NKTR
#Well, I think, good question.
I will let J.
Z.
give you some sense of mechanistically where the differences are.
I can tell you that we're probably at least a year ahead of that program, we will be in the clinic this month.
give you a sense of how we have achieved that.
Thanks <UNK>.
A lot of this came from everything that we learned from NKTR-214.
We learned a lot about how the receptor ligand interaction between IL-2 and its receptors is regulated and controlled, the kinetics of the binding.
Also we learned an awful lot about the different cellular sensitivities of the IL-2 signal, and in particular, the T reg, which is really tuned to signal to respond to the lowest amounts of IL-2, which is why you see the kind of efficacy you see with low dose IL-2.
And we have also had a chance of course in the 214 context, we always compare it against all of the other competing molecules, and we always ask the question of bias versus selectively in that context, and you know the answer to that story, we have talked about it for many months, and now are seeing it in action in the clinic.
And really it's a very similar situation for NKTR-358, by using a polymer the way we do, we can really achieve a much better ability to interact with the receptors, and we have even gone as far as generating surrogates of the mutant versions of IL-2, the same ones that really mimic some of the biological properties of both the Delinia, and the other molecules that are in this class as well.
And really when you test it head-to-head, NKTR-358 has a much superior performance in the cellular assays that we test them in.
So we're really excited about where we are.
We are really excited with the fact that the IND just went in late last month, and that we plan to open our first clinical trial later this month as well.
So we're very, very excited about our position and this program.
And I'm glad you raised the issue of Celgene buying Delinia.
You can see how important molecule that can stimulate regulatory T-cell production, as opposed to suppressing the entire immune system, and clearly the value that a program like that has in treating numerous diseases.
So it's certainly sets a standard for a molecule like NKTR-358, which as J.
Z.
said, we believe is actually a much better approach to doing this.
Yes, we can hear you.
Hi.
This is <UNK> <UNK>.
How are you.
So Shire has stated that they do have plans to globally develop hemophilia, and so that would be in all of the same that ADYNOVATE is in.
So their idea is to replicate the ADYNOVATE label, with what they have done with the Advate label, so the strategy would be the same.
Yes.
And I think clearly, I mean certainly talking from Baxalta's point of view, and now Shire's point of view, they would like to ADYNOVATE be the successor to ADVATE, and it certainly makes sense.
It's a better molecule, and we have put a lot of effort into making sure that ADYNOVATE is the exact same molecule as ADVATE, but long-acting.
It is full in ADVATE, and that was done intentionally, so that they could eventually switch over patients, and maintain their dominant position in the space.
Well, I can't speak for them directly.
I imagine they would do it fairly quickly.
It's difficult for me to speak for Shire, but I would imagine that they're very interested in getting as many patients on ADYNOVATE as possible, as quickly as possible.
Thanks.
Thank you.
Well thank you everyone for joining us this afternoon.
Of course, I want to think all of our employees for their hard work, and their dedication to the Company this past year.
As you can see from today's call, we have a number of milestones and catalysts coming up for Nektar over the next several quarters.
The potential conditional approval for Onzeald in Europe, the Phase 3 data for the Bayer programs, the Phase 3 data for NKTR-181 efficacy trial, and of course, data from the first 15 to 20 patients in the combination program of NKTR-214 with nivo, and data from the first trial of NKTR-358 in Lupus.
So we're very excited about this, and we look forward to seeing many of you at the Cowen conference next week.
Thank you very much.
