On June 14, 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, are now available on Geron’s website as well as to participants of the EHA (Free EHA Whitepaper)2021 Virtual Congress (Press release, Geron, JUN 14, 2021, View Source [SID1234583987]).
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"These poster presentations further support imetelstat’s differentiated approach to potentially target the malignant stem and progenitor cells in the bone marrow by inhibiting telomerase activity," said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. "Through this novel mechanism of action, imetelstat has the potential to alter the course of MDS and MF which distinguishes it from other treatments currently approved or in development. We look forward to confirming these results in our ongoing Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory MF."
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)
Poster Code: EP910
New data and analyses were presented on the clinical efficacy of imetelstat in molecularly defined subtypes based on cytogenetic and mutation profiles for patients in the IMerge Phase 2 clinical trial. As reported at previous EHA (Free EHA Whitepaper) meetings, meaningful and durable transfusion independence were observed in patients from IMerge Phase 2, including transfusion-free periods greater than one year, as well as substantial increases in hemoglobin. The current presentation reported clinical responses across different cytogenetic and molecularly defined categories whereby responses were independent of mutation status or number of mutations. These data support the unique telomerase inhibition mechanism of action of imetelstat and the potential to target the malignant stem and progenitor cells of the underlying disease.
Title: Imetelstat Demonstrates an Acceptable Safety Profile in Myeloid Malignancies
Poster Code: EP1106
Safety data from the Phase 2 IMbark and IMerge trials were further analyzed to understand the characteristics of hematologic and non-hematologic adverse events. These analyses highlighted that the imetelstat-related cytopenias are short, reversable and with limited clinical consequence when managed with the dose modification guidelines in the protocols. These data are further evidence for the on-target effect of imetelstat based on the selective reduction of malignant cells in the bone marrow through telomerase inhibition resulting in the observed meaningful clinical benefits for patients in the Phase 2 trials.
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.