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APRE - Aprea Therapeutics Inc News Story

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Aprea Therapeutics Receives FDA Fast Track Designation for Eprenetapopt in the Treatment of TP53 Mutant Acute Myeloid Leukemia (AML)

Mon 30th November, 2020 1:00pm
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BOSTON, Nov. 30, 2020 (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
granted Fast Track designation for eprenetapopt in the treatment of patients
with TP53 mutant acute myeloid leukemia (AML). The Company previously received
Breakthrough Therapy, Orphan Drug and Fast Track designations for eprenetapopt
in the treatment of patients with TP53 mutant myelodysplastic syndromes (MDS).

The FDA’s Fast Track designation is intended to facilitate the development
and review of drug candidates that treat serious conditions and address an
unmet medical need. A drug candidate that receives Fast Track designation may
be eligible for more frequent interaction with the FDA to discuss the drug
candidate’s development plan as well as eligibility for accelerated approval
and priority review.

“We are pleased to have received Fast Track designation for eprenetapopt in
the treatment of TP53 mutant AML, a cancer for which outcomes are poor and
there are no current therapeutic options specifically for these patients,”
said Eyal C. Attar, M.D., Chief Medical Officer of Aprea. “Emerging data
from our AML trials evaluating eprenetapopt with azacitidine, and with
eprenetapopt, azacitidine and venetoclax, are promising and we continue to
enroll patients to identify the best treatment regimen. As these data mature
in 2021, we look forward to continued interaction with FDA as we map out
opportunities for an accelerated pathway to potential approval.”

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, including myelodysplastic syndromes (MDS) and
acute myeloid leukemia (AML). Eprenetapopt has received Breakthrough Therapy,
Orphan Drug and Fast Track designations from the FDA for MDS, Fast Track
designation from the FDA for AML,and Orphan Drug designation from the European
Commission for MDS, AML and ovarian cancer. 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

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. In addition to pre-clinical testing, a Phase 1/2 clinical program
with eprenetapopt has been completed, demonstrating a favorable safety profile
and both biological and confirmed clinical responses in hematological
malignancies and solid tumors with mutations in the TP53 gene.

A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline
treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received
Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for
MDS, Fast Track designation from the FDA for AML, and Orphan Drug designation
from the European Medicines Agency for MDS, AML and ovarian cancer.

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.
Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin in
the first quarter of 2021

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 clinical trials, regulatory
submissions and projected cash position. We may, in some cases use terms such
as “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

Gregory A. Korbel
Vice President of Business Development


GlobeNewswire, Inc. 2020
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