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Clinical Holds Lofted and Aprea Embarks Key Cancer Candidate

Aprea Therapeutics can begin testing of its key asset, eprenetapopt, after a series of Clinical pauses in August 2021. The biotech company intends to test the medicine in fresh studies for a variety of myeloid and lymphoid cancers. Aprea announced Tuesday after market close that it will begin a new study of eprenetapopt in patients with relapsed/refractory Myelodysplastic syndrome, or MDS, which affects blood cell formation, and acute myeloid leukaemia.

A new experiment in patients with non-Hodgkin lymphomas, or NHL, is also being considered by the business. The phases of the new investigations were not specified by Aprea. The changes to the trials came after the FDA urged Aprea to postpone several Clinical trials last summer. Aprea’s NHL study has been put on hold, as have partial pauses on a phase 3 MDS study, a midstage MDS/AML post-transplant trial, and a phase 1/2 AML test.

In December 2021, the NHL trial was lifted, and Aprea got FDA approval to begin a new MDS and AML research in the first quarter of this year. Aprea’s stock jumped over 5% on the news Wednesday morning, reaching $1.82 per share at 10:04 a.m. ET. Aprea will have a’show-me’ year in 2022, according to RBC Capital Markets analysts, as the biotech offers updates on the Clinical prospects of its compounds throughout the year.

Eprenetapopt, also known as APR-246, previously failed a phase 3 trial in which it was combined with azacitidine, an MDS and AML medication marketed by Bristol Myers Squibb under the names Vidaza and Onureg.  Aprea reported in December 2020 that the combination did not achieve the complete remission rate goal in patients with TP53 mutant MDS. The FDA has given the medicine orphan drug and fast-track designations for MDS and AML. In the same indications, the European Commission has accorded the medicine orphan status.

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