Tocagen Appoints Asha Das, M.D, as Vice President Clinical Development and Medical Affairs

Experienced Oncology Drug Developer and Neuro-Oncologist will Lead Tocagen’s Registrational Toca 5 Study
Previously Led Activities Surrounding Approval and Launch of Avastin® for Glioblastoma

SAN DIEGO, – June 17, 2015 – Tocagen Inc., today announced Asha Das, M.D., has been named vice president of clinical development and medical affairs. Prior to joining Tocagen she held positions of increasing responsibility at Genentech, including leading activities related to the approval and launch of Avastin® in recurrent glioblastoma, expansion into platinum-resistant ovarian cancer and metastatic cervical cancer as well as clinical activities related to PD-L1.

“As we prepare to begin enrollment in Toca 5, our registrational trial investigating Toca 511 & Toca FC in patients with recurrent glioblastoma or anaplastic astrocytoma, we have further strengthened our clinical leadership team,” said Jamey Skillings, M.D., chief medical officer of Tocagen. “Our clinical group now boasts three oncologists, and their perspectives, particularly Asha’s insights from her work expanding Avastin into use in recurrent glioblastoma, will be extremely valuable as we transition into late-stage development. I look forward to working with Asha again, as during our time together at Genentech I was extremely impressed with her depth of expertise and knowledge of the clinical development of oncology therapeutics.”

Prior to Genentech, Dr. Das was an associate director at Eisai, focused on clinical activities related to the oncology therapeutics HALAVEN® and LENVIMATM. Previously, she was head of the neuro-oncology program at Cedars-Sinai in Los Angeles. Dr. Das is certified in neurology by the American Board of Psychiatry and Neurology and in the sub-specialty of neuro-oncology and was a clinical fellow in neuro-oncology at Massachusetts General Hospital. She completed a residency in neurology at Cornell Medical Center. Dr. Das also held academic appointments at the University of California, Los Angeles; University of California, San Francisco; and National University of Singapore. She obtained her medical degree and bachelor’s degree from Cornell University.

About Tocagen Inc.
Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products using a broadly applicable, cancer-selective immuno-oncology platform. These products leverage retroviral replicating vectors (RRVs) that selectively infect cancer cells creating a factory of RRV in the tumor, which can then infect other cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively and broadly against multiple tumor associated antigens through a combination of mechanisms resulting in a durable, systemic benefit. A registrational trial, called Toca 5, will evaluate lead therapeutic candidate Toca 511 & Toca FC in patients with recurrent glioblastoma or anaplastic astrocytoma and begin enrolling subjects in 2015.

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 please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584, NCT01985256, or NCT02414165.

Tocagen Appoints David R. Parkinson, M.D., to the Board of Directors

Executive Previously Led Oncology Clinical Development at Amgen and Novartis, Drug Development Activities at the National Cancer Institute

SAN DIEGO – May 5, 2015 — Tocagen Inc. a clinical-stage immuno-oncology company, today announced that David R. Parkinson, M.D., a venture partner at New Enterprise Associates (NEA), has been appointed to the board of directors of Tocagen. Dr. Parkinson has more than twenty years of experience in oncology clinical development, including leading clinical activities at Amgen and Novartis that resulted in global approvals of the cancer therapeutics Gleevec®, Femara®, Zometa®, Kepivance® and Vectibix®, as well as serving as chief of the Investigational Drug Branch at the National Cancer Institute.

“I have had the pleasure of working with David on several occasions, and I welcome the opportunity to work with him again as I have seen firsthand his tremendous depth of expertise in oncology drug development, ranging from late-stage clinical and registration activities to preclinical drug development,” said Faheem Hasnain, chairman of the board of directors of Tocagen and president and chief executive officer of Receptos, Inc. “As Tocagen continues to advance its lead product into pivotal trials and develop its immuno-oncology platform, David’s insights from years of experience in drug development and strategic partnering will be an invaluable resource to the company.”

Dr. Parkinson added, “Tocagen’s technology, which leverages retroviral replicating vectors to selectively infect cancer cells, break immune tolerance and persistently activate the immune system against multiple tumor associated antigens, is a highly differentiated approach to treating cancer. I look forward to working with the Tocagen team to advance this novel immuno-oncology technology, which holds much promise as a treatment for patients with brain cancer and also has the potential to be broadly applicable across other cancers.”

