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I am out so depressing not to have a partnership but I guess I will take the tax loss.
Geron Corporation (Nasdaq:GERN) today announced that the Company's analyst and investor event will take place in New York, N.Y., on Monday, December 10, 2018. Management will be joined by clinical investigators from both IMerge and IMbark who will reprise oral presentations from the 60th American Society of Hematology (ASH) Annual Meeting occurring in early December, as well as discuss the unmet medical need in hematologic myeloid malignancies. The event will begin at 8:00 a.m. ET.
Also On December 10, 2018, Geron plans to host a webcasted event for analysts and investors. At the event, an investigator from each of the IMbark and Part 1 of IMerge trials will reprise the oral presentations from the ASH Annual Meeting. A press release with event details, including how to access a webcast link, will be available at the end of November.
Time and date for ASH,
Title: Imetelstat Treatment Leads to Durable Transfusion Independence (TI) in RBC Transfusion-Dependent (TD), Non-Del(5q) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Who Are Lenalidomide and HMA Naïve (Abstract #463)
Session Name: 637. Myelodysplastic Syndromes—Clinical Studies: Novel Therapeutics II
Session Date: Sunday, December 2, 2018
Session Time: 4:30 p.m. PT - 6:00 p.m. PT
Presentation Time: 4:30 p.m. PT
The oral presentation is expected to provide more mature efficacy and safety data from the combined initial and expansion cohorts in Part 1 of IMerge, a Phase 2 clinical trial of imetelstat in transfusion dependent, lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to an erythropoiesis stimulating agent (ESA), do not have a del(5q) chromosomal abnormality and are hypomethylating agent (HMA) and lenalidomide treatment naïve.
Title: Imetelstat Is Effective Treatment for Patients with Intermediate-2 or High-Risk Myelofibrosis Who Have Relapsed on or Are Refractory to Janus Kinase Inhibitor Therapy: Results of a Phase 2 Randomized Study of Two Dose Levels (Abstract #685)
Session Name: 634. Myeloproliferative Syndromes: Clinical: Emerging Therapies and Prognostic Scoring in Myelofibrosis and Other MPNs
Session Date: Monday, December 3, 2018
Session Time: 10:30 a.m. PT - 12:00 p.m. PT
Presentation Time: 10:30 a.m. PT
The oral presentation will highlight efficacy and safety data from a primary analysis of IMbark, a Phase 2 clinical trial that evaluated two starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in more than 100 patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. More mature data from the extension phase of IMbark, including median overall survival, is expected to be presented.
Upcoming Milestones
Data Presentations
?ASH abstracts published online November 1, 2018
IMerge Phase 2 data presentation at ASH
December 2, 2018
IMbark Phase 2 data presentation at ASH
December 3, 2018
Analyst and investor event
December 10, 2018
Clinical Development Plans
Discussions with MF experts and regulatory authorities to determine next steps
Start of first quarter 2019
Imetelstat IND transfers from Janssen to Geron
Second quarter 2019
Initiate screening and enrollment for Phase 3 portion of IMerge
By mid-year 2019
Outline decision regarding potential late- stage development in MF
End of third quarter 2019
The second agreement requiring J and J to develop and commercialize a product remains in place.
Posted sept 12 SOHO 2018 | Promising approaches and clinical trials in MDS
David Steensma
A number of promising therapeutic approaches are under investigation for the treatment of myelodysplastic syndromes (MDS). We got on update on these exciting developments from David Steensma, MD, of the Dana-Farber Cancer Institute, Boston, MA, at the 2018 Society of Hematologic Oncology (SOHO) Annual Meeting, held in Houston, TX. Dr Steensma highlights the potential combination of hypomethylating agents with immunotherapies such as checkpoint inhibitors, or the BCL2 inhibitor venetoclax. He also expresses his excitement for the telomerase inhibitor imetelstat and APR-246, which targets p53, before briefly mentioning the potential for CAR T-cells in MDS.
Johnson & Johnson (JNJ) will host a conference call for investors at 8:00 a.m. (Eastern Time) on Thursday,
Schwab no longer wants my shares to lend out.
Buyout is coming very soon,Johnson & Johnson (JNJ) will host a conference call for investors at 8:00 a.m. (Eastern Time) on Thursday, September 13th, to review its Pharmaceutical Business.
Janssen reaffirms imetelstat's potential as a billion dollar drug
In his comments during JNJ's quarterly earnings conference call, Mr. Gorsky unambiguously referred to Geron's therapeutic candidate when discussing Janssen's key focus areas for growth for the remainder of 2018. If you don't have time to listen to the entire hour and 20-minute call, we would urge you to devote just two minutes beginning at the 23:50 mark of the earnings call, when Mr. Gorsky discusses the Janssen Pharmaceutical business.
