Tocagen Presents Preliminary Toca 6 Phase 1 Data in Patients with Advanced Solid Tumors at the American Association for Cancer Research (AACR) Annual Meeting 2018

CHICAGO, April 16, 2018 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today reported preliminary data from the Toca 6 Phase 1 trial of Toca 511 & Toca FC in advanced solid tumors at the American Association for Cancer Research (AACR) Annual Meeting 2018 in Chicago. The poster was presented by Jaime Merchan, M.D., director, Phase 1 clinical trials program at Sylvester Comprehensive Cancer Center, part of UHealth, the University of Miami Health System; associate professor of medicine at the University of Miami Miller School of Medicine.

As of the data cutoff date of March 27, 2018, 7 patients with advanced solid tumors received Toca 511 & Toca FC intravenously (IV). Among these patients, 4 also received Toca 511 via intratumoral administration.

Data highlights are below. The poster will be placed on Tocagen's website following its presentation.

• Cancer-selective expression of the Toca 511 transgene following IV administration was demonstrated in metastatic tumors of 5 patients for whom tissue analyses had been completed, indicating successful delivery of the retroviral replicating vector (RRV).
• Viral RNA, DNA and cytosine deaminase (CD) protein expression was detected in liver metastases from 4 patients with colorectal cancer and retroperitoneal lymph node metastases from 1 patient with pancreas cancer.
• Toca 511 was cleared from blood plasma within 6 weeks following IV administration, indicating the virus is well controlled outside of tumors.
• Toca 511 & Toca FC were well tolerated, supporting the favorable safety profile of the product candidate.

"The preliminary data from the Toca 6 trial represent an important milestone for our RRV platform technology and lead product: for the first time we have demonstrated Toca 511's ability to selectively infect metastases from solid tumors other than glioma following IV delivery, opening potential expansion opportunities for our lead product," said Marty Duvall, chief executive officer of Tocagen. "In the year ahead we plan to initiate studies that evaluate the efficacy of our regimen in patients with advanced cancers." 

Additional data from Tocagen's Phase 1 trial demonstrating the immune profile of the tumor microenvironment is associated with response in patients with recurrent high-grade glioma who received Toca 511 & Toca FC via resection will be presented on Wednesday, April 18, 8:00 a.m. - 12:00 p.m. CT (Abstract: 5630). The poster will also be placed on Tocagen's website following the presentation.

About Toca 6

Toca 6 is an ongoing 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 HGG. 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 additional product candidates. 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; 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:
Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com

Investor Contact:
Gitanjali Jain Ogawa
Solebury Trout
(646) 378-2949
Gogawa@troutgroup.com

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SOURCE Tocagen Inc.