Among other prior roles, Dr. Parkinson was vice president of oncology development at Amgen, vice president of global clinical oncology development at Novartis and senior vice president at Biogen Idec, leading oncology research and development. Dr. Parkinson presently serves on the board of directors of Threshold Pharmaceuticals and Cerulean Pharma Inc. and previously served on the board of directors of Facet Biotech, acquired by Abbott, and Ambit Biosciences Corporation, acquired by Daiichi Sankyo. Prior to joining industry, Dr. Parkinson worked at the National Cancer Institute for almost a decade, including serving as chief of the Investigational Drug Branch. He has also served as the chairman of the FDA Biologics Advisory Committee.

About Toca 511 & Toca FC
Toca 511 & Toca FC is a combination treatment being investigated in four clinical trials in patients with recurrent high grade glioma, including glioblastoma. A pivotal Phase 2/3 study in patients with recurrent glioblastoma or anaplastic astrocytoma (the “Toca 5” study) is anticipated to initiate in 2015. The combination of Toca 511 & Toca FC is designed to break immune tolerance to the tumor using a combination of mechanisms. Toca 511, a retroviral replicating vector (RRV), delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell converts orally administered Toca FC, an investigational extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5-fluorouracil (5 FU), which kills the infected cancer cell and neighboring 5-FU sensitive tumor cells. Glioma cells and myeloid derived suppressor cells in the tumor are known to be sensitive to 5-FU. In animal models, the production of 5-FU locally kills dividing tumor cells during 5-FC cycles, which leads to durable and selective anticancer immune responses.. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical benchmarks, excellent safety, and evidence to support the proposed mechanism of action.

About Tocagen
Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products using a broadly applicable, cancer-selective immuno-oncology platform. These products leverage retroviral replicating vectors (RRVs) that selectively infect cancer cells creating a factory of RRV in the tumor, which can then infect other cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively and broadly against multiple tumor associated antigens through a combination of mechanisms resulting in a durable, systemic benefit. Tocagen’s lead program is entering late-stage clinical development for patients with recurrent high grade glioma (glioblastoma or anaplastic astrocytoma).

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, NCT01985256, or NCT02414165.

Tocagen Announces Updates from FDA Meeting and Clinical Data Presentations at AANS/CNS

Tocagen Presents Updated Interim Survival Data from Ongoing Clinical Studies at American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors

Following Meeting with FDA, Company Advances Towards Pivotal Phase 2/3 Trial in Patients with Recurrent High Grade Glioma

WASHINGTON, D.C. – May 4, 2015 – Tocagen Inc. a clinical-stage immuno-oncology company, today announced updated interim data from Tocagen’s ongoing investigational studies were presented at the 11th Biennial Satellite Symposium of the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors, held May 1-2, 2015, in Washington, D.C. In addition, Tocagen announced the company held a meeting with FDA and continues to advance towards initiation of a pivotal, randomized, controlled Phase 2/3 trial of Toca 511 & Toca FC in patients with recurrent glioblastoma and recurrent anaplastic astrocytoma this year.

“Based on the strength of our interim clinical data involving Toca 511 & Toca FC and a positive meeting with FDA, we continue to move forward with our plans to initiate a pivotal Phase 2/3 trial in 2015,” said Harry Gruber, M.D., chief executive officer of Tocagen. “Initiating this trial is an important advance towards a potential new treatment for patients with primary brain cancer.”

The podium presentations were delivered by Manish K. Aghi, M.D., associate professor of neurological surgery at the University of California, San Francisco, and Michael A. Vogelbaum, M.D., Ph.D., professor of neurosurgery at the Cleveland Clinic, on behalf of the clinical investigators participating in the trials.
“High grade glioma is an extremely deadly disease and there is a great need for new treatments that prolong patient survival,” said Dr. Vogelbaum. “With encouraging safety data and preliminary evidence of clinical activity in two independent studies we look forward to helping advance Toca 511 & Toca FC into a randomized, controlled trial.”

Interim results from an ongoing study, which forms the basis of the planned Phase 2/3 trial design, included 38 patients with recurrent high grade glioma. In this study, Toca 511 was administered into the resection cavity wall at the time of surgery, followed by cycles of orally administered Toca FC. Results are summarized as follows:

  • Median overall survival was 13.7 months across the efficacy evaluable high grade glioma study population, compared to historical benchmarks of around 7 to 8 months.
  • Patients with high grade glioma at first or second recurrence, the subgroup that mirrors the anticipated patient population in the Phase 2/3 trial, had a median overall survival of 14.6 months.
  • Four partial responses identified by independent radiology review support antitumor activity.
  • There was a trend towards increased survival for higher dose cohorts versus lower dose cohorts.
  • Safety was excellent with only one grade 3/4 related event and one subject with Toca FC discontinued for toxicity. The most common related adverse event was fatigue.

