Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced that three abstracts related to imetelstat, the Company’s first-in-class telomerase inhibitor, have been accepted as poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting to be held from December 11-14, 2021. The abstracts are available on the ASH website at www.hematology.org.
“The abstracts for this year’s ASH Meeting reflect the breadth of ongoing activity with imetelstat from pre-clinical studies in a new indication, as well as use of imetelstat as a single agent and in combination with other therapies, to analyses of clinical data supporting our Phase 3 development,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “We look forward to continued work in these areas as we expand the potential applications for imetelstat in hematologic malignancies.”
Clinical Data – Lower Risk Myelodysplastic Syndromes (MDS)
Abstract Title: On-Target Activity of Imetelstat Correlates with Clinical Benefits, Including Overall Survival (OS), in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)
The abstract describes new analyses of data from the IMerge Phase 2 clinical trial. In the analyses, a significant correlation was observed between achieving an optimal pharmacodynamic (PD) effect in imetelstat-treated patients with durable red blood cell transfusion independence (RBC-TI). In addition, a trend of improved overall survival rate was seen in patients who achieved optimal PD effect. The authors believe these results demonstrate a potential link between imetelstat activity and clinical efficacy. Additionally, patients in IMerge Phase 2 who achieved an optimal PD effect with imetelstat treatment did not have higher rates of cytopenias or liver enzyme elevations compared to patients without an optimal PD effect.
Poster Presentation Details
Abstract: #2598
Date: Sunday, December 12, 2021
Time: 6:00 p.m. – 8:00 p.m. ET
Pre-Clinical Data – Pediatric Acute Myeloid Leukemia
Abstract Title: Imetelstat Significantly Reduces Leukemia Stem Cells in Patient-Derived Xenograft Models of Pediatric AML
The abstract reports results from pre-clinical studies of imetelstat in pediatric acute myeloid leukemia (AML) cell lines (in vitro studies) and patient derived (PDX) mouse models (in vivo studies). The efficacy of imetelstat either as a single agent or in combination with chemotherapy or azacitidine was evaluated. In cell line experiments, imetelstat treatment resulted in cell apoptosis/death of leukemia stem cells (LSCs) in a dose-dependent manner. In the in vivo studies, imetelstat treatment reduced LSC numbers and increased median survival in mice. In addition, combining imetelstat with chemotherapy or azacitidine further enhanced activity against LSCs. The authors conclude that the results of these pre-clinical studies suggest imetelstat could represent an effective therapeutic strategy for pediatric AML.
Poster Presentation Details
Abstract: #3352
Date: Monday, December 13, 2021
Time: 6:00 p.m. – 8:00 p.m. ET
Trials in Progress Poster Presentation – IMpactMF Phase 3 trial in Refractory MF
Abstracts for this category describe innovative clinical trials that have not reached their primary endpoint to provide opportunities for early engagement and collaboration amongst investigators, translational research, clinical and industry investigators, statisticians and regulators.
Abstract Title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat Versus Best Available Therapy (BAT) in Patients with Intermediate-2 (Int-2) or High-risk Myelofibrosis (MF) Refractory to Janus Kinase Inhibitor (JAKi)
Poster Presentation Details
Abstract: #1503
Date: Saturday, December 11, 2021
Time: 6:00 p.m. – 8:00 p.m. ET
In accordance with ASH policies, abstracts submitted to the ASH Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the ASH Annual Meeting, any additional data or information to be presented at the Annual Meeting may not be made public before the presentation. The posters will be available at www.geron.com/r-d/publications following the ASH Annual Meeting presentations.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in myeloid hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis. 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 such statements, include, without limitation, those regarding: (i) the potential link between imetelstat activity and clinical efficacy in lower risk MDS; (ii) that imetelstat may have potential disease-modifying activity; (iii) that there may be additional potential applications for imetelstat in hematologic malignancies; and (iv) other statements that are not historical facts, constitute forward-looking statements. These forward-looking 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 whether: (i) imetelstat demonstrates disease-modifying activity in clinical trials; (ii) regulatory authorities permit the further development of imetelstat; (iii) imetelstat is safe and efficacious in clinical trials; and (iv) any future efficacy or safety results cause the benefit-risk profile of imetelstat to become unacceptable. 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 June 30, 2021. 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.
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Contacts
Olivia Bloom
Chief Financial Officer
investor@geron.com
media@geron.com
