| From: Savant | 8/26/2022 9:52:17 AM | | | | | | Geron Announces First Patient Dosed in IMproveMF Phase 1 Combination Study in Frontline Myelofibrosis
08/22/2022
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- Preclinical data showed synergistic and additive effects of combination imetelstat and ruxolitinib
- Study intended to explore potential for disease modification with imetelstat in earlier, frontline myelofibrosis setting
- Single-agent imetelstat currently being studied in a separate Phase 3 trial designed to confirm clinically meaningful benefits observed in relapsed/refractory MF patients in Phase 2 study
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the first patient has been dosed in IMproveMF, a Phase 1 study evaluating imetelstat, a first-in-class telomerase inhibitor, in combination with ruxolitinib in patients with frontline myelofibrosis (MF).
“We designed the Phase 1 IMproveMF study based on preclinical data that showed the sequential treatment of ruxolitinib followed by imetelstat had a selective inhibitory effect on malignant MF stem cells, while sparing normal hematopoietic stem cells. This disease-modifying potential of imetelstat to affect the malignant clones driving disease progression differentiates it from any other drug currently approved or in development for myelofibrosis treatment,” said Faye Feller, MD, Executive Vice President, Chief Medical Officer of Geron. “Given these preclinical data, we want to explore the potential for disease modification with imetelstat in the earlier, frontline disease setting. In parallel, our separate IMpactMF Phase 3 trial is ongoing in MF patients who are relapsed/refractory to JAK inhibitors. This Phase 3 trial is designed to confirm the results from the IMbark Phase 2 study where single-agent imetelstat treatment resulted in multiple clinically meaningful benefits, including symptom response and potential improvement in overall survival.”
“Upon diagnosis, intermediate-2 and high-risk myelofibrosis patients typically receive ruxolitinib as the primary therapy, which reduces enlarged spleens and alleviates symptoms, but does not change the course of the disease. As a non-JAK inhibitor treatment option with a potentially novel mechanism of action, imetelstat could provide an additive benefit of disease modification when combined with ruxolitinib,” said John Mascarenhas, MD, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and a principal investigator on the IMproveMF study. “The dosing of the first patient is an important step in identifying a potential safe and efficacious dose and schedule of imetelstat and ruxolitinib in frontline MF.”
IMproveMF is a single arm, open label, two-part Phase 1 study to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of imetelstat in combination with ruxolitinib as a frontline treatment in patients with Intermediate-2 or High-risk MF (frontline MF). In both parts, patients will receive ruxolitinib followed by imetelstat, a dosing schedule that showed synergistic and additive effects of the two drugs in preclinical experiments. Part 1 will enroll up to 20 frontline MF patients who, at the time of enrollment, have received an optimized dose of ruxolitinib, to which imetelstat treatment will be added at increasing dose levels based on safety and tolerability. The primary purpose of Part 1 is to identify a safe dose for treating frontline MF patients with a combination of imetelstat and ruxolitinib. If a safe dose is identified in Part 1, participants in Part 2 will be JAK inhibitor naïve and will receive treatment with ruxolitinib after screening and enrollment at a starting dose based on standard-of-care or local prescribing information. Treatment with single-agent ruxolitinib will continue for at least 12 weeks, including four consecutive weeks at a stable dose prior to the addition of imetelstat. Part 2 is designed to confirm the safety profile of imetelstat in combination with ruxolitinib and to evaluate for preliminary clinical activity of the combination. Geron expects to present preliminary results from this study by the end of 2023.
The study is enrolling patients and is being conducted at three trial sites in the U.S., two of which are currently open for patient screening. For more information, please visit ClinicalTrials.gov (Identifier NCT05371964).
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. |
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| From: cycleupcycledown | 10/8/2022 12:12:11 AM | | | | | | | I'm hoping for some sort of deal or good news before Jan results. In sum at $2.30 in trading acct.......recent dojis might precede a rally |
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| From: Savant | 10/24/2022 10:04:47 AM | | | | | | Major stock option grants to new hires
GERN
-1.9396%
Thu, October 20, 2022 at 3:30 PM
In this article:
GERN
-1.9396%
Recommendation Rating
Buy
FOSTER CITY, Calif., October 20, 2022--( BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 843,260 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company.
The stock options were granted on October 19, 2022 at an exercise price of $2.25 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 710,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 133,260 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees. |
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| From: tktrimbath | 12/30/2022 4:57:38 PM | | | | | | INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.
Geron
GERN (market cap is $0.922B was $0.585B)
Geron is a leading-edge biotech aimed at treating blood disorders by using innovative telomerase techniques. Telomeres are the end caps to chromosome that regulate cell division and cell death. Too aggressive cell death can be associated with autoimmune diseases. Too aggressive cell division can be cancerous. Control cell division and cell death and it may be possible to treat more than their target disorder, thereby multiplying the treatments' and the company's impact.
The company has been working on developing a commercially viable treatment for over twenty years and may finally be within a year or two of applying for FDA approval. That's the good news.
(Mostly a copy&paste for my biotech investments with the names changed)
One hurdle with biotechs is making sure the treatment is reliable, effective, safe, and commercially viable. Another hurdle with innovative treatments is gaining FDA approval is a reasonable time. Treatments for unmet needs have pressure for early approval. Innovative treatments have pressures encouraging the FDA to be cautious. We may soon see how the technical, political, medical, and societal pressures affect Geron's treatment and Geron's viability and GERN's performance.
