Geron Corporation announced the recent issuance of three US patents related to the company’s telomerase inhibitor, imetelstat.
The first patent, US 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, US 9,388,415 and US 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 US 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.
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.
Janssen is conducting two clinical trials of imetelstat under the terms of the collaboration agreement between Geron and Janssen:
IMbark, 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.
Imerge, a phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with International Prognostic Scoring System (IPSS) Low or Intermediate- risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA).
Imetelstat 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.
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.