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Is TRACON Pharmaceuticals Inc (NASDAQ:TCON) About To Put Out Follow Up Data?

Is TRACON Pharmaceuticals Inc (NASDAQ:TCON) About To Put Out Follow Up Data?
Written by
Chris Sandburg
Published on
September 6, 2017
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TRACON Pharmaceuticals Inc (NASDAQ:TCON) is running this week on news that the company is set to present at 2017 Wells Fargo Healthcare Conference at 1:40 pm EDT on Thursday, September 7, 2017. The event, which will take place in Boston, is high up on the list of major calendar dates in the healthcare and biotechnology spaces and that TRACON is set to take the stage at the event is a big deal for the company and its shareholders.Exactly what management intends to present remains to be seen, but there is a good chance that CEO Charles Theuer will center the presentation around a drug called TRC105 and, more specifically, the most recently released data associated with the asset.Here is what we are expecting at the presentation and why this company could run post-event.The data in question relates to a phase 1/2 study that was conducted by the National Cancer Institute (NCI) and for which data was released back on August 16, 2017. The study was set up to investigate the safety and efficacy of the above-mentioned TRC105 when combined with an already established anticancer agent called Nexavar in a target indication of hepatocellular cancer, or HCC, which is another term for primary liver cancer.It's a real tough cancer to treat and it's one for which that just aren’t that many treatment options available right now. With TRC105, TRACON is trying to change this, and the latest data suggests that it might be able to do just that. TCON Daily ChartThe trial enrolled 26 patients, all of which were dosed at one of four levels of TRC105 (3, 6, 10 and 15 mg/kg every two weeks) and with the standard dose of Nexavar of 400 mg twice daily.As per the release, the overall response rate (ORR) in the 20 evaluable patients with measurable disease over all four dose levels was 25%, measured using what's called the Response Evaluation Criteria in Solid Tumors, or RECIST, an industry gold standard measurement of solid tumor severity and progress. The ORR in the two highest dose levels of the drug was 33%. Further, median progression free survival (PFS) was 3.8 and median overall survival (OS) was 15.5 months.What do these numbers mean?Well, the comparator drug (Nexavar) was approved based on data from what was referred to at the time as the SHARP trial. In this trial, which compared the drug to placebo, patients with advanced HCC recorded a median OS of 10.7 months versus 7.9 months for placebo. This is around five months short of the OS recorded above in the combination trial that TRACON conducted.Further, and just as importantly, in the SHARP trial, the ORR for Nexavar treatment (as measured by RECIST) was 2%. The comparable figure in the TRACON study was 25% across all four dose levels and 33% across the two highest doses. That's a dramatic increase and one that should really start to draw a lot of attention towards TRACON and, specifically, it's TRC105.And it's exactly the sort of attention that we are pretty certain Theuer is pitching to attract by attending conferences like the one outlined in the introduction to this piece, the above mentioned Wells Fargo Healthcare Conference.So what's next?Well, this trial was sponsored by the NCI but TRACON is currently conducting an investigative sponsored trial (i.e. it is paying for the trial itself) in the same indication with the same combination of drugs. Our primary focus right now, then, is the wrapping up of this trial and the subsequent data release, with a specific focus on whether or not the numbers fall in line with those reported from the NCI trial.The trial listing here suggests the study should have wrapped up in July, meaning data should hit press any day now. If it hits, the stock is going to run.We will be updating our subscribers as soon as we know more. For the latest updates on TCON, sign up below!Image courtesy of Derek K. Miller via FlickrDisclosure: We have no position in TCON and have not been compensated for this article.

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