Trial completion date moved up by 1 year,
https://clinicaltrials.gov/ct2/history/NCT02598661?A=30&B=31&C=Side-by-Side#StudyPageTop
Time to buy
05/07/2018 Broker: FBR Capital Rating: Buy New Target: $5.75 Initiates Coverage On
19/03/2018 Broker: Piper Jaffray Rating: Buy New Target: $7.0 Maintain
18/03/2018 Broker: Stifel Nicolaus Rating: Hold New Target: $4.0 Maintain
Upon closing the private placement, TapImmune will issue 17,500,000 shares of its common stock at a price of $4.00 per share. The aggregate offering size, before deducting the placement agent fees and other offering expenses, is expected to be $70 million. Additionally, TapImmune will issue warrants to purchase 13,125,000 shares of TapImmune common stock at an exercise price of $5.00 per share that will be exercisable for a period of five years from the date of issuance.
Abstract: S1557
Type: Oral Presentation
Presentation during EHA23: On Sunday, June 17, 2018 from 08:30 - 08:45
Location: Room A4
Background
Patients with lower-risk MDS that is relapsed/refractory to ESA have few treatment options. The first-in-class telomerase inhibitor imetelstat, which targets cells with short telomere lengths and active telomerase, has the potential to provide clinical benefit in this patient population.
Aims
Here we report updated safety and efficacy data from IMerge, an ongoing 2-part, global, phase 2/3 study of imetelstat in RBC TD patients with IPSS Low or Intermediate-1 (Int-1) risk MDS.
Methods
The IMerge population includes patients with MDS relapsed/refractory to ESA with a transfusion requirement of ≥4 units over 8 weeks prior to entry and ESA-naïve patients with sEPO >500 mU/mL. In Part 1 (open-label, single-arm), imetelstat 7.5 mg/kg was administered IV every 4 weeks (escalation to 9.4 mg/kg permitted after 3 cycles). The primary endpoint is the rate of RBC transfusion-independence (TI) lasting ≥8 weeks; secondary endpoints include safety, ≥24-week TI rate, time to and duration of TI, and hematologic improvement (HI) rate. Updated results for the first 32 patients enrolled in Part 1 (median follow up, 75.3 weeks) are reported here.
Results
Median age was 68.5 years. 59% of patients were IPSS Low and 41% Int-1. 13 patients (43%) had sEPO>500 mU/mL. 34% had a cytogenetic abnormality, including 22% with del(5q). Prior MDS treatments included ESAs (88%), lenalidomide (38%), and decitabine or azacitidine (HMAs) (25%); 41% were both lenalidomide and HMA naïve and non-del(5q). As of Jan 2018, RBC-TI ≥8-week was achieved in 38% of patients. Median time to onset of TI was 8 weeks with a median duration of TI of 23 weeks. 16% of patients achieved ≥24-week TI, and 63% achieved erythroid HI. Of 13 lenalidomide and HMA naïve and non-del(5q) patients, 54% achieved ≥8-week TI. Median time to onset of TI in the subset was 8 weeks with a median duration of TI of 43 weeks. 31% of these patients had ≥ 24-week TI, and 69% achieved erythroid HI. TI response did not differ based on the presence of ringed sideroblasts or baseline sEPO level (41% [7/17] ≤500 mU/L; 38% [5/13] >500 mU/L). Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events (AEs) overall and in the lenalidomide/HMA naive and non-del(5q) subset. The subset had a lower incidence of gr ≥3 neutropenia relative to the overall population (54% vs 66%) but a higher rate of gr ≥3 thrombocytopenia (62% vs 53%). Gr 4 neutropenia incidences were 41% overall and 38% for the subset. Overall, 28 patients (88%) had reversible LFT elevations by at least one grade. Four patients had gr 3 worsening of AST and/or ALT (1 also had gr 3 worsening of bilirubin), all of which were reversible. Eleven patients received growth factors during the study for treatment of an AE or ongoing medical history (n=10) or as prophylaxis (n=1).
Conclusion
Safety and efficacy reported here support continued investigation of imetelstat using the current dosing regimen of 7.5 mg/kg every 4 weeks in IPSS Low/Int-1 RBC TD MDS patients relapsed/refractory to ESA. AEs (mostly cytopenias) were predictable, manageable, and reversible. TI was observed in 38% and erythroid HI in 63% of patients with imetelstat therapy, with a 16% durable 24-week TI rate. Patients naïve to lenalidomide and HMAs and who lacked del(5q) had a 54% 8-week TI rate and responses were more durable (31% 24-week TI rate). To further validate these findings, additional patients meeting these criteria have been enrolled and are currently being followed.
