Tocagen to Present at Three Oncology Conferences

SAN DIEGO – March 17, 2016Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced that members of the management team will present at the 9th Annual Oncology Commercialization & Market Access meeting, to be held March 22-23 in San Francisco; participate in a panel discussion at the Cancer Advance Boston conference, to be held April 4-5 in Boston; and present at the Phacilitate Oncology Leaders Forum, to be held April 5-6 in Boston.

Details of the presentations are as follows:

Conference: 9th Annual Oncology Commercialization & Market Access meeting
Title: Examine a Biotech’s Pathway Towards First Product Launch — From Early Grass Roots Efforts to Pre-launch Planning
Date and Time: Tuesday, March 22, 4:30-5:15 p.m. PT
Presenter: Nicholas Boyle, Ph.D., product manager and head of business development at Tocagen

Conference: Cancer Advance Boston
Panel Title: Checkpoint Inhibitors: What’s New?
Date and Time: Tuesday, April 5, 9:50-10:30 a.m. ET
Participant: Harry Gruber, M.D., chief executive officer of Tocagen

Conference: Phacilitate Oncology Leaders Forum
Title: Viral immunotherapy as a novel therapeutic modality: mechanisms and clinical utility
Date and Time: Wednesday, April 6, 2:20-2:35 p.m. ET
Presenter: Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen

About Tocagen
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within. 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. In 2016, Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in patients with newly diagnosed HGG and other solid tumors. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration, for Toca 511 & Toca FC for the treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (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.

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

Patient Enrollment in the United States Ongoing

SAN DIEGO – March 8, 2016 — Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced that its randomized, controlled Phase 2/3 clinical trial, called Toca 5, has expanded internationally and is now enrolling patients in Canada. Read more

Tocagen Appoints John Wood as Vice President, Regulatory Affairs and Quality Assurance

SAN DIEGO – Feb. 16, 2016 — Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced that John Wood has been named vice president of regulatory affairs and quality assurance. Mr. Wood holds more than 20 years of regulatory affairs experience focusing on first-in-class drugs for diseases with high unmet need. Read more

First Patient Enrolled in Toca 5, Tocagen’s Phase 2/3 Clinical Trial

Study Designed to Serve as a Potential Registrational Trial

SAN DIEGO – Dec. 3, 2015 — Tocagen Inc. a clinical-stage, cancer-selective immunotherapy company, today announced that the first patient has been enrolled in the Phase 2 portion of its randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC against current standard of care in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.

“The current lack of effective therapies for high grade gliomas, such as glioblastoma and anaplastic astrocytoma, leaves doctors with few options for treating patients,” said Tom Mikkelsen, M.D., co-director of the Hermelin Brain Tumor Center at Henry Ford Hospital, which enrolled the first patient in the Toca 5 clinical trial. “Tocagen’s cancer-selective immunotherapy has shown encouraging results to date and provides new hope for people with these types of brain cancer.”

The primary endpoint for the Toca 5 clinical trial is overall survival and the study is expected to enroll patients in multiple countries. Investigators may choose chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for the control arm. Tim Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program, is the principal investigator in the United States for the Toca 5 clinical trial.

“Enrolling the first patient in the Toca 5 trial is an important step in advancing this potential new treatment option for patients with high grade glioma,” said Harry Gruber, M.D., chief executive officer of Tocagen. “We are especially thankful to our clinical trial sites and the broader brain tumor community for their continued support of Tocagen in our shared fight against brain cancer.”

High grade gliomas (HGGs) are among the most common and aggressive primary brain cancers. The total number of newly diagnosed HGGs expected in 2015 is about 160,000 worldwide and about 14,000 in the United States. The two most common forms of HGGs are glioblastoma (GBM) and anaplastic astrocytoma. Patients with newly diagnosed GBM who receive maximal therapy have a median survival of approximately 16 months. Median survival after recurrence is approximately seven to nine months.

As of Sept. 25, 2015, Tocagen has treated 116 patients with recurrent HGG with Toca 511 & Toca FC in three ongoing Phase 1 clinical trials. In these studies, potential benefits were found, including extended overall survival and a favorable safety profile. In particular, patients with recurrent HGG who received Toca 511 at the time of surgical resection of tumor, which mirrors the delivery method in the Toca 5 trial, had a median survival of 13.6 months (N=43) and a 12 and 24-month survival rate of 52.5 percent and 31.6 percent, respectively. A summary of clinical data from Tocagen’s ongoing Phase 1 clinical trials can be found on Tocagen’s website.

