I can find no news to explain NKTR price action today. I am assuming that people are adjusting their positions for the data to be presented at the ASCO meeting this weekend.
We are leading up to an important binary event for this Saturday where NKTR will present one of six abstracts detailing progress and interim results for several of their IO clinical trials, with the most attention to NKTR-214 PIVOT phase II trial, longer term response data (beyond that of February, the deadline for abstract submission).
NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT
This presentation will occur at 5:00pm and is 10 minutes long. The question here is really does the tumor response improve with time, beyond the early time points already submitted. As NKTR is an immune modulating agent (modified IL-2), the idea here is that repetitive and prolonged dosage will increasingly help stimulate the immune T-cell and NK cell response to malignancy and refine the immune response, much as it takes the immune response a few weeks to rev up and finally clear any other illness. Thus, over time there should be further tumor shrinkage in responding patients, and further prior non responders or poor responders who become responders.
There will be a webcast investor and analyst event at the end of the day on June 2. See the following for info: http://ir.nektar.com/events-and-presentations/events
I do not have informational advantage as to whether the results will be overwhelmingly positive or merely unchanged from what has already presented. However, a few statements I have come across make me lean toward positivity:
-
Regarding abstract selection: ,The oral abstract for PIVOT was also selected for presentation as part of the Best of ASCO Program, which presents the scientific and educational highlights of the ASCO Annual Meeting selected from the year’s notable abstracts . This abstract is a pretty big deal in the judgement of the ASCO members.
-
The following statement from the earnings call: At ASCO we will also share our first presentation of data from the second part of the ongoing PIVOT study of NKTR-214 plus Opdivo knows as the expansion stage. At JP Morgan I provided an update on the patients from the first part of the ongoing PIVOT study, the 38 patients from the dose escalation stage. To remind you, the response rates we reported at JP Morgan were 75% response in second line I-O naïve non-small cell lung cancer, a 64% response rate in first line I-O naïve melanoma patients, and a 57% response rate in first-line I-O naïve renal cell carcinoma patients. Further, all of the partial and complete responses observed in the dose escalation stage of the trail has been confirmed and we see ongoing tumor shrinkage and all patients with responses from dose escalation continue on treatment. Importantly, there have been no patients with responses who relapsed in any of the tumor types. This highlights that the length of time patients spend on treatment with the combination of NKTR-214 plus nivolumab is correlated with further tumor shrinkage and improved and continued response.. No relapses!!!
-
New tumor types being enrolled into PIVOT: The PIVOT study continues to enroll patients into the second expansion stage. As you’ll recall we plan to enroll 330 patients into 13 different expansion cohorts that’s been in five different tumor types. We expect to complete enrolment for the first five tumor types by the end of the third quarter of 2018. In the second quarter we will add three new expansion cohorts to PIVOT, gastric, colorectal and small cell lung cancer. Expanding PIVOT Phase II trial.
-
New partnerships: As we retain the ability to develop NKTR-214 in combination with other anti-cancer agents, we plan to initiate additional development collaborations this year. This will ensure that we maximize our potential to rapidly establish NKTR-214 as the future backbone of immuno-oncology therapy. Today, we have several NKTR-214 combination programs underway in non-clinical tumor models, including a collaboration with Takeds with five different targets, as well as vaccine and other small molecule programs. More new combo clinical investigations beginning.
-
Regarding the partnership between BSM and NKTR: Onto the framework of the new collaboration, Bristol-Myers Squibb and Nektar will be initiating over 20 registration enabling studies that will enroll approximately 15,000 patients in nine tumor types. These trials will start within the first 14 months of the collaboration and the first two Phase 3 studies which Bristol will start in the middle of this year will be conducted in patients with first line melanoma and first line renal cell carcinoma.. 15,000 patients, 20 studies, 9 tumor types. They are not waiting on Phase 2 data. They have it and have started the wheels turning on some massive expensive clinical trials.
So I wrote this mostly to assuage myself, but thought I might share. We will see what Saturday, and then Monday, will bring.
Jack