imetelstat.info

Information about imetelstat: the first clinical stage telomerase inhibitor

2018

(08-02-2018) - Janssen BioTech applies for global patent for COMBINATION TREATMENT FOR HEMATOLOGICAL CANCERS, including Imetelstat.

The present invention relates to a combination treatment for hematological cancers. More specifically; a combination of a telomerase inhibitor and a Bcl-2 inhibitor are useful in treating hematological cancers, including AML. In certain embodiments, the telomerase inhibitor is imetelstat or imetelstat sodium and the Bcl-2 inhibitor is ABT-199.

International Application No.:  PCT/US2017/044348

Publication date: 08-02-2018
International filing date: 28-07-2017

2017:

Geron Announces First Patient Dosed in Expanded Part 1 of IMerge Clinical Trial in Myelodysplastic Syndromes

MENLO PARK, Calif., Nov. 20, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that the first patient has been dosed in the expanded Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis.

IMerge is designed in two parts: Part 1 is a Phase 2, open-label, single-arm trial, and Part 2 is designed to be a Phase 3, randomized, controlled trial. As previously announced, 32 patients were enrolled in Part 1 of IMerge, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality. As of May 2017, the 13-patient subset showed an increased durability and rate of red blood cell (RBC) transfusion independence (TI) compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%).

Geron Announces Fast Track Designation Granted to Imetelstat for Lower Risk Myelodysplastic Syndromes

Expanded Part 1 of IMerge is Open for Patient Enrollment

MENLO PARK, Calif., Oct. 31, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.

The FDA's Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and supported by data that demonstrate the potential to address an unmet medical need. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug's development plan and to ensure the collection of appropriate data needed to support approval. Through the Fast Track Program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.

Geron Announces Presentations at American Society of Hematology Annual Meeting Imetelstat Clinical Data from Part 1 of IMerge in Myelodysplastic Syndromes to be Presented

MENLO PARK, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that four abstracts related to the telomerase inhibitor imetelstat have been accepted for presentation at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in Atlanta, Georgia from December 9-12, 2017. The abstracts were published today on the ASH website at www.hematology.org.

Geron Announces Updates to Imetelstat Clinical Development

Conference Call Scheduled for 8:00 a.m. ET on Tuesday, August 1

MENLO PARK, Calif., July 31, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced updates to the clinical development plans for IMerge and IMbark, the ongoing trials of the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively, being conducted by Janssen Research & Development, LLC. For IMerge, Part 1 will be expanded to enroll additional patients in a refined MDS population to confirm the clinical benefit and safety observed from current results. For IMbark, the trial remains unchanged. Geron expects that the IMbark protocol-specified primary analysis, the completion of which triggers a future Continuation Decision by Janssen, will begin no later than the third quarter of 2018.

In Part 1 of IMerge, 32 patients were enrolled, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality. As of May 2017, the 13-patient subset showed an increased durability and rate of transfusion independence compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%).

The Joint Steering Committee has agreed that the timing of the protocol-specified primary analysis for IMbark will begin upon the earlier of either a pre-specified number of deaths occurring in the trial or the end of the third quarter of 2018. Following completion of this primary analysis, which includes an assessment of potential survival benefit associated with imetelstat treatment, Janssen will notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication, i.e., the Continuation Decision.

Geron Announces Completion of Second Internal Data Reviews for Imetelstat Trials Being Conducted by Janssen

Both IMerge and IMbark Continue in Lower Risk Myelodysplastic Syndromes and Relapsed or Refractory Myelofibrosis

Conference Call Scheduled for 8:00 a.m. EDT Today, April 10

MENLO PARK, Calif., April 10, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that Janssen Research & Development, LLC has completed the second internal data reviews of IMerge and IMbark, the clinical trials of the telomerase inhibitor imetelstat in lower risk myelodysplastic syndromes (MDS) and relapsed or refractory myelofibrosis (MF), respectively. For IMerge, the benefit/risk profile of imetelstat in the treated patients supports continued development in lower risk myelodysplastic syndromes. A data package and proposed trial design refinements are planned to be provided to the FDA. For IMbark, the current results suggest clinical benefit and a potential overall survival benefit associated with imetelstat treatment in relapsed or refractory myelofibrosis; the trial will continue unchanged to evaluate maturing efficacy and safety data, including an assessment of overall survival.

