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Aprea Therapeutics to Present Data from Phase 1/2 Trial of Eprenetapopt in Advanced Solid Tumors at ESMO Congress 2021

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Aprea Therapeutics (Nasdaq: APRE) announced a presentation of data regarding eprenetapopt in combination with pembrolizumab for treating advanced solid tumors at the ESMO Congress 2021, scheduled from September 16-21, 2021. This presentation will cover the Phase I/II study and is set for September 20, 2021. The company is focused on developing therapies targeting the mutant tumor suppressor protein p53. Notably, a pivotal Phase 3 clinical trial of eprenetapopt in TP53 mutant myelodysplastic syndromes recently failed to meet its primary endpoint.

Positive
  • Upcoming ESMO 2021 presentation for eprenetapopt and pembrolizumab.
  • Eprenetapopt received multiple designations from the FDA and European Commission.
Negative
  • Failed to meet primary endpoint in the pivotal Phase 3 clinical trial for eprenetapopt.
  • Eprenetapopt is currently on clinical hold in myeloid and lymphoid malignancies.

BOSTON, Sept. 14, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today announced an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16 – 21, 2021.

Details for the ESMO 2021 mini oral presentation are as follows: 

Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies
Speaker: Haeseong Park, Washington University in St. Louis
Presentation #: 516MO
Session: Mini oral session – Developmental therapeutics
Date and Time: Monday, September 20, 2021; 17:35 – 17:40 CEST (11:35 – 11:40am EDT)

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.

Forward-Looking Statement

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,” “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


FAQ

What is the purpose of Aprea Therapeutics' presentation at ESMO 2021?

The presentation will discuss the Phase I/II study of eprenetapopt combined with pembrolizumab in patients with solid tumor malignancies.

When will Aprea Therapeutics present data for eprenetapopt at ESMO 2021?

The presentation is scheduled for September 20, 2021, from 17:35 to 17:40 CEST.

What were the results of the Phase 3 clinical trial for eprenetapopt?

The pivotal Phase 3 trial for eprenetapopt in TP53 mutant myelodysplastic syndromes failed to meet its primary endpoint.

What designations has eprenetapopt received?

Eprenetapopt has received Orphan Drug and Fast Track designations from the FDA for MDS and AML, and Orphan Drug designation from the European Commission.

What is the current status of eprenetapopt in clinical trials?

Eprenetapopt is currently on clinical hold in myeloid and lymphoid malignancies.

Aprea Therapeutics, Inc.

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