BRAVO : lift off and listen to Noble ask two important questions :
101T, I liked the answers that SK provided here from Nobles "Rahul" questions (still trying to fix SA's mistakes on some words though...)
MDSC's and red highlighted section below I believe will soon allow many researchers to "scientifically prove" all of this via blood tests and how can the FDA not approve Bavituximab for combination in many SOC treatments? All Peregrine requires is one (AstraZeneca) to get the ball rolling and the rest will fall in line........ soon hopefully : )
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Operator
And our next question comes from the line of Rahul Jasuja from Noble Life Science. Your line is now open.
Rahul Jasuja - Noble Life Science Partners
Hey everybody, thanks for taking the questions. So just a couple of questions here and maybe some clarifications from me. So in planning your combination studies going forward in the news that have combination landscape we are looking at PD-L1 low tumors because PD-L1 low tumors are likely to be non-responsive to PD-1 in the patient so far [indiscernible]. So is that the only the rational or do we know for a fact that or is it likely that PD-L1 low tumors also more responsive to bavituximab or is it both of those?
Steven King - President and CEO
Yeah I think that’s what we want to show out in some of these studies we’re starting. So we’re not finding on selecting for PD-L1 negative patients in the Phase II study or the initial combination of bavi with chemo and durvalumab, but rather taking all comers and then doing some subset analysis and determining which patient populations we’re having biggest impact it. Because really I mean based on our translational data that’s been presented this year at ASMO and SITC. We’ve shown that we can take PD-L1 negative tumors and actually listed in immune response in those tumors.
And that’s the reason that we think that we can really have this potential to turn those into better responders on a PD-1 or PD-L1 therapy as I mentioned during the prepared remarks it’s basically use bavi to get the immune response going and then you use durvalumab to keep it going.
And so it’s the reason there is a great scientific rationale right now for why we maybe will have the biggest impact in those patients who don’t do well because the delta between how they would normally do and how they might do with bavituximab may be the largest. But again we’re going to have some great inside into that from the studies we’re planning on running and the ability to go in and do subset analysis. Joe I don’t know if you add any more to that.
Joseph Shan - VP, Clinical and Regulatory Affairs
No I think I was going to use the word delta, but you beat me to it. I think the PD-L1 negative patient there again you have more opportunities to demonstrate the delta.
Rahul Jasuja - Noble Life Science Partners
Great, thanks. So one of the concepts that’s evolving pretty rapidly is that you’ve got the two negative and the till positive and till positives are responding to PD-1 checkpoint immunotherapy. So is it fair to say or is it an extrapolation that PD-L1 positive tumors are the ones that I feel positive more likely. And in your case are you also seeing that till negative tumors probably the ones that are going to respond to chemo combination therapy better than our other ones that are the non-responders in combination with PS you can make them responders.
Steven King - President and CEO
Yeah I think that’s certainly what our evidence has so far is that or I think the general assumption is that till negative or till low tumors the ones that have low levels of the need for PD-L1, right. I mean that’s really meant to stop an ongoing immune response. So I think that’s generally true. Now it gets a little bit more complex because you’ve got T-rigs and all kinds of T-cells present inside the tumor. So it also depends on the particular makeup.
What we know is that when you get bavituximab, we seem to see a nice change in the levels of MDSCs its Myeloid Derived Suppressor Cells who are really the cell type that’s responsible for controlling the immune response in the tumors. As been shown that patients with high level of MDSCs do where you have very poor prognosis. So as much as probably getting new tails end of the tumors is important it’s probably more important to change the makeup of those cells into a more productive immune response positive genotype type.
And again that’s exactly what we see with when you get bavituximab treatment when we take a look a look at our translational data it shows an increase in CD4 positive T-Cells and an increase in CDA positive T-Cells along with the changes in the suppressor cells types and the expression of immuno suppressor cytokinese in which both decrease after treatment. So I think it’s a matter of getting things move in the right direction. Again this is what we think PS plays by blocking it and activating immune response were able to turn that around so.
Rahul Jasuja - Noble Life Science Partners
You I mean that does make sense, I mean I think you’re looking at patient selection as being helpful in defining the population as well as the data you showed that fits where you talked about immuno-profiling and looking at response to bavituximab. Those are very interesting datasets. The other question I have was there is a couple of trials running that are IST trials, one of them is the one in combination with [indiscernible]. And then the other one is the rectal cancer any updates on those?
Steven King - President and CEO
Yeah so the rectal adenocarcinoma we expect to have some data coming up this year from that study. If any investigate sponsored trial I think it’s always a bit difficult we do whatever we can to encourage them. But we do expect data to be becoming out of that study in 2016, which I think will be a little real positive because in that study we did have the opportunity to collect pre and post-treatment biopsies. Number one, so we can see what happens following bavituximab treatment, but also that was a combination with radiation which we expect to be a very strong inducer of piece tumor antigens, which can then be taking advantage of by bavituximab treatment to make PDA positive T-Cells or killer T-Cells.
For the myeloma study, obviously the since that investigator started this study the standard of care has changed pretty substantially. So right now I think we're trying to work with that investigators as well as some others to probably change the profile of that study or start a new multi-center study in which we can then look at little bit more closely at what is the current standard of care and make sure it’s an attractive trial for patient.
So just advantage of as the treatment options for patient’s change you need to be able to change with it and luckily it's a small IST trial and we may have an opportunity here to run a trial that I think would be very attractive for patients and will allow us to answer some key questions. Because that was really the point to that study was to answer some of the key questions of combining with [indiscernible]. But in addition obviously we’re starting the combination of durvalumab in multiple solid tumor types after the beginning of the year. So one way or another we’ll have lots of information coming from those studies.
Rahul Jasuja - Noble Life Science Partners
Great. And then one final question is that any updates any more color or comments on collaboration with Sloan Kettering and Jed Wolchok on combination approaches more likely now in the preclinical study any data coming that way in the next few months?
Joseph Shan - VP, Clinical and Regulatory Affairs
Yeah I think it’s an ongoing process. We’re very actively working with them to study a new combinations so looking for potential and different indications as well as those different combinations. So yeah I mean we fully expect that will be a fruitful collaborations, there will be a lots of data coming from that that we’ll see a very scientific meetings coming up. Obviously we already see a lot of data coming out of all for other collaborators. We’ve had examples of presentations in multiple conferences this year. So it always takes a while for them to get started but then once they are going you tend to have a lot of data that continuously comes through them because the all the systems are up and running.
Rahul Jasuja - Noble Life Science Partners
Great thank you and congratulations on the healthy revenues of your Avid. Thanks.
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