Tocagen’s cancer-selective gene therapy platform is built on retroviral replicating vectors (RRVs) which are designed to selectively integrate into the DNA of cancer cells which then serve as factories for these RRVs to replicate and infect neighboring cancer cells, providing long-term presence of the therapeutic gene(s). Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule drug, Toca FC, designed to be used together. Toca 511 is a proprietary injectable RRV that encodes a prodrug activator enzyme, cytosine deaminase (CD). Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD protein. Toca FC is an orally administered, proprietary extended-release version of 5-FC, a prodrug that is inactive as an anti-cancer drug. Toca FC is converted into the active anti-cancer drug, 5-FU, at high concentrations in Toca-511-infected cancer cells that are producing CD protein. 5-FU is a well-established anti-cancer agent used effectively in many conventional chemotherapy settings. In addition to the direct killing of Toca 511-infected cancer cells, 5-FU kills neighboring uninfected cancer cells and myeloid derived suppressor cells (MDSCs) in the tumor.

In addition to Henry Ford Hospital, the University of California, Irvine and JFK Medical Center are also recruiting patients. More information about the clinical trial can be found at www.tocagen.com/toca5 or by searching clinicaltrials.gov using the clinical trial identifier NCT02414165.

About Tocagen
Tocagen is a clinical-stage, cancer-selective immunotherapy company focused on developing first-in-class, broadly-applicable product candidates designed to activate a patient’s immune system against their own cancer from within. The company is developing its lead product candidate, Toca 511 & Toca FC, 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. In 2016, Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in patients with newly diagnosed HGG and other solid tumors. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration, for Toca 511 & Toca FC for the treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (GBM), a subset of HGG. For more information visit www.tocagen.com or follow @Tocagen.

Tocagen Presents Updated Data at the SNO and SNO-SCIDOT Conferences

SAN DIEGO, – Nov. 23, 2015 – Tocagen Inc., a clinical-stage, cancer-selective immunotherapy company, today announced interim data from ongoing Phase 1 and preclinical studies of Toca 511 in combination with Toca FC were presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) and the SNO-SCIDOT Joint Conference on Therapeutic Delivery to the CNS in San Antonio, TX.

Together, the presented data demonstrate Toca 511 & Toca FC continue to show potential benefits, including a favorable safety profile and extended overall survival (OS) in patients with recurrent high grade glioma (HGG) compared to historical benchmarks. In addition, data supported further evaluation of intravenous (IV) delivery of Toca 511 in metastatic solid tumors, and evidence of anti-cancer immune activation following treatment with Toca FC was reported.

Highlights of results from the podium and poster presentations are below.1 More information about the presentations, including abstract number and title, can be found on Tocagen’s website. In the ongoing clinical studies, Toca 511 is administered first and followed by cycles of orally administered Toca FC.

Survival Data from Administration of Toca 511 at the Time of Tumor Removal (Resection/Injection)

  • Survival rates for patients with recurrent HGG at 12 and 24 months were 52.5 percent and 31.6 percent, respectively
  • Patients with recurrent HGG had a median survival of 13.6 months (N=43)
  • Patients with first or second recurrence of HGG and no prior bevacizumab (the patient population to be studied in Tocagen’s ongoing Phase 2/3 clinical trial) had a median survival of 14.6 months (N=30)
  • Patients with first or second recurrent glioblastoma (GBM) had a statistically significant improvement (p=0.0028) in OS of 13.6 months compared to 7.1 months for an external lomustine historic data set
  • Higher dose cohorts had a median OS of 14.4 months compared to 11.9 months for lower dose cohorts in patients with recurrent HGG, suggesting a dose-response trend for survival

IV Administration of Toca 511

  • Following IV delivery of Toca 511, the tumor was removed and Toca 511 administered to resection cavity walls
  • Ten of eleven patients in this ongoing clinical trial remain alive with follow up of up to 15.4 months
  • Viral DNA and cytosine deaminase (CD) protein were present in resected tumor, with increasing levels of viral DNA with increasing dose
  • Trial results support evaluation of IV delivery of Toca 511 in metastatic solid cancers, including breast, lung, colorectal, melanoma and renal

