There are many ways to think about partnering

[LWS]

Acceptance and approval of the Imetelstat NDA is the focus by patients, caregivers and investors. That is now on the front-burner, with Geron's future and viability on the line. When it happens, Imetelstat becomes a factor in all telomere/telomerase (about 90%) cancers for potential off-label uses, alone and in combinations. JNJ and AbbVie are now pushing Geron to get through the NDA process. With "remarkable trial results" a matter or record, it is now happening.


-----------------------------------------------------

The FDA must make sure that a drug is safe and effective for a specific use. However, it does not control the decision doctors make about which drugs to use for their patients. This means that once the FDA approves a drug, doctors can prescribe it for any purpose they think makes sense for the patient.

Off-label uses may include using an approved drug for a different type of cancer than the one it is approved to treat
at a different dose or frequency to treat a child when it is approved to treat adults

Off-label uses of a drug can become approved uses if the company that makes it obtains approval from the FDA. To gain the added approvals, the company must conduct research studies to show that the treatment is safe and effective for the new uses. However, a company may decide not to invest time and money in this research.

[LWS]

It obvious to all that are closely following Geron that much of the modular Imetelstat NDA is now in the hands of the FDA and under review. Considering patients' needs, the very good safety profile, and the very successful trials, acceptance and approvals are on the horizon. Some are pointing to May 11, as a very important date (EHA abstracts). Most of this has been confirmed at the Needham chat by John Scarlett.

-----------------------------------------

Reference Material Going Forward (potential partners, collaborators and allies)

Imetelstat can go in many directions from single-agent to a variety of combinations, with numerous patents now in place. Disease modification, the good safety profile, and the ability to kill cancer-stem-cells (normal cells not affected), all are unique and very positive factors. Single-agent approvals are close, with the FDA, MHRA (UK),and the EMA all in the picture.

1/ Big pharma with special relations or combinations---Bayer AG/Vividion, AbbVie, JNJ/Janssen
2/ People-- Dr. Rizo, Dr. Feller, Dr. Scarlett-- key people at Geron
3/ Imetelstat---single-agent, blood cancers, combinations, vaccines, solid tumors, all telomeres & telomerase interactions --- all under consideration
4/ Approvals coming--- UK, EU, USA
5/ Processes-- staff, manufacturing-- in place and ready to go
6/ Collaborators--- MD Anderson, NIH (moonshot)
7/ Competition & potential allies --- MAIA, Incyte
8/ Other interested European companies--- Novo Nordisk, Novartis

[jayfish101]

You do know that major announcements can not come through via a conference call or a presentation. There has to be a release that goes out to the public.

[LWS]

You do know that major announcements can not come through via a conference call or a presentation. There has to be a release that goes out to the public.

--- from jayfish
=========================================================================
Of course any announcement or important statement can be made in conjunction with a presentation. I believe that is what bp is suggesting when he talks about a "Miracle in May". The trials and data leave no doubt that Imetelstat is a very good single-agent blood cancer medicine, with the whole universe of telomere/telomerase combinations just beginning research and trials (Geron: TELOMERE for AML, MAIA: several solid cancers).

John Scarlett has been a very controversial figure on the business side, and will continue to surprise us. On the medical side Imetelstat is already a success, with the Imetelstat NDA ready for review, acceptance and approval. The discussion seems to come down to: 1. Will there be new partners and who will they be?, 2. What will Geron's PPS rise to with an approved NDA?, 3. When will approval come (timeline)?, 4. What is the 'dilution-factor'?, 5. What is the patent arrangement between Geron and MAIA?

These are interesting times for cancer research and the NIH moonshot program.

[LWS]

Imetelstat on the move:

1/ Remarkable phase 2 & 3 trials and data ("bigger than all of us") -- Blood cancer treatment breakthrough

2/ IMerge oral presentation (at ASCO, by Yale medical -- June 2)

3/ Patients' needs

4/ Modular, rolling, fast-tracked NDA being reviewed

5/ EHA abstracts (May 11)

6/ Partners & collaborators in the wings (JNJ, AbbVie, Nova Nordisk, Novartis, Bayer AG) with deep pockets

[LWS]

Partners & collaborators in the wings (JNJ, AbbVie, Nova Nordisk, Novartis, Bayer AG) with deep pockets

========================================================================
Where do JNJ and AbbVie figure in Geron's future as strong supporters, collaborators or partners?

They have shown interest in Imetelstat for a very long time. The top combination trial in progress is with AbbVie (TELOMERE for AML). JNJ has been supportive in many ways, including staff at the highest levels. Also, the big-3 medicines (Imetelstat, Venetoclax, Imbruvica) are in combinations that we know about, and in combinations that are on the drawing-board.

