Full Press Release Details
Aprea Therapeutics Announces Removal of
FDA Clinical Hold on Eprenetapopt in Lymphoid Malignancies
BOSTON, MA, December 9, 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 that the U.S. Food and Drug Administration
(FDA) has removed the full clinical hold on the Company's clinical trial evaluating the combination of its lead compound, eprenetapopt,
with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.
"We are pleased to have addressed the
FDA's concerns and receive clearance to proceed with future clinical study of eprenetapopt in non-Hodgkin's lymphomas,"
said Eyal Attar, M.D., Chief Medical Officer of Aprea Therapeutics. "We look forward to continued evaluation of eprenetapopt as
a therapeutic option for these patients with unmet medical need."
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 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.
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.
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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.
Sr. Vice President and Chief Financial Officer
Sr. Vice President and Chief Business Officer