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Friday, January 15, 2016

Update On BriaCell Therapeutics Following Meeting With CEO

Last week in San Francisco, I had a good talk with Joseph P. Wagner, PhD, the CEO of BriaCell Therapeutics (BCT.V / BCTXF). He provide a good update on the current situation, which I report to investors in this article. Right now, the company's is in active preparation to begin the Phase 2 trial, with a goal to complete all the necessary work in the next few months. That's the main takeaway from the meeting. However, one thing I did find very interesting is that the companion diagnostic is further along in development than I suspected.

Quick Background

As a quick reminder, BriaCell is developing a breast cancer vaccine called BriaVax. BriaVax is a Her2/neu positive human breast cancer cell line engineered to produce and secrete granulocyte / macrophage-colony stimulating factor (GM-CSF), a protein that promotes dendritic cell function. Company scientists believe BriaVax "awakens the patient’s immune system" to recognize tumor cells as foreign, and hence destroy them. Specifically, BriaVax is thought to stimulate the dendritic cells, a key component of the antigen-presenting system, to display certain immunogenic protein fragments to T cells, which activates the T Cells to destroy the tumor cells either directly, or by inducing a humoral (antibody-generating) response.

I wrote a fairly detailed article back in October 2015 that gives investors a good overview of BriaVax, as well as a nice summary of the existing Phase 1 and Phase 1/2 clinical data. BriaVax has only been tested on 18 women with metastatic breast cancer, but some of the results are impressive. In fact, if you are interested in the story, I really encourage you to take a look at my article from November 2015 that highlights a single patient case study of the Phase 1/2 data.

Next Step - Phase 2 

As I've noted above, the next step is now a Phase 2 trial planned in 24 women. The primary endpoint of the study will be safety, with a secondary endpoint of complete response in 20% of the women. Patients will be followed for a total of 12 months. I'm suspecting that if the trial starts in the next few months, we should see data roughly 15-18 months later - so likely during the second half of 2017. I forecast a trial like this will cost about $3-5 million, fully burdened, so we are not talking about a huge amount of money here to potentially delivery a major infection point for the valuation. As such, I think the company will be successful moving forward with clinical development.

BriaDx Moving Forward

In terms of the companion diagnostic, the company's goal is to develop a product that helps identify the best possible responders to the therapeutic vaccine, BriaVax. As I noted above, the vaccine has been tested in 18 women with metastatic disease. The company still has all the tumor and blood samples from each patient. They are now going back and looking at the specific biomarkers in the responder vs. non-responder population using cutting-edge technologies including gene expression analysis and proteomics. I do not think we will see the incorporation of BriaDx in the currently planned Phase 2 trial, but the company will surely do a retrospective analysis of the data using the screening tools they are developing in-house right now. They may even pre-screen patients using a preliminary version of BriaDx and make hypothetic calls on responder vs. non-responder outcomes in an effort to validate the technology.

Conclusion

There are obviously three possible outcomes to the planned Phase 2 study: 1) The results are positive for all patients, 2) The results are positive in patients with a specific expression (or lack of expression) of certain biomarkers, and 3) The results fail to demonstrated a benefit for BriaVax in any population. Outcome #1 or #2 is a win for the company. I'm hoping to see more from BriaDx in the near future and to see the Phase 2 trial start this summer.

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10 comments:

  1. Summer 2016 seems slow to get the trial started given FDA clearance was announced at start of Nov 2015 and in the announcement they expected enrollment to start late 2015/ early 2016. Any sense why the slow start? I understand they didnt initiate production of the actual test drug until they got clearance, is this part of it?

    Another question I got is that I understand that the Phase 1 is "open-label" from which I understand means that data will likely be trickling in to the company over the course of the trial 'unblinded' and would potentially be available for release. For example some early safety info as well as possibly some good news around strong responders. Here you suggest that we won't see data until the end of the trial. I noticed with another biotech you discussed the release of patient info as the trial proceeded and suggested this was a positive. Can you confirm that the release of info on the trial will wait until its end ( was that a specific part of your discussion with Dr Wagner)? I tried to email Briacell about this but got no response.
    Thanks for the info

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  2. Hi HR,

    You are correct. The Phase 1 trial will be an open label study. As a result, any results will be reportable / publishable if management believes it to be newsworthy. This is good news for investors because that means we may not have to wait to hear good news. So for example, if management can find more uber-responders (out > 30 months as seen in 3 out of the 4 last patients) then I believe they will be in position to discuss potential for BriaVax to obtain breakthrough status with the FDA.

    I did speak with management on timing. They are currently negotiating with CROs, finalizing manufacturing, budget, etc..., and they are working to start the trial as soon as possible. No exact guidance on when that will be however.

    Sorry it took me so long to respond!

    Jason

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    Replies
    1. Hi , what about financing/licensing ... any update ? Do you think they would finance at this level ? 5 million at 20 cents that's 25 million shares , very big dilution . Thanks for the input

      Happy thursday , Jerome Forcier

      Naples , Florida

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    2. They need to finance to get the planned Phase 1 trial underway. Yes, it will be dilutive but the valuation is so low there is no real other option.

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    3. Hi , what is your opinion on the resignation of Dr. Wagner ?

      Happy sunday , Jerome Forcier

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  3. i think it is a negative sign, if Wagner believes BCT has something earth shattering he would have stayed to cash on it

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    Replies
    1. I think it's a money issue. BriaCell needs to raise money, so at this point "execution" by the CEO is getting them money. I don't know for sure, but this seems like the kind of thing where Dr. Wagner might have been a great CEO if the company was further along in development, but what the company really needs right now is a business person that can talk and engage with bankers and sell the story to investors so they can raise enough money to move forward.

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  4. Jason
    do you think the CRO partner will bring the money or BCT still needs to raise 5 M for the trials ?

    cheers

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  5. Hi , what do you think of the " gene signature " NR and the latest financing ?

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    Replies
    1. See here >> http://www.bionapcfa.com/2016/04/briacell-identifies-biomarkers.html

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