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.
Clinical Trials of Imetelstat
Janssen is conducting two clinical trials of imetelstat under the terms of the collaboration agreement between Geron and Janssen:
- IMbarkTM, a Phase 2 clinical trial evaluating two dosing levels of imetelstat in patients with Dynamic International Prognostic Scoring System (DIPSS) Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a Janus Kinase (Jak) inhibitor. Further information about this clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT02426086; and
- IMergeTM, a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with International Prognostic Scoring System (IPSS) Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). Further information about this clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT02598661.
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.
About the Collaboration with Janssen
On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) expectations regarding the scope and duration of patent protection, as well as availability of extensions of patent term, for any of (a) U.S. 9,375,485 remaining in force until at least March 2033; (b) U.S. 7,494,982 remaining in force until at least December 2025, and (c) U.S. 9,388,415 and U.S. 9,388,416 remaining in force until at least September 2024; (ii) conduct and continuation of IMbarkTM and IMergeTM and other potential activities under the collaboration agreement with Janssen; (iii) the safety and efficacy of imetelstat; (iv) the current timelines, milestones and designs of IMbarkTM and IMergeTM, including planned reviews and analyses of clinical data; (v) imetelstat having disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner; and (vi) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) the uncertain, time-consuming and expensive product development and regulatory process, including whether Geron and Janssen will succeed in overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges in the development and commercialization of imetelstat; (ii) regulatory authorities permitting the current clinical trials to continue to proceed and potential future clinical trials to begin or continue to proceed; (iii) Janssen’s ability to enroll patients in a timely manner, or at all, in any of the current or potential clinical trials of imetelstat; (iv) the ability of Geron and Janssen to protect and maintain intellectual property rights related to imetelstat; (v) that U.S.7,494,982, U.S. 9,375,485, U.S. 9,388,415 and U.S. 9,388,416 are not invalidated; (vi) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (vii) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit/risk profile of imetelstat to become unacceptable; (viii) whether imetelstat can be applied to any or to multiple hematologic malignancies; and (ix) Geron’s need for future capital. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2016. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.