Geron to Present New RYTELO™ (Imetelstat) Data at ASH Annual Meeting

Geron Corporation, a biopharmaceutical company based in Foster City, California and listed on Nasdaq as GERN, has recently made a significant announcement regarding new data for its telomerase inhibitor, RYTELO™ (imetelstat). This medication is being investigated for its potential in treating various myeloid hematologic malignancies. Geron revealed that six abstracts showcasing new data on imetelstat have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting, scheduled for December 7-10, 2024, in San Diego, California, and also available virtually.

Faye Feller, M.D., Geron's Executive Vice President and Chief Medical Officer, expressed anticipation in working with trial investigators to present data that continues to highlight telomerase inhibition as a promising approach for treating myeloid hematologic malignancies.

One of the key presentations, abstract #352, will be delivered by Dr. Uwe Platzbecker from Leipzig University Hospital. This abstract focuses on the effects of prior treatments on the clinical activity of imetelstat in patients with lower-risk myelodysplastic syndromes (LR-MDS) who are transfusion-dependent. The analysis pooled data from several studies and suggested that imetelstat can provide clinical benefits such as an increase in hemoglobin and reduction in red blood cell transfusions, irrespective of previous therapies. Dr. Platzbecker highlighted the clinical implications of these findings, noting the limited treatment options for patients with symptomatic anemia and dependency on transfusions.

Another significant abstract, #4590, will be presented by Dr. Rami S. Komrokji from Moffitt Cancer Center. It reports the initial results from the QTc substudy of the IMerge Phase 3 Trial. This study, which included 51 patients, demonstrated clinically meaningful efficacy and manageable safety for imetelstat, even among patients who had received prior therapies beyond erythropoiesis-stimulating agents. The data indicated no significant effects on cardiac repolarization and no new safety signals, with Grade 3/4 neutropenia and thrombocytopenia resolving within four weeks in most cases.

Abstract #3210, to be presented by Dr. Mikkael Sekeres from the University of Miami Health System, discusses patient-reported outcomes in the IMerge trial. This analysis involved 175 patients and used validated questionnaires to evaluate fatigue and quality of life. The results indicated that imetelstat-treated patients experienced sustained improvements in fatigue and maintained their quality of life, contrasting with the placebo group, which saw a decline.

In the domain of myelofibrosis (MF), abstract #998 will be presented by Dr. John Mascarenhas from the Icahn School of Medicine at Mount Sinai. This abstract details the first safety results from the Phase 1/1B IMproveMF trial, evaluating a combination of imetelstat with ruxolitinib. Thirteen patients participated, showing that the combination was well-tolerated with no dose-limiting toxicities, suggesting potential for future development as a combination therapy.

For acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS), abstract #3222 will present interim results from the IMpress trial. Conducted by the European Myelodysplastic Neoplasms Cooperative Group, this study evaluated imetelstat in patients resistant or intolerant to HMA-based therapies. Initial findings from 23 patients showed some hematological improvements and antiproliferative effects, leading to protocol amendments for more frequent dosing in subsequent cohorts.

Lastly, abstract #52 will discuss preclinical data on overcoming resistance to venetoclax/azacitidine in AML through imetelstat-mediated lipophagy, to be presented by Claudia Bruedigam from QIMR Berghofer Medical Research Institute.

RYTELO™ (imetelstat) represents a pioneering treatment targeting telomerase in myeloid malignancies. Approved by the FDA for certain patients with lower-risk myelodysplastic syndromes, it offers a new therapeutic option for those with transfusion-dependent anemia. This first-in-class telomerase inhibitor works by hindering the enzyme's activity, crucial for the unchecked division of malignant cells.