$0.54 -$0.19 (-25.9%)

03:58 PM EST on 12/12/19

Tocagen (NASDAQ:TOCA)

CAPS Rating: No stars

Current Price $0.54 Mkt Cap $12.7M
Open $0.69 P/E Ratio 0.00
Prev. Close $0.72 Div. (Yield) $0.00 (0.0%)
Daily Range $0.46 - $0.69 Volume 3,733,097
52-Wk Range $0.46 - $12.00 Avg. Daily Vol. 468,403

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NASDAQ:TOCA VS S&P 500 (SPY)

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Member Avatar mdriver78 (68.96) Submitted: 6/13/2019 3:10:23 PM : Outperform Start Price: $5.83 NASDAQ:TOCA Score: -100.55

The company is realizing a vision that “no one should die of cancer” via its gene therapy platform.

For over a century people have noticed a connection between cancer regression and viral infection. We now know that cancer cells have greatly compromised antiviral defenses.

TOCA exploits this gap in cancer’s armor by using a retrovirus to deliver gene therapy to cancer cells.

Healthy cells don’t get infected by the company’s retroviral replicating vector (RRV) gene therapy platform. That means that any gene therapies delivered by Tocagen’s RRVs are selectively taken up only by cancer cells.

Tocagen was founded in 2007 as a pioneering cancer gene therapy company. Today, the company has multiple programs, including two clinical trial-stage cancer therapies.

Of special interest to us as FDA traders is TOCA 5 for patients with glioma brain cancer, which is currently in Phase 3 trials.

TOCA 5 is a two-part therapy.

After a patient receives surgery for brain cancer, the first part, called Toca 511, is injected into the site the tumor occupied.

Toca 511 is an RRV carrying genetic code for an enzyme called cytosine deaminase (CD). The retrovirus infects cancer cells that may be remaining even after surgery.

Additionally, infected cancer cells go on to infect other uninfected cancer cells in the same region.

Once infected, these cells start producing the CD enzyme.

That’s important as I’ll explain…

The patient is then given a pill called Toca FC, which is known as a prodrug — meaning it isn’t active until transformed by cells inside the body.

When molecules of Toca FC are taken up by Toca 511-infected cancer cells, the cytosine deaminase present in those cells transforms it into 5-FU, a common, long-standing chemo drug.

This means that Tocagen has figured out a way to selectively deliver a powerful chemo drug to cancer cells using gene therapy as a way to make sure only cancer cells turn a prodrug into 5-FU, thanks to the fact that only they are easily infected by a gene-carrying retrovirus.

As I mentioned, TOCA 5 is in Phase 3 trials right now in over 400 patients. The patients are divided into two evenly matched groups, with one receiving TOCA 5 and the other just receiving standard therapies. These are brain cancer patients who have experienced disease recurrence at least once already.

The primary goal of the trial is to establish overall survival between patient groups, as well as response rates and other secondary measures of efficacy.

Last month, an independent data-monitoring committee performed an interim analysis of the trial to determine whether or not it should be continued. This is a common occurrence in blinded late-stage cancer trials.

After reviewing data in the trial last month, the monitoring committee recommended it continue to completion.[1]

Shares of TOCA sold off on the event, perhaps because investors were hoping for an early win — of which the therapy proved statistically significant improvement ahead of the planned ending for the trial. This is a rare occurrence in cancer clinical trials, but it’s worth noting that insiders have purchased over 50,000 shares in the aftermath.

TOCA 5 has already generated impressive earlier-stage data in patients with glioblastoma multiforme brain cancer.

Historical survival data show perhaps one in 20 patients surviving out to five years post-diagnosis.

However, in Phase 1 trials, a significant percentage of patients showed a complete response to the therapy and are still alive after a period of years.

The therapy has shown a 26% survival rate at three years.

Tocagen expects a final analysis to take place in the fourth quarter of this year for patients with recurrent glioma brain cancer. If data are favorable, the company will then prepare a rolling biologics application with the FDA to bring to market, as well as launch a trial for newly diagnosed brain cancer patients.

Right now TOCA is valued at just $126 million, and as of its last filing it reports over $80 million in cash and short-term investments.

A successful Phase 3 outcome would put the company in line to file for approval with the FDA by the end of the year.

It would bring access to thousands of patients within reach — meaning TOCA 5 could generate billions in revenues in this underserved indication.

A successful Phase 3 outcome could put the value of TOCA up more than 10 times higher than currently.

Leaderboard

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Score Leader

WildShaman

WildShaman (95.60) Score: +111.11

The Score Leader is the player with the highest score across all their picks in TOCA.

Top
Pick
Member Name Member
Rating
Start
Date
Call Time
Frame
Start
Price
Stock
Gain
Index
Gain
Score Commentary
WildShaman 95.60 7/5/2018 Underperform 5Y $10.08 -94.69% +16.42% +111.11 0 Comment
mdriver78 68.96 6/14/2019 Outperform 5Y $5.83 -90.82% +9.73% -100.55 1 Comment
wellfindout 60.96 12/6/2018 Outperform 5Y $13.58 -96.06% +19.15% -115.21 0 Comment
gunda7907 < 20 10/11/2017 Outperform 5Y $10.20 -94.75% +24.49% -119.25 0 Comment
efarev 98.91 7/5/2017 Outperform 5Y $12.25 -95.63% +30.59% -126.22 0 Comment

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