Administration of Toca 511 via Biopsy Needle or Convection Enhanced Delivery (Intratumoral)

  • Median survival for patients with recurrent HGG who were not surgical candidates was 13.8 months using biopsy needle delivery (transcranial) versus 7.9 months using convection enhanced delivery (non-biopsy needle delivery)

Evidence of Safety and Mechanism of Action

  • Across all ongoing studies, Toca 511 & Toca FC continue to be well tolerated
  • Quantitative viral RNA and DNA from Toca 511 was cleared from blood by all patients within early cycles of Toca FC, and detected at low levels in the urine or saliva of a few patients
  • Tumor resections from patients previously receiving Toca 511 demonstrate Toca 511 selectively infects and persists in tumor cells in situ

Independent Radiology Reviews

  • Objective responses seen in the resection/injection clinical trial and the intratumoral clinical trial

Evidence of Anti-Tumor Immune Activation Following Toca FC Treatment in Patients

  • Average increases of 42 percent and 21 percent were observed in total CD4 and CD8 counts respectively
  • Nearly significant association (p=0.0587) for CD8 increase with better survival in multivariate model

Toca 5, Phase 2/3 Clinical Trial in Patients with First or Second Recurrent High Grade Glioma Undergoing Resection, Now Enrolling Patients

  • Randomized, controlled Phase 2/3 clinical trial designed to serve as potential registrational trial
  • Primary endpoint is OS; investigators may choose chemotherapy (lomustine or temozolomide) or antiangiogenic therapy (bevacizumab) for control arm
  • More information about the clinical trial can be found at www.tocagen.com/toca5 or by searching clinicaltrials.gov using the clinical trial identifier NCT02414165

About Toca 511 & Toca FC
Tocagen’s cancer-selective gene therapy platform is built on retroviral replicating vectors (RRVs) which are designed to selectively integrate into the DNA of cancer cells which then serve as factories for these RRVs to replicate and infect neighboring cancer cells, providing long-term presence of the therapeutic gene(s). Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule drug, Toca FC, designed to be used together. Toca 511 is a proprietary injectable RRV that encodes a prodrug activator enzyme, cytosine deaminase (CD). Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD protein. Toca FC is an orally administered, proprietary extended-release version of 5-FC, a prodrug that is inactive as an anti-cancer drug. Toca FC is converted into the active anti-cancer drug, 5-FU, at high concentrations in Toca-511-infected cancer cells that are producing CD protein. 5-FU is a well-established anti-cancer agent used effectively in many conventional chemotherapy settings. In addition to the direct killing of Toca 511-infected cancer cells, 5-FU kills neighboring uninfected cancer cells and myeloid derived suppressor cells (MDSCs) in the tumor.

About Tocagen Inc.
Tocagen is a clinical-stage, cancer-selective immunotherapy company focused on developing first-in-class, broadly-applicable product candidates designed to activate a patient’s immune system against their own cancer from within. The company is developing its lead product candidate, Toca 511 & Toca FC, 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. In 2016, Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in patients with newly diagnosed HGG and other solid tumors. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration, for Toca 511 & Toca FC for the treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (GBM), a subset of HGG. For more information visit www.tocagen.com or follow @Tocagen.

Tocagen Announces Presentations at the SNO and SNO-SCIDOT Conferences

Tocagen to Present Interim Results from Studies Evaluating Toca 511 & Toca FC at the Annual Meeting of the Society for Neuro-Oncology (SNO)

SAN DIEGO, – November 18, 2015 – Tocagen Inc., a clinical-stage, cancer-selective immunotherapy company, today announced that interim results from ongoing Phase 1 and preclinical studies of Toca 511 in combination with Toca FC will be presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), to be held Nov. 19-22, 2015, in San Antonio, TX. An additional podium presentation will be presented at the SNO-SCIDOT Joint Conference on Therapeutic Delivery to the CNS, held Nov. 18-19 in San Antonio, TX.

