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.
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.
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.