EHA Abstracts

[jingledsassy]

EHA Abstracts will be released Tuesday May 14th @5.00....posted on ymb and denied twice......hoping for Ferroptosis abstract.....

[LWS]

Dr. Feller (Recording of Virtual Shareholders meeting -- May 9th) emphasized the importance of "no leaks" concerning the EHA abstracts. Geron's employee count is going from 162 to between 250 and 300. We can be certain that there will be important and interesting presentations concerning Imetelstat announced tomorrow (May 14th), the next important chapter before FDA official approval of Geron's NDA (any time between tomorrow & June 16).

=================================================================

Join us in Madrid (June 13-16) for access to a wide range of sessions, including plenary lectures, oral presentations, poster sessions, interactive workshops, and more. The scientific program will focus on cutting-edge hematology and various topics, including hemostasis and thrombosis, hematologic malignancies, transfusion medicine, and stem cell transplantation.

In addition to the scientific program, the EHA2024 Hybrid Congress is an opportunity for attendees to network, connect with fellow members, and interact with colleagues, experts, and industry partners.

We look forward to making EHA2024 Hybrid Congress an engaging and informative Congress for professionals in hematology. Whether you are a clinician, researcher, or industry professional, the EHA Congress is a unique opportunity to get up-to-date on the latest developments in the field and connect with colleagues from around the world.

[LWS]

EHA Abstract (Many authors)
============

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES

Prof. Valeria Santini
Author(s): Valeria Santini, Rami S. Komrokji, Mikkael A. Sekeres, Michael Savona, Pierre Fenaux, Yazan Madanat, Esther Oliva, Rena Buckstein, Anna Jonasova, Ulrich Germing, Moshe Mittelman, Sylvan Thepot, Jennifer Riggs, Souria Dougherty, Tymara Berry, Shyamala Navada, Qi Xia, Libo Sun, Amer M. Zeidan, Uwe Platzbecker
(Abstract release date: 05/14/24) EHA Library. Santini V. 06/13/2024; 422288; S184

[Ryan]

Lots and lots of familiar names on this paper. Will read it tonight…

[LWS]

Interesting how the subjects are listed in the title:

1/ OVERALL SURVIVAL
2/ CLINICAL BENEFIT
3/ DURABLE TRANSFUSION INDEPENDENCE

This could be considered a list of important successes, with overall survival time and the quality of life (clinical benefit -- fatigue, feeling good, disease modification, hemoglobin level) being more important than transfusion independence, which is very important. Also, June 16th looks like an important date (EHA, FDA deadline). As John Scarlett said: These are not separate processes, but all part of the blood-cancer transformations (paraphrase) at the molecular level.
==================================

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES

[Hoosier Investor]

To be fair, Geron executives only had one (1) priority on their mind at the time these abstracts were due. The EHA abstracts were due on 3/1 while Geron's ODAC was scheduled for 3/14. I was a bit disappointed we didn't have more EHA abstracts, but I think they made the right priority call (i.e. focus on ODAC preparation) which resulted in our 12-2 vote.

[biopearl123]

HI, you are most certainly correct. No PR? To be sure Geron is maintaining radio silence and avoiding anything that might piss off the almighty FDA including updates on P I or P II studies. Once there is an approved drug on the market, maybe they will grow a pair, till then mums the word. Interesting that there does not even appear to be a booth at EHA even though the FDA should provide apostolic blessing by then. Geron not taking even a small chance. bp

[rccola335]

I dont think a PR was done because there was nothing exciting new there - I am a big fan of imetelstat and think it should be approved - I believe it is disease modifying which one would expect an increase in overall survival - I think overtime we will see an increase in overall survival but it is to hard to see that with this study - fortunately the numbers didn't hint at the possibility of a decrease in OS - that would be a big problem

1- decrease in overall survival - curtains for Geron
2 - no change - acceptable with improved QOL
3 - increase in OS - imetelstat becomes first line therapy

Getting approval during the EHA is a nice way to get the word out but I think approval will be before June 16th - usually approval comes 2 months after ADCOM's

[Ryan]

I agree with these points. I also agree in my belief that PRs will ramp up in re: mid-stage trials after approval.

