Request for Imetelchat Board thoughts

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Lekola_
Posts: 6
Joined: Thu Jun 04, 2020 4:31 pm

Request for Imetelchat Board thoughts

Post by Lekola_ » Sun Jun 21, 2020 7:16 pm

Bp and others here. Saw an exchange on the INCY YMB with regard to Roo asking INCY followers if they think INCY would want to buyout GERN. Obviously a fervent INCY supporter the user Jocasa responded the below message.

Now - let me be clear - I do not agree with Jocasa. And for many of the reasons already discussed on this board, Imetelstat is truly a Miracle in progress, bone marrow, and many factors BP and others here listed, even in the very last topics, which I have read over many times in the last few days.

I am just reposting this exchange wondering if a proper argument by those smarter than I here can as well as comments generally on the supposed ‘salvage’ treatment response left behind in the YMB thread. The bias is clear in the INCY defense in the message. I have commented that INCY could not afford GERN at this point I see other much more suitable BO or partners if that route is taken that can further Imet & GERN (acknowledge Ryan’s belief that Geron can go it alone - and I think they could as well.

Anyway - just thought it would be interesting to see the Imetelchat board comments on this exchange. I’ll also admit on this beautiful Sunday in NY I would like to spur on further conversation as I am refreshing the page because of my own fervent belief in Imetelstat and find that reading as much Imetelstat as possible brings me joy. Sitting back having a beer and wondering what you all think.

I am with Jingle on much of his stances regarding Geron and I’ll leave it at that to speak for most of my stance.

———-
Jocasa:
No chance. Incyte doesn't want a salvage treatment for relapsed / resistant patients, Incyte wants to cut R / R to as low as possible.

I'm still reading tea leaves suggesting that an outright successor to ruxo is in pre-clinical development. It would naturally have more JAK-1 inhibition and less non-JAK inhibition relative to ruxo. Preferably, since the JAKs are signaling partners of receptor proteins, there might be some selectivity relative to receptors (the lipid alterations are on-target, but not necessarily impossible to select against). Most of the anemia seen is exactly on target, but it seems to be worsened by "other targets."

A few years ago, MDSs would have been a worthwhile target. The field is getting too crowded.
————————————————
Cathy also remarked in response
@jacosa Imetelstat is not necessarily a salvage treatment - it has only been tested in that fashion in P2 Imerge/Imbark. From the KOL last week it seems it could be a frontline treatment for MF TN patients as well as patients that carry certain biomarkers that have been identified (short TL for eg).
——
And Roo mentioned Imetelstat in combos.
—-

Health and well wishes to all. Happy start to the summer
Lekola

biopearl123
Posts: 348
Joined: Fri Jul 20, 2018 5:13 pm

Re: Request for Imetelchat Board thoughts

Post by biopearl123 » Sun Jun 21, 2020 8:46 pm

Hi Lekola, hope you are well and healthy. Jacosa is really smart and has been right about a lot of things about Incyte and has also been right about a lot of things Geron over the years. But Rux does probably not prolong life except to the extend that anorexia and overall sense of well being might be improved as well as reducing abdominal bulk re spleen. There has been little convincing reversal of fibrosis or direct effects on the malignant clone itself. With regard to being a palliative or salvage treatment, the only Imet studies in front line date back to Dr. Tefferi's NEJM study. There has been no other front line studies that showed clear cut CRs and PRs. The FDA derailed the front line study proposed by Dr. T because of liver tox concerns which never materialized and set back development for at least a year. Incyte should be quaking in their boots and thinking of a way to buy a competitor that will attack the root (malignant clone) not the leaf of the weed. Also the abstract that looked at sequential Rux and Imet administration must be in their sites. Whether they can afford Geron is another question and may be the "root" of the issue.