Details of the podium and poster presentations at SNO are as follows:

Presentation Type: Podium
Title: Results of a dose escalation trial of Toca 511 with Toca FC in recurrent HGG undergoing repeat resection
Date and Time: Sunday, Nov. 22, 3:20-5:00 p.m. CT
Presenter: Michael A. Vogelbaum, M.D., Ph.D., professor of neurosurgery at the Cleveland Clinic

Abstract Number: DDEL-06
Title: Preliminary safety of Toca 511, a retroviral replicating vector, in patients with recurrent high grade glioma across three separate Phase 1 studies
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Steven N. Kalkanis M.D., chair of the department of neurosurgery and co-director of the Neuroscience Institute at Henry Ford Hospital

Abstract Number: DDEL-07
Title: Intravenous Toca 511 delivery leads to viral DNA in resected HGG
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Timothy Cloughesy, M.D., director of the University of California, Los Angeles, Neuro-Oncology Program

Abstract Number: DDEL-08
Title: Overall safety and efficacy in subjects with recurrent HGG treated across 2 Tocagen studies – Prognostic Factors associated with survival
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Joseph Landolfi, M.D., chief of neurology at JFK Neuroscience Institute and director of neuro-oncology at JFK Brain Tumor Center

Abstract Number: IMCT-04
Title: Toca 5: Phase 2/3 randomized, open-label study of Toca 511 with Toca FC versus standard of care in patients undergoing planned resection for recurrent high grade glioma (NCT02414165)
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Gelareh Zadeh, M.D., Ph.D., scientist at Labatt Brain Tumor Research Centre and adjunct scientist at The Hospital for Sick Children

Abstract Number: IMCT-05
Title: Combinability of Toca FC and Toca 511 with chemotherapy and targeted agents
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Santosh Kesari, M.D., Ph.D., director of neuro-oncology at Moores Cancer Center at UC San Diego Health

Abstract Number: SURG-10
Title: Transcranial Toca 511 followed by Toca FC in subjects with recurrent high grade glioma (HGG)
Date and Time: Friday, Nov. 20, at 7:30 p.m. CT
Lead Author: Manish Aghi, M.D., Ph.D., associate professor of neurological surgery at University of California, San Francisco

Abstract Number: GENO-30
Title: Distinct gene expression profile that is not a known survival predictor in tumors from long-term high grade glioma survivors treated with a retroviral replicating vector encoding yeast cytosine deaminase
Date and Time: Saturday, Nov. 21, at 5:00 p.m. CT
Lead Author: Derek Ostertag, Ph.D., department leader of R&D Diagnostics at Tocagen, Inc.

Details of the podium presentation at the SNO-SCIDOT Joint Conference on Therapeutic Delivery to the CNS are as follows:

Title: Clinical Development of a Retroviral Vector: Delivery Questions
Date and Time: Wednesday Nov. 18, at 4:05 p.m. CT
Presenter: Manish Aghi, M.D., Ph.D., associate professor of neurological surgery at University of California, San Francisco

About Toca 511 & Toca FC

Tocagen’s cancer-selective gene therapy platform is built on retroviral replicating vectors (RRVs) which are designed to selectively integrate into the DNA of cancer cells which then serve as factories for these RRVs to replicate and infect neighboring cancer cells, providing long-term presence of the therapeutic gene(s). Tocagen’s lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule drug, Toca FC, designed to be used together. Toca 511 is a proprietary injectable RRV that encodes a prodrug activator enzyme, cytosine deaminase (CD). Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD protein. Toca FC is an orally administered, proprietary extended-release version of 5-FC, a prodrug that is inactive as an anti-cancer drug. Toca FC is converted into the active anti-cancer drug, 5-FU, at high concentrations in Toca-511-infected cancer cells that are producing CD protein. 5-FU is a well-established anti-cancer agent used effectively in many conventional chemotherapy settings. In addition to the direct killing of Toca 511-infected cancer cells, 5-FU kills neighboring uninfected cancer cells and myeloid derived suppressor cells (MDSCs) in the tumor.

About Tocagen Inc.

Tocagen is a clinical-stage, cancer-selective immunotherapy company focused on developing first-in-class, broadly-applicable product candidates designed to activate a patient’s immune system against their own cancer from within. The company is developing its lead product candidate, Toca 511 & Toca FC, 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. In 2016, Tocagen plans to initiate clinical trials of Toca 511 & Toca FC in patients with newly diagnosed HGG and other solid tumors. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration, for Toca 511 & Toca FC for the treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma (GBM), a subset of HGG. For more information visit www.tocagen.com or follow @Tocagen.