KOL (Key Opinions Leaders) Day is June 14 after ASCO and EHA conferences. We will learn much more in June.

========================================================================
For Reference

Summary--- 3 Ways to Kill Cancer Cells

Venetoclax (approved -- AbbVie), Imbruvia (approved -- JNJ ) and Imetelstat (pending approval -- Geron) all kill cancer cells by different methods. Together, in combinations, there likely will be important synergies.

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.

[LWS]

Johnson & Johnson, the world’s largest drugmaker, announced Tuesday (April 18) it has agreed to settle tens of thousands of lawsuits against its asbestos-contaminated talcum powder products for $8.9 billion.
Earlier this week, J&J’s subsidiary, LTL Management, filed for bankruptcy protection. It requested a reorganization plan to resolve current and future claims against its talc products.

===================================================================================
KOL (Key Opinions Leaders) Day is June 14 after ASCO and EHA conferences. We will learn much more in June.

Will we finally find out how JNJ fits into Geron's future? Many thought that the so-called JNJ "walk" was tied to their financial and legal problems with talc and asbestos. Those problems seemed to be finally resolved, as JNJ splits into two companies (JNJ & KVUE). JNJ can now focus on Imetelstat and various combinations.

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

Where do JNJ and AbbVie figure in Geron's future as strong supporters, collaborators or partners?

They have shown interest in Imetelstat for a very long time. The top combination trial in progress is with AbbVie (TELOMERE for AML). JNJ has been supportive in many ways, including staff at the highest levels. Also, the big-3 medicines (Imetelstat, Venetoclax, Imbruvica) are in combinations that we know about, and in combinations that are on the drawing-board.

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

[LWS]

JNJ and AbbVie have been and currently are very involved with Imetelstat, especially in combinations with Venetoclax (AbbVie) and Imbruvia (JNJ) --- both approved medicines. When Imetelstat gets their NDA approved, the game will have changed, with 3 very good approved medicines that can be used in all sorts of combinations and off-label. Synergies have been observed preclinically with Ventetoclax and Imetelstat.

Geron, IMO, will not be bought out, but will enter into some very important partnerships, with JNJ and AbbVie the most obvious. Perhaps the KOL (Key Opinion Leaders) will give us a better perspective on June 14.

JNJ never left the building.

==================================================================================
For Reference:

KOL (Key Opinions Leaders) Day is June 14 after ASCO and EHA conferences. We will learn much more in June.

Will we finally find out how JNJ fits into Geron's future? Many thought that the so-called JNJ "walk" was tied to their financial and legal problems with talc and asbestos. Those problems seemed to be finally resolved, as JNJ splits into two companies (JNJ & KVUE). JNJ can now focus on Imetelstat and various combinations.

===================================================================================
Where do JNJ and AbbVie figure in Geron's future as strong supporters, collaborators or partners?

They have shown interest in Imetelstat for a very long time. The top combination trial in progress is with AbbVie (TELOMERE for AML). JNJ has been supportive in many ways, including staff at the highest levels. Also, the big-3 medicines (Imetelstat, Venetoclax, Imbruvica) are in combinations that we know about, and in combinations that are on the drawing-board.

[LWS]

Everything that I post is future looking and is based upon successful previous trials completed by Geron, and some 'crystal ball gazing' into the future.

1/ The KOL on June 14 will be very positive
2/ The modular, fast-tracked NDA will be completed in June. It will be quickly accepted and approved
3/ JNJ and AbbVie will be the main collaborators and partners to Geron going forward
4/ TELOMERE will be a success.
5/ MD Anderson will be very important to Geron going forward

[LWS]

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

=======================================================
Now that the NDA has been submitted, we can concentrate on Geron's potential collaborators, partners and investors. I have always believed that JNJ (with Geron's connected staff and long-term interests) and AbbVie (TELOMERE AML combinations), with their very deep pockets, both have a permanent interest in Imetelstat and all of its possibilities, both as it is now and in oral forms under development.

Geron needs technical support, financial support, marketing support and sales support, all of which JNJ and AbbVie can provide.

[LWS]

I have always believed that JNJ (with Geron's connected staff and long-term interests plus combinations), with their very deep pockets, JNJ has a permanent interest in Imetelstat and all of its possibilities, as it is now and in oral forms under development.

================================================
With the NDA approval now a 'given' (99.98% says Ryan), JNJ's place in Imetelstat's (IMET) future is still a question to be answered. There have been many thoughts about this. Some have said that the 'walk' ended JNJ's interest. I believe that JNJ has always had a continuing interest in IMET, and now that interest has peaked with IMET's continuing successes and endorsements.

