Sapience Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program investigating ST101 for the treatment of recurrent glioblastoma (GBM). ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes a GBM expansion cohort.
Source:- Sapience Therapeutics, Inc.
A subtype of GBM, accounting for nearly 10% of all glioblastomas, has been observed to display isocitrate dehydrogenase 1 or 2 (IDH) mutations; mutant IDH proteins acquire the enzymatic ability to convert ?- ketoglutarate (?-KG) to d-2-hydroxyglutarate (d-2-HG), eventually leading to aberrant DNA and histone methylation. The total incident population of Glioblastoma Multiforme in 8 ma-jor markets ranges from ~78,975 in 2020 to 102,586 by 2030 while the total diagnosed incident population of Glioblastoma Multiforme in 8 major markets ranges from ~65,998 in 2020 to 79,653 by 2030. In the case of Glioblastoma Multiforme patients in the United States, the diagnosed cases range from ~15,419 cases to 19,188 cases during the study period i.e 2020-2030.
Comprehensive insight on patient segmentation based on Age group, Sex, Type (Primary & Secondary GBM), Grade and stages (I, II, III & IV), classification of GBM (Frontal, Parietal, Occipital, Temporal and Unknown and others), Glioblastoma Types (Astrocytomas, Ependymomas, Oligodendrogliomas, and Mixed gliomas), Comorbidity conditions (Hypertension, Depression, Anxiety, Diabetes, etc.), biomarker-based segmentation has been provided into the epidemiology (Incidence and Prevalence) section of the GBM and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China.
Therapies targeting tumor growth factor receptors and downstream pathways, angiogenesis, modulation of cancer stem-like cells, cell cycle regulation, oncolytic viruses, new radiotherapy techniques, and immunotherapy, including vaccines and modulation of immune checkpoints, are under investigation. In addition to novel agents, techniques to circumvent the blood-brain barrier to facilitate central nervous system drug exposure are being developed. The majority of industry-sponsored drugs in active clinical development for glioblastoma are in Phase II. Therapies in mid-and late-stage development for glioblastoma focus on a wide variety of targets. The majority of pipeline drugs for glioblastoma are administered via the oral and intravenous routes. High-impact upcoming events for drugs in the glioblastoma space comprise topline Phase II trial results for Opdivo and GDC0084, and expected program partnership or acquisition for ICT-107, topline Phase III trial results for DCVax-Brain, Toca 511, and Trans Sodium Crocetinate (TSC), and topline Phase Ib/IIa trial results for INO-5401.
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