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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)

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.