Geron Corp files 10-K / 2017 Annual Report

3 January 2017

(www.geron.com)

Geron files new patent: Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms

23 February 2017

The invention provided herein discloses, inter alia, methods for using telomerase inhibitor compounds to treat and alleviate symptoms associated with myeloproliferative neoplasms such as Essential Thrombocythemia (ET), Polycythemia Vera (PV), Myelofibrosis (MF), and Acute Myelogenous Leukemia (AML) by targeting the neoplastic progenitor cells characteristic of these diseases. The invention provided herein also discloses, inter alia, methods for using telomerase inhibitor compounds to treat and alleviate symptoms associated with myelodysplastic syndromes (MDS) such as, for example, refractory anemia, refractory anemia with excess blasts, refractory cytopenia with multilineage dysplasia, refractory cytopenia with unilineage dysplasia, and chronic myelomonocytic leukemia by targeting the neoplastic progenitor cells responsible for producing the abnormally high numbers of cells characteristic of these diseases.

Geron Corporate Presentation (8-K filing)

January 2017

(www.geron.com)

2016:

Geron Files new patent: Synthesis of protected 3'-amino nucleoside monomers (filed 16 May 2016)

Inventors: Gryaznov; Sergei M.; (San Mateo, CA); Pongracz; Krisztina; (Oakland, CA); Zielinska; Daria; (Emerald Hills, CA)

A method of preparing an adenosine, guanosine or cytidine monomer having a protected nucleoside base and a protected 3'-amino group, wherein said base and said 3'-amino group are orthogonally protected, the method comprising: (a) providing a 3'-amino-3'-deoxy adenosine, cytidine, or guanosine monomer in which the 5'-hydroxyl group, nucleoside base, and 3'-amino group are unprotected; (b) selectively reacting said 3'-amino group with a first protecting group; reacting said 5'-hydroxyl group with a second protecting group; and reacting said nucleoside base with a third protecting group; wherein said first protecting group can be removed from said 3'-amino group under conditions which do not deprotect said nucleoside base, and said second protecting group can be removed from said 5'-hydroxyl group under conditions which do not deprotect said nucleoside base or said 3'-amino group.

Geron Reports Imetelstat Presentations at American Society of Hematology Annual Meeting

MENLO PARK, Calif., Dec. 06, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced four presentations of exploratory preclinical and clinical data related to the imetelstat program at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 3-6, 2016. The presentations are available on Geron’s website at www.geron.com/presentations. 

“The imetelstat data presented at ASH this year indicate the potential application of imetelstat in multiple myeloid malignancies,” said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. “These presentations reflect the ongoing work by academic scientists, clinical investigators and our colleagues at Janssen to advance the imetelstat program, and support the clinical trials being conducted by Janssen in patients with myelofibrosis and myelodysplastic syndromes, who are in need of new treatment options.”

New patent application by Geron: Methods of polynucleotide preparation using multivalent cation salt compositions (27 October 2016)

Aspects of the disclosure include methods for the preparation of a polynucleotide. In some embodiments, the method includes contacting a first polynucleotide composition.

New patent application by Geron: Method for eliciting an immune response to human telomerase reverse transcriptas (15 September 2016)

Inventors: Thomas R. Cech, Joachim Lingner, Toru M. Nakamura, Karen B. Chapman, Gregg B. Morin, Calvin B. Harley, William H. Andrews

The invention provides compositions and methods related to human telomerase reverse transcriptase (hTRT), the catalytic protein subunit of human telomerase. The polynucleotides and polypeptides of the invention are useful for diagnosis, prognosis and treatment of human diseases, for changing the proliferative capacity of cells and organisms, and for identification and screening of compounds and treatments useful for treatment of diseases such as cancers. ../.. The invention provides a nucleic acid construct comprising a sequence that encodes a human telomerase reverse transcriptase (hTERT) protein which is devoid of telomerase catalytic activity and of a nucleolar localization signal. The construct is useful triggering an immune response in a subject, against cells that overexpress telomerase, preferably dysplasia cells or tumor cells.


