Tocagen’s Lead Candidates for High Grade Glioma Granted FDA Fast Track Designation

Tocagen’s Lead Candidates for High Grade Glioma Granted FDA Fast Track Designation

California-based clinical-stage immuno-oncology company, Tocagen, Inc., recently announced its drug candidates, Toca 511 and Toca FC for recurrent high grade glioma, have been granted Fast Track Designation by the US Food and Drug Administration.

A glioma is a type of tumor that starts in the brain or spine and arises from glial cells, which comprise about 30% of all brain and central nervous system tumors and 80% of all malignant brain tumors. A high grade glioma is associated with a much worse prognosis and includes glioblastoma and anaplastic astrocytoma.

“The granting of Fast Track designation for Toca 511 & Toca FC underscores the urgent need for new treatments for high grade glioma, an extremely deadly and aggressive cancer,” said Harry Gruber, M.D., chief executive officer of Tocagen. “In addition to the excellent safety profile and encouraging median survival we have seen in two separate studies evaluating Toca 511 & Toca FC in patients with recurrent high grade glioma, this designation will help accelerate our development plans to address this unmet need.”

The two drug candidates are set to advance into registrational trials later this year. They were formulated to specifically target and modify cancer cells into chemotherapy-producing sources within the tumor itself, at the same time stimulating the immune system to attack the tumor.

Toca 511 is a retroviral replicating vector (RRV) that works by delivering a gene responsible for the enzyme cytosine deaminase to tumor cells. This is then followed by oral doses of Toca FC, an innovative antifungal drug that is transformed into chemotherapeutic 5-fluorouracil (5 FU). This combination effectively kills cancer cells, boosts immune responses and preserves healthy host cells.

To learn more about Tocagen, Inc. and its lead drug candidates, visit

In an earlier report on immuno-oncology and brain cancer, researchers at Duke’s Cancer Institute (DCI) and the Preston Robert Tisch Brain Tumor Center have made a remarkable discovery that may have direct implications on how solid cancerous tumors are successfully treated in the future. Their study entitled “Tetanus toxoid and CCL3 improve dendritic cell vaccines in mice and glioblastoma patients” tested the innovative theory that a tetanus shot may increase the effectiveness of a vaccine used to treat lethal brain tumors, leading to improved patient survival. The results were published this week in the journal Nature.