Chris McAleer: So if we could get results in AMP-270 that are, similar to the Early Access Program, which it was a single armrest historical controls. I think that in – of itself would be sufficient to move to a Phase 3 trial, improving progression free survival by over three months and overall survival by 12 months. Should be sufficient to move on, right? And that’ll be a randomized controlled trial that the FDA will consider. Based on the understanding that we have from the initial trial, I think my target is greater than 12 months overall survival based solely on limiting the responders, that will come in. There will be slightly different than the Erasmus study where, they’re not going to go through eight-week cycles. They’ll continue to take Ampligen continuously until they progress instead of taking eight-week cycles and stopping.
So, if we can get the progression free survival to be three or four months and the overall survival greater than 12 months in a randomized controlled trial that the FDA will consider, that would be a win for us.
Thomas Equels: And we’re hoping for better than that. And with regard to the AstraZeneca collaboration, we see that as having the potential for great breakthrough, because for example, in advanced recurrent ovarian cancer, when we combine Ampligen with cisplatin and pembrolizumab, we see the poor efficacy of pembrolizumab alone. Certainly without treatment after you’ve completed the standard of care, it’s a very quick and legal path. But when you add Ampligen, you see a 60 plus percent clinical benefit, you see – and this is very important 15% a little over 15% and complete responses that’s unheard of in – that deadly cancer. Now pancreatic cancer is much the same way. There is nothing that creates complete responses and significant partial responses on any kind of a scale to make it a usable therapy.
But if we’re able to with durvalumab, to replicate what we were seeing in our combination work with pembrolizumab, we could have a major breakthrough in pancreatic cancer. Now we don’t know how this is going to work. I mean, that’s the whole point of a clinical trial. But, the people with pancreatic cancer, late stage pancreatic cancer don’t have any options. So, we feel it’s important for us to explore every avenue that might bring a meaningful therapy to those people.
Jason McCarthy: And just briefly on the collaboration with AstraZeneca – so if you have the Ampligen and durvalumab, combined, is that really kind of mutation agnostic? And the reason I ask is, I think AstraZeneca just recently started the study of their PARP inhibitor olaparib and durvalumab in pancreatic cancer, but it was very specific to BRCA1 and BRCA2 mutations, which is a really relatively small population. So the long winded way of saying is the interest here for AstraZeneca, because Ampligen is mutation agnostic and if you can combine it with the durvalumab, you can basically hit almost all pancreatic cancer?
Chris McAleer: Yes, you’re spot on. The durvalumab, there’s high PD-L1 expression in pancreatic tumors. And so, the issue is that the immune regulatory environment is hostile. So even if you can get PD-L1 suppression in the tumor microenvironment, what AstraZeneca has found is that it doesn’t necessarily mean that you’re going to get a high immune response. What we have shown through Erasmus and through other preclinical data is that Ampligen based on its CXCL pan expression and its regulation of the toll-like receptor on immune cells in the tumor microenvironment, charges them. You have an upregulation of T effector cells, down-regulation of Treg cells. And that primes the immune functionality in the tumor micro environment regardless of the mutations that exist. And so, once we can – we prime the tumor and microenvironment with Ampligen then hit them with durvalumab and that should synergistically fight the tumor regardless of its indication or mutation.