New presentation

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Ryan
Posts: 114
Joined: Sat Jul 08, 2017 1:41 pm

Re: New presentation

Post by Ryan » Wed Jun 09, 2021 7:23 am

Slide 32 - lighter box than the rest in 2022 ~ EU Commercialization Strategy Finalized...

So EU partner still very much currently on execution, by next yea whatever is happening now in terms of Biz Dev for Partnership will be “finalized”.

Zhears
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Joined: Mon Oct 08, 2018 12:19 pm

Re: New presentation

Post by Zhears » Wed Jun 09, 2021 10:59 am

So the thesis for the stock price is that it's quite likely that nothing will happen for at least the next 6 months at least, possibly even 12

Full enrollment, but I doubt that will give any real rise, as dilution will put people off.

What I don't understand is the interim analysis being scheduled so far away. Given the results from phase 2 they should have enough evidence to get early approval, or at least an update at a conference in the next 6 months. It seems to be setting explicitly low expectations.
Or am I confusing updates to conferences with interim analysis?

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

Re: New presentation

Post by biopearl123 » Fri Jul 02, 2021 5:19 pm

Zhears, interim analysis is not a “scheduled” event. It is dependent on a pre defined number of deaths. So it’s a moving target. Presumably there will be significantly more deaths in the control group but when that happens is of course unknown and unscheduled. The FDA and the scientific community have emphasized the need for drugs that improve survival not just symptoms. That’s why this study is so important. And probably unique in MF. bp

biopearl123
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Re: New presentation

Post by biopearl123 » Fri Jul 02, 2021 9:38 pm

Ryan, yes, re slide 32. It appears Geron is telegraphing the timeline for embracing a non US partner.

LWS
Posts: 10
Joined: Thu Jul 14, 2016 2:00 am

Re: New presentation

Post by LWS » Mon Jul 05, 2021 2:25 pm

EHA 2021 | Imetelstat efficacy is independent of molecular subtypes in R/R LR-MDS
Valeria Santini • 18 Jun 2021 EHA 2021 Anemia Myelodysplastic Syndromes Imetelstat IMerge

Valeria Santini, MD, University of Florence, Florence, Italy, shares an update on the Phase II/III IMerge study (NCT02598661) of imetelstat, a first-in-class telomerase inhibitor in patients with lower-risk, transfusion-dependent myelodysplastic syndromes (LR-MDS) who are relapsed/refractory (R/R) to erythropoiesis-stimulating agents. Dr Santini reports that all molecular subtypes of LR-MDS responded to imetelstat with no sensitivity differences between subtypes and no impact of the number of mutations on response. Dr Santini also gives an overview of the safety profile of imetelstat in LR-MDS. This interview took place at the virtual European Hematology Association (EHA) Congress 2021.

TRANSCRIPT (EDITED FOR CLARITY)
My name is Valeria Santini, and I have been involved in the study with imetelstat in lower risk MDS, anemic and transfusion dependent. Now, imetelstat has shown a great activity in inducing transfusion independence because 42% of patients treated are indeed achieving the goal of stopping transfusion.

Now, what was interesting to see was that all molecular subtype of MDS were responding to imetelstat, without any particular subtype more sensitive than others. Now, the most important thing is that the number of mutations did not influence response. As a matter of fact, few patients, now this is a small cohort of 38 patients resistant to ESAs but having not received other treatment.

So, in this small group of patients, few had three or more mutations, but as we know the number of mutation correlates with overall survival. The number of mutation didn’t show any correlation with the response and type of response to imetelstat. Having said that, I have to stress the fact that the majority of patients included in the study had an SF3B1 mutation with other co-mutation or isolated, but they responded independently of the co-mutation and independently of the SF3B1. So, the patient did show indeed a good response rate.

That means that imetelstat, having a specific mechanism of action that is independent of the most frequent mutation alteration, or the alteration induced by the mutation, is an agent that can be used widely and independently of the mutational pattern of MDS as well as IPSS are low, very low or intermediate. So, I think it’s a very interesting agent.

And we also wanted to go back and evaluate the safety of this agent. Now, as, as you know, in myelofibrosis, there have been some warnings for a homoeopathic toxicity that was not observed in MDS patients. So, the main adverse event where the neutropenia and thrombocytopenia that were of low grade and were reversible, there were some increase in transaminases, but no hepatic toxicity in MDS. And overall, I would say that, generally imetelstat has a good profile. There are ongoing trials that will re-evaluate, even more profoundly, the adverse event and the toxicity of imetelstat, but this large evaluation in all myeloid malignancy treated with imetelstat did show that the most frequent, let’s say the most frequent adverse event for MDS was nausea and diarrhea. But otherwise, I mean the non-hematological, or otherwise very well-tolerated even in patient who received very long treatments.

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

Re: New presentation

Post by biopearl123 » Mon Jul 05, 2021 6:04 pm

Thanks LWS, note “long treatments”. This probably applies to longer life, patients have to stay alive to allow for “long treatments” bp

rccola335
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Re: New presentation

Post by rccola335 » Tue Jul 06, 2021 4:59 am

Not long treatment - she said very long treatment - I like the word very

FC4364
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Joined: Sun Dec 23, 2018 11:02 pm

Re: New presentation

Post by FC4364 » Wed Jul 07, 2021 12:59 am

Curious and may have missed it but why is there a new presentation? Did it just pop up out of the blue? What is the motivation for it? Thanks in advance

Ryan
Posts: 114
Joined: Sat Jul 08, 2017 1:41 pm

Re: New presentation

Post by Ryan » Wed Jul 07, 2021 1:15 am

FC4364 wrote:
Wed Jul 07, 2021 12:59 am
Curious and may have missed it but why is there a new presentation? Did it just pop up out of the blue? What is the motivation for it? Thanks in advance
European Hematology Association (EHA) Congress 2021 - she was interviewed at the virtual event.

biopearl123
Posts: 646
Joined: Fri Jul 20, 2018 5:13 pm

Re: New presentation

Post by biopearl123 » Thu Jul 08, 2021 12:01 am

FC4364, periodically the company updates their standard slide set. Usually the information that is updated is incremental and includes any new data from either publications or presentations. This can occur after company earnings calls or scientific presentations or publications. It is their attempt to "communicate" with stock holders and perhaps BP or investors. bp

biopearl123
Posts: 646
Joined: Fri Jul 20, 2018 5:13 pm

Re: New presentation

Post by biopearl123 » Thu Jul 08, 2021 12:07 am

An effort to communicate better could begin with updating the pathetic Geron website with its infantile rocking horse and deleting the existing letter to stockholders which is well over a year old and replacing it with the more relevant stockholders letter of 2021. 2020 was last year. Maybe those who peruse the web site might want to know what has happened since.? bp

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