Lori Kunkel, M.D., Joins Tocagen’s Board of Directors

Former Chief Medical Officer at Pharmacyclics, Proteolix and Loxo Oncology Brings Expertise in Immuno-Oncology Drug Development and Commercialization

SAN DIEGO, – Sept. 10, 2015 – Tocagen Inc., a clinical-stage immuno-oncology company, today announced that Lori Kunkel, M.D., has joined the company’s board of directors. Dr. Kunkel has more than twenty years of experience in oncology and immunology drug development and commercialization, including serving as chief medical officer at Pharmacyclics (acquired by AbbVie) and Proteolix, Inc. (acquired by Onyx Pharmaceuticals), which ultimately resulted in the global approvals of cancer therapeutics IMBRUVICA® and Kyprolis®, respectively.

“Lori’s deep experience developing successful clinical and regulatory strategies leading to the global commercialization of oncology products will be a great addition to our board, and we are delighted to have her join our team,” said Faheem Hasnain, chairman of the board of directors of Tocagen and former president and chief executive officer of Receptos, Inc (acquired by Celgene). “Her knowledge and insights surrounding oncology drug development, in addition to her strategic consulting and corporate board experience, will be invaluable as Tocagen starts enrollment in its pivotal trial and enters its next phase of growth.”

Dr. Kunkel added, “Tocagen’s immuno-oncology platform has a unique ability to target and kill cancer cells while activating the immune system through multiple mechanisms, and holds great potential for the treatment of cancer. I look forward to helping guide the development of Tocagen’s highly differentiated platform and product candidates as the company advances towards commercialization of their lead product, Toca 511 & Toca FC, for patients with high grade glioma.
Dr. Kunkel presently serves on the board of directors of Loxo Oncology, where she was previously the acting chief medical officer. Prior to that role she was the chief medical officer of Pharmacyclics, the chief medical officer of Proteolix, and the vice president of clinical development at Xencor, Inc. Previous to these positions she was a clinical scientist at Genentech where she worked on the development of RITUXAN®. Additionally, as a clinical drug development specialist, Dr. Kunkel has advised multiple clients including Chiron (acquired by Novartis), Genentech/Roche, Salmedics (acquired by Celgene), and currently is an advisor to Curis, Inc., Stemcentrx, Inc. and Amphivena Therapeutics.

Prior to joining the biotechnology industry, Dr. Kunkel spent ten years in academic medicine and served as a faculty member at the Bone Marrow Transplant Unit in the Division of Hematology/Oncology at University of California, Los Angeles. Dr. Kunkel obtained a medical degree from University of Southern California and a bachelor’s degree in biology from University of California, San Diego. She is board certified in internal medicine and held board certifications in hematology and oncology.

About Tocagen Inc.

Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of products built upon a broadly applicable, highly cancer-selective immuno-oncology platform. The company’s lead investigational combination product, Toca 511 & Toca FC, is advancing into a pivotal Phase 2/3 study in 2015 for patients with recurrent glioblastoma or anaplastic astrocytoma. The FDA has granted Toca 511 & Toca FC both Fast Track and orphan drug designations. A study evaluating Toca 511 & Toca FC in five additional metastatic solid tumor indications is planned for 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 clinical trials please visit www.clinicaltrials.gov using the identifiers NCT01470794, NCT01156584, NCT01985256, or NCT02414165. For more information about Tocagen please visit www.tocagen.com or follow @Tocagen.

Media Contact:
Monica May
Canale Communications
619-849-5383

Tocagen to Present at BioCentury’s NewsMakers in the Biotech Industry Conference

 SAN DIEGO – Sept. 3, 2015 — Tocagen Inc., a clinical-stage immuno-oncology company, today announced the company will present at the BioCentury 22nd Annual NewsMakers in the Biotech Industry Conference. The presentation will take place on Thursday, Sept. 10, 2015 at 10:30 a.m. ET in room 508 of the Millennium Broadway Hotel in New York City.

The presentation will provide a company overview and program update, with a focus on lead immuno-oncology product, Toca 511 & Toca FC, and the Toca 5 pivotal study in patients with recurrent glioblastoma or anaplastic astrocytoma, which the company plans to start enrolling this year.

