Geron Reports Two Presentations at Virtual European Hematology Association Annual Congress
Geron Corporation (Nasdaq: GERN) announced new clinical data for imetelstat, a first-in-class telomerase inhibitor, presented at EHA2021 Virtual Congress. The data support imetelstat's mechanism targeting malignant stem and progenitor cells, emphasizing its potential to transform treatment for myelodysplastic syndromes (MDS) and myelofibrosis (MF). Results from the IMerge Phase 2 trial indicate durable transfusion independence, while safety analyses show manageable adverse events. Geron is conducting two Phase 3 trials for imetelstat, which has received Fast Track designation from the FDA.
- New clinical data supports imetelstat's unique mechanism targeting malignant stem and progenitor cells.
- Durable transfusion independence reported in IMerge Phase 2 trial, with transfusion-free periods exceeding one year.
- Imetelstat has Fast Track designation from the FDA for treating specific MDS and MF patients.
- Risks and uncertainties exist regarding the completion of Phase 3 trials, impacted by COVID-19.
- Potential regulatory challenges may delay the development of imetelstat.
- Forward-looking statements may not reflect actual future results due to various risks.
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced 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 EHA2021 Virtual Congress.
“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 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.
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 hematologic myeloid 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) imetelstat’s potential to alter the course of MDS and MF; (ii) that imetelstat has potential disease-modifying activity; (iii) the potential of imetelstat to target the malignant stem and progenitor cells of the underlying disease; 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: (a) whether Geron overcomes all of the potential delays and other adverse impacts caused by the current or evolving effects of the COVID-19 pandemic, and overcomes all the enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges to complete its two Phase 3 clinical trials; (b) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (c) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (d) whether imetelstat actually demonstrates disease-modifying activity in patients; and (e) whether imetelstat demonstrates that it targets the malignant stem and progenitor cells of the underlying disease in patients. 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 filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2021 and future filings and reports by Geron. 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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FAQ
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