In addition, preliminary results from a second ongoing study involving 38 patients with recurrent high grade glioma that had Toca 511 administered transcranially into the tumor, followed by cycles of orally administered Toca FC, were presented. Results are summarized as follows:

  • 17 of 38 patients survived for more than one year, including two patients who were alive beyond three years as of April 4, 2015.
  • Independent radiology review revealed a clinical benefit rate of 46 percent, with 15 of 35 patients showing stable disease at week eight. One patient had a partial response.
  • Delivery of Toca 511 via two different methods showed median overall survival of 13.8 months and 10.6 months compared to historical benchmarks of approximately 7 to 8 months.

Interim results from Tocagen’s ongoing study administering intravenous (IV) Toca 511 in 11 patients with recurrent glioblastoma scheduled for tumor resection and subsequent Toca 511 injections into the resection cavity wall were also presented. Results are summarized as follows:

  • Preliminary data show all subjects remain alive to date, with two patients alive at fourteen and eleven months respectively.
  • Viral DNA encoding cytosine deaminase (CD) and the CD protein were detected in resected tumor samples, indicating that IV delivery results in integration and expression of the vector in the tumor and demonstrating potential for treating other tumor types with systemic infusions. Tocagen is planning to initiate a study of Toca 511 & Toca FC delivered intravenously to patients with metastatic solid tumors.

About Toca 511 & Toca FC

Toca 511 & Toca FC is a combination treatment being investigated in four clinical trials in patients with recurrent high grade glioma, including glioblastoma. A pivotal Phase 2/3 study in patients with recurrent glioblastoma or anaplastic astrocytoma (the “Toca 5” study) is anticipated to initiate in 2015. The combination of Toca 511 & Toca FC is designed to break immune tolerance to the tumor using a combination of mechanisms. Toca 511, a retroviral replicating vector (RRV), delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell converts orally administered Toca FC, an investigational extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5-fluorouracil (5 FU), which kills the infected cancer cell and neighboring 5-FU sensitive tumor cells. Glioma cells and myeloid derived suppressor cells in the tumor are known to be sensitive to 5-FU. In animal models, the production of 5-FU locally kills dividing tumor cells during 5-FC cycles, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical benchmarks, excellent safety, and evidence to support the proposed mechanism of action.

About Tocagen Inc.

Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products using a broadly applicable, cancer-selective immuno-oncology platform. These products leverage retroviral replicating vectors (RRVs) that selectively infect cancer cells creating a factory of RRV in the tumor, which can then infect other cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively and broadly against multiple tumor associated antigens through a combination of mechanisms resulting in a durable, systemic benefit. Tocagen’s lead program is entering late-stage clinical development for patients with recurrent high grade glioma (glioblastoma or anaplastic astrocytoma).

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, NCT01985256, or NCT02414165.

Tocagen Announces Presentations at the AANS/CNS Joint Section on Tumors

Tocagen to Present Updated Interim Results from Studies Evaluating Toca 511 & Toca FC at the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors

SAN DIEGO, – (April 30, 2015) — Tocagen Inc., a clinical-stage immuno-oncology company, today announced updated interim results from ongoing investigational studies of Toca 511 in combination with Toca FC will be presented by two principal investigators at the 11th Biennial Satellite Symposium of the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Section on Tumors, to be held May 1-2, 2015, in Washington, D.C.

Details of the presentations are as follows:

Title: Surgical Trial Results: Tocagen
Date and Time: Saturday, May 2, at 2:48 p.m. ET
Presented By: Manish K. Aghi, M.D., associate professor of neurological surgery at the University of California, San Francisco

Title: Administration of Toca 511 to Subjects with Recurrent HGG Undergoing Repeat Resection
Date and Time: Saturday, May 2, at 4:48 p.m. ET
Presented By: Michael A. Vogelbaum, M.D., Ph.D., professor of neurosurgery at the Cleveland Clinic

