Tocagen Announces Presentations at ASGCT and ASCO Annual Conferences

Data for Tocagen’s Toca 511 Presented at the American Society of Gene and Cell Therapy Annual Meeting

In Addition, Toca 511 Clinical Data to be Presented at American Society of Clinical Oncology Annual Meeting

SAN DIEGO – (May 22, 2014) — Tocagen Inc. today announced multiple scientific contributions at the American Society of Gene and Cell Therapy (ASGCT) 17th Annual Meeting, held May 21 to 24, 2014 at the Marriott Wardman Park in Washington, DC.

At the ASGCT Annual Meeting, data from clinical and preclinical studies of Toca 511 will be presented in two podium presentations:

  • Abstract #28, “Interim report from two ongoing ascending dose trials of a retroviral replicating vector (Toca 511) in patients with recurrent high grade glioma,” was delivered by Douglas Jolly, Ph.D. in a podium presentation at 4:15 p.m. ET on Wednesday, May 21, 2014 during the Cancer-Oncolytic Viruses session.
  • Abstract #273, “Toca 511 intravenous study in humans based on uniform distribution of viral spread within the tumor and increased survival in a syngeneic, orthotopic mouse glioma model,” will be delivered by Tiffany Huang, Ph.D. in a podium presentation at 5:30 p.m. ET on Thursday, May 22, 2014 in the Delaware AB room during the Cancer-Targeted Gene and Cell Therapy session.

Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen, will also participate as a panelist during an ASGCT scientific symposium titled “Things You Wished You’d Known Early on Your way to Late Stage Development” at 10:30 a.m. ET on Friday, May 23, 2014 in the Virginia room.

In addition Toca 511 clinical data will be presented at the American Society of Clinical Oncology (ASCO) 50th Annual Meeting, held May 30 to June 3, 2014 at McCormick Place in Chicago. Tocagen will present a poster titled “Ascending dose trials of a retroviral replicating vector (Toca 511) in patients with recurrent high-grade glioma” from 8 to 11:45 a.m. CDT on Sunday, June 1, 2014 during the Developmental Therapeutics –Immunotherapy poster session.

About Toca 511 & Toca FC
The combination of Toca 511 (vocimagene amiretrorepvec) for injection and Toca FC (flucytosine) extended-release tablets, is being investigated in clinical studies at leading centers across the United States in patients with recurrent high grade glioma, including glioblastoma (GBM). Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a prodrug activator gene called cytosine deaminase (CD) selectively to cancer cells. After allowing time for Toca 511 to spread through the tumor, those cancer cells expressing the CD gene can convert the antifungal drug flucytosine into the anticancer drug 5-fluorouracil (5-FU). By producing 5-FU locally with CD, this technology has the potential to produce much higher intra-tumoral concentrations of 5-FU than can be currently attained with systemic administration. In addition to this initial, direct killing of cancer cells, data suggests a selective, local and systemic anticancer immune response without off-target toxicity, such as autoimmunity. The Toca 511 & Toca FC combination product is being investigated in three ascending dose trials in patients with recurrent high grade glioma.

About Tocagen
Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products for the selective treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company’s lead investigational combination product, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma (GBM). 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 identifier NCT01470794, NCT01156584 or NCT01985256.

Tocagen Clinical Data Presented at AANS Annual Conference

Results Continue to Show Safety and Promising Survival; Program to Advance into a Randomized, Controlled Trial

SAN DIEGO, – (April 10, 2014) — Tocagen Inc. today announced that updated interim clinical data from two ongoing investigational studies of Toca 511 in combination with Toca FC in 68 patients with recurrent high grade glioma were presented at the American Association of Neurological Surgeons (AANS) Annual Meeting in San Francisco. High grade gliomas include glioblastoma (GBM), the most common and aggressive form of primary brain cancer.

In patients treated to date, Toca 511 & Toca FC was shown to be safe and well-tolerated with minimal treatment-related toxicity. In both studies, landmark six and twelve month survival rates were higher than historical published data and the effect was consistent in both studies. In addition, during one of the presentations, a clinical case was described that supported the proposed dual mechanism of action involving direct cancer cell killing followed by immune activation selectively against residual tumor. The data were presented in sequential talks by Manish Aghi, M.D., associate professor of neurological surgery at the University of California, San Francisco, and Michael Vogelbaum, M.D., Ph.D., associate director of the brain tumor and neuro-oncology center at the Cleveland Clinic, both of whom are principal investigators of the Toca 511 & Toca FC studies.

“We are encouraged by the safety and tolerability profile from these trials and the preliminary survival data to date appear to surpass historical benchmarks,” said Dr. Vogelbaum. “There is an urgent need for effective treatment options for patients with recurrent glioblastoma so we look forward to completing the ongoing studies and help advance this promising therapy into a randomized controlled trial.”

