Recap and Update of Positive Data from Three Presentations in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Presented at the 2021 American Society of Hematology (ASH) Annual Meeting
15 December 2021 - 12:00AM
Lead investigators from clinical trials evaluating eprenetapopt in
patients with TP53 mutant MDS or AML presented positive,
updated data at the 2021 ASH Annual Meeting. All studies evaluated
the tolerability and efficacy of Aprea Therapeutics,
Inc. (Nasdaq: APRE) lead product candidate, eprenetapopt.
Data summaries of the presentations are as follows:
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)Presenter: Asmita Mishra, M.D., H. Lee
Moffitt Cancer Center and Research Institute Tampa,
FloridaOral Abstract Session: 723. Allogeneic
Transplantation: Long-term Follow-up and Disease Recurrence |
|
Data Summary: 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. The post- transplant regimen of eprenetapopt and
azacitidine was well tolerated among patients in the clinical
trial. |
|
|
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)Presenter: David Sallman, M.D., H. Lee
Moffitt Cancer Center and Research Institute, Tampa,
FloridaOral Abstract Session: 637. Myelodysplastic
Syndromes—Clinical and Epidemiological: Treatment of High Risk
Myelodysplastic Syndrome |
|
Data Summary: By ITT analysis (n=100), ORR was 69%
and CR was 43% by International Working Group criteria; Biallelic
TP53 mutation or complex karyotype was significantly associated
with higher CR rate (49% versus 8%; P=0.01); combination therapy
was well tolerated in treated patients. |
|
|
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)Presenter: Guillermo Garcia-Manero, M.D., The
University of Texas MD Anderson Cancer Center, Houston,
TexasPoster Abstract Session: 616. Acute Myeloid
Leukemias: Investigational Therapies, Excluding Transplantation and
Cellular Immunotherapies: Poster III |
|
Data Summary: In 39 efficacy evaluable patients
ORR was 64%, CR was 39%, and CR + CRi and the CR + CRh rates were
each 56%. The triplet combination of eprenetapopt, venetoclax and
azacitidine, was tolerable as an outpatient regimen. |
Presentations of these data 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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