On April 5, 2017 Geron Corporation (Nasdaq:GERN) reported a poster presentation by Janssen Research & Development, LLC describing non-clinical data on the telomerase inhibitor imetelstat at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Washington, D.C. from April 1-5, 2017 (Press release, Geron, APR 5, 2017, View Source [SID1234518483]). The poster presentation is available on Geron’s website at www.geron.com/presentations. Schedule your 30 min Free 1stOncology Demo! "These data from preclinical studies presented at AACR (Free AACR Whitepaper) this year provide further insight into the mechanisms by which inhibiting telomerase with imetelstat may impact cancer cells," said John A. Scarlett, M.D., Geron’s President and Chief Executive Officer. "These studies also build on previously published reports that suggest the potential application of imetelstat in the treatment of multiple hematologic myeloid malignancies, including acute myeloid leukemia, and reflect the ongoing work by our colleagues at Janssen to advance the imetelstat program for patients in need of new therapies."
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Poster Presentation
Title: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101)
Prior research by others has shown that telomerase and BCL-2 are overexpressed in acute myeloid leukemia (AML) cells and are involved in blocking apoptotic signals. Therefore, Janssen designed preclinical studies to test whether inhibiting telomerase expression and/or activity and BCL-2 could enhance cell killing and result in a greater anti-tumor effect in AML through the combined administration of imetelstat and venetoclax, a selective BCL-2 inhibitor, as compared to either treatment alone.
Janssen presented data of imetelstat’s activity in combination with venetoclax in AML cell lines, patient samples and a mouse xenograft model. In AML cell lines, telomerase expression and activity were decreased by imetelstat and further reduced in combination with venetoclax. In addition, imetelstat enhanced apoptosis induced by venetoclax in AML cell lines and AML patient samples. Combining imetelstat with venetoclax in an AML mouse model prolonged survival, with four of ten mice alive approximately 80 days after treatment was stopped.
About Imetelstat
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 malignant progenitor cell 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 Biotech, Inc., 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.