Samus Therapeutics announced today that the FDA cleared its investigational new drug (IND) application for its glioma treatment.

Boston-based Samus Therapeutics develops the PU-AD (icapamespib) orally administered small molecule drug for the treatment of recurrent malignant glioma, according to a news release.

Under the IND, Samus will move forward with its Phase 1b study to address the safety, tolerability and pharmacokinetics of PU-AD, a specific inhibitor of epichaperomes, in treating recurrent malignant glioma.

Dr. John de Groot of the University of Texas M.D. Anderson Cancer Center and Dr. Howard Colman of the University of Utah’s Huntsman Cancer Institute will conduct the Phase 1b study in two stages across multiple U.S. sites. The study 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,” Samus Therapeutics president & CEO Dick Bagley said in the release.

“Through the work of our scientific founder Gabriela Chiosis 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,” added CSO Barbara Wallner. “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.”