eClinical Technology and Industy News

Aprea Therapeutics Receives OK from FDA to Initiate Phase 1 Clinical Studies for Next-Generation Mutant p53 Reactivator, APR-548

Excerpt from the Press Release:

BOSTON, Oct. 07, 2020 (GLOBE NEWSWIRE) — Aprea Therapeutics Inc., (NASDAQ: APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for APR-548 to treat TP53 mutant myelodysplastic syndromes (MDS). APR-548 is a next-generation small molecule reactivator of mutant p53 that is being developed for oral administration.

“The IND acceptance by FDA is an important milestone for APR-548 and Aprea’s development of next-generation reactivators of mutant p53,” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. “We look forward to initiating the Phase 1 clinical trial of APR-548 in MDS and to expanding our leadership in the development of needed therapeutic options for patients with p53 mutated cancers.”

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