Geron provides update on IMbark and IMegre

(Menlo Park, 12 September 2016)

Excerpt of the press release:
To inform an assessment of the appropriate dose and schedule for relapsed or refractory MF patients in IMbarkTM, Janssen conducted a planned internal interim review of safety, efficacy and pharmacokinetic data from 20 patients from each dosing arm who have been followed on the trial for at least 12 weeks. Based on this first internal review at the early 12-week time point, the following has been determined by Janssen:

IMbark:

  • No new safety signals were identified.
  • 4.7 dosing arm will change to 9.4
  • In the 9.4 arm encouraging trends in the efficacy data were observed.
  • Janssen plans to conduct an additional internal data review in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks.

IMerge:

  • Emerging safety and efficacy in IMergeTM are consistent with data reported from the pilot study conducted at Mayo Clinic in MDS patients. IMergeTM will continue unmodified at this time.
  • Further assessment of data from IMergeTM is expected to occur in the second quarter of 2017
  • If Janssen decides to move forward with Part 2, the Phase 3 clinical trial is expected to be open for patient enrollment in mid-2017

(click the link button below for the full press release)

Geron Announces Issuance of U.S. Patents Related to Imetelstat

MENLO PARK, Calif., July 13, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the recent issuance of three U.S. patents related to the company’s telomerase inhibitor, imetelstat.

The first patent, U.S. 9,375,485, has claims covering the use of telomerase inhibitor compounds, including imetelstat, for alleviating at least one symptom of myelofibrosis or myelodysplastic syndromes, including chronic myelomonocytic leukemia. This patent is expected to remain in force until at least March 2033. The other two patents, U.S. 9,388,415 and U.S. 9,388,416, have claims covering methods for using imetelstat to inhibit the activity of telomerase and using imetelstat to inhibit cancer cell proliferation, as well as methods for using imetelstat to treat cancer, and are expected to remain in force until at least September 2024. These patents are related to Geron’s existing imetelstat composition of matter patent U.S. 7,494,982, which issued in 2009 and is expected to remain in force until at least December 2025. Further extensions of patent term may be available for regulatory review periods. Full text patents are available on the United States Patent and Trademark Office website at www.uspto.gov.

Geron’s portfolio of patents related to imetelstat and related products whose mechanism of action is telomerase inhibition have been licensed to Janssen Biotech Inc., (Janssen) under an exclusive worldwide license and collaboration agreement for all human disorders or medical conditions.

Geron announces new patent protection involving the use of any telomerase inhibitor to treat MF, MDS, or CMML 

(US9375485, 28 June 2016)

US9375485 is a newly granted US patent assigned solely to Geron. It grants broad protection involving the use of a telomerase inhibitor for MF, MDS, or CMML. The patent extends Imetelstat's patent protection by eight years, thus providing 16+ years of patent protection from today. The patent expires on 17 december 2032.

Link to an interesting article from Hoosier Investor on Seeking Alpha: click here

Morgan Stanley raised its position in shares of Geron Co. (NASDAQ:GERN) by 194.2%

(Ticker Report, 21 April 2016)

Morgan Stanley raised its position in shares of Geron Co. (NASDAQ:GERN) by 194.2% during the fourth quarter, according to its most recent Form 13F filing with the SEC. The fund owned 268,626 shares of the biopharmaceutical company’s stock after buying an additional 177,313 shares during the period. Morgan Stanley owned about 0.17% of Geron worth $1,300,000 as of its most recent SEC filing.

