FDA granted Orphan Drug Designation to AMXT 1501 in combination with difluoromethylornithine (DFMO) for the treatment of malignant glioma
“This second Orphan Drug Designation is a powerful validation of AMXT 1501’s potential to make a meaningful difference for patients facing some of the most devastating cancers,” said Mark Burns, PhD, Chief Scientific Officer and President of Aminex Therapeutics. “DIPG is heartbreaking — children diagnosed with this brain tumor have virtually no effective treatment options and very little time. We are committed to changing that.”
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“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
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