Added Harry Gruber, M.D., CEO of Tocagen, “We are excited to advance our investigational treatment into the next stage of clinical development and are grateful for the strong support we have received from the brain cancer community.”

Toca 511 & Toca FC is an investigational gene therapy that is designed to selectively infect and kill cancer cells via a proposed dual mechanism of action: first, the Toca 511 virus selectively infects and mediates direct cancer cell killing via local production of 5-FU, a potent anticancer agent, and second, the immune system becomes activated selectively against the tumor resulting in long-term, systemic anticancer activity.

More information about the trials can be found at ClinicalTrials.gov using the identifiers NCT01470794 and NCT01156584. If interested in participating in a Tocagen trial, an inquiry can be submitted here.

About Toca 511 & Toca FC

The combination of Toca 511 (vocimagene amiretrorepvec) for injection and Toca FC (flucytosine) extended-release tablets, is being investigated in clinical studies at leading centers across the United States in patients with recurrent high grade glioma, including glioblastoma (GBM). Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a prodrug activator gene called cytosine deaminase (CD) selectively to cancer cells. After allowing time for Toca 511 to spread through the tumor, those cancer cells expressing the CD gene can convert the antifungal drug flucytosine into the anticancer drug 5-fluorouracil (5-FU). By producing 5-FU locally with CD, this technology has the potential to produce much higher intra-tumoral concentrations of 5-FU than can be currently attained with systemic administration. In addition to this initial, direct killing of cancer cells, data suggests a selective, local and systemic anticancer immune response without off-target toxicity, such as autoimmunity. The Toca 511 & Toca FC combination product is being investigated in three ascending dose trials in patients with recurrent high grade glioma.

About Tocagen Inc.

Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products for the selective treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company’s lead investigational combination product, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma (GBM). 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 identifier NCT01470794, NCT01156584 or NCT01985256.

Tocagen Names Jamey Skillings, M.D., Chief Medical Officer

Pharmaceutical Executive Brings Additional Expertise in Oncology Drug Development and Commercialization Oversaw Approvals of Numerous Oncology Products, including Avastin®, Xalkori® and Erbitux®

SAN DIEGO, – (March 25, 2014) — Tocagen Inc. today announced that Jamey Skillings, M.D., has been named Senior Vice President and Chief Medical Officer. Dr. Skillings joins Tocagen from Pfizer, where she was most recently vice president of global medical affairs for oncology. Dr. Skillings’ clinical leadership at prior pharmaceutical companies led to several oncology drug approvals, including crizotinib (Xalkori, Pfizer) in ALK-positive metastatic lung cancer, cetuximab (Erbitux, Bristol-Myers Squibb) in EGFR-expressing metastatic colorectal cancer and bevacizumab (Avastin, Genentech), which targets VEGF, in glioblastoma, advanced lung cancer and metastatic renal cell cancer.

“Jamey has a remarkable track record of success in developing and commercializing truly ground-breaking oncology products over the last 14 years,

” said Harry Gruber, M.D., CEO of Tocagen. “Her wealth of expertise is a valuable asset for us as we move into the next stages of clinical development based on the continued encouraging results from our ongoing clinical trials involving lead drug candidate Toca 511 & Toca FC in advanced brain cancer.”

Added Dr. Skillings, “To address the complex problem of cancer, we need to develop new therapies that attack tumor cells in different ways. Tocagen’s selective cancer immunotherapeutics are based on a novel gene therapy platform that delivers therapeutic genes selectively to cancer cells. The preclinical and clinical data generated thus far with Tocagen’s lead product are very promising and I am excited to further advance this program and other pipeline products.”

As vice president of global medical affairs for Pfizer Oncology, Dr. Skillings provided medical affairs leadership across both early and late-stage products. Prior to joining Pfizer, Dr. Skillings held positions of increasing responsibility at Genentech and Bristol-Myers Squibb. Previously, she held academic positions as a practicing oncologist at Dalhousie University and at the University of Western Ontario. Dr. Skillings began her career as a fellow of the Royal College of Physicians in Canada, having completed her residency training in internal medicine and hematology.

Dr. Skillings received her medical degree and bachelor’s degree from Queen’s University, master’s degree in epidemiology and biostatistics at the University of Western Ontario and a master’s degree in business from Saint Mary’s University in Nova Scotia.

About Tocagen Inc.

Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of products that activate the immune system selectively against cancer (selective cancer immunotherapeutics), built on a novel gene therapy platform. Toca 511 & Toca FC, the company’s lead investigational combination product, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma multiforme (GBM). Toca 511 & Toca FC is designed to selectively infect and kill cancer cells via a proposed dual mechanism of action. First, the Toca 511 virus selectively infects and mediates direct cancer cell killing via local production of 5-FU, a potent anticancer agent, and second, the immune system becomes activated selectively against the cancer resulting in long-term, systemic anticancer activity. Tocagen has received grant support from the National Cancer Institute and 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 identifier NCT01470794, NCT01156584 or NCT01985256.

