On June 13, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that the first patient has been dosed in the investigator-led Phase 2 IMpress clinical trial evaluating imetelstat, the Company’s first-in-class telomerase inhibitor, in patients with acute myeloid leukemia (AM)L, or higher risk myelodysplastic syndromes (MDS), who are relapsed/refractory/intolerant to hypomethylating agents (HMAs) (Press release, Geron, JUN 13, 2023, View Source [SID1234632658]).

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"This trial is based on multiple preclinical publications that describe the role of telomerase in AML, which have reported that inhibiting telomerase in both mouse and human AML models targets and potentially depletes leukemic stem cells and impairs their leukemic progression," said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. "We are delighted that the first patient has been dosed in the investigator-led IMpress Phase 2 study, an important first step to understanding the potential impact of imetelstat in relapsed/refractory AML and higher risk MDS."

"Despite some recent advances in the treatment of AML and higher risk MDS, there is still a tremendous unmet need for new agents, especially in the relapsed/refractory setting," said Uwe Platzbecker, M.D., Department of Hematology, Cellular Therapy and Hemostaseology, Leipzig University Hospital, Leipzig, Germany, and Principal Investigator of IMpress. "With the first patient dosed and several in screening, we are pleased that IMpress Phase 2 is underway and look forward to understanding more about the potential efficacy of imetelstat in this rather frail and elderly patient population."

About IMpress Phase 2

IMpress Phase 2 (NCT05583552) is an open-label, single-arm, multicenter study aiming to enroll approximately 45 patients AML and higher risk MDS patients who are relapsed, refractory, or intolerant to HMAs. The objective of this trial is to evaluate the efficacy, in terms of hematologic improvement, of imetelstat in this patient population. The primary endpoint of this trial is overall response rate. The combined response assessment criteria for MDS and AML based on IWG 2018 criteria (MDS) and the criteria of the European LeukemiaNet (AML) will be used to define responders. Study sites will be located in Australia, France and Germany.

IMpress Phase 2 is an investigator-led study being led by The European Myelodysplastic Neoplasms Cooperative Group (EMSCO) and Australasian Leukaemia & Lymphoma Group (ALLG).

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat 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 U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in June 2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication.