Aprea Shares Update On Its Eprenetapopt Program In Various Blood Cancer Settings

  • Aprea Therapeutics Inc APRE plans to study eprenetapopt in new trials across various myeloid and lymphoid malignancies after a string of clinical holds on the therapy in August 2021. 
  • The agency placed a clinical hold on Aprea's NHL (lymphoid malignancy) study and partial holds (Myeloid Malignancy) on a phase 3 MDS study, midstage MDS/AML post-transplant trial, and a phase 1/2 AML study. 
  • In December last year, the Company discussed the data and analyses from the Phase 3 trial with the FDA. It reached a preliminary agreement on proposals for new clinical trials in myeloid malignancies. 
  • According to the latest 10K filing, the FDA said that the partial clinical hold on these three trials would continue. Aprea said that it has no plans to enroll new patients into any of these trials. 
  • But, the FDA cleared to proceed under its existing myeloid malignancy IND with a new trial in relapsed/refractory MDS and AML.
  • The NHL trial hold was lifted in December 2021, and Aprea received the FDA green light to proceed with a new trial in relapsed / refractory TP53 mutant Richter's transformed NHL.  
  • Preliminary tolerability and efficacy data from these studies may be available in 2H of 2022.
  • The Company held cash and cash equivalents of $53.1 million at the end of 2021, sufficient to meet its operating requirements into 2023.
  • Aprea expects an FY 22 cash burn of $25 million - $30 million. 
  • Price Action: APRE shares are up 7.47% at $1.87 during the market session on the last check Wednesday.
  • Editor's Note: The story has been corrected to include that FDA clinical hold on Myeloid Malignancy program continues and other information from the 10-K.
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