MENLO PARK, Calif., April 05, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced 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) Annual Meeting held in Washington, D.C. from April 1-5, 2017. The poster presentation is available on Geron’s website at www.geron.com/presentations.
“These data from preclinical studies presented at AACR 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.”
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.
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.
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) imetelstat having activity in other hematologic myeloid malignancies, including acute myeloid leukemia; (ii) imetelstat having disease-modifying activity by inhibiting malignant progenitor cell clones associated with hematologic malignancies in a relatively select manner; (iii) the potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (iv) 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) whether imetelstat will succeed in current and potential future clinical trials by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (ii) 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; (iii) the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the collaboration agreement for any reason; (iv) 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; (v) whether imetelstat can be applied to any or to multiple hematologic malignancies; (vi) whether pre-clinical data has any correlation to clinical results; and (vii) the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat. 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 annual report on Form 10-K for the year ended December 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.
Anna Krassowska, Ph.D.
Investor and Media Relations