Aprea Therapeutics to Present Data from Clinical Trials Evaluating Eprenetapopt at 63rd American Society of Hematology Annual Meeting
Aprea Therapeutics (NASDAQ: APRE) announced presentations of clinical trial data for eprenetapopt at the 63rd American Society of Hematology Annual Meeting. Key oral presentations include long-term follow-up results combining eprenetapopt with azacitidine in TP53 mutant myelodysplastic syndromes and acute myeloid leukemia, scheduled for December 11 and 12, 2021. A poster presentation is also planned for December 13, 2021, featuring a Phase I study of eprenetapopt with venetoclax and azacitidine for TP53-mutant AML. The company continues to develop innovative therapies targeting mutant p53.
- Key presentations scheduled at the 63rd ASH Annual Meeting on December 11-13, 2021.
- Eprenetapopt shows potential with promising results in combination therapies for TP53 mutant cancers.
- The drug has received Orphan Drug and Fast Track designations from the FDA for specific indications.
- Pivotal Phase 3 trial of eprenetapopt did not meet the primary endpoint of complete remission in TP53 mutant MDS.
- Eprenetapopt is currently on clinical hold in myeloid and lymphoid malignancies.
BOSTON, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that investigators will present data from clinical trials evaluating eprenetapopt at the 63rd American Society of Hematology Annual Meeting (ASH).
Oral presentations are as follows:
Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
Date & Time: Saturday, December 11, 2021 at 3:15 pm ET
Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical and Epidemiological: Treatment of High Risk Myelodysplastic Syndrome
Abstract: 246
Location: Georgia World Congress Center, B207-B208
Presenter: David Sallman, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
Title: Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)
Date & Time: Sunday, December 12, 2021 at 9:30 am ET
Oral Abstract Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence
Abstract: 409
Location: Georgia World Congress Center, B304-B305
Presenter: Asmita Mishra, M.D., H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida
Poster presentation is as follows:
Title: Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
Date & Time: Monday, December 13, 2021, 6:00 – 8:00 pm ET
Poster Abstract Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Abstract: 3409
Location: Georgia World Congress Center, Hall B5
Presenter: Guillermo Garcia-Manero, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company’s lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies and solid tumors. A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary statistical endpoint of complete remission. Eprenetapopt is currently on clinical hold in myeloid and lymphoid malignancies. Eprenetapopt has received Orphan Drug and Fast Track designations from the FDA for myelodysplastic syndromes (MDS), Orphan Drug and Fast Track designations from the FDA for acute myeloid leukemia (AML), and Orphan Drug designation from the European Commission for MDS and AML. APR-548, a next generation small molecule reactivator of mutant p53, is being developed for oral administration. For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
About p53, eprenetapopt and APR-548
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately
Eprenetapopt (APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt 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.
APR-548 is a next-generation small molecule p53 reactivator. APR-548 has demonstrated high oral bioavailability, enhanced potency relative to eprenetapopt in TP53 mutant cancer cell lines and has demonstrated in vivo tumor growth inhibition following oral dosing of tumor-bearing mice.
Forward Looking Statements
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “seeks,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Source: Aprea Therapeutics, Inc.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385
Gregory A. Korbel
Sr. Vice President and Chief Business Officer
617-463-9385
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