Tocagen Presents Preliminary Data from Toca 6 Trial Supportive of Immune Activation in Patients with Advanced Solid Tumors at CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference

NEW YORK, Sept. 30, 2018 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today is presenting data describing the tumor microenvironment and immunogenicity  of Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) in patients with solid tumor malignancies at the International Cancer Immunotherapy Conference hosted by The Cancer Research Institute (CRI), the Association for Cancer Immunotherapy (CIMT), the European Academy of Tumor Immunology (EATI), and the American Association for Cancer Research (AACR)  in New York City. The lead author is Jaime Merchan, M.D., director, Phase 1 clinical trials program at Sylvester Comprehensive Cancer Center; associate professor of medicine at the University of Miami Miller School of Medicine.

The poster describes data available as of August 31st for 20 patients with advanced solid tumors, including colorectal, sarcoma, pancreas and non-small cell lung cancer, treated with intravenous Toca 511 followed by oral Toca FC in the Phase 1b Toca 6 clinical trial. Among these patients, 15 also received Toca 511 via intratumoral administration.

In this preliminary analysis of immune activation in patients with advanced solid tumors, analysis of peripheral blood shows immune cell modulation that is consistent with what has been observed in preclinical studies and in patients with recurrent high grade glioma treated with Toca 511 & Toca FC in previous clinical trials. In addition, available tumor samples from three patients show Toca 511 infected both "hot" (T cells present) and "cold" (T cells low or absent) areas of metastatic tumor, suggesting Toca 511 can penetrate multiple tumor microenvironments. Toca 511 & Toca FC treatment was well tolerated.

"The encouraging preliminary immune activity data from the Toca 6 trial continue to support the proposed mechanism of action for Toca 511 & Toca FC and its potentbiial in the treatment of multiple cancers," said Asha Das, M.D., chief medical officer of Tocagen. "We look forward to advancing expansion opportunities for our lead product in patients with solid tumors."

CRI-CIMT-EATI-AACR Abstract/Poster Number: A018
Abstract Title: Effects of Toca 511 & Toca FC on tumor microenvironment and peripheral blood populations in patients with advanced malignancies
Date: Sunday, September 30, 2018
Time: 11:45 a.m. - 2:15 p.m. ET
The poster is available on Tocagen's website.

About Toca 6
Toca 6 is a multi-center, open-label Phase 1b study evaluating Toca 511 & Toca FC in patients with advanced solid tumors. The study will evaluate the safety and presence of Toca 511 genes in tumors of patients with widely disseminated disease, immunologic activity in blood and tumor, and clinical activity such as tumor response and clinical benefit. More information can be found at www.tocagen.com/toca6 or by searching clinicaltrials.gov using the clinical trial identifier NCT02576665.

About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

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. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives, timing and success of our clinical trials and planned clinical trials, timing of results from our clinical trials and our plans regarding selection of potential additional indications for our lead product candidate. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; the ability to replicate outcomes from early-stage clinical trials in later-stage trials; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact:
Pam Lord
Canale Communications
(619) 849-6003
pam@canalecomm.com 

Investor Contact:
Elizabeth Broder
Endurance Advisors
ebroder@enduranceadvisors.com

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Company Codes: NASDAQ-NMS:TOCA