Aprea Therapeutics can resume testing its main asset, eprenetapopt, after a string of clinical holds iced the therapy in August 2021. The biotech plans to study the drug in new trials across various myeloid and lymphoid malignancies.
The Boston biotech will initiate a new study of eprenetapopt in patients with relapsed/refractory Myelodysplastic syndrome, or MDS, in which blood cell production is impacted, and acute myeloid leukemia, Aprea said Tuesday after market close. The company is also looking at a new trial in patients with non-Hodgkin lymphomas, or NHL. Aprea did not specify the phases of the new studies.
The trial adjustments come after the FDA told Aprea to hold off on multiple clinical trials last summer. The agency placed a clinical hold on Aprea’s NHL study and partial holds on a phase 3 MDS study, midstage MDS/AML post-transplant trial and a phase 1/2 AML test. The NHL trial hold was lifted in December 2021, and Aprea received the FDA green light to proceed with a new MDS and AML study in the first quarter of this year.
Aprea’s shares rose nearly 5% Wednesday morning on the news, reaching $1.82 apiece as of 10:04 a.m. ET.RBC Capital Markets analysts noted that 2022 will be a ‘show-me’ year for Aprea as the biotech provides updates on the clinical potential of its molecules throughout 2022.
Eprenetapopt, also known as APR-246, previously failed a phase 3 trial in combination with azacitidine, an MDS and AML drug marketed by Bristol Myers Squibb as Vidaza and Onureg. The combo did not meet the complete remission rate goal in patients with TP53 mutant MDS, Aprea said in December 2020.
The drug has orphan drug and fast-track designations from the FDA for MDS and AML. The European Commission has also given the drug orphan status in the same indications.
Aprea “is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities,” the company said in its full-year 2021 earnings update Tuesday night.
The biotech is also evaluating a future clinical trial of an orally-administered formulation of eprenetapopt in combination with anti-PD-1 therapy in advanced solid tumors. Aprea has completed enrollment in a phase 1/2 study testing the combo in patients with relapsed/refractory gastric, bladder and non-small cell lung cancers.
Further down the pipeline, Aprea said it does not plan to enroll any more patients in a phase 1 trial of its second asset, APR-548. The biotech wrapped enrollment in the first dosing cohort, which included patients with relapsed/refractory MDS and AML. Aprea will collect and analyze pharmacokinetic and adverse event data.