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 Q&A.
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-548The 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
617-463-9385
Gregory A. Korbel
Vice President of Business Development
617-463-9385
Source: Aprea Therapeutics, Inc.
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