Aprea’s APR-246 Receives the US FDA’s Breakthrough Therapy Designation for Myelodysplastic Syndromes with a TP53 Mutation

Shots:

• The US FDA has granted BTD for APR-246 in combination with azacitidine to treat myelodysplastic syndromes (MDS) with a susceptible TP53 mutation
• The BTD supports the development program for APR-246. The company continued its interaction with FDA regarding ongoing P-III study and clinical development program to advance APR-246
• APR-246 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function and thereby inducing programmed cell death in human cancer cells

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