About Toca 511 & Toca FC

Toca 511 & Toca FC is being investigated in four clinical trials in patients with recurrent high grade glioma, including glioblastoma. A pivotal Phase 2/3 study in patients with recurrent glioblastoma or anaplastic astrocytoma (the “Toca 5” study) is anticipated to initiate in 2015. The combination of Toca 511 & Toca FC is designed to break immune tolerance to the tumor using a combination of mechanisms. Toca 511, a retroviral replicating vector (RRV), delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell is designed to activate orally administered Toca FC, an investigational extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5 FU, which kills the infected cancer cell and neighboring 5-FU sensitive tumor cells. Glioma cells and myeloid derived suppressor cells in the tumor are known to be sensitive to 5-FU. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical benchmarks, excellent safety, and evidence to support the proposed mechanism of action.

About Tocagen Inc.

Tocagen is a clinical-stage biopharmaceutical company pursuing the discovery, development and commercialization of gene therapy products using a broadly applicable, cancer-selective immuno-oncology platform. These products leverage retroviral replicating vectors (RRVs) that selectively infect cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively and broadly against their tumor associated antigens, with subsequent durable, systemic benefit. Tocagen’s lead program is entering late-stage clinical development for patients with recurrent high grade glioma (glioblastoma or anaplastic astrocytoma).

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, NCT01985256, or NCT02414165.

Media Contact:

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

Tocagen Appoints Paul Schimmel, Ph.D, to the Board of Directors

Industry and Academic Leader Co-Founded Several Successful Biotechnology Companies, Including Alnylam, Cubist and Alkermes

SAN DIEGO, – February 25, 2015 – Tocagen Inc., a clinical-stage cancer-selective immunotherapy company, today announced that Paul Schimmel, Ph.D., Hahn professor of molecular biology and chemistry at The Scripps Research Institute, has been appointed to the board of directors.

Dr. Schimmel co-founded Alnylam Pharmaceuticals and currently serves as a member of the company’s board of directors. In addition to Alnylam, Dr. Schimmel co-founded and served as a founding director of Cubist Pharmaceuticals, acquired by Merck and Co.; Alkermes; Sirtris Pharmaceuticals, acquired by GlaxoSmithKline; as well as aTyr Pharma, Abide Pharmaceuticals, RepliGen Corporation and Momenta Pharmaceuticals.

“Paul has a unique combination of deep scientific expertise as well as an impressive track record founding and leading life science companies, of which six have become publicly traded,” said Faheem Hasnain, chairman of the board of directors of Tocagen and president and chief executive officer of Receptos, Inc. (Nasdaq: RCPT). “His experience and success developing new treatments for unmet medical needs and his corporate board and business acumen will be invaluable in providing pipeline and strategic direction as Tocagen advances into late-stage trials.”

Added Dr. Schimmel, “In order to make true breakthroughs in the fight against cancer, especially difficult-to-treat cancers such as glioblastoma, we need to explore unique technological approaches. Tocagen’s cancer-selective immunotherapy platform technologies and lead product candidate represent a new approach to treating cancer, and I look forward to working with Tocagen to advance the company and their potentially disruptive technology.”

Dr. Schimmel is an author or coauthor of more than 450 scientific papers, co-author of a three-volume textbook on biophysical chemistry, and has received numerous awards for his contributions to the field. Prior to joining The Scripps Research Institute, Dr. Schimmel was the MacArthur professor of biophysics and biochemistry at the Massachusetts Institute of Technology. He also served as chairman for the division of biological chemistry at the American Chemical Society and is an elected member of the American Academy of Arts and Sciences, the National Academy of Sciences, the American Philosophical Society and the Institute of Medicine. Dr. Schimmel obtained a doctorate from the Massachusetts Institute of Technology and bachelor’s degree from Ohio Wesleyan University. He conducted his post-doctoral work at Stanford University.

About Toca 511 & Toca FC
Toca 511 & Toca FC, the company’s lead investigational combination product candidate, is being evaluated in four clinical trials in patients with recurrent high grade glioma, including glioblastoma. Toca 511 & Toca FC is designed to have a dual mechanism of action. Toca 511, a retroviral replicating vector, delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5-FU, selectively in the cancer cell. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical controls, safety and tolerability, antitumor activity and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late-stage clinical trials in patients with high grade glioma.

About Tocagen Inc.
Tocagen is a biopharmaceutical company pursuing the discovery, development and commercialization of cancer-selective immunotherapeutic products for the treatment of cancer. These products leverage a novel retroviral replicating vector gene therapy platform that selectively infects cancer cells. Tocagen’s lead program is entering late-stage clinical development for patients with recurrent brain cancer. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit.

