Geron - Imetelstat achievements since 2014

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Fishermangents
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Geron - Imetelstat achievements since 2014

Post by Fishermangents » Mon Feb 22, 2016 5:23 pm

I revisited an earlier overview from YMB of Geron's state of play since 2nd part of 2014. I am reposting it here, including some new facts.

(version 5, updated 15 July 2016)

on imetelstat:
1. partial clinical hold lifted;
2. 3 x ODD status: for MF in the US and EU, for MDS in the US
4. JnJ deal with 35 mln upfront payment, up to 900 mln in milestone payments
5. Geron to finance the upcoming trials with revenue stream from JnJ
6. IMbark running at 76 sites, 58 recruiting
7. global distribution and clinical partnerships network being established and expanded
8. IMbark recruitement and infusion started
9. JnJ has moved the expected first trial data readouts IMbark from 2018 to 2017
11. NEJM confirms ET and MF trial results at the highest scientific level
13. IMerge for MDS started at 66 locations, 38 recruiting; patients are being infused (source: Geron press release 14 Jan 2016); Listed as Phase 3 on CT-site; DMC installed
14. multiple indications being investigated at the Mayo Study, to start with MF, MDS and other myeloid malignancies
15. JnJ to start AML trial later this year
16. JnJ CEO and CFO publicly confirm imetelstat as their next 1 of 10 multi billion blockbuster drugs

on Geron:
17. strong cash position
18. low burn rate
19. no debt
20. extensive patent portfolio

Any comments/suggestions are welcome.

(I will add changes to list based on new input/facts and will try to find how I can show the changes. The version number changes every time when amendments have been made. The new changes are in bold and underlined)

biopearl
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Re: Geron - Imetelstat achievements since 2014

Post by biopearl » Mon Feb 22, 2016 10:04 pm

Fisher, old friend, I would say the wording is too inexact for my taste. For example to say the IMbark study has started at 80 sites is not correct in the total number of anticipated sites and the total number of sites actually enrolling currently. Rather than go line by line, you see my point. I like optimism but I like accuracy more. I think this list needs a work over. Just an observation. Best regards, bp

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Mon Feb 22, 2016 10:53 pm

Hi Bio, as I said, comments and improvements are appreciated. So let's start making this list more precise. What are your other observations?

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Mon Feb 22, 2016 11:08 pm

So IMbark has 76 locations now of which recruiting:

Duarte, California, United States
La Jolla, California, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Rochester, Minnesota, United States
St. Louis, Missouri, United States
Bronx, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Greenville, South Carolina, United States
Seattle, Washington, United States
Antwerpen, Belgium
Brugge, Belgium
Brussel, Belgium
Leuven, Belgium
Montreal, Quebec, Canada
Angers, France
Lille, France
Marseille Cedex 9, France
Paris, France
Pierre Benite, France
Toulouse Cedex 9, France
Aachen, Germany
Dresden, Germany
Duesseldorf, Germany
Hamburg, Germany
Heidelberg, Germany
Koeln, Germany
Leipzig, Germany
Mannheim, Germany
Haifa, Israel
Kfar Saba, Israel
Nahariya, Israel
Barcelona, Spain
Las Palmas Gc, Spain
Madrid, Spain
Salamanca, Spain
Valencia, Spain
Chiayi, Taiwan
Taipei, Taiwan
Glasgow, United Kingdom
London, United Kingdom

I count 42. Correct?

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Mon Feb 22, 2016 11:22 pm

IMerge 57 locations, of which recruiting at:

Louisville, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
Bethesda, Maryland, United States
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
Antwerpen, Belgium
Brasschaat, Belgium
Gent, Belgium
Kortrijk, Belgium
Tours, France
Seoul, Korea, Republic of
Amsterdam, Netherlands
Groningen, Netherlands
Nijmegen, Netherlands
Barcelona, Spain
Salamanca, Spain

Total recruiting: 18

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Mon Feb 22, 2016 11:41 pm

Bio, I changed the list a bit according to the CT website info. I can also add sources to the items of the list. Would that be of help?
Maybe its better to leave subjective statements out. I will look at that.

biopearl
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Re: Geron - Imetelstat achievements since 2014

Post by biopearl » Tue Feb 23, 2016 2:29 am

Fisher, did my last post (suggested modifications to your list) fail to post? Or did you feel it was too harsh to post. Please let me know bp

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Tue Feb 23, 2016 9:28 am

Bio, I didn't receive your post. Strange, as a regular poster you are not on the moderation queue, so it should have appeared here straight away. So please send it again.

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Tue Feb 23, 2016 9:53 am

For IMbark I missed Haifa, Israel, recruiting. That makes 42.
(I will update the list later, if more input is received)

irishtrader52
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Re: Geron - Imetelstat achievements since 2014

Post by irishtrader52 » Tue Feb 23, 2016 12:19 pm

Hi Fisher & Bio - In my limited experience, a trial is able to enroll a patient (open to enrollment/recruiting) as soon as the institutional IRB approves. One could technically jump in before the gov trial site is even updated. The clinical site is updated when the trial administrator at the site enters the data. There is likely a time lag as these are busy people. So the exact number of sites updated as recruiting probably has some lag time and is a moving metric. The awesome and important part is the total number of targeted institutions that intend to become part of the studies. I think these study sites could morph into treatment sites quickly - possibly pre/market distribution sites under ODD designations as on-going registry studies pending full approval. Oops - can I widely speculate here?

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Tue Feb 23, 2016 2:39 pm

irish, your speculation is acceptable as there are no significant facts to my knowledge that indicate your speculation being unrealistic. If imetelstat keeps performing without saftey problems, I don't see why your speculation couldn't become reality. Any other opinions?

biopearl
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Re: Geron - Imetelstat achievements since 2014

Post by biopearl » Tue Feb 23, 2016 5:00 pm

Hi Irish, Phil and Fisher, Irish, the sun always rises a little earlier when I know you have posted. Fisher--looks like my modified list did fail to post, it was nothing great, I just tried to temper some of the unknown speculation (eg value of IP portfolio, and J and J statements re potential future value of drug.) We are clearly entering a long wait period. The only short term events I can see are new studies (AML) and finally some statement on longevity based on the 1951 ongoing data (probably at ASH in Dec 2016.) Otherwise I doubt J and J will say more than they have already. Irish I look forward to your weekly updates and don't feel I have much to add based on the data we have. Regards, to all, bp

Fishermangents
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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Wed Feb 24, 2016 1:54 am

Bio, points taken. I will amend the list.

phil
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Re: Geron - Imetelstat achievements since 2014

Post by phil » Fri Feb 26, 2016 3:02 pm

I agree with Irish on the enrollment issue. I know someone in California that had two infusions before his trial site was officially put up on clinical trials (currently doing very well). I think the key here (as stated previously) is that it took the MF trial 6 months to start enrolling at more than 10 sites, but after just 1 1/2 months, MDS hit that same mark. Things started slower than many of us wanted, but Geron and JNJ were always saying things were moving rapidly, and now we see MDS is really going fast. These trials just take a while to get going, but like snowballs, they start building.

I suspect doctors will be getting wind of new remissions and will start guiding more and more patients in these trials. It takes time, but it is simply the process.

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Re: Geron - Imetelstat achievements since 2014

Post by Fishermangents » Thu Jun 30, 2016 10:53 am

I will add that IMerge is in Phase 3.

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