ImetelChat

I went through the K-10 and apart from some repetitive content from earlier K-10's there were some interesting things I picked out:

- "We expect Janssen's decision-making regarding IMbark, IMerge, the imetelstat program or the Collaboration Agreement to occur in the second quarter of 2017."

- "Second internal data review is initiated by JnJ" (i.e. Q1 2017)

- "clinical data from Part 1 of IMerge to be presented at a medical conference to be determined in the future"

- "We expect the outcomes from the second internal data reviews for both IMbark and IMerge, regulatory considerations and the totality of other program information, including the evolving treatment landscapes in MF and MDS, to inform Janssen's decisions regarding future development plans for imetelstat."

- "In the event that IMbark is terminated early, or placed on clinical hold or suspended by a regulatory authority for an extended period of time, then Janssen must instead notify us of their Continuation Decision by the date that is approximately 24 months after the initiation of IMerge" (i.e. Jan 2018).

Link to 10-K / 2016: http://ir.geron.com/phoenix.zhtml?c=673 ... =1&sXBRL=1

Then there is a lot of elaboration on the structure of the collaboration agreement, which are basically repetitions from earlier years. For me the most important news is that 1) JnJ has started second internal data review and 2) that they will take some material decisions end Q2, including a potential Continuation Decision (or not).

We have discussed it before, but it is also notable that if IMbark is delayed or ended for whatever reason, JnJ needs to take the Continuation Decision not later than 24 months after initiation of IMerge. That started in January 2016, which means that a Continuation Decision will be taken before January 2018 at the latest (that is within 10 months from now).

Some have advocated that we only will see some material movements in 2018. I think these quotes and observations from the latest 10-K don't support that view. Other opinions are welcome.

Nice post from sdrawkcabeman (YHMB):

"Things are coming to a head in a few short months. It's taken a rather circuitous path to get here, between the 2014 hold and its release, the silence on the AML front, and the unexpected 2016 review. But we are finally here. In hindsight, IMbark's focus on R/R patients may have been ambitious; but they had plenty of reason to have that optimism at that time due to the CRs/PRs in the pilot; not to mention, as he said, pts who fail on Rux have a 7 month survival rate. Whether IMbark continues in its present form, there's no doubt in my mind that there will be a frontline MF trial. The calculus for such a trial is simple, the fact of the matter is that the CRs/PRs are a very sharp competitive edge over any and all JAK inhibitors. In other words, the commercial prospect of CRs/PRs naturally demands the frontline MF trial.

As for IMerge, he repeated again that IMerge continues unmodified, and that safety and efficacy are in-line with prior data. I read that unequivocally as Janssen's positive forecast for the next review. Keep in mind, IMbark for R/R was conceived as a P2; while IMerge had the P3 written into it, seemingly for expediency to move the trial even more quickly than IMbark. Assuming the results of the next review are congruent to the pilot MDS, as Dr. S has been indicating they are, then they have every reason to move forward in IMerge. I think that's a sensible reading of the dearth of info we're given: IMbark may be modified or discontinued, IMerge will likely move into the next phase; and I think we should expect a frontline for MF.

And regarding the AML front, I'm so disappointed by their snail's pace approach. Except that the 50/50 trial costs for GERN would swell, I don't understand why, after the preclinicals already conducted and the forthcoming ones, that they wouldn't have something more concrete to say for this year. It does seem that JNJ holds the steering wheel, Dr. S is just along for the ride. I read Dr. S's reticence to say anything substantive as a JNJ-imposed gag order; but one that will be lifted after the next review. Here's to an IMerge P3 in 2017!"

Sdraw's observations have always been well considered and grounded. Thanks for sharing them. Fish this is a question for you. Do you remember reading in prior 10K's, updates on some patient deaths early in the study? These were expected given the severity of disease and the late stage that therapy was started. Is there anyplace in the recent filings that address an update on patient death on study? Thanks, bp

Bio, good question. But the answer is no. I haven't seen any updates/details on that. Indeed it would be VERY interesting to know given the LE of 7 months for the R/R patients.