NKTR: It's time to get in for people with longer term time frame. The main problem is there aren't many major short term catalysts. They have decided to go alone with NKTR102, which I think it is not a bad idea at all. Partner reduces risk, but the big player might not take your best drug as urgently as you do. Case in point is NKTR118, licensed to AZN in 2009 with huge upfront payment after phase II, AZN is going to phase III only this quarter.
Here are summaries of key points from NKTR late stage pipeline - NKTR has great website, click on each drug candidate, related data and press release are listed in sequential order on the same page.
Oncology NKTR102: key focus of the company, phase II data presented last year were very strong. Should present survival data this year but time is uncertain due to longer than expected survival.
On ovarian cancer: Had had discussion with FDA on OC last month, two plans: on accelerated approval front, expand single arm trial enrollment to 125 patients in refractory patients, plan to finish enrollment in 6 months; on regular approval front, in the process of designing of randomized trial, most likely vs investigator's choice.
On breast cancer: Going to have meeting with FDA this month regarding registration trial design. Plan to initiate phase III by the end of this year.
NKTR118: AZN plans to initiate phase III this qtr.
NKTR105: finishing phase I trial, found MTD, need to confirm with a few more patients, but will not move to phase II this year due to resource restrain.
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