Zentalis Pharmaceuticals Announces FDA Has Lifted Partial Clinical Hold on Azenosertib Studies
September 16 2024 - 7:00AM
Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage
biopharmaceutical company discovering and developing clinically
differentiated small molecule therapeutics targeting fundamental
biological pathways of cancers, today announced that the U.S. Food
and Drug Administration (FDA) has lifted the partial clinical hold
on studies of azenosertib, the Company’s novel, selective, and
orally bioavailable inhibitor of WEE1. The FDA has cleared the
Company to resume enrollment in all ongoing azenosertib clinical
studies with no changes in the clinical development plan. Zentalis
will be working with clinical trial investigators to resume study
activities across the azenosertib development program as quickly as
possible.
"We are grateful to the FDA for their collaboration
and review of our complete response package, which included a
comprehensive safety assessment of the azenosertib program,” said
Kimberly Blackwell, M.D., Chief Executive Officer. “We are
extremely pleased with the successful resolution of the partial
clinical hold. Our confidence in the therapeutic index of
azenosertib has been unwavering, and we continue to believe in the
potential for this treatment to address unmet medical needs faced
by people living with gynecologic malignancies.”
At a corporate event later this year, Zentalis will
present azenosertib monotherapy data and provide additional updates
to azenosertib clinical development and other data presentation
timelines. The Company remains on track to meet all previously
disclosed data guidance for the remainder of 2024.
About Azenosertib Azenosertib
is a novel, selective, and orally bioavailable inhibitor of WEE1
currently being evaluated in monotherapy and combination clinical
studies in ovarian cancer and additional tumor types. WEE1 acts as
a master regulator of the G1-S and G2-M cell cycle checkpoints,
through negative regulation of both CDK1 and CDK2, to prevent
replication of cells with damaged DNA. By inhibiting WEE1,
azenosertib enables cell cycle progression, despite high levels of
DNA damage, thereby resulting in the accumulation of DNA damage and
leading to mitotic catastrophe and cancer cell death.
About Zentalis
Pharmaceuticals Zentalis® Pharmaceuticals, Inc.
is a clinical-stage biopharmaceutical company discovering and
developing clinically differentiated small molecule therapeutics
targeting fundamental biological pathways of cancers. The Company’s
lead product candidate, azenosertib (ZN-c3), is a potentially
first-in-class and best-in-class WEE1 inhibitor for advanced solid
tumors. Azenosertib is being evaluated as a monotherapy and in
combination across multiple clinical trials and has broad franchise
potential. In clinical trials, azenosertib has been well tolerated
and has demonstrated anti-tumor activity as a single agent across
multiple tumor types and in combination with several chemotherapy
backbones. As part of its azenosertib clinical development program,
the Company is exploring enrichment strategies targeting tumors of
high genomic instability, such as Cyclin E1 positive tumors,
homologous recombination deficient tumors and tumors with oncogenic
driver mutations. The Company is also leveraging its extensive
experience and capabilities across cancer biology and medicinal
chemistry to advance its research on protein degraders. Zentalis
has operations in San Diego.
For more information, please
visit www.zentalis.com. Follow Zentalis on X/Twitter
at @ZentalisP and on LinkedIn
at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements regarding our plans to resume study activities
across the azenosertib development program as quickly as possible;
the potential of azenosertib to benefit patients; our plans to
disclose clinical data, and the timing thereof; our plans to
provide additional updates to the azenosertib clinical development
timelines and other data timelines and the timing thereof; the
potential for azenosertib to be first-in-class and best-in-class;
the broad franchise potential of azenosertib; and our plans with
respect to the development of our product candidates. The terms
“believe,” “continue,” “on track,” “potential,” and “will” and
similar references are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: our limited operating history, which may make it
difficult to evaluate our current business and predict our future
success and viability; we have and expect to continue to incur
significant losses; our need for additional funding, which may not
be available; our plans, including the costs thereof, of
development of any diagnostic tools; our substantial dependence on
the success of azenosertib; the outcome of preclinical testing and
early trials may not be predictive of the success of later clinical
trials; failure to identify additional product candidates and
develop or commercialize marketable products; potential unforeseen
events during clinical trials could cause delays or other adverse
consequences; risks relating to the regulatory approval process or
ongoing regulatory obligations; failure to obtain U.S. or
international marketing approval; our product candidates may cause
serious adverse side effects; inability to maintain our
collaborations, or the failure of these collaborations; our
reliance on third parties; effects of significant competition; the
possibility of system failures or security breaches; risks relating
to intellectual property; our ability to attract, retain and
motivate qualified personnel, and risks relating to management
transitions; significant costs as a result of operating as a public
company; and the other important factors discussed under the
caption “Risk Factors” in our most recently filed periodic report
on Form 10-K or 10-Q and subsequent filings with the U.S.
Securities and Exchange Commission (SEC) and our other filings with
the SEC. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis
and/or its affiliates. All website addresses and other links in
this press release are for information only and are not intended to
be an active link or to incorporate any website or other
information into this press release.
Contact:Elizabeth Pingpank
Hickinehickin@zentalis.com860-463-0469
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
Historical Stock Chart
From Sep 2024 to Oct 2024
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
Historical Stock Chart
From Oct 2023 to Oct 2024