On May 11, 2021 Samus Therapeutics, Inc. ("Samus Therapeutics" or the "Company"), a privately held, Boston-based biopharmaceutical company developing epichaperome inhibitors to treat CNS diseases and hematologic malignancies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to develop PU-AD for the treatment of recurrent malignant glioma (Press release, Samus Therapeutics, MAY 11, 2021, View Source [SID1234579728]). Under this IND, Samus will proceed with its Phase 1b study addressing the safety, tolerability and pharmacokinetics of PU-AD (icapamespib) in patients with recurrent malignant glioma. Icapamespib is an orally administered small molecule that is a specific inhibitor of epichaperomes.
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Under the leadership of Dr. John de Groot, at the University of Texas M.D. Anderson Cancer Center and Dr. Howard Colman at the Huntsman Cancer Institute at the University of Utah, the multicenter Phase 1b study will be conducted in two stages at multiple sites across the U.S. The dose escalation will address daily administration of icapamespib in patients with a first, second or third recurrence of isocitrate dehydrogenase (IDH) wild type glioblastoma, or grade 3 or 4 IDH mutant astrocytoma.
"The expansion stage of this trial will not only confirm safety of the Phase 2 dose, but also investigate the biology of recurrent disease through biomarker analysis and evidence of target engagement," said Dick Bagley, President and CEO of Samus Therapeutics.
Malignant glioma is a characterization of Stage 3 and 4 glioblastoma/astrocytoma diagnoses. Standard of care at outset is varied but predominantly includes surgery, chemotherapy, and radiation therapy. According to the American Cancer Society, glioblastoma is the most common and most aggressive form of the primary brain tumors in adults, accounting for half of all primary brain cancers. Despite extensive research, available treatments have not improved the median survival of 14-16 months.
"Through the work of our scientific founder Gabriela Chiosis, PhD and her collaborators, we have established that glioblastomas express high levels of epichaperomes as evidenced in explants, primary and secondary neurospheres, and glial stem cells. Epichaperome driven glioblastoma cells respond well to icapamespib treatment in xenograft mouse models and ex vivo studies even when resistant to Temodar (temozolomide) and Avastin (bevacizumab), giving us a signal that icapamespib could have a clinical impact on this devastating disease," commented Barbara Wallner, PhD, Chief Scientific Officer.