Aprea Therapeutics Announces Expansion of Clinical Trial Evaluating Eprenetapopt for the Front-Line Treatment of TP53 Mutant Acute Myeloid Leukemia (AML)
- Commenced expansion cohort in combination with venetoclax and azacitidine
- Added cohort to be activated in combination with azacitidine
The lead-in portion of the Phase 1 AML Trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in patients receiving either regimen. The expansion part of the clinical trial will treat approximately 30 front-line TP53 mutant AML patients with the triplet therapy of eprenetapopt with venetoclax and azacitidine. The Company will also evaluate front-line treatment with the doublet therapy of eprenetapopt and azacitidine in approximately 30 additional TP53 mutant AML patients. Safety and efficacy will be evaluated in both patient cohorts.
“We are encouraged by the tolerability of the eprenetapopt regimens observed to-date in the trial and look forward to continued evaluation of the potential efficacy of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML,” said Dr.
About Aprea Therapeutics, Inc.
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About p53 and APR-246 (eprenetapopt)
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.
APR-246 (eprenetapopt) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.
AML is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells which impairs production of normal blood cells. AML can develop de novo or may arise secondary to progression of other hematologic disorders or from chemotherapy or radiation treatment for a different, prior malignancy. Mutations in p53 are found in up to 20% of AML patients and are associated with poor overall prognosis. There are no currently approved therapies specifically for TP53 mutant AML patients.
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Source: Aprea Therapeutics, Inc.
Scott M. CoianteSr. Vice President and Chief Financial Officer 617-463-9385 Gregory A. KorbelVice President of Business Development 617-463-9385
Source: Aprea Therapeutics