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Re: jbog post# 214944

Wednesday, 11/08/2017 7:59:05 AM

Wednesday, November 08, 2017 7:59:05 AM

Post# of 252311
NKTR:

With the caveat that its a very small n still (16 total). The RCC data seems most encouraging. At the presentation saturday (I linked it in prior post if interested) they said they will present data from all 38 patients with spider graph (showing when measurements taken). I think they'll also show by PD-L1 level. Initial 214 (single agent) was a bit disappointing so it wasn't clear how combo therapy would do. I was actually disappointed they couldn't dose beyond the .006/.009 level, I know IL2 is toxic but thought they could go a lot higher. Its actually quite impressive that the dose is so low.

They also have a deeper IO pipeline (though its preclinical) one molecule is specifically designed to work with 214 and should soon enter the clinic. The preclinical data are pretty impressive. They had an IDO compound (preclinical) a couple years back but have since removed it from presentations not sure if ran into tox issues or gave up on MOA.

On 181 heard the call again and to clarify a few things.
- The type C meeting was in October, don't have minutes yet.
- FDA indicated safety and abuse data sufficient
- The review issue will be what I suspected the fact that they had just the 1 trial.
- Agency indicated likely would have an Adcom
- Discussion with agency was that data supports DISCUSSION of whether label could allow for BETTER than C2
- participation in MULTIPLE government private and public meetings on Opiods
- Still intend to partner 181 (Globally)

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