Aprea Therapeutics Presents Primary Analysis from Phase 2 Trial of Eprenetapopt + Azacitidine for Post-Transplant Maintenance Therapy in TP53 Mutant MDS and AML at the 2021 American Society of Hematology (ASH) Annual Meeting
14 December 2021 - 12:00AM
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 updated results from its Phase 2 trial evaluating
eprenetapopt with azacitidine for post-transplant maintenance
therapy in patients with TP53 mutant MDS and AML at the 2021 ASH
Annual Meeting.
In 33 patients enrolled in the trial, the relapse free survival
(RFS) at 1 year post-transplant was 60% and the median RFS was 12.5
months. The overall survival (OS) at 1 year post-transplant was
79%, with a median OS of 20.6 months. Published studies evaluating
post-transplant outcomes in TP53 mutant MDS and AML patients have
reported a 1-year post-transplant RFS of ~30% and a median OS of
~5-8 months. In addition, the post- transplant regimen of
eprenetapopt and azacitidine was well tolerated among patients in
the clinical trial. Given the encouraging data, the Company intends
to explore opportunities to conduct future randomized clinical
trials to further assess safety and efficacy of this combination in
the post-transplant maintenance setting.
“This update of data at ASH, representing the primary analysis,
highlights the very encouraging outcomes for these TP53 mutant MDS
and AML patients who received eprenetapopt and azacitidine as
post-transplant maintenance therapy,” said trial principal
investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer
Center and Research Institute. “As these patients
characteristically have poor outcomes, even with transplantation,
this post-transplant maintenance regimen is potentially
paradigm-shifting and I look forward to investigating it
further.”
Slides for this presentation can be accessed from
“Presentations” in the News and Events section of the Company’s
website at Link.
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
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 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”
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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