Tocagen Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Toca 511 & Toca FC in Recurrent High Grade Glioma

SAN DIEGO – Feb. 23, 2017 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of patients with recurrent high grade glioma (HGG). Toca 511 & Toca FC is currently under evaluation in an international, randomized Phase 2/3 clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment in the Phase 2 portion of the trial has completed and top-line results are anticipated in the first half of 2018.

The Breakthrough Therapy Designation application was based on data from three Phase 1, ascending-dose clinical trials involving 126 patients with recurrent brain cancer. The clinical data includes results published in Science Translational Medicine, including safety data, patient survival data and durable, complete or partial tumor shrinkage determined by independent radiology review. In addition, preclinical information was provided supporting a novel immunological mechanism of action involving the depletion of immune-suppressive myeloid cells in the tumor microenvironment. The FDA previously granted Fast Track designation to Toca 511 & Toca FC for the treatment of recurrent HGG.

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Tocagen Achieves Key Development Milestone for Lead Product: Phase 2 Randomized Trial in Patients with Recurrent Brain Cancer Fully Enrolled Top-Line Results Anticipated 1H 2018

SAN DIEGO – Feb. 23, 2017 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced it has completed patient enrollment in the Phase 2 portion of Toca 5, a randomized, international Phase 2/3 clinical trial of Toca 511 & Toca FC, for the treatment of patients with recurrent brain cancer. Read more

Tocagen to Present at Phacilitate Cell & Gene Therapy World 2017

SAN DIEGO – Jan. 17, 2017Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced Douglas J. Jolly, Ph.D., executive vice president, research and pharmaceutical development at Tocagen, will present at Phacilitate Cell & Gene Therapy World 2017, to be held Jan. 17-20 in Miami.

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

SAN DIEGO – Jan. 13, 2017 — Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced its randomized, controlled Phase 2/3 clinical trial, called Toca 5, is now enrolling patients in South Korea. The trial is ongoing in the United States, Canada and Israel. The study compares a cancer-selective virus, Toca 511 (vocimagene amiretrorepvec), in combination with Toca FC (extended-release 5-fluorocytosine), to standard of care in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.

“Brain tumors are among the deadliest of all cancers and there are very few treatment options available,” said Do Hyun Nam, M.D., professor, department of neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, which enrolled the first patient in South Korea. “Data from Phase 1 studies of this investigational agent showed very promising safety, survival and durable tumor response data so we are excited to continue evaluation of this therapy in the Toca 5 trial.”

Sin-Soo Jeun, M.D., professor of neurosurgery at Seoul St. Mary’s Hospital, is the principal investigator for the Toca 5 clinical trial in South Korea.

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

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

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

About Toca 511 & Toca FC

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

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer(VABC). For more information, visit www.tocagen.com or follow @Tocagen.

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

Patient Enrollment in the United States and Canada Ongoing

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

Tocagen Presents Updated Clinical and Preclinical Data at Scientific Meetings

SCOTTSDALE, Ariz. – Nov. 21, 2016 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced updated interim data from ongoing Phase 1 and preclinical studies of Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (extended-release 5-fluorocytosine) were presented at the 21st Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), the 2nd CNS Anticancer Drug Discovery and Development Conference and the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting. Read more

Tocagen to Present Clinical and Preclinical Data at Upcoming Scientific Meetings

SAN DIEGO – Nov. 10, 2016Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced updated data from the company’s clinical and preclinical studies of Toca 511 and Toca FC in high grade glioma will be highlighted in oral and poster presentations at the 21st Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), the 2nd CNS Anticancer Drug Discovery And Development Conference and the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting. Read more

Tocagen Strengthens Leadership Team: Martin Duvall Appointed as Chief Executive Officer

SAN DIEGO, Nov. 2, 2016 — Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the appointment of Martin “Marty” Duvall as chief executive officer and member of the company’s board of directors. Harry Gruber, M.D., who previously served as Tocagen’s chief executive officer, has assumed the role of president, research and development, and will remain a member of Tocagen’s board of directors.

“Marty has clearly demonstrated over his career that he is skilled in building oncology focused companies and successfully commercializing major oncology products, including Taxotere® and Abraxane®,” said Dr. Gruber. “Tocagen has entered a new era as we advance towards potential commercialization of our lead product candidate, and Marty’s expertise and strategic vision will guide us at this pivotal point in the company’s growth. I enthusiastically welcome Marty to lead our team and inspire us to continue developing first-in-class immunotherapy drugs to help patients in their fight against cancer.”

Mr. Duvall holds more than 30 years of experience in oncology drug development and commercialization at mid-stage and global pharmaceutical companies, including building numerous successful oncology teams. Prior to joining Tocagen he served as executive vice president, chief commercial officer of ARIAD Pharmaceuticals, and helped lead the company’s transformation into a fully integrated, global biotechnology company.

“While we have made strides in treating some cancers, it is clear that we need to think ‘outside the box’ and pursue approaches with unique mechanisms of action to truly impact this disease, particularly for difficult-to-treat tumors,” said Mr. Duvall. “I was impressed by Tocagen’s team and the clinical data demonstrated by the company’s lead immunotherapy product candidate. I am honored that Tocagen’s board has entrusted me to lead the company and I look forward to working with all of Tocagen’s key stakeholders as we advance its novel cancer-selective gene therapy technology platform towards potential commercialization.”