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 & Toca FC please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584 or NCT01985256.

Media Contact

Canale Communications
Monica May
monica@canalecomm.com

Tocagen Appoints Franklin M. Berger, CFA, to the Board of Directors

SAN DIEGO – (December 2, 2014) — Tocagen Inc. a clinical-stage selective cancer immunotherapy company, today announced that Franklin M. Berger, CFA, has been appointed to the board of directors. Mr. Berger will also serve as the chairman of a newly formed audit committee responsible for overseeing Tocagen’s accounting, financial reporting, disclosure and financial risk management activities.

Mr. Berger is a biotechnology industry analyst with over 25 years of experience in capital markets and financial analysis. He previously served as managing director, equity research, and senior biotechnology analyst at J.P. Morgan Securities from 1998 to 2003. During this time he was involved in the issuance of over $12 billion in biotechnology company equity or equity-linked securities. These activities included Genentech’s IPO, the largest biotechnology financing ever executed, and the first large financings for Celgene Corporation and Gilead Sciences. Previously, Mr. Berger served in a similar capacity at Salomon Smith Barney.

“Franklin is one of the most respected and accomplished Wall Street investment professionals and advisors in the biotechnology industry today,” said Harry Gruber, M.D., chief executive officer of Tocagen. “We are pleased that Franklin has joined the board and Tocagen will benefit greatly from his expertise in finance, business and technology as we advance into the next phase of development for Toca 511 & Toca FC.”

Added Mr. Berger, “Tocagen’s potentially transformative gene delivery technology platform and highly differentiated product candidates stand out among cancer immunotherapeutics. The company’s initial indication, glioblastoma, arguably has the greatest unmet medical need in cancer today, and I look forward to playing a role in the company’s continued work to make a difference in the lives of brain cancer patients.”

Presently, Mr. Berger serves on the board of directors of Immune Design and Five Prime Therapeutics. He has served on the board of directors for numerous companies, including Seattle Genetics, Inc. Mr. Berger is a founder and managing director of FMB Research and previously co-founded the small-cap focused NEMO fund at Sectoral Asset Management.

Mr. Berger is a CFA charterholder, holds a master’s degree in business from Harvard Business School, and received a master’s degree in international economics and a bachelor’s degree in international relations from Johns Hopkins University. He is a founding fellow of the Biotechnology Study Center at NYU School of Medicine.

About Toca 511 & Toca FC
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. Toca 511 & Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), is designed to have a dual mechanism of action. Toca 511 delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC given in cycles, into a powerful antimetabolite, 5-FU, selectively in the cancer. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical controls, safety and tolerability, antitumor activity and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late-stage clinical trials in patients with high grade glioma.

About Tocagen
Tocagen is a clinical-stage selective cancer immunotherapy company pursuing discovery, development and commercialization of gene therapy drugs using a novel retroviral replicating vector platform, which selectively infects cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit.

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 & Toca FC please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584 or NCT01985256.

Media Contact:

Canale Communications
Monica May
monica@canalecomm.com

Toca 511 & Toca FC Survival and PFS-6 Data Surpasses Published Benchmarks

Results Presented at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

MIAMI – November 18, 2014 — Tocagen Inc. today announced that interim data showed increased median overall survival and progression free survival at six months for recurrent high grade glioma (HGG) patients treated with Toca 511 & Toca FC, compared to published benchmarks. HGG includes glioblastoma, the most common and aggressive form of primary brain cancer. The data were delivered in an oral presentation at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) by Tim Cloughesy, M.D., director of the University of California, Los Angeles (UCLA) Neuro-Oncology Program on behalf of the trial investigators participating in the study. Additional clinical and preclinical studies were also presented at the conference. To date, 78 patients have been dosed with Toca 511 & Toca FC across Tocagen’s three ongoing investigational studies.

In the study presented by Dr. Cloughesy, 34 patients with recurrent HGG had Toca 511 administered into the resection cavity wall at the time of surgery followed by cycles of orally administered Toca FC. Median overall survival was 52.0 weeks. Patients with recurrent glioblastoma that had two or fewer prior recurrences had a median overall survival of 59.0 weeks. The presented data with the most relevant historical benchmarks are summarized in the table below:

E. Antonio Chiocca, M.D., Ph.D., professor of neurosurgery, Harvard Medical School, Brigham and Women’s Hospital and surgical director at the Center for Neuro-oncology, Dana-Farber Cancer Institute said, “There is an urgent need for effective treatment options for patients with recurrent glioblastoma, and I look forward to seeing this promising gene therapy advance into a randomized controlled trial to determine its effectiveness.”