SOURCE Tocagen Inc.

RELATED LINKS
http://www.tocagen.com

Tocagen Media Contact:
Heidi Chokeir, Ph.D.
(619) 849-5377
heidi@canalecomm.com

Tocagen Announces Dosing of First Patient In Intravenous Study

Tocagen Doses First Patient Intravenously in Clinical Trial of Selective Cancer Therapy, Toca 511 & Toca FC

Intravenous Delivery Is An Important Advancement in the Development of Toca 511, Creates Opportunity For Use In Additional Cancer Indications

SAN DIEGO, – (March 11, 2014) — Tocagen Inc. today announced that the first patient has been dosed in its clinical trial investigating the intravenous administration of selective cancer therapy Toca 511 & Toca FC, in patients with recurrent high grade glioma (HGG) including glioblastoma multiforme (GBM, Grade 4 HGG), the most common and aggressive form of primary brain cancer.

The multicenter, open-label study is evaluating the safety, tolerability and pharmacokinetics of ascending doses of Toca 511 administered intravenously before scheduled tumor removal. Toca 511 is also administered into the wall of the resection cavity at the time of tumor removal, followed by cycles of oral Toca FC. Removed tumor will be tested for the presence of Toca 511. Patients will be monitored for changes in clinical status and clinical response data will be collected.

“Patients diagnosed with recurrent brain cancer have limited treatment options, with patients typically surviving less than eight months, so there is a high level of need for new therapies to fight this disease,” said Steven Kalkanis M.D., vice chair, department of neurosurgery at the Henry Ford Hospital and principal investigator of this study. “Early data involving intra-tumoral delivery have shown Toca 511 & Toca FC can selectively kill cancer cells and not healthy brain cells. As the first center to enroll a patient in this new study, we look forward to evaluating the potential of this additional delivery approach.” Ian Y. Lee, M.D., neurosurgeon at the Henry Ford Hospital conducted the brain tumor surgery for this first case.

Toca 511 & Toca FC is an investigational gene therapy that is designed to selectively infect and kill cancer cells via a proposed dual mechanism of action: first, the Toca 511 virus selectively infects and mediates direct cancer cell killing via local production of 5-FU, a potent anticancer agent, and second, the immune system becomes activated selectively against the tumor resulting in long-term, systemic anticancer activity.

Harry Gruber, M.D., CEO of Tocagen, added, “We are making exciting progress with our selective cancer immunotherapeutic programs. Exploring the intravenous delivery of Toca 511 is an important step in our fight against brain cancer and towards expanding the types of cancers we can target using Tocagen’s technology, including metastatic cancers. We are also advancing our preclinical candidates that are designed to activate the immune system selectively to kill cancer cells: Toca gamma, which produces gamma interferon within cancer cells, as well as Toca RNAi, which inhibits immune checkpoints in cancer cells.”

More information about the trial can be found at ClinicalTrials.gov using the identifier NCT01985256. If interested in participating in this trial, an inquiry can be submitted here. In addition to Henry Ford Hospital, clinical trials with Toca 511 & Toca FC in patients with recurrent high grade glioma, including GBM, are being conducted at other leading neurooncology centers in the United States.

About Toca 511 & Toca FC

The combination of Toca 511 (vocimagene amiretrorepvec) for injection and Toca FC (flucytosine) extended-release tablets, is being investigated in Phase I/II studies at leading centers across the United States in patients with recurrent high grade glioma, including glioblastoma multiforme (GBM). Toca 511 is a retroviral replicating vector (RRV) that is designed to deliver a prodrug activator gene called cytosine deaminase (CD) selectively to cancer cells. After allowing time for Toca 511 to spread through the tumor, those cancer cells expressing the CD gene can convert the antibiotic drug flucytosine into the anticancer drug 5-fluorouracil (5-FU). By producing 5-FU locally with CD, this technology has the potential to produce much higher intra-tumoral concentrations of 5-FU than can be currently attained with systemic administration. In addition to this initial, direct killing of cancer cells, preclinical data suggests a selective, local and systemic anticancer immune response without off-target toxicity, such as autoimmunity. The Toca 511 & Toca FC combination product is being investigated in three ascending dose trials in patients with recurrent high grade glioma.

About Tocagen Inc.

Tocagen Inc. is a privately funded, clinical stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products for the selective treatment of cancer. Tocagen is initially focusing on treatments for patients with advanced cancer for whom no adequate treatments currently exist. Toca 511 & Toca FC, the company’s lead investigational combination product, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma multiforme (GBM). 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 identifier NCT01470794, NCT01156584 or NCT01985256.

SOURCE Tocagen Inc.

RELATED LINKS
http://www.tocagen.com