Aprea Therapeutics Announces Clinical Hold on Lymphoid Malignancy Program
August 12 2021 - 5:00AM
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 the U.S. Food and Drug Administration (FDA)
has placed a clinical hold on its clinical trial evaluating
eprenetapopt with acalabrutinib or with venetoclax and rituximab in
lymphoid malignancies. No additional patients can be enrolled until
the clinical hold is resolved, though patients on study deriving
clinical benefit can continue to receive study treatment.
Subsequent to receiving notification of a partial clinical hold
on its myeloid malignancies program, Aprea was informed by FDA of a
clinical hold on its lymphoid malignancy study. The FDA’s concerns
referred to the safety and efficacy data from the Phase 3 MDS
clinical trial. One CLL patient is currently on study treatment
receiving eprenetapopt in combination with venetoclax and rituximab
and has achieved complete remission (CR). Aprea intends to work
closely with the FDA to address the specific questions raised, and
seek to resolve the clinical hold as soon as possible.
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 Breakthrough Therapy, 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,”
“seek” 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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