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 investigators will present data from clinical
trials evaluating eprenetapopt at the 63rd American Society of
Hematology Annual Meeting (ASH).
Oral presentations are as follows:
Title: Long-Term Follow-up and Combined Phase 2
Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients
with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic
Acute Myeloid Leukemia (AML)Date & Time:
Saturday, December 11, 2021 at 3:15 pm ETOral Abstract
Session: 637. Myelodysplastic Syndromes—Clinical and
Epidemiological: Treatment of High Risk Myelodysplastic
SyndromeAbstract: 246Location:
Georgia World Congress Center, B207-B208Presenter:
David Sallman, M.D., H. Lee Moffitt Cancer Center and Research
Institute, Tampa, Florida
Title: Phase II Trial of Eprenetapopt (APR-246)
in Combination with Azacitidine (AZA) As Maintenance Therapy for
TP53 Mutated AML or MDS Following Allogeneic Stem Cell
Transplantation (SCT)Date & Time: Sunday,
December 12, 2021 at 9:30 am ETOral Abstract
Session: 723. Allogeneic Transplantation: Long-term
Follow-up and Disease RecurrenceAbstract:
409Location: Georgia World Congress Center,
B304-B305Presenter: Asmita Mishra, M.D., H. Lee
Moffitt Cancer Center and Research Institute Tampa, Florida
Poster presentation is as follows:
Title: Phase I and Expansion Study of
Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and
Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia
(AML)Date & Time: Monday, December 13, 2021,
6:00 – 8:00 pm ETPoster Abstract Session: 616.
Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster
IIIAbstract: 3409Location:
Georgia World Congress Center, Hall B5Presenter:
Guillermo Garcia-Manero, M.D., The University of Texas MD Anderson
Cancer Center, Houston, Texas
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 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.
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 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 study
analyses, clinical trials, regulatory submissions, and projected
cash position. We may, in some cases use terms such as “future,”
“predicts,” “believes,” “potential,” “continue,” “seeks,”
“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. CoianteSr. Vice President and Chief Financial
Officer617-463-9385
Gregory A. KorbelSr. Vice President and Chief Business
Officer617-463-9385
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