Added Harry Gruber, M.D., chief executive officer of Tocagen, “Based on the safety profile, evidence to support the mechanism of action and survival data from these three ongoing studies, we are now planning to advance Toca 511 & Toca FC into late-stage trials.”

In addition, six month progression free survival for patients with glioblastoma was 26.9 percent compared to 6.8 percent for historical published data. Independent radiology review in evaluable patients using bidimensional measurement excluding FLAIR showed four partial responses and seven cases of stable disease for a clinical benefit rate of 36.7 percent (11/30). The partial responses were seen in the higher dose cohorts. Analysis of RNA expression levels in the resected tumors revealed increased survival with Toca 511 & Toca FC treatment with reduced gene expression of a known viral resistance gene in patient tumors. There was one Grade 3 adverse event of transient asthenia that was classified as related to Toca 511.

The following additional interim results from other clinical trials of Toca 511 were also presented in a poster session:

  • Interim results showed no drug-related Grade 3 or Grade 4 adverse events for the initial five patients enrolled in a study evaluating ascending doses of intravenous administration of Toca 511 in patients with recurrent glioblastoma scheduled for tumor resection. The treatment has been safe and well tolerated to date. In addition, two of the three patients in the highest dose cohort had quantifiable Toca 511 genes found in resected tumor samples and in the blood. The investigators in this study were represented by lead author Steven Kalkanis, M.D., chair of the department of neurosurgery and co-director of the Neuroscience Institute, Henry Ford Hospital.
  • Interim results showed a median overall survival of 53 weeks and survival rate of 93.8 percent at 6 months in a study evaluating direct intratumoral delivery of Toca 511 in patients with recurrent HGG. Historical published data report median overall survival of 33.2 weeks and a six month survival rate of 59 percent. In this study of 37 patients, a favorable safety profile was also demonstrated. The investigators in this study were represented by lead author Manish Aghi, M.D., associate professor of neurological surgery, University of California, San Francisco.

In addition, three preclinical studies related to Toca 511 were presented. These studies were performed in the laboratory of Dr. Noriyuki Kasahara in the departments of cell biology and pathology, University of Miami, and the David Geffen School of Medicine at UCLA:

  • Radiation therapy combined with Toca 511 and multiple cycles of 5-FC treatment significantly prolonged survival in pre-established intracranial U87/EGFRvIII radio-resistant glioma models with a median survival of longer than 89 days (median not reached) for the treated group versus 15 days for the control group, supporting the clinical investigation of Toca 511 and 5-FC in combination with radiation in the first-line or recurrent setting for patients with HGG. The results were presented orally by Masamichi Takahashi, M.D., Ph.D., from the department of neurosurgery and neuro-oncology, National Cancer Center in Tokyo, and the David Geffen School of Medicine at UCLA.
  • Toca 511 and 5-FC treatment significantly prolonged survival in an intracranial 231-BR model of CNS-metastatic breast cancer with a median survival of 97.5 days for the treated group versus 45 days for control group, supporting continued investigation in future clinical studies in patients with brain metastases from breast cancer. The poster was presented by Akihito Inagaki, Ph.D., from the department of cell biology, University of Miami, and the David Geffen School of Medicine at UCLA.
  • A retroviral replicating vector carrying a gene encoding a codon optimized bacterial nitroreductase A (RRV-NAO), which converts the prodrug CB1954 into an anticancer drug, was evaluated in an intracerebral U87-fLuc2 orthotopic tumor model. Results demonstrated significantly prolonged survival, with 100 percent of mice treated with RRV-NAO followed by multiple prodrug cycles surviving at 80 days, compared to a median survival of 36 days for the prodrug-only control. The poster was presented by Sara Collins, Ph.D., from the department of cell biology, University of Miami, and the David Geffen School of Medicine at UCLA.

About Toca 511 & Toca FC

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. Toca 511 & Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), is designed to have a dual mechanism of action. Toca 511 delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC given in cycles, into a powerful antimetabolite, 5-FU, selectively in the cancer. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical controls, safety and tolerability, antitumor activity and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late-stage clinical trials in patients with high grade glioma.