Previous to Mr. Duvall’s role at ARIAD, he served as senior vice president and general manager, oncology, at Merck and & Co., Inc. Prior to this role, Mr. Duvall was the senior vice president, global marketing and commercial operations at Abraxis Bioscience, Inc. (acquired by Celgene), where he guided global commercial strategy for Abraxane. Prior to joining Abraxis, he was the senior vice president, commercial operations, for MGI Pharma, Inc. (acquired by Eisai Co., Ltd.), where he held a key role in the launch and commercialization of Aloxi®. Previous to MGI, Mr. Duvall held roles of increasing responsibility related to commercialization, marketing and sales of oncology drugs at Sanofi and its predecessor companies.

Faheem Hasnain, chairman of Tocagen’s board of directors, added, “The Tocagen team has transformed an academic technology into a promising cancer immunotherapy treatment that is now under evaluation in a Phase 2/3 trial. With the addition of Marty as chief executive officer, and Harry serving as president, research and development, Tocagen is well positioned to continue pursuit of the company’s founding vision: No One Should Die Of Cancer.”

Mr. Duvall holds a master’s degree in chemistry from Johns Hopkins University, master’s degree in business from The University of Kansas and bachelor’s degree in chemistry from Muhlenberg College.

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.

Tocagen Presents Updated Tumor Response Data for its Cancer-Selective Gene Therapy

VANCOUVER, Canada – October 5, 2016 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced updated clinical data for Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (extended-release 5-fluorocytosine) for the treatment of recurrent high grade glioma.

The new data were presented at the 10th International Oncolytic Virus Meeting in Vancouver, Canada by Douglas J. Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen. The podium presentation was titled Molecular analyses and immune activity of Toca 511 a retroviral replicating vector in preclinical models and three ascending dose trials in patients with recurrent high grade glioma.

The presentation included updated response and survival data from Tocagen’s Phase 1, ascending dose study of Toca 511 administered at the time of tumor removal followed by cycles of orally administered Toca FC. Both Toca 511 and Toca FC are investigational agents. In the efficacy evaluable subset of twenty four patients with recurrent glioblastoma or anaplastic astrocytoma who received higher doses of Toca 511 and met the entry criteria for Tocagen’s ongoing Toca 5 trial1, the results were as follows:

CriteriaToca 511 & Toca FC (N=24)
Median overall survival14.3 months
Overall response, n (%)5 (20.8)

(3 CR, 2 PR)*

Median duration of response, months20.7
Stable disease (SD), n (%)5 (20.8)
Progressive disease, n (%)14 (58.3)
Clinical Benefit Rate, n (%)

(CR, PR, and SD at 8 weeks)

10 (41.7)
*Complete response (CR) and partial response (PR). Data cutoff date was September 1st 2016. Responses were assessed using Macdonald Criteria including MRI assessment by independent radiology review and clinical data.

In addition, Toca 511 & Toca FC continued to demonstrate a favorable safety profile and was well tolerated by patients.

“The complete and partial responses occur 6 to 19 months after study entry, consistent with the immunologic mechanism of action observed in our preclinical models,” said Dr. Jolly. “Furthermore, all responding patients have durable responses, remain alive at 21-42 months after study entry, and were clinically stable or improved. We are very encouraged by these data and the potential of this virus treatment for cancer patients.”

The ongoing Toca 5 trial is enrolling patients with recurrent glioblastoma or anaplastic astrocytoma. A current list of participating sites can be found here and a patient/care-giver inquiry form can be submitted here.

1 A phase 2/3 study for patients with first or second recurrence of recurrent glioblastoma or anaplastic astrocytoma; no prior bevacizumab for recurrence; recurrent tumor less than or equal to 5 centimeters.

About Tocagen
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.

Tocagen to Present Clinical and Preclinical Data at Two Scientific Meetings

SAN DIEGO – September 30, 2016 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced clinical and preclinical data involving Toca 511 & Toca FC for the treatment of recurrent high grade glioma will be presented at the 10th International Oncolytic Virus Meeting, to be held Oct. 1-4 in Vancouver, Canada and the European Society of Gene & Cell Therapy Annual Meeting, to be held Oct. 12-21 in Florence, Italy.

Details of the International Oncolytic Virus Meeting presentation are as follows:

Presentation Type: Presentation
Title: Molecular analyses and immune activity of Toca 511 a retroviral replicating vector in preclinical models and three ascending dose trials in patients with recurrent high-grade glioma
Date and Time: Tuesday, Oct. 4, afternoon session. PT
Presenter: Douglas J. Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen

Details of the European Society of Gene & Cell Therapy presentations are as follows:

Presentation Type: Presentation
Title: Clinical update, molecular analyses, and proposed mechanism of action of Toca 511 a retroviral replicating vector in three ascending dose trials in patients with recurrent high-grade glioma
Date and Time: Friday, Oct. 21, 9:00 a.m. CET
Presenter: Douglas J. Jolly, Ph.D. executive vice president, research and pharmaceutical development at Tocagen

About Tocagen
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.