Aprea Therapeutics Announces Expansion of Clinical Trial Evaluating Eprenetapopt for the Front-Line Treatment of TP53 Mutant ...
July 16 2020 - 7:00AM
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 the expansion of patient enrollment in its Phase 1
clinical trial evaluating eprenetapopt in TP53 mutant AML.
Following the completion of the safety lead-in portion of the
clinical trial, the first expansion cohort will evaluate the
combination of eprenetapopt with venetoclax and azacitidine in
frontline TP53 mutant AML. The Company also plans to activate a
cohort in the trial that will evaluate eprenetapopt with
azacitidine in frontline TP53 mutant AML, expanding upon results
for TP53 mutant AML patients recently presented from two
independent Phase 1b/2 clinical trials.
The lead-in portion of the Phase 1 AML Trial evaluated the
tolerability of eprenetapopt with venetoclax, with or without
azacitidine, and no dose-limiting toxicities were observed in
patients receiving either regimen. The expansion part of the
clinical trial will treat approximately 30 front-line TP53 mutant
AML patients with the triplet therapy of eprenetapopt with
venetoclax and azacitidine. The Company will also evaluate
front-line treatment with the doublet therapy of eprenetapopt and
azacitidine in approximately 30 additional TP53 mutant AML
patients. Safety and efficacy will be evaluated in both patient
cohorts.
“We are encouraged by the tolerability of the eprenetapopt
regimens observed to-date in the trial and look forward to
continued evaluation of the potential efficacy of eprenetapopt with
venetoclax and azacitidine for the frontline treatment of TP53
mutant AML,” said Dr. Eyal Attar, Senior Vice President and Chief
Medical Officer of Aprea. “In addition, we plan to also enroll a
cohort of patients with TP53 mutant AML that will receive
eprenetapopt with azacitidine to expand on the promising data
generated in the two Phase 1b/2 MDS/AML trials, where the results
in AML patients compare favorably to recently presented data for
the venetoclax and azacitidine doublet regimen in TP53 mutant
AML.”
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 APR-246 (eprenetapopt), a small molecule
in clinical development for hematologic malignancies, including
myelodysplastic syndromes (MDS) and acute myeloid leukemia
(AML). APR-246 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. 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 and APR-246 (eprenetapopt)
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.
APR-246 (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 APR-246 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 APR-246 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 FDA for MDS, and Orphan Drug designation from
the EMA for MDS, AML and ovarian cancer.
About AML
AML is the most common form of adult leukemia, with the highest
incidence in patients aged 60 years and older. AML is characterized
by proliferation of abnormal immature white blood cells which
impairs production of normal blood cells. AML can develop de novo
or may arise secondary to progression of other hematologic
disorders or from chemotherapy or radiation treatment for a
different, prior malignancy. Mutations in p53 are found in up to
20% of AML patients and are associated with poor overall prognosis.
There are no currently approved therapies specifically for TP53
mutant AML patients.
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 clinical trials, regulatory
submissions and projected cash position. We may, in some cases use
terms such as “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. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385
Gregory A. Korbel
Vice President of Business Development
617-463-9385
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