Other hedge funds have also bought and sold shares of the company. Russell Frank Co acquired a new stake in Geron during the fourth quarter worth approximately $1,099,000. California State Teachers Retirement System boosted its stake in Geron by 1.8% in the fourth quarter. California State Teachers Retirement System now owns 292,950 shares of the biopharmaceutical company’s stock worth $1,418,000 after buying an additional 5,223 shares during the period. American Century Companies Inc. boosted its stake in Geron by 22.6% in the fourth quarter. American Century Companies Inc. now owns 687,621 shares of the biopharmaceutical company’s stock worth $3,328,000 after buying an additional 126,770 shares during the period. Finally, EAM Investors LLC acquired a new stake in Geron during the fourth quarter worth approximately $1,317,000.

Geron Announces Two Imetelstat Poster Presentations at the American Association for Cancer Research Annual Meeting

MENLO PARK, Calif., April 20, 2016 (GLOBE NEWSWIRE) --

Geron Corporation (Nasdaq:GERN) today announced two poster presentations of data from non-clinical studies of the telomerase inhibitor, imetelstat, at the 2016 American Association for Cancer Research (AACR) Annual Meeting held in New Orleans, Louisiana. The first poster presentation described results that treating acute myeloid leukemia (AML) cell lines with imetelstat enhanced the effects of agents currently used for the treatment of AML. These data extend the rationale from prior non-clinical studies for the potential use of imetelstat in hematologic myeloid malignancies, such as AML, including in combination with standard therapies. The second poster presentation described results from non-clinical studies that provide further evidence of potential on-target mechanisms of telomerase inhibition by imetelstat underlying the reduction in platelets observed in previously conducted imetelstat clinical trials.

The non-clinical studies were conducted by scientists at Janssen Research & Development, LLC and academic collaborators under the terms of the exclusive worldwide imetelstat license and collaboration agreement between Geron and Janssen Biotech, Inc. The poster presentations are available on Geron’s website at www.geron.com/presentations

Geron Corp files 10-K / 2015 Annual Report (10 March 2016)

Geron Announces Initiation of Janssen Phase 2/3 Clinical Trial of Imetelstat in Myelodysplastic Syndromes and Orphan Durg Designation for MDS in the US

MENLO PARK, Calif., Jan. 14, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the dosing of the first patient in a Phase 2/3 clinical trial to evaluate imetelstat in patients with myelodysplastic syndromes (MDS). This clinical trial, also referred to as the IMergeTM study, is being conducted by Janssen Research & Development, LLC, and is the second study to be initiated under the terms of the exclusive worldwide imetelstat license and collaboration agreement between Geron and Janssen Biotech, Inc. (Janssen).

Geron's January 2016 Corporate Presentation

This presentation was filed 11 January 2016 as part of the SEC K-8 From (cash and investment balances as of December 31, 2015). 

Corporate presentation; click here

Full SEC K-8 Form + files: click here


2015:


Geron Announces Initiation of Janssen Phase 2 Clinical Trial of Imetelstat in Myelofibrosis

(Geron, 16 September 2015)

MENLO PARK, Calif., Sept. 16, 2015 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the dosing of the first patient in a Phase 2 clinical trial to evaluate imetelstat in patients with myelofibrosis (MF). This clinical trial, also referred to as the IMbarkTM study, is being conducted by Janssen Biotech, Inc. (Janssen), under the terms of the exclusive worldwide imetelstat license and collaboration agreement between the companies.


Dual Publications in the New England Journal of Medicine Highlight Transformative Potential of Imetelstat in Hematologic Myeloid Malignancies

(Geron, 3 September 2015)

MENLO PARK, Calif., Sept. 02, 2015 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced the publication of two papers in The New England Journal of Medicine (NEJM) in which the company’s telomerase inhibitor, imetelstat, was shown to have disease-modifying activity thought to be associated with selective inhibition of the malignant progenitor cell clones responsible for the underlying disease in two hematologic myeloid malignancies, essential thrombocythemia (ET) and myelofibrosis (MF). The papers are available online in the September 3rd issue at www.NEJM.org.

