On May 12, 2021 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that two poster presentations of new clinical data and analyses related to imetelstat, the Company’s first-in-class telomerase inhibitor, will be made at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress meeting to be held virtually from June 9 – 17 (Press release, Geron, MAY 12, 2021, View Source [SID1234579781]). The abstracts for the posters are available on the EHA (Free EHA Whitepaper) website at www.ehaweb.org. Both posters will be published on the EHA (Free EHA Whitepaper) Virtual Congress platform on June 11, 2021.
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"We are pleased that the EHA (Free EHA Whitepaper) accepted both of our abstracts which allows us to present what we believe to be imetelstat’s compelling potential to become a leading treatment for lower risk MDS and MF patients," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "The new data and analyses from our Phase 2 IMbark and IMerge trials continue to highlight imetelstat’s disease-modifying activity and potential to achieve remarkable clinical benefits, including durable transfusion independence in lower risk MDS patients and improvement in MF patients’ overall survival. We look forward to the presentations and remain confident that imetelstat, with its unique telomerase inhibition mechanism of action, is a highly differentiated treatment that can positively impact patients."
Abstract Title: Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)
Abstract Code: EP910
The abstract reports new data and analyses of the clinical efficacy of imetelstat in molecularly defined patient subtypes from the IMerge Phase 2 clinical trial in transfusion dependent, non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to ESAs. Clinical responses were analyzed across multiple molecularly defined subgroups based on cytogenetic and mutation profiles. The abstract concluded that imetelstat demonstrated clinical efficacy across different molecularly defined subgroups, including patients with poor prognosis.
Abstract Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies
Abstract Code: EP1106
The abstract describes new analyses of safety data from the Phase 2 IMbark and IMerge trials to further characterize hematologic and non-hematologic adverse events (AEs). Based on these analyses, the abstract concluded that imetelstat-related cytopenias observed in the trials were on-target effects based on the selective reduction of malignant cells through telomerase inhibition. Also, these cytopenias were of short duration, reversible and with limited clinical consequences when managed with the dose modification guidelines in the respective trial protocols. The difference in toxicity profiles between the two trials could be attributed to the different disease pathologies (proliferation vs. dysplasia) of patients with myelofibrosis or myelodysplastic syndromes.
In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the EHA (Free EHA Whitepaper) Annual Congress are embargoed from the time of submission. To be eligible for presentation at the EHA (Free EHA Whitepaper) Annual Congress, any additional data or information to be presented at the EHA (Free EHA Whitepaper) Annual Congress may not be made public before the posters are published. The posters will be available on Geron’s website at www.geron.com/r-d/publications after June 11, 2021.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid 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 hematologic myeloid 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 kinase (JAK) inhibitor treatment.