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This Day That Year: Tocagen

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Shares of Tocagen Inc. (TOCA) have returned a little over 7 percent in the last one year, lagging behind the iShares NASDAQ Biotechnology Index (ETF), which is up 11 percent during the same period.

It was on this day last year, i.e. April 13, 2017, that Tocagen debuted on the Nasdaq by setting a public offering at $10.00 per share.

Tocagen is a cancer-selective gene therapy company developing therapies that are designed to destroy tumors, leaving the healthy tissues unharmed.

The Company's lead drug candidate is a combination of Toca 511, an investigational injectable retroviral replicating vector (RRV) that encodes a prodrug activator enzyme, cytosine deaminase, and Toca FC, an investigational, orally administered, extended-release formulation of 5-fluorocytosine (5-FC). Toca 511 and Toca FC are to be used together.

When Toca 511 is administered to patients, it selectively infects and spreads through the tumor. Toca 511 delivers a gene to cancer cells called cytosine deaminase (CD). As part of the regimen, patients are also given oral tablet called Toca FC.
Toca FC is converted by the CD enzyme into anticancer drug, 5-FU within infected cancer cells. 5-FU kills cancer cells, and the immune system is activated leading to clearance of the tumor, according to the Company.

A phase III trial of Toca 511 & Toca FC in patients with recurrent high-grade glioma, or HGG, the most common and aggressive primary brain cancer, dubbed Toca 5, is underway.

The Toca 5 study is expected to enroll 380 patients. The Company expects to complete enrollment in the study this year.

Toca 511 & Toca FC is also under a phase Ib study in patients with metastatic cancers (colorectal cancer, triple negative breast cancer, pancreatic cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, lymphoma, sarcoma, bladder cancer, or melanoma). This study, known as TOCA 6, is designed to enroll 30 patients.

Another indication for which Toca 511 & Toca FC combination is being explored is newly diagnosed high grade glioma. Currently, preclinical tests are underway for this indication.

Recent event:

On March 7, 2018, the European Medicines Agency granted orphan medicinal product designation to Toca 511 & Toca FC for the treatment of patients with glioma.

Toca 511 & Toca FC also carries the FDA's Breakthrough Therapy Designation and the European Medicines Agency's PRIME (PRIority MEdicines) designation for the treatment of high grade glioma.

Near-term Catalysts:

Enrollment in the pivotal phase III Toca 5 study is expected to be completed in 2018. Planned interim analyses of this study at 50% and 75% of events are estimated to occur in the second half of 2018 and first half of 2019, respectively.

The preliminary data from the Toca 6 phase Ib study is slated to be presented at the American Association for Cancer Research (AACR) Annual Meeting on April 16, 2018.

Initiation of a phase Ib trial, called Toca 7, evaluating Toca 511 & Toca FC combined with standard of care in patients with newly diagnosed high grade glioma is expected in the second half of 2018.

*Some key numbers… (As of Dec. 31, 2017)

Cash: $88.7 million
Total Debt: $10.82 million
Shares Outstanding: 19.91 million
Float: 17.6 million

(*Data sourced from Yahoo Finance).

TOCA has thus far hit a low of $8.60 and a high of $17.95. The stock closed Thursday's trading at $11.02, down 0.09%.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

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