Go Big or Go Home - Pt 1

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Go Big or Go Home - Pt 1

Post by kmall » Sun May 31, 2020 4:41 am

Go Big, or Go Home -

Targeting just about every major hematologic myeloid malignancy is not only a confirmation of Imetelstats efficiency of doing exactly that, but it ratchets up the possibilities for Geron as a leader in a space which has yet to scratch the surface. The resonating tone from the 3 members of the team who spoke on Thursday was upbeat, focused and from my perspective, somewhat conservative given the path(s) going forward.

We all know how the data so far stacks up against what has been approved in MDS and MF as of now. Overall, Imetelstat is anywhere from 2-3x more effective. When you have a fatal disease, there would be no hesitation on which treatment one would choose, given Imetelstat as a choice.

Now throw in “Disease modification,”…..“a remarkable durability of transfusion independents,”…….“potential recovery of normal hematopoiesis in patients treated,”…and…“Imetelstat will be the first drug to demonstrate a survival benefit in this poor prognosis patient population (MF).”…..
….and you truly do have a “possibility or the chance to have a paradigm shift in the thinking of how you approach treatment.” – Dr. Aleksandra Rizo

It most certainly is “the Go Big or Go Home approach.” - Chad Messer

The data so far speaks for itself. However, as Andrew-bp pointed out earlier, the embargoed data in the EHA 2020 abstracts “could be the research bombshell Geron is waiting to drop at the meetings.”

Let’s all hope this is the case.

Getting off the clinical data since there are many of you more knowledgeable in that area, there are a few key points discussed which have yet to be touched on here that I find intriguing.

First is the possible expansion of the ongoing IMerge P3 trial.

“…we are currently evaluating the addition of potentially 6 new countries and approximately 40 new clinical sites for participation in the trial, which could result in a total of up to approximately 130 sites.” – Dr. Aleksandra Rizo

Several questions and possibilities come to mind with this revelation.

1. Does this mean more patients will be enrolled? And if so, why? – AA prerequisite perhaps?

2. 6 new countries? Kind of sounds as if EMA approval is coming first to me. What part of the world could you carve out 6 countries from?....possibly Asia, but Europe seems more likely. Just a hunch on my part.

3. 40 new clinical sites is a fairly substantial percentage above what is now ongoing. Maybe due to Covid, some were closed for good or rerouted? If not it’s about a 35% change to the upside. – Is this due to an overwhelming demand from patients who are eligible to enter the trial?
When corresponding to patient support groups for the better part of 4 months last year, I received a great deal of interest from many on what was then the upcoming P3 trial back in the spring and early summer of 2019.

4. The trial itself must be doing much better than expected, despite the recent pandemic hurdles. You don’t open up 40 additional locations in 6 additional countries if your data is lacking expectations.

Next is the current state of manufacturing of Imetelstat.

“Do you have sufficient quantities of Imetelstat for both studies?” - Charles Duncan

“Yes. So, we have multiple years' worth of drug supply at this point and a very well-established manufacturing process.” – Dr. John Scarlett

“As you know, Imetelstat is contract manufactured out. And so, we have been validating all those vendors as part of the process in readiness for potential not only for Phase 3 trial supply, but also for potential commercialization down the road. And so those activities are ongoing right now.” – Olivia Bloom

……let’s go over that last sentence again from Ms. Bloom…….

“And so those activities are ongoing right now.”

About 2 months ago I uncovered 2 drug supply houses – BOC Sciences, which is based in Shirley, NY and Hamburg, Germany - (see my earlier post on Imetelchat – BOC Sciences and the Chinese Connection? – for the link) And “Chemical Book” – a Chinese drug supply listing depot, which back in March had 3 vendors listed as having Imetelstat and now has only one - (see my earlier post on Imetelchat – “YMB Censorship and Geron’s ex-US Partner Pt2” – for the link)

So, we know from our own research that Imetelstat is being manufactured in at least 2 locations, and distributed / or slated for distribution on 3 continents. – N. America, Europe and Asia

Now let’s go back to Ms. Blooms quote once more……”but also for potential commercialization down the road.”

Does that sound like a company which doesn’t have approval in its sights to you? Remember who Geron hired as Vice President, Head of Regulatory? Sharon McBain? Who has 40 years of Global Regulatory Approval under her belt – most of it with J&J and GSK. She most certainly isn’t letting the grass grow under her feet, I can assure you. Just read her resume. It speaks for itself.

What is almost as intriguing as those 2 points was one that was rather mysterious. Our Chief Commercial Officer, Anil Kapur was mentioned on the call as being a “key team member” by Dr. Scarlett, but was absent. Why was that? I have some strong assumptions, but that’s all they are, so I’ll let you draw your own conclusions.

The final bit of information given was probably the most important of all to where Geron stands as a company poised “to become a leader in the treatment of hematologic myeloid malignancies.” – Dr. John Scarlett

I’ve done some extensive research on this in the past – as well as something else that coincides with it – hand and hand if you will - so I will continue this on another post. As far as I can remember, it is the most Dr. Scarlett has emphasized this particular subject. He came shooting out of the gate as if it is high on his agenda for where their focus as a team may be right now. That’s the overall marketplace for MDS and MF Globally.
……In my opinion, $2.5 Billion is being slightly conservative. See what you think in the follow up post here.


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