Aprea Therapeutics, Inc. ( APRE Quick Quote APRE - Free Report) announced promising top-line data from a phase I/II study evaluating a combination regimen of pipeline candidate, eprenetapopt, in patients with acute myeloid leukemia (AML). The study met its pre-specified primary efficacy endpoint of complete remission (CR) rate.
The study was evaluating eprenetapopt in combination with
Roche ( RHHBY Quick Quote RHHBY - Free Report) / AbbVie’s ( ABBV Quick Quote ABBV - Free Report) Venclexta (venetoclax) and chemotherapy drug, azacytidine, as a potential treatment for TP53 mutant AML.
Data from the study showed that 37% of patients achieved complete remission with 53% composite response rate (which includes complete response with incomplete hematologic recovery). The company plans to discuss the study data with the FDA in the second half of 2021.
Shares of Aprea rose almost 11% on Jun 16, following the study data readouts. In fact, the company’s shares have gained 9.3% in the year so far against the
industry’s decline of 0.7%. Image Source: Zacks Investment Research
Apart from AML, the company is also developing eprenetapopt for treating myelodysplastic syndromes (MDS). A phase II study is evaluating a combination of eprenetapopt with azacitidine as maintenance therapy for TP53 mutant MDS and AML in patients who have received allogeneic stem cell transplant. Moreover, a previously completed phase I/II study along showed that treatment with eprenetapopt achieved both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene along with favorable safety profile.
However, previously completed pivotal late-stage study evaluating eprenetapopt in combination with azacytidine as front-line treatment of TP53 mutant MDS failed to meet the primary statistical endpoint of complete remission last year.
Zacks Rank & Stock to Consider
Aprea currently carries a Zacks Rank #3 (Hold).
BioNTech SE ( BNTX Quick Quote BNTX - Free Report) is a better-ranked biotech stock, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioNTech’s earnings per share estimates have increased from $30.71 to $30.85 for 2021 and from $25.05 to $25.20 over the past 30 days. The company delivered an earnings surprise of 70.52%, on average, in the last four quarters.
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