SAN DIEGO – July 09, 2015 — Tocagen Inc. a clinical-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead immuno-oncology product, Toca 511 & Toca FC, for the treatment of recurrent high grade glioma, which includes glioblastoma and anaplastic astrocytoma. This treatment will enter a registrational study called Toca 5 later this year in patients with recurrent glioblastoma or 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 FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the goal of getting important new drugs to patients earlier. Fast Track designation allows for more frequent interactions with the FDA review team, including meetings to discuss the drug’s development plan to support potential drug approval and the opportunity to submit sections of an NDA on a rolling basis as data become available.
About Toca 511 & Toca FC
Toca 511 & Toca FC is an immuno-oncology therapy that will be evaluated in a registrational study to be initiated in 2015 in patients with recurrent glioblastoma or anaplastic astrocytoma. Toca 511 & Toca FC are designed to selectively transform the tumor into a chemotherapy factory while also activating the immune system against the tumor both locally and systemically. Toca 511 is a retroviral replicating vector (RRV) that selectively delivers a gene for the enzyme cytosine deaminase to the tumor. The patient then takes oral cycles of Toca FC, a novel formulation of an antifungal drug, which is converted into the FDA-approved chemotherapy drug, 5-fluorouracil (5 FU). As result, infected cancer cells are selectively killed, subsequently activating the immune system to recognize cancer cells, while leaving healthy cells unharmed. Immune activation locally in the tumor occurs through a combination of mechanisms which leads to breaking of immune tolerance and activation of the immune system selectively against the cancer cells.
Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of products built upon a broadly applicable, highly selective immuno-oncology platform. Lead combination product Toca 511 & Toca FC will advance into a registrational trial this year in patients with recurrent glioblastoma or anaplastic astrocytoma. Interim data from two ongoing clinical trials have shown extended survival compared to historical benchmarks, encouraging dose response effect and durable tumor shrinkage while maintaining an excellent safety profile. A study evaluating Toca 511 & Toca FC in additional cancer indications will initiate in 2016.
Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information about Tocagen or Toca 511 please visit www.tocagen.com or www.clinicaltrials.gov using the identifiers NCT01470794, NCT01156584, NCT01985256, or NCT02414165. For more information about Tocagen please visit www.tocagen.com or follow @Tocagen.