combination product consisting of a biologic and a small molecule, respectively, is designed to destroy cancer cells and immune-suppressive myeloid cells resulting in the activation of the immune system.

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