J&J 1B+ blockbuster pipeline: imetelstat NME filing by 2017

(J&J Investors Meeting, 20 May 2015)

This presentation shows the strategic partnerships of JnJ and their "Next Wave of Billion Dollar Drugs", which includes imetelstat (slide 42).

Anticipated NME approval for imetelstat in 2017 (slide 49)

Presented by Dominic Caruso (Vice President, Finance / Chief Financial Officer J&J) and William N. Hait (Global Head, Janssen R&D).

(links directly to the PDF presentation)

Geron Corp (GERN) Announces Receipt of FDA Orphan Drug Designation for Imetelstat as Myelofibrosis Treatment

StreetInsider.com, 15 June, 2015

On June 11, 2015, the United States Food and Drug Administration (the “FDA”) granted orphan-drug designation to imetelstat for the treatment of myelofibrosis. Imetelstat is a telomerase inhibitor discovered by Geron Corp (NASDAQ: GERN) that has been exclusively licensed to Janssen Biotech, Inc. (“Janssen”) on a worldwide basis for development and commercialization in oncology indications, including hematologic myeloid malignancies, and all other human therapeutic uses. Janssen sponsored the application to the FDA for orphan designation.

Link to 8-K Form

Janssen Pharma (JNJ) Plans to Gain FDA Approval for 10 New Products by 2019

New Brunswick, 20 May, 2015

At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (Janssen) will announce plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue1, as well as more than 40 line extensions of existing and new medicines. This includes imetelstat.

Geron Corporation Reports Q1 2015 Financial Results; IND application Imetelstat transfered

Menlo Park, Calif., April 30, 2015 

In March 2015, the company transferred its investigational new drug application (IND) for imetelstat to Janssen, as required by the collaboration agreement with them. In addition, in March 2015, the company transferred the IND for the study in patients with myelofibrosis being conducted at Mayo Clinic to Janssen, whereupon Janssen assumed responsibility as the sponsor for the study.

The company expects Janssen to initiate a Phase 2 study in patients with myelofibrosis in mid-2015, followed by a Phase 2 study in patients with myelodysplastic syndromes at the end of 2015.

(GlobeNewswire)

Press release here

2014:

Geron Announces Global Strategic Collaboration with Janssen to Develop and Commercialize Imetelstat

Menlo Park, Calif., November 13, 2014

Geron Corporation (Nasdaq: GERN) announced today that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. ("Janssen") to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis (MF) and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome (MDS) a

Geron Announces Early HSR Clearance for Global Strategic Collaboration with Janssen

Menlo Park, Calif., December 16, 2014

Geron Corporation (Nasdaq: GERN) announced today that the  Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Acts of 1976 (HSR Act) in connection with the exclusive worldwide license and collaboration agreement executed by the company on November 13, 2014 with Janssen Biotech, Inc. (Janssen) to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate.

Telomerase Inhibition and Imetelstat in Hematologic Malignancies


ASH2014 Analyst & Investor Event
December 8, 2014


Temorease Inhibition and Imetelstat in Hematologic Malgnancies

Presentation by:

  • - John A. Scarlet, President & CEO, Geron
  •   Corperation
- Steven Lane M.D., PhD, Queensland Institute of
   Medical Research

(PPT presentation)

Geron-Janssen collaboration: SEC Form 8-K


On November 13, 2014, Geron Corporation and Janssen BiomTech Inc. entered into an exclusive collaboration and license agreement to develop and commercialize imetelstat worldwide for oncology, including hematologic myeloid malignancies, and all other human therapeutic uses. Under the Collaboration Agreement Geron has granted to Janssen exclusive rights to develop and commercialzie imetelstat for all indications, ans Janssen is responsible for the development of, seeking regulatory approval for, and commercializing imetelstat worldwide.

(Source: SEC Form K-8)