About Tocagen Inc.

Tocagen is a clinical-stage selective cancer immunotherapy company pursuing discovery, development and commercialization of gene therapy drugs using a novel retroviral replicating vector platform, which selectively infects cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit.

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.

Media Contact:

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

Tocagen Appoints Faheem Hasnain as Chairman of the Board of Directors

Builds Expert Independent Board As Company Advances Towards Late-Stage Brain Cancer Trials

SAN DIEGO, – November 14, 2014 – Tocagen Inc., a clinical-stage selective cancer immunotherapy company, today announced that Faheem Hasnain, president and chief executive officer of Receptos, Inc. (Nasdaq: RCPT), has been appointed as chairman of the board of directors.

“Faheem’s impressive track record and extensive experience leading the development and commercialization of novel oncology and immunology drugs brings valuable insight and strategic guidance to Tocagen as we advance towards late-stage clinical trials of Toca 511 and Toca FC in patients with high grade glioma,” said Harry Gruber, M.D., chief executive officer of Tocagen. “We are delighted that Faheem has joined us as chairman of the board.”

Added Mr. Hasnain, “Tocagen has an excellent scientific foundation and an exciting future for its lead- and second generation-gene therapies that are designed to help cancer patients activate their immune systems to fight their cancers. I look forward to working closely with Harry, the board and the Tocagen leadership team to contribute to the continued growth and success of the company.”

Mr. Hasnain is a distinguished industry leader with over 30 years of experience in the biopharmaceutical industry. Presently, he serves as chairman of the board of Sente, Inc. Previously, he was chairman of the board of Ambit Biosciences Corporation, acquired by Daiichi Sankyo Company, and he served on the board of directors of Seragon Pharmaceuticals, acquired by Roche; Aragon Pharmaceuticals, acquired by Johnson & Johnson; and Tercica, Inc., acquired by Ipsen.

Prior to joining Receptos, Mr. Hasnain was the president and chief executive officer and a director of Facet Biotech, an antibody company acquired by Abbott Laboratories with a focus on multiple sclerosis and oncology. Before Facet Biotech was spun off from PDL BioPharma, Inc., Mr. Hasnain was president, chief executive officer and a director of PDL BioPharma. Prior to this position, Mr. Hasnain held various roles at Biogen Idec Inc., most recently serving as executive vice president of the oncology/rheumatology strategic business unit. Prior to this role, Mr. Hasnain held roles with Bristol-Myers Squibb, where he was president of the Oncology Therapeutics Network, as well as GlaxoSmithKline and its predecessor organizations.

About Tocagen Inc.
Tocagen is a clinical-stage selective cancer immunotherapy company pursuing discovery, development and commercialization of gene therapy drugs using a novel retroviral replicating vector platform. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit.

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 & Toca FC please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584 or NCT01985256.

About Toca 511 & Toca FC
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). Toca 511 & Toca FC is designed to have a dual mechanism of action. Toca 511 delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5-FU, selectively in the cancer. The production of 5-FU locally kills tumor cells, which leads to prolonged and selective anticancer immune responses in animal models. Data from ongoing clinical trials show encouraging safety and tolerability, antitumor activity, and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late stage clinical trials in patients with high grade glioma.

Media Contact

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

Tocagen Announces Presentations at SNO 2014 Annual Conference

Tocagen to Present Toca 511 Data at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

MIAMI – November 11, 2014 — Tocagen Inc., a clinical-stage selective cancer immunotherapy company, today announced podium and poster presentations of multiple clinical and preclinical studies of Toca 511 at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), to be held Nov. 13-16, 2014, in Miami.

Podium presentations are as follows:

Abstract #: IT-05
Title: “Administration of Toca 511 to subjects with recurrent HGG undergoing repeat resection”
Time: Saturday, Nov. 15, at 11:30 a.m. ET
Delivered by: Tim Cloughesy, M.D., director of the University of California, Los Angeles (UCLA) Neuro-Oncology Program
Location: Americana 3

Abstract #: ET-60
Title: “Enhanced therapeutic efficacy of prodrug activator gene therapy with a non-lytic retroviral replicating vector (Toca 511) combined with radiation therapy in experimental glioma”
Time: Saturday, Nov. 15, at 8:20 a.m. ET
Delivered by: Masamichi Takahashi, M.D., Ph.D., from the department of neurosurgery and neuro-oncology, National Cancer Center in Tokyo, and the David Geffen School of Medicine at UCLA
Location: Poinciana 1,2,3,4