DISCLOSURE LTBH since 1999 and continuing to hold. I bought more when they mentioned specific years for clinical trials and approval goals.
(I've also collected links to the other discussion boards and my other stocks over on my blog. trimbathcreative.net
& from my One Company One Story series on YouTube
youtu.be ) |
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| From: tktrimbath | 6/30/2023 7:25:24 PM | | | | | | INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.
Geron
GERN (market cap is $1.63B was $0.922B)
Geron is a leading-edge (some say bleeding-edge, but that sounds too graphic) biotech firm that is applying their knowledge of telomere management for treatments like hematological disorders. My understanding is that they plan to apply (or did they already?) for FDA approval within the next 6-9 months, with commercialization happening shortly after that.
Geron started decades ago with much broader, yet even more ambitious goals. Geron takes its name from gerontology, a field that the company saw as a large unmet need, as in, everyone who wants to live a longer life. They were developing technologies that are attractive to the immortality set. Now, their scope and depth are smaller. They've sold off most of their intellectual property to remain in business (disclosure: I also hold stock in Lineage Cell Therapeutics - LCTX, to invest in one of those technologies), which has also resulted in significant stock dilution.
I believe many have been ignoring GERN because it involves learning about telomeres (something manages cell death or cell life) and terms like hematological (blood-related). The company has not delivered the product despite decades of work, and there's that significant dilution.
If Geron receives FDA approval, they should get a lot of attention in the medical community, among patients, and GERN should get more positive interest from the investment community.
If, may, probably are the kinds of terms that have always been more speculative in Geron's work, but they may be on the cusp of less speculation and more real application.
IF Geron succeeds with this treatment, and IF the treatment can be extended to other ailments, then Geron, the patients, GERN, and the stockholders may benefit.
(Mostly a copy&paste for my biotech investments with the names changed)
One hurdle with biotechs is making sure the treatment is reliable, effective, safe, and commercially viable. Another hurdle with innovative treatments is gaining FDA approval is a reasonable time. Treatments for unmet needs have pressure for early approval. Innovative treatments have pressures encouraging the FDA to be cautious. We may soon see how the technical, political, medical, and societal pressures affect Geron's treatment and Geron's viability and GERN's performance.
DISCLOSURE LTBH since 1999 and continuing to hold. I bought more when they mentioned specific years for clinical trials and approval goals.
(I've also collected links to the other discussion boards and my other stocks over on my blog. trimbathcreative.net
& from my One Company One Story series on YouTube
youtu.be ) |
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| From: tktrimbath | 12/29/2023 5:00:26 PM | | | | | | my semi-annual exercise of GERN
INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.
Geron
GERN (market cap is $1.15B was $1.63B)
For decades I've been able to simply describe Geron because so little changed. Now, they've finally announced news "Geron announces FDA acceptance of New Drug Application for imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk." Simple descriptions run into detailed progress reports that sound encouraging while also being hard to understand. Their web site says it better. "Our ambition is to change lives by changing the course of blood cancer." And, "We’re committed to bringing the potential power of telomerase inhibition to patients with imetelstat." That's clearer. Let's see if my amateur understanding suffices to describe the situation.
Years, decades ago, Geron had a diversified portfolio of innovative and somewhat controversial treatments that could fight cancer by convincing certain cells to die, and fighting auto-immune disorders to allow certain cells to live. From that broad range of possibilities they've narrowed down to blood cancer.
The good news is in that first paragraph, "Geron announces FDA acceptance of New Drug Application..." That sort of news could apply a premium to a stock price. I looked forward to it. It hasn't happened. There are several possibilities for why it didn't.
- The premium is already included.
- No one knows, or no longer cares about news from Geron. I've held the stock for over two decades. Few folks have that patience.
- News in the industry may lower confidence.
- Dilution has so reduced the value of the shares that the premuim is built in, but share price doesn't show it because there are so many shares in the market.
- People want more proof of the technology, or the market.
- The product may be considered too expensive (ala DNDN from ten years ago.)
- Competition may have caught up to them.
I don't know. My style of investing involves some research, but nothing detailed until it matters. As I am a LTBH shareholder, I do not plan to trade the stock; so, there's less urgency for me to track the details. My curiosity may inspire to bring my understanding up to date.
New medical treatments have the potential to be used for more than one ailment. Geron's trails are targeted at blood cancer, but if it proves successful the company can expand and the stock price can reflect the multiplier effect.
Speculation is easy, but also moot. The FDA is the power, and they've accepted the New Drug Application. It is possible that a long wait may be over.
And...
(Mostly a copy&paste for my biotech investments with the names changed)
One hurdle with biotechs is making sure the treatment is reliable, effective, safe, and commercially viable. Another hurdle with innovative treatments is gaining FDA approval is a reasonable time. Treatments for unmet needs have pressure for early approval. Innovative treatments have pressures encouraging the FDA to be cautious. We may soon see how the technical, political, medical, and societal pressures affect Geron's treatment and Geron's viability and GERN's performance.
DISCLOSURE LTBH since 1999 and continuing to hold. I bought more when they mentioned specific years for clinical trials and approval goals.
(I've also collected links to the other discussion boards and my other stocks over on my blog. trimbathcreative.net
& from my One Company One Story series on YouTube
youtu.be )
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