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APRE - Aprea Therapeutics Inc News Story

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Aprea Therapeutics to Highlight Changing Treatment Paradigm in MDS as well as Development Pipeline Progress at Virtual R&D Day Today

Fri 30th October, 2020 8:00am
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BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq:
APRE), a biopharmaceutical company focused on developing and commercializing
novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53,
will host a live virtual R&D Day Webinar, with presentations by key opinion
leaders in hematology, today from 1:00 – 3:00 pm Eastern Time.

R&D Day Webinar Agenda:

1:00 pm – 2:00 pm:
Introduction and discussion with Drs. David Sallman (Moffitt Cancer Center),
Guillermo Garcia-Manero (MD Anderson Cancer Center), and Eyal Attar (Aprea’s
Chief Medical Officer) to review current clinical therapy options for TP53
mutant MDS/AML patients and the potential role of eprenetapopt. Discussion
with review of Aprea’s Phase 3 Clinical program in MDS to be followed by

2:00 pm – 2:15 pm:
Overview of Aprea’s ongoing commercial preparations in front-line MDS by
Greg Wessels, Aprea’s Chief Commercial Officer

2:15 pm – 3:00 pm:
Review of Aprea’s hematology and solid tumor clinical pipeline, by Dr. Eyal
Attar followed by Q&A and Wrap-up.

Virtual R&D Day Webinar Information

The live webinar will begin at 1:00 pm Eastern Time and conclude at
approximately 3:00 pm. Registration is accessible on the Events
page of Aprea’s website. Following the webinar, a replay will be available
for a limited time on Aprea’s website.

About Aprea Therapeutics

Aprea Therapeutics, Inc., (NASDAQ: APRE) is a biopharmaceutical company
headquartered in Boston, Massachusetts with research facilities in Stockholm,
Sweden, focused on developing and commercializing novel cancer therapeutics
that reactivate the 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, 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.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 is a small molecule that has demonstrated reactivation of mutant
and inactivated p53 protein – by restoring wild-type p53 conformation and
function – and thereby induce 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 U.S.
Food and Drug Administration for MDS, 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. A Phase 1
clinical trial of APR-548 in TP53 mutant MDS is planned.

Forward-Looking Statements

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 and regulatory
submissions. We may, in some cases use terms such as “predicts,”
“believes,” “potential,” “continue,” “anticipates,”
“estimates,” “expects,” “plans,” “intends,” “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 and the other risks set forth in our filings
with the U.S. Securities and Exchange Commission, including in our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2020. 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.

Corporate Contacts:

Scott M. Coiante

Sr. Vice President and Chief Financial Officer


Gregory A. Korbel

Vice President of Business Development


Source: Aprea Therapeutics, Inc.


GlobeNewswire, Inc. 2020
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