About Tocagen
Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of products built upon a broadly applicable, highly cancer-selective immuno-oncology platform. The company’s lead combination product, Toca 511 & Toca FC, is advancing into a pivotal Phase 2/3 study in 2015 for patients with recurrent glioblastoma or anaplastic astrocytoma. The FDA has granted Toca 511 & Toca FC Fast Track and orphan drug designations for the treatment of recurrent high grade glioma and glioblastoma, respectively. A study evaluating Toca 511 & Toca FC in five additional metastatic solid tumor indications is planned for 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 ongoing clinical trials please visit www.clinicaltrials.gov using the search identifiers NCT01470794, NCT01156584, NCT01985256, or NCT02414165. For more information about Tocagen please visit www.tocagen.com or follow @Tocagen.

Media Contact:
Monica May
Canale Communications
619-849-5383

FDA Grants Orphan Designation for Toca 511 & Toca FC

FDA Grants Orphan Drug Designation for Tocagen’s Toca 511 & Toca FC, an Investigational Immuno-Oncology Treatment for Glioblastoma

SAN DIEGO – Aug. 25, 2015 — Tocagen Inc., a clinical-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to the company’s lead immuno-oncology product candidate, Toca 511 & Toca FC, for the treatment of glioblastoma. As previously announced, the investigational drug was granted FDA Fast Track designation for the treatment of recurrent high-grade glioma, which includes glioblastoma and anaplastic astrocytoma, and is poised to move into a pivotal clinical trial later this year.

Glioblastoma is the most common form of primary brain cancer, with over 10,000 people diagnosed every year in the United States. The disease is extremely aggressive; newly diagnosed patients have a five-year survival rate of less than 5 percent, and the tumor typically recurs following standard-of-care treatment. Median survival following recurrence is approximately eight months. Toca 511 & Toca FC is an investigational treatment that is designed to program cancer cells to convert the prodrug 5-FC into the anticancer drug 5-FU, killing tumor cells and leading to activation of the immune system via a combination of mechanisms.

“There’s an extraordinary need for new treatment options for patients with this devastating disease,” said Harry Gruber, M.D., chief executive officer of Tocagen. “We believe FDA’s granting of both orphan drug and Fast Track designations to Toca 511 & Toca FC will enable us to more efficiently advance our program, which we hope will ultimately offer physicians and patients a new option in the fight against brain cancer.”

The FDA’s orphan drug designation is intended to encourage development of treatments for diseases that affect fewer than 200,000 individuals in the United States. Orphan drug designation qualifies the drug developer for various development incentives, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee for the condition for which the drug was designated. Orphan designation does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

About Toca 511 & Toca FC
Toca 511 & Toca FC is designed to program cancer cells to convert the prodrug 5-FC into the anticancer drug 5-FU, killing tumor cells and leading to activation of the immune system selectively against the tumor via a combination of mechanisms. Toca 511 is a retroviral replicating vector (RRV) that selectively delivers a gene for the enzyme cytosine deaminase to the tumor. Patients then take oral cycles of Toca FC, a novel formulation of an antifungal drug, which is converted within infected cancer cells into the FDA-approved anticancer drug, 5-fluorouracil (5 FU). As a result, in addition to direct 5-FU mediated killing the immune system is activated to recognize and kill cancer cells, leaving healthy cells unharmed. Immune activation locally in the tumor occurs through a combination of mechanisms that together break the barrier of immune tolerance and may lead to durable tumor response.

About Tocagen
Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of products built upon a broadly applicable, highly tumor-selective immuno-oncology platform. The company’s lead combination product, Toca 511 & Toca FC, is advancing into a pivotal Phase 2/3 study in 2015 for patients with recurrent glioblastoma or anaplastic astrocytoma. The FDA has granted Toca 511 & Toca FC both Fast Track and orphan drug designations. A study evaluating Toca 511 & Toca FC in five additional metastatic solid tumor indications is planned for 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.

Media Contact:
Monica May
Canale Communications
619-849-5383

FDA Grants Fast Track Designation to Tocagen’s Toca 511 & Toca FC for Treatment of Recurrent High Grade Glioma

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.

About Tocagen
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.