Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical
company focused on developing and commercializing novel cancer
therapeutics that reactivate the mutant tumor suppressor protein,
p53, today presented data at the European Society of Medical
Oncology (ESMO) Congress 2021 from its Phase I/II clinical trial in
advanced solid tumors. The trial is evaluating the safety and
efficacy of eprenetapopt in combination with pembrolizumab.
As of the July 31, 2021 data cutoff, 33 patients were enrolled
on study and 31 had initiated treatment. The Phase I safety lead-in
part was a dose de-escalation design and no dose-limiting
toxicities were reported in the 6 enrolled patients. A Phase II
expansion part was initiated and, as of the data cutoff, has
enrolled 3 patients in the gastric/GEJ cancer, 3 in the
bladder/urothelial cancer and 19 in the non-small cell lung cancer
(NSCLC) cohorts. Patients in the NSCLC Phase II cohort were
required to have prior exposure to a PD-1 or PD-L1 inhibitor.
Across all patients, 25 (76%) had a mutation in the TP53 gene. The
trial continues to enroll and treat patients and exploratory
studies involving analyses of patient-derived immune cell
populations are ongoing.
In the bladder/urothelial cohort, 1 patient with locally
advanced TP53 mutant high-grade transitional cell bladder cancer
had achieved complete remission (CR) by RECIST criteria at the
first response assessment at 9 weeks. In the NSCLC cohort, 2
patients with TP53 mutant squamous NSCLC had reductions in target
lesions of 26.7% and 8.2%, respectively, from baseline by RECIST
criteria at the first response assessment at 9 weeks. Adverse
events, regardless of causality, were mostly grade 1/2. Grade ≥3
events occurring in more than 1 patient included anemia (3),
dyspnea (3), dizziness (2), pain (2) and malnutrition (2).
Dizziness (2 patients) was the only grade ≥3 adverse event assessed
by an investigator as eprenetapopt-related and occurring in more
than 1 patient. One patient experienced a fatal adverse event of
disease progression which was assessed by an investigator as not
related to study treatment, and one patient experienced adverse
events of fatigue, dyspnea and maculo-papular rash leading to
discontinuation of eprenetapopt.
“The emerging data for the combination of eprenetapopt and
pembrolizumab in these difficult-to-treat patients is very
encouraging,” said Dr. Haeseong Park of Washington University in
St. Louis. “Particularly promising are tumor reductions in lung
cancer patients who previously received I/O therapy, and the
complete remission in a bladder cancer patient with prior
chemotherapy exposure, which is rare. In addition, the clinical
experience to-date suggests the combination is well-tolerated with
adverse events readily managed with standard of care measures. The
other investigators and I look forward to maturation of the data
from this clinical trial as we seek to enroll and treat additional
patients with this novel combination.”
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 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,” “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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