Session topic: 10. Myelodysplastic syndromes – Clinical
We have 343 million in cash why?
Why are they having such a hard time selling this merger?
Real or fake?
Phantom why don’t you ask your buddy Peter why the MSKCC trial has been in a holding position since Feb. 2017. Ask him how they are going to pay for all these trials period. I don’t like the merger and don’t consider it a windfall for Tapimmune,science has to be proven and it will take 3 to 5 years to find out what Marker has. Finally you sound like a paid pumper for Peter if you are really talking to him which I am leaning toward not.
Rosalind Advisors, Inc. Sold 51.1% of their holdings in KTOV.
Anybody explain the 13g just posted?
Breakfast with our new partner should be interesting......
CEO and Cell Culture Device Expert
Wilson Wolf Corporation
1995 – Present (23 years)
Wilson Wolf Corporation is dedicated to inventing, developing, and manufacturing superior cell culture devices for use in biotechnology.
A current focus is on expansion of our G-Rex® product line, which is demonstrating itself to be the most cost effective and practical technology for production of T cells (CAR, APC, NK, Treg, TIL, etc.).
Marker Therapeutics
CEO and Co-Founder
Marker Therapeutics
2015 – 2018 (3 years)
Marker Therapeutics, dedicated to commercializing T cell therapies intended to eradicate liquid and solid tumors, was co-founded with key personnel at the Center for Cell and Gene Therapy at Baylor College of Medicine. Clinical data are demonstrating Marker's therapies have the capacity to activate the patient's immune system in the fight against cancer by a process called "antigen spreading."
ViraCyte
Managing Director and Co-Founder
ViraCyte
2013 – 2018 (5 years) | www.viracyte.com
ViraCyte is dedicated to commercializing virus-specific T cell therapies in order to effectively prevent or treat viral infections within highly immunocompromised patients. As one example of need, patients undergoing a hematopoietic stem cell transplant are at great risk of death from subsequent viral infections and the current standard of care is inadequate and extremely expensive. ViraCyte, now sponsoring several clinical trials, was co-founded with key personnel at the Center for Cell and Gene Therapy at Baylor College of Medicine after virus specific T cell therapy was shown to be safe, effective, and far superior to conventional care.
John Wilson is currently associated with three companies, according to public records. The companies were formed over a one year period with the most recent being incorporated eleven months ago in June of 2017. All companies are still active.
Phantom why isn’t the market responding to the merger. More phase 2 trials to pay for I expect more cash to be needed as well. Where are the interim results?
AstraZeneca flop a fresh blow to cancer immunotherapy combination
Reuters ReutersApril 24, 2018
* No benefit from Imfinzi plus tremelimumab combination
* Marks latest disappointment for double immunotherapy
* AstraZeneca raises stake in Circassia to 19.9 pct (Adds market reaction, context on other companies)
By Ben Hirschler
LONDON, April 24 (Reuters) - The concept of combining two immunotherapy drugs to fight lung cancer - not so long ago one of the hottest ideas in cancer research - has suffered a fresh blow from the failure of an AstraZeneca clinical study.
Adding the company's experimental drug tremelimumab to its existing product Imfinzi failed to slow disease progression or extend life in patients who had already received at least two previous treatments, the drugmaker said on Tuesday.
Shares in AstraZeneca fell 1 percent following the news.
The result of the study, known as ARCTIC, is disappointing but not a huge surprise, since evidence has been building that there may be little value in using a so-called CTLA-4 drug like tremelimumab on top of a PD-L1 such as Imfinzi.
Indeed, since Imfinzi on its own showed some signs of efficacy, whereas adding tremelimumab did not, analysts believe the second drug might actually offset the efficacy that Imfinzi can offer.
An ARCTIC sub-study that was not powered for statistical significance found that Imfinzi monotherapy showed a clinically meaningful reduction in the risk of death compared to chemotherapy.
A year ago, the notion of combining the two medicines was the big hope driving AstraZeneca's stock price - but that hope was dealt a major blow in July when its main first-line lung cancer trial, called MYSTIC, failed to slow disease progression.
It is still possible the two-drug combination might succeed in lengthening first-line patients' lives - a measure called overall survival - but Deutsche Bank analyst Richard Parkes said expectations for this "should now be very low".
AstraZeneca is due to report overall survival data from the MYSTIC trial in the second half of this year.