Tocagen Expands Toca 5, Phase 2/3 Clinical Trial for Recurrent Brain Cancer, to Israel

Patient Enrollment in the United States and Canada Ongoing

SAN DIEGO – Dec. 13, 2016 — Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced its randomized, controlled Phase 2/3 clinical trial, called Toca 5, is now enrolling patients in Israel. Enrollment in the trial is ongoing in the United States and Canada. The study compares a cancer-selective virus, Toca 511 (vocimagene amiretrorepvec), in combination with Toca FC (extended-release 5-fluorocytosine) to standard of care in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.

“Brain cancer remains one of the most aggressive and difficult-to-treat cancers, and there is significant need for new approaches. We are excited to be able to offer the Toca 5 gene therapy trial to patients in Israel,” said Rachel Grossman, M.D., attending neurosurgeon at Tel-Aviv Sourasky Medical Center and principal investigator for the Toca 5 clinical trial in Israel. “This investigational treatment is designed to activate the patient’s immune system selectively against the cancer, while maintaining a favorable safety profile.”

“Receiving a brain cancer diagnosis is devastating for patients and their families, and if the tumor returns there are very few treatment options,” said Alexander Lossos, M.D., head of the neuro-oncology center at the Hadassah Medical Center, which enrolled the first patient in Israel. “Our dedicated brain tumor care team is delighted to be the first clinical site in Israel to randomize a patient for this new study.”

The primary endpoint for the Toca 5 clinical trial is overall survival with secondary endpoints including objective response rate. Investigators may choose chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for the control arm. More information about the clinical trial can be found at www.tocagen.com/toca5.

Added Zvi Ram, M.D., Ph.D., department director of neurosurgery at Tel-Aviv Sourasky Medical Center, “The Phase 1 results for this treatment in patients with recurrent high grade glioma showed encouraging data including a favorable safety profile, durable tumor responses and promising survival. We now eagerly anticipate the results from the randomized Toca 5 study.”

High grade gliomas are among the most common and aggressive primary brain cancers. The two most common forms of high grade glioma are glioblastoma and anaplastic astrocytoma. Standard treatment for newly diagnosed high grade glioma includes safe surgical removal of as much of the tumor as possible followed by radiation therapy and chemotherapy. Despite these treatments, the tumor often recurs. Median survival after recurrence is approximately seven to nine months.

A total of 126 patients have been treated in Tocagen’s Phase 1 ascending-dose studies. Clinical data were recently published in Science Translational Medicine. In the subset of patients in the higher dose cohorts that mirror the patient population under evaluation in the ongoing Toca 5 trial, a clinical benefit rate of 41.7% was reported at the 21st Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology. This included 3 complete responses, 2 partial responses and 5 patients with stable disease (N=24). All patients with an objective response remain alive and the median duration of response is at least 26.7 months. A summary of clinical data from Tocagen’s ongoing Phase 1 clinical trials can be found on Tocagen’s website.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational oral tablet, Toca FC. Toca 511 encodes a prodrug activator enzyme, CD. Its selective delivery to cancer cells means that the infected cancer cells carry the CD gene and produce CD protein. Toca FC is an orally administered, proprietary extended-release formulation of 5-fluorocytosine (5-FC), a prodrug that is inactive as an anti-cancer drug. Within Toca-511-infected cancer cells that are producing CD, Toca 511 is designed to convert Toca FC into the anti-cancer drug, 5-fluorouracil (5-FU) at local high concentrations. In addition to the direct killing of Toca 511-infected cancer cells, 5-FU kills neighboring uninfected cancer cells and immunosuppressive myeloid cells including myeloid derived suppressor cells (MDSCs) and tumor associated macrophages (TAM) in the tumor.

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. 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, visit www.tocagen.com or follow @Tocagen.

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Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com