Posters will be presented on Friday, Nov. 14, at 7:30 p.m. ET in Americana 4 and are as follows:

Abstract #: AT-29
Title: “Intravenous administration of Toca 511 in patients with recurrent glioblastoma”
Presented by: Steven Kalkanis, M.D., chair of the department of neurosurgery and co-director of the Neuroscience Institute, Henry Ford Hospital

Abstract #: AT-02
Title: “Intratumoral delivery of the retroviral replicating vector (RRV) Toca 511 in subjects with recurrent high grade glioma: interim report of Phase 1 study (NCT 01156584)”
Presented by: Manish Aghi, M.D., associate professor of neurological surgery, University of California, San Francisco

Abstract #: ET-23

Title: “Therapeutic efficacy of retroviral replicating vectors in a human breast cancer CNS metastasis model”
Presented by: Akihito Inagaki, Ph.D., from the department of cell biology, University of Miami, and the David Geffen School of Medicine at UCLA

Abstract #: ET-13
Title: “Retroviral replicating vector (RRV)-mediated prodrug activator gene therapy with codon-optimized nitroreductase”
Presented by: Sara Collins, Ph.D., from the department of cell biology, University of Miami, and the David Geffen School of Medicine at UCLA

About Tocagen
Tocagen is a clinical-stage selective cancer immunotherapy company pursuing discovery, development and commercialization of gene therapy drugs using a novel retroviral replicating vector platform. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit.

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 & Toca FC please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584 or NCT01985256.

About Toca 511 & Toca FC
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). Toca 511 & Toca FC is designed to have a dual mechanism of action. Toca 511 delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), into a powerful antimetabolite, 5-FU, selectively in the cancer. The production of 5-FU locally kills tumor cells, which leads to prolonged and selective anticancer immune responses in animal models. Data from ongoing clinical trials show encouraging safety and tolerability, antitumor activity, and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late stage clinical trials in patients with high grade glioma.

Tocagen Expands Clinical Development Team

Tocagen Expands Clinical Development Team; Names Wayne Saville, M.D., Vice President, Clinical Development, and Mary Rose Keller Vice President, Clinical Operations

SAN DIEGO, CA – August 26, 2014 – Tocagen Inc. today announced Wayne Saville, M.D., has been named vice president, clinical development, and Mary Rose Keller has been named vice president, clinical operations.

“As we advance Toca 511 & Toca FC into late-stage registration studies, we are expanding our clinical team with individuals who have deep experience in drug development, regulatory approval, launch and commercialization activities,” said Jamey Skillings, M.D., Chief Medical Officer of Tocagen. “Wayne and Mary Rose bring decades of valuable expertise in clinical development and medical affairs at a pivotal time for Tocagen.”

Dr. Saville has more than a decade of experience in clinical development and medical affairs for cancer products. Prior to joining Tocagen, he headed medical affairs at Genoptix, an oncology diagnostics laboratory acquired by Novartis. Previous to that position he was a director of clinical research at Amgen, where he led late-stage development of a cancer drug as well as medical affairs for ProliaTM. Prior to this role, Dr. Saville was the director of oncology clinical research at Biogen Idec, leading clinical and medical affairs programs for Zevalin® and Rituxan®. Previous to this position, he was an associate professor at the University of California, San Diego, and trained in internal medicine at the University of Minnesota Medical Center. He was a medical oncology fellow at the National Cancer Institute and obtained his medical degree and bachelor’s degree in medicine at Northwestern University.

Ms. Keller has more than two decades of experience in drug development and clinical operations, and has worked with numerous research-focused organizations while at University of California, San Francisco’s Cancer Research Institute, including the Brain Tumor Research Group, Children’s Cancer Study Group and Radiation Therapy Oncology Group. Previously she was the vice president of clinical development and operations at a number of pharmaceutical companies including Prometheus Laboratories and Shire. Prior, she was the senior director of clinical operations at Agouron, leading activities for Viracept®. She subsequently led Agouron’s oncology and ophthalmology programs through mergers with Warner-Lambert and Pfizer, ultimately becoming Pfizer’s worldwide head development operations, global team leads and clinical trial recruitment services. Ms. Keller also previously worked at New Drug Services, where she participated in eight New Drug Applications. Ms. Keller obtained her bachelor’s degree at the University of California, Davis.

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.