[LWS]

Some history, as I remember it (please add or correct):

Most of us were totally surprised at the time of the JNJ so-called walk (2018 ?). Imetelstat (IMET), at the time, was on JNJ/Janssen's list of about 10 medicines (including Imbruvica) that they believed would be very successful. JNJ was looking at the business and Janssen was looking at IMET's medical potential.

To this day, we do not know exactly why JNJ walked but we suspect it had to do with business reasons and the talcum powder legal expenses. They said at the time that IMET would eventually be approved. They stayed with Imbruvia, but put IMET on the back burner, where it has remained all of these years. The numerous former JNJ employees that are now at Geron, is a strong indication of the continuing successes of IMET, with NDA approvals now very close.

As some have said, JNJ never left the house.

There also has been some talk about European partners. The 3 names that have popped up from time to time are: Bayer, Novo Nordisk and Novartis.
===================================================

Previous:

JNJ obviously has an interest in Imetelstat and JNJ-74856665 (with Venetoclax in UK, clinical AML). Of course, I don't know the details, and I am not a mind reader. As an investor, looking to the future, I see both AbbVie and JNJ being there (with their deep pockets) in some very important ways, fully supporting Geron and Imetelstat.

=========================
For Reference:

Venetoclax (approved -- AbbVie), Imbruvia (approved -- JNJ ) and Imetelstat (pending approval -- Geron) all kill cancer cells by different methods. Together, in combinations, there likely will be important synergies.

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.

[rccola335]

LWS - you really like posting on this thread - you have put in a lot of work - hopefully you are rewarded for your time

[KTArsenal]

Personally, I think LWS is a spam sandwich to a banquet.

[LWS]

rccola --- I believe that this thread ties everything together, from the synergies of the 3-medicines (Imetelstat, Venetoclax, Imbruvia) in combinations, to use of Imetelstat off-label (when approved) alone and in combinations, to the next goal (AML), to potential associates (partners, collaborators, etc.), to blood cancer disease modifications, to recognition by the investment world that Imetelstat is a breakthrough blood cancer treatment with many applications.

JNJ knows the history of Imetelstat and all about the successes. JNJ will be part of its future. Also, AbbVie (TELOMERE) will be part of Geron's future.

Nothing is a sure thing, but this is close. Ryan says 99.98%.

[LWS]

Partners for Geron with more to come:

About WEP

At WEP Clinical, we are With Every Patient, as we believe every patient should have access to treatment! With this as our guiding principle, we have created a market leading, solutions driven, healthcare services company that partners with drug developers to create broader treatment access solutions for patients worldwide. We take pride in the high-quality output and positive customer experience we create while delivering our services. We specialize in the following: Expanded Access and Post-Approval Named Patient Programs; Market Access Solutions; Home Nursing Services for Decentralized Clinical Trials; and Clinical Trial Sourcing. For more information, please visit www.wepclinical.com.

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.

[rccola335]

Last week I posted that on the EMA website in June 2023, paraxel transferred imetelstat back to Geron for MF & MDS - have the parted ways?

[biopearl123]

Good question. It may be that Geron now has the in house staff to take over responsibilities that were previously contracted out to Parexel but that is just speculation.

[LWS]

With the NDA acceptance and approval near, I made a list of organizations, that have been associated with Geron and Imetelstat one way or the other. All have been discussed on this board. Some have a continuing strong interest and others only a passing interest. In the coming months we will find out what associations, approvals, collaborations and partnerships are enhanced or newly created to manufacture, market and distribute Imetelstat.
=========================================================
USA Big Pharma
1. JNJ
2. AbbVie

USA Research and Cancer Hospitals
3. Mayo Clinic
4. MD Anderson

Ex-USA
5. Novo Nordisk (Denmark)
6. Novartis (Switzerland)
7. Bayer AG (Germany)

USA Government (Cancer Moonshot)
8. NIH/NCI

Outside Contractors
9. WEP
10. Parexel

Other Considerations
11. Incyte
12. MAIA

Approval Agencies
13. FDA (USA)
14. MHRA (UK)
15. EMA (EU)


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

[LWS]

As far as I can tell, Imetelstat is the blood cancer miracle drug of the 21st century, with treatments as a single-agent for a variety of blood cancers, and with synergies going forward in many telomerase type cancers (about 90%) in combinations (with partners and collaborators), leading to partial remissions, complete remissions, and (hopefully) cures.

It is too early to tell how good, and how far reaching Imetelstat will be. KOLs and Webinars are very promising and very encouraging.