Wow, 4 weeks (or less, this I don’t necessarily agree with) left to *wait. I feel like we’re so accomplished at that now

[LWS]

The approval went through very smoothly. Now the focus is on the EHA conference (June 13 to 16) and the oral paper that is authored by many of the world's leading blood experts. I am looking for an excellent paper that will introduce Rytelo (Imetelstat) to the world.

=================
Previous

Interesting how the subjects are listed in the title:

1/ OVERALL SURVIVAL
2/ CLINICAL BENEFIT
3/ DURABLE TRANSFUSION INDEPENDENCE

This could be considered a list of important successes, with overall survival time and the quality of life (clinical benefit -- fatigue, feeling good, disease modification, hemoglobin level) being more important than transfusion independence, which is very important. Also, June 16th looks like an important date (EHA, FDA deadline). As John Scarlett said: These are not separate processes, but all part of the blood-cancer transformations (paraphrase) at the molecular level.
==================================

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES
===========================================

“With the approval and availability of RYTELO, we believe eligible patients with lower-risk MDS can potentially experience meaningful clinical benefit, particularly the potential for greater than 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anemia,” said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. “The approval of RYTELO as the first telomerase inhibitor is a testament to the power of our science and the passion of our people to innovate in the field of blood cancer. As we celebrate today’s momentous milestone, I would like to thank the patients and families, advocates, clinicians, study coordinators and site personnel, scientists, and Geron employees and collaborators past and present whose participation was integral to this achievement and to supporting our transformation into a commercial company.”

=================

Geron's studies are based on important Nobel Prize-winning scientific discoveries in the field of
Telomeres and aging (Blackburn, Szostak, Greider - Nobel prize 2009): awarded for their
discoveries on telomerase, an enzyme that maintains telomeres, the ends of chromosomes that
shorten with each cell division.

[LWS]

Last week Imetelstat (experimental), this week Rytelo (commercial)

Last week we were concerned that the FDA had been compromised in some (undefined) way, and that approval could be denied. This week we are in an approved world with subjects such as "Overall Survival Time" and "Better Quality of Life" now front and center as the EHA conference (June 13 - 16, in Madrid) rapidly approaches. The emphasis now is about expanding the use of Rytelo, and this oral paper by numerous blood cancer experts will do that (worldwide).
======================

Previous and Current Considerations

Some important and unique disease modification considerations beyond TI (Transfusion Independence):

1/ 2018 IYG data analysis updates
2/ Overall Survival time longer
3/ Better quality of life
4/ Higher hemoglobin levels
5/ Less fatigue
6/ In combinations
7/ With chemotherapy
8/ Off label uses
9/ Molecular level interactions
10/ Two ways to kill cancer stem cells

[LWS]

EHA -- With Dr. Santini leading the charge, the newly approved Rytelo will be introduced to the world.

We will all be very interested in the leading subject of this oral presentation, Overall Survival (June 14th I believe). With approval, various procedures can now be considered (off label, combinations, with chemotherapy). This should open up the conversation and the possibilities.
===============

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES

Prof. Valeria Santini
Author(s): Valeria Santini, Rami S. Komrokji, Mikkael A. Sekeres, Michael Savona, Pierre Fenaux, Yazan Madanat, Esther Oliva, Rena Buckstein, Anna Jonasova, Ulrich Germing, Moshe Mittelman, Sylvan Thepot, Jennifer Riggs, Souria Dougherty, Tymara Berry, Shyamala Navada, Qi Xia, Libo Sun, Amer M. Zeidan, Uwe Platzbecker
(Abstract release date: 05/14/24) EHA Library. Santini V. 06/13/2024; 422288; S184

[LWS]

June 14, 2024 --- Tomorrow is the first day that Rytelo, now as an FDA approved medicine, can be talked about openly at a major, important conference (EHA -- European Hematology Association in Madrid). Dr. Valeria (backed up by many blood cancer experts from all over the world) will be the presenter. This is a very important paper with ASH2024 over the horizon. It can be considered a 'victory dance' for everyone at Geron, patients, and investors.
=================

OVERALL SURVIVAL, CLINICAL BENEFIT, AND DURABLE TRANSFUSION INDEPENDENCE WITH IMETELSTAT IN THE IMERGE PHASE 3 TRIAL OF RED BLOOD CELL-TRANSFUSION DEPENDENT LOWER-RISK MYELODYSPLASTIC SYNDROMES

Prof. Valeria Santini