Lekola_
Posts: 6
Joined: Thu Jun 04, 2020 4:31 pm

Re: Request for Imetelchat Board thoughts

Post by Lekola_ » Sun Jun 21, 2020 10:32 pm

BP, All is good here. Relaxing in NY, beer in hand, thinkng of ways I can continue to grow my Geron share counts. My goal is 15k Geron shares. I have mentioned that Geron at the moment is my sole investment with 12k shares that I’ve averaged down to $1.89 cost avg. Otherwise, I am climbing out of student debt and some personal loans that add up to about $35-38k left. Hope to be debt free by Independence Day 2021 — 7/04/21 based on paychecks at a post college marketing desk job. Geron is my only investment (the only stock symbol I own) because I truly believe in the science of Imetelstat and confirmation from EHA/recent trials makes me more excited than ever! Per Stig, I am celebrating as if I am out of debt already because of EHA. Geron may get me way far out of debt sooner ;), or pay off after 7/04/21. I care deeply about investments contributing to worthy causes and helping patients in the case of Geron has become a big interest to me. I lost my Uncle Roger from Texas a few years ago to cancer. I wish he had access to a treatment like Imetelstat.

Great analysis and response BP. Much appreciated. This provides great clarity to many things for me. Your thought leadership on Imetelchat is fantastic and I encourage you to continue to post any thoughts you may have. Many watch for your comments. I know I have for years prior to my membership on this board, which I am very happy to have become a member.

Welcome any other feedback.

Happy Father’s Day to all! Cheers!
Lekola

CKTC
Posts: 5
Joined: Sun May 31, 2020 4:26 am

Re: Request for Imetelchat Board thoughts

Post by CKTC » Sun Jun 21, 2020 11:07 pm

Jacosa is correct in that thus far, Incyte's game plan has been to look for ways to extend a patient's response time to ruxolitinib. To this end, the company itself and numerous other sponsors have, for years, been testing ruxolitinib combinations. I count twenty-three combination trials active, and completed, on clinicaltrials.gov.

There will always be a need for ruxolitinib salvage treatment. That will be true even if any of the above combinations pan out. Imetelstat has an excellent chance to be that salvage treatment.

Jacosa is also likely correct that the successor to ruxolitinib for front-line treatment is in pre-clinical development. I can't entirely agree it will be a JAK inhibitor.

Hoosier Investor
Posts: 2
Joined: Thu Jun 18, 2020 5:48 pm

Re: Request for Imetelchat Board thoughts

Post by Hoosier Investor » Mon Jun 22, 2020 3:47 am

If we demonstrate a survival benefit and/or fibrosis improvement in our P3 Registration trial, we could realize significant off-label sales as a frontline MF treatment (following our R/R MF approval). Thus, we may be more of a threat to Jakafi sales than one would think....based solely on our current pursuit of the second-line (R/R) treatment opportunity.

A large pharma partner with an established sales function would help in this regard.

biopearl123
Posts: 348
Joined: Fri Jul 20, 2018 5:13 pm

Re: Request for Imetelchat Board thoughts

Post by biopearl123 » Tue Jun 23, 2020 8:20 pm

Lekola, maybe another way to look at is via the GOAT, Groucho (Duck Soup maybe? ) who said, "Who are you going to believe me or your lying' eyes"? When you look at the 4 recent EHA presentations there are close to 100 authors (with a lot of overlap so lets call it 20 experts), each with first hand experience with this drug and 3 high profile presenters at the KOL meeting expressing strong support for Imetelstat which included a preliminary discussion of where Imetelstat might be useful in front line MF. We have surmised with the guidance of the likes of CKTC and HI that the reason R/R was pursued over front line was expediency (a front line study of less sick patients would presumably take much longer to reach MOS--note-- I have always disagreed thinking a molecular marker end point would be appropriate here but never mind), therefore as HI notes the R/R study may be the path for earlier use eventually. So the question here is "who are you going to believe?" Regards, bp

Lekola_
Posts: 6
Joined: Thu Jun 04, 2020 4:31 pm

Re: Request for Imetelchat Board thoughts

Post by Lekola_ » Wed Jul 01, 2020 4:26 am

Appreciate everyone’s responses here. Thought provoking to say the least. I am wondering what the board thinks at this early stage about ASH in December. Per Jingle, I was made aware the deadline to submit abstracts is August 1st. A) in your opinion is it definite that Geron will submit B.) What do you believe the submissions could contain (both in optimistic sense but also grounded-in-reason as you what you believe). Obviously, this part is a bit of speculation. However, I believe some well informed speculation actually can help stimulate good conversation, ideas, and potentially even hit the mark with many great minds here.

