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 partial clinical hold on its clinical trials of
eprenetapopt in combination with azacitidine in its myeloid
malignancy programs. The partial clinical hold does not apply to
the Company’s ongoing clinical trials in lymphoid malignancies and
solid tumors, or the APR-548 clinical trial.
There are approximately 20 patients currently receiving
eprenetapopt in combination with azacitidine in the Company’s
myeloid malignancy programs, which includes the MDS, AML and
post-transplant maintenance trials, all of which have completed
enrollment. Patients who are benefiting from treatment can continue
to receive study treatment. As part of the clinical hold, no
additional patients can be enrolled to these trials until the
partial clinical hold is resolved. Aprea intends to work closely
with the FDA to analyze the data, address the specific questions
raised, and seek to resolve the partial clinical hold as soon as
possible.
“Patient safety is our highest priority,” said Christian S.
Schade, Chairman and Chief Executive Officer of Aprea. “Based on
the totality of the data we have for eprenetapopt, we believe that
it continues to be a promising therapeutic option for cancer
patients. We are working closely with the FDA to review the data
specific to eprenetapopt with azacitidine in our myeloid malignancy
trials and will provide an update when we have additional
information.”
The Company will host a webcast conference call to discuss this
announcement on August 6, 2021 at 8:30 AM (ET). Connection details
are provided below and are also available on the Events page of
Aprea’s website.
Webcast Link:
https://edge.media-server.com/mmc/p/8kjgeas4
Participant Dial in Number:
US/CANADA Participant Toll-Free Dial-In Number: (855)
547-3866
US/CANADA Participant International Dial-In Number: (409)
217-8798
Conference ID: 3119839
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. 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.
About p53, eprenetapopt and APR-548
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.
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.
Aprea’s myeloid malignancy program consists of clinical trials
in frontline MDS, AML and post-transplant maintenance therapy in
MDS/AML. 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. Additional clinical trials, including lymphoid
malignancies and solid tumors, are ongoing.
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 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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