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Zenith's BET Inhibitor ZEN-3694 is Currently Being Evaluated in Multiple Oncology Clinical Trials

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Message: ZEN-3694 Single Agent Trial Status

Toniv,

Let me offer you a different perspective that may improve your outlook.

RVX-208 first began Phase 1 trial in Q4 2007/Q1 2008. RVX-208 will have been in clinical trials for 10 years when 2018 rolls around. ZEN-3694 has been in clinical trials for 13 months. Even if you start the clock on Zenith with the terminated ZEN-3365 program, that is still less than 3 years.

The current two Phase 1 trials with ZEN-3694 are scheduled to be competed by April 2018 according to ClinicalTrials.gov. If things go well, then we should very quickly be in Phase 2 for mCRPC sometime in 2018. Phase 2 would very likely compare ZEN-3694 (or a combo of ZEN-3694 and another mCRPC therapy) against current standard of care therapy for that stage of mCRPC. Very likely that this would have a timeline similar to the Phase 1 trial. So by 2020, ZEN-3694 could theoretically be looking at Phase 3. This all assumes that no problems along the way, that Zenith isn't bought out, and that my estimated timelines are correct.

In theory, we could also start into Phase 1 for breast cancer (and other solid tumors) or hematological malignancies at anytime. Clinical investigators and the Zenith team surely have learned a lot about the general safety and pharmacokinetics of ZEN-3694 during the ongoing mCRPC trial. The longest patient has been on drug for over 12 months now. They've already identified the maximum tolerated dose and surely have a good handle on the pharmacokinetics. I'm not even sure if Phase 1 is required for these other cancers. They may be able to go straight to Phase 2, or at the very least design a Phase 1/2 trial that has an initial Phase 1 exploratory period before expanding to larger Phase 2 population. The compound is already IND'd and they have safety data, so things could move quick. For combo trials, Zenith told us last year that for some of them they’re trying to get the other companies that own the rights to the partner molecule to pay for the combo trial because clearly it’s going to benefit them. This could be a mechanism of keeping costs down and lining up future partners.

Also, keep in mind that the collective expertise of Resverlogix/Zenith in BET bromodomain inhibitors puts them in the upper tier, if not the top, of the world. If BET bromodomain inhibitors have a future, then there is a high likelihood that Zenith will be a part of it. Zenith didn't really start from square one with the spin-off. Zenith and the epigenetic platform and knowledge of BET bromodomain inhibitors started when it was one company. For example, the pre-clinical autoimmune program started long ago when one company and in theory we could see clinical autoimmune programs pop up anytime.

In a company update from last year, one slide with company goals stated: “Co-development and Licensing Opportunities Working with regional or global pharma’s in countries with regional issues such as China’s expanding cancer rates. Pathway 1-4 years.” Related to this is the patent position of Zenith, which they recently news released about. Recall they're strategy was to get US Fast track patents granted first, which are relatively quick, while simultaneously doing what's necessary to get the standard divisional patent done, which can take up to three years. Management stated that they need a published patent to get a licensing deal over the finish line in China. And that once you have fast track approved, the follow on patents in subsequent other countries happen very fast. So a lot could be going on behind the scenes.

Management has also listed on their goals slide in previous presentations last year that they are interested in the application of BET bromodomain inhibitors to animal health applications (i.e. pet oncology). In a company update from last year, one slide stated: "Animal Health BRD4 research has indicated numerous opportunities for both companion and food animals Pathway 1-2 years.

I am not happy that we haven't had a webcast/corporate update in over 7 months. However, just because Zenith is quiet doesn't mean that they aren't active and heading in the right direction.

BearDownAZ

 

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