Aprea Therapeutics Inc. (NASDAQ: APRE) stock gained by 41.03% at the last check in the current market trading. Aprea Therapeutics is a pharmaceutical business based in Boston, Massachusetts, with research centers in Stockholm, Sweden. Aprea Therapeutics is aiming on discovering and promoting new cancer therapeutics that reactivates mutant tumor suppressor protein, p53.
What happened?
APRE reported that the primary efficiency endpoint of complete remission (CR) rate was met in the Phase 1/2 study assessing the frontline therapy of eprenetapopt with venetoclax and azacitidine in individuals with TP53 mutant AML.
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The CR value was 37 percent in 30 patients who could be evaluated for effectiveness at the time of the analyzation, and the composite response rate of CR plus CR with incomplete hematologic recovery, CR/CRi, was 53 percent. The trial’s main efficacy endpoint, CR, was met using a Simon 2-stage design. At the time of the data cut, 11 patients were still receiving study treatment and were being monitored for safety and efficacy. In the second half of 2021, APRE intends to meet with the US Food and Drug Administration to discuss the dataset, and data from the trial will be presented at a future scientific or medical conference.
Eyal Attar, Chief Medical Officer of Aprea Therapeutics said,
The findings of combining eprenetapopt with venetoclax and azacitidine in this complicated TP53 mutant AML population, a patient group with high unmet medical need, are encouraging. These findings, which come after the FDA recently granted eprenetapopt Fast Track and Orphan Drug designations, show that the drug has potency to treat the myeloid malignancies. They’re making great progress in their myeloid malignancies program, and they’ll provide an update in July 2021 on their Phase 2 study testing eprenetapopt with azacitidine as maintenance treatment in TP53 mutant MDS and AML patients who have had allogeneic stem cell transplantation.