Constellation Pharmaceuticals Advances CPI-0209 into Clinical Trials, Expanding its EZH2 Franchise
24 Septembre 2019 - 1:00PM
Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a
clinical-stage biopharmaceutical company using its expertise in
epigenetics to discover and develop novel therapeutics, today
announced that the Company has dosed the first patient in a Phase
1/2 clinical trial of CPI-0209.
CPI-0209 is a second-generation EZH2 inhibitor that has been
designed to achieve comprehensive target coverage through extended
on-target residence time and enhanced potency compared with
first-generation EZH2 inhibitors. These features lead to faster
onset of action than first-generation EZH2 inhibitors as well as
robust anti-tumor activity in models of multiple cancer
types.
“We recognized that a best-in-class molecule with enhanced
potency and residence time may help to access the full potential of
EZH2 inhibition in cancer,” said Dr. Patrick Trojer, Chief
Scientific Officer. “We believe that CPI-0209 can deliver on this
need, and we are eager to learn more about CPI-0209 in the clinic.
We have seen impressive pre-clinical activity of CPI-0209 and are
excited to take the first steps toward bringing CPI-0209 to
patients.”
Constellation has utilized its epigenetics platform, including
expertise in translational science, to identify novel, targeted
patient contexts that may be responsive to inhibition by
next-generation EZH2 inhibitors. For instance, in xenografts
derived from bladder cell lines harboring ARID1A mutations,
once-daily treatment with CPI-0209 achieved regression at
well-tolerated doses – activity that was superior to that from the
chemotherapeutic agent cisplatin, a standard of care in bladder
cancer. At the American Association for Cancer Research Bladder
Cancer meeting on May 19, 2019, Constellation presented a poster
with supporting data from these studies.
The Phase 1 dose escalation phase of the clinical trial will
study CPI-0209 monotherapy in advanced, relapsed solid tumor
patients. After determining the recommended Phase 2 dose (RP2D) for
the monotherapy, we will pursue expansion arms in selected tumor
indications as well as combination therapy development, employing a
biomarker strategy that includes assessment of ARID1A.
About Constellation Pharmaceuticals
Constellation Pharmaceuticals is a clinical-stage
biopharmaceutical company developing novel therapeutics that
selectively modulate gene expression to address serious unmet
medical needs in patients with cancer. The Company has a deep
understanding of how epigenetic and chromatin modifications in
cancer cells and in the tumor and immune microenvironment play a
fundamental role in driving disease progression and drug
resistance. Constellation is driving development of the EZH2
inhibitors CPI-1205 and CPI-0209 for the treatment of metastatic
castration-resistant prostate cancer and other cancers as well as
the BET inhibitor CPI-0610 for the treatment of myelofibrosis. The
Company is also applying its broad research and development
capabilities to explore other novel targets that directly and
indirectly impact gene expression to fuel a sustainable pipeline of
innovative small-molecule product candidates.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties, including
statements regarding the implications of preclinical data and the
development status of, and development plans and timelines for, the
Company’s product candidates. All statements, other than statements
of historical facts, contained in this press release, including
statements regarding the Company’s strategy, future operations,
future financial position, prospects, plans and objectives of
management, are forward-looking statements. The words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in, or implied by,
such forward-looking statements. These risks and uncertainties
include, but are not limited to, risks associated with
Constellation’s ability to: obtain and maintain necessary approvals
from the FDA and other regulatory authorities; continue to advance
its product candidates in clinical trials; whether preliminary or
interim results from preclinical studies or a clinical trial will
be predictive of the final results of a clinical trial; advance the
development of its product candidates under the timelines it
anticipates, or at all, in current and future clinical trials;
obtain, maintain or protect intellectual property rights related to
its product candidates; manage expenses; and raise the substantial
additional capital needed to achieve its business objectives. For a
discussion of other risks and uncertainties, any of which could
cause the Company’s actual results to differ from those contained
in the forward-looking statements, see the “Risk Factors” section,
as well as discussions of potential risks, uncertainties, and other
important factors, in the Company’s most recent filings with the
Securities and Exchange Commission. In addition, the forward-
looking statements included in this press release represent the
Company’s views as of the date hereof and should not be relied upon
as representing the Company’s views as of any date subsequent to
the date hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. CPI-1205, CPI-0610, CPI-0209,
and other product candidates are investigational in nature and have
not yet been approved by the FDA or other regulatory
authorities.
Contact Ronald Aldridge Senior Director,
Investor RelationsConstellation Pharmaceuticals+1
617-714-0539ron.aldridge@constellationpharma.com
Lauren ArnoldMedia RelationsMacDougall Biomedical
Communications+1 781-235-3060larnold@macbiocom.com
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