Thursday, October 22, 2020 1:20:29 AM
Question 2: What is the status of combination trials?
Answer (LP): “I can talk about what we’ve said publicly.. . . What we’ve said publicly is a couple of things. First off, we feel that our technology is very well suited for a lot of combinations. Combinations with checkpoint inhibitors, combinations with targeted agents, it’s really well suited for combinations because of the mechanism of action of how our technology works and because the safety profile is so utterly benign. You know, if you’ve seen other combination trials for example of two checkpoint inhibitors together, the toxicity of that is so high that there’s a 40% dropout rate from the patients just because of the side effects, right? So we are very much looking forward to doing combination trails. There has been public disclosure about two combination trials that we would like to do with DC Vax-L for example. One that we announced publicly was a . . . and its still there on the table for us to go forward with when we are ready . . . it’s a combination trail with DC Vax-L and Keytruda, the checkpoint inhibitor drug of Merck. That trial, which we did announce publicly and has been approved by Merck, and those agreements were signed and all that, but as small as we are we haven’t yet been able to launch that trial in parallel with everything else. But that should be a very interesting trials when we do it. Colo-rectal cancer is the number two cancer, second only to lung cancer. And if you’ve noticed in a lot of the publicity about immune-therapies, there’s been surprisingly little attention to colon cancer. If you also notice in the literature, checkpoint inhibitors, which are the big darlings of the pharma industry right now, have had no effect, none at all, in any patients with colo-rectal cancer except patients who have what’s called MSI, microsatellite instability a particular version of colon cancer, which only 5% of colon patients have. So we think that’s going to be a very interesting combination trial and we are looking forward to the day when we have enough resources and we can go forward with it. The other combination trial that we have said publicly, and actually it wasn’t us that really said it publicly, it was UCLA that said it publicly, is a combination trial together with BMS’s checkpoint inhibitor in brain cancer, and that would be for recurrent brain cancer. Gioblastoma. Our current trial, as you probably remember, phase III trial is for newly diagnosed Gioblastoma. Just to finish on that, that’s the beauty of, in our view, of the DC Vax-L and DC Vax-Direct technologies, they’re platform technologies. We believe, forward-looking statement, will be applicable to any type of solid-tumor cancer. So those are probably the two most tangible ones, those are the ones we talked about publicly. For us it’s a resource and bandwidth issue. Both of them are there to proceed when we have the resources and bandwidth to be able to proceed.”
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