What Geron knows but can not say

[biopearl123]

Subtitle: What you know but don’t know that you know (hat tip to Rumsfeld, the real Rumsfeld).

What follows is conjecture and opinion. We know now that the Commands study has utility for R/S+ patients and has been compared to ESA’s. We also know the study was used in treatment naive patients, i.e. front line. We further know that neither the ESA treated patient nor the Luspatercept patient lived longer. By extension and with the foreknowledge of the drugs MOA it is reasonable to expect that the bone marrow picture did not change. (Read:does not return the bone marrow to normal).

Geron’s IMerge study looked at ESA failures with a study arm and a placebo arm. In other words all patients had failed an established front line treatment. Also a few patients were Luspatercept failures as well. So the Geron patients were much further along in their disease process.

What Geron knows and has said: 1. The bone marrow picture has the potential to improve (?return to normal?—that’s a strong statement and we have not seen conclusive normalization yet). 2. The MOA strikes at the root of the problem. 3. Both R/S + and R/S - patients can benefit. 4. The VAF picture improves

What Geron knows but has not said: Patients will live longer and better. This supposition is based on what we already know. What we don’t know is will that effect be magnified (when), if treatment is started front line and or in combination with other drugs. They can’t say it but they know it and so do we, even if we don’t know we know it. Best Wishes, bp

[rccola335]

Really positive responses to the Imerge presentation at ASCO23 from the attendees on Twitter - when one of the docs says “wow!” Can’t get much better then that - Scarlet has been confidant and we are seeing why

[LWS]

What Geron knows but has not said: Patients will live longer and better. This supposition is based on what we already know. What we don’t know is will that effect be magnified (when), if treatment is started front line and or in combination with other drugs. They can’t say it but they know it and so do we, even if we don’t know we know it. Best Wishes, bp

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bp --I wonder what they know about TELOMERE (the Geron & AbbVie commination trial for AML). The preclinical trials showed spectacular results with synergies. I suspect there have been some undercover clinical trials (non-USA) with (hopefully) very positive results with synergies. When Imetelstat gets approved, off-label combinations are feasible. Combinations are the best part of Imetelstat's future.

What do we already know? What do you think? --- Best Wishes Returned

[biopearl123]

LWS, clinical trials mean trials on patients. I highly doubt your supposition that non US trials have been done with Imetelstat and Venetoclax in combination. There is a process for doing these trials and Geron adheres to high ethical standards in preparation and execution.

[LWS]

bp -- The discussion is about what we know, what Geron knows and what we suspect. I agree with you that Geron knows much more than they are telling us. The AML PRECLINICAL results were unbelievably successful with synergies, and a goodly amount of time has passed.

I do think that these results have been tested someplace on humans, but, obviously, I do not know. The 3 medicines (Imetelstat, Venetoclax, Imbruvica) and the 3 companies (Geron, AbbVie, JNJ) have been working together for a longtime. They know quite a bit about combinations and the future of Imetelstat.

We are all waiting for the KOL and the completion of the modular NDA.
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For Reference:

The topic and discussion of this thread centered on JNJ-74856665 ("miracle cure") used in combination with Azacitidine or Venetoclax. Similar to the upcoming TELOMERE P1/2 Clinical Trial using Imetelstat in combination with Azacitidine or Venetoclax. -- from Kmall
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1/ Imetelstat (telomerase, an enzyme, inhibitor) -- kills cancer cells,
2/ Venetoclax (BCL-2 protein inhibitor) -- kills cancer cells
3/ Imbruvica is a targeted medicine that works by inhibiting the enzyme Bruton tyrosine kinase (BTK), which is part of a crucial signaling pathway in certain cancers, especially B-cell leukemias and lymphomas. By blocking this pathway Imbruvica triggers the death of cancer cells
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***Results (PRECLINICAL): A dose-dependent synergistic activity in inducing apoptosis was observed in multiple AML cell lines when combining imetelstat with venetoclax. In the MOLM-13 cell line, single-agent imetelstat and venetoclax had modest apoptotic activity after 48 hours (22% and 30% respectively), but the combination achieved 88% at 48 hours and nearly 100% at 96 hours. ****

[LWS]

Geron is talking

The investment world is waiting to hear from the Imetelstat KOL (Key Opinion Leaders) experts on June 14. The next day (June 15) Geron presents at the Goldman Sachs Conference. Also, the modular, fast-tracked NDA (New Drug Application) has been partially summited to the FDA and will be completed in June.

The remaining days in June will be very important to Geron, doctors, patients and investors. The medical world has a blood cancer breakthrough medicine (as a single-agent) that appears to have vast potential in combinations.

[LWS]

"June is Busting Out All Over"

ASCO + EHA + KOL + Webinar (June 20) + modular NDA completed = Good news for patients, doctors and investors.

What else will June reveal for Geron and Imetelstat? What else does Geron know about Imetelstat's future?