Outside of ASH, we are in extremely interesting times for Geron and I for one feel encouraged and extremely excited at the long term, but also at the short term prospects and potential even in the coming weeks in months.

Welcome thoughts from everybody here on Imetelchat. I value your opinions, facts, and guidance.

Most of all I wish you all a healthy and happy Independence Day. July 4th was my grandfather’s birthday. A WWII vet. Fought in the pacific islands. Passed away many years ago but miss him and celebrate him still the same.

Cheers and a toast,
Lekola

biopearl123
Posts: 348
Joined: Fri Jul 20, 2018 5:13 pm

Re: Request for Imetelchat Board thoughts

Post by biopearl123 » Fri Jul 03, 2020 6:56 pm

Lekola, have thought about your questions and have some preliminary thoughts. First off, happy Fourth to all board members we are most fortunate to be part of this country despite or perhaps because of its many problems. My father was a WW II vet also (medical corps) in the Philippines. He once said to me when we were discussing the atom bomb, that he thought is was a "miracle" because in his view it ended the war, saved lives and brought him home. I never before or after heard of the bomb referred to that way but it did bring home the point that good can come from bad and many world views exist within our own. Anyway to ASH. The only "new" data on the clinical side would continue to confirm (one hopes) the remarkable duration of TI and "remissions" in MDS. The MF data seems almost fully mined with one exception IMHO and that is some statement as to whether transformation to AML has been altered. Full overall survival data should be available since it is unlikely that few if any patients are still alive. There could be further analysis of molecular data. There will certainly be updates to highlight the presence of P III studies in both indications and encouragement to physicians to facilitate enrollment. Depending on the chiaroscuro of future partnerships/approvals new studies could be highlighted for AML (still hopeful), PV etc. More likely will be some pre clinical lab studies re combinations/radiation and the like that we have been seeing in the basic literature. In short, probably no bombshells. It looks like the good stuff has been geared to the European meetings. This is a pattern. Dr. Rizo has strong European/Asian ties and Janssen is a European based company. Given the recent VERY relevant observations by other board members following the granting of orphan designation by the EU it seems the likelihood of approval will go through Europe before the US. The requirement for further supportive studies is met with the active PIII studies world wide and ramp up is ongoing. Perhaps we will see new contributions from Asian investigators, this connections was emphasized by
kmall. Once orphan designation is formally granted (end of July), I do wonder if Dr. Scarlett might give us a glimpse as to whether a conditional European market authorization is possible. Best regards, bp

rccola335
Posts: 37
Joined: Sat Sep 28, 2019 10:00 pm

Re: Request for Imetelchat Board thoughts

Post by rccola335 » Fri Jul 03, 2020 7:18 pm

Lekola - to fully understand why Europe is so interesting you had to be around to live thru August/Sept 2018 - imetelstat was doing well with Janssen - they would have their updates and imetelstat was listed as one of their blockbuster drugs for MF in their presentations (the last one being in late July if I am correct) - a Janssen employee (in Denmark) had listed on his Linkedn account that he was a member of the launch team for the telomerase inhibitor imetelstat (his page still says that today) - later someone found job postings for a pricing manager from Janssen for the EMEA for Imbruvica and Imetelstat , and what was interesting was it wasn't for MF, it was for MDS and AML (where the hell did AML come from) - that sent the market into a frenzy - a few days later Janssen added imetelstat to their compassionate use list - when they were asked about it Janssen said it was a mistake and removed it

There was an article about Geron's big day on seeking alpha - some of the Janssens scientists started "liking" the article with a thumbs up and one lead scientist called imetelstat "a strong compound" in a post

Janssen had called for a press conference announced premarket in mid september at the Canadian meeting and then later changed the meeting to 10 am without announcing the change - was there an announcement planned and then scrapped? Janssen dropped Geron and the rest is history

we haven't heard anything about Europe since except they would partner up for the rights for European distribution - I was curious what was going on over there and out of the blue comes the announcement on Wednesday

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