Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) today announced
that two abstracts relating to the MANIFEST clinical trial of
CPI-0610 for myelofibrosis – one in association with the American
Society for Clinical Oncology (ASCO) annual meeting and the other
in association with the European Hematology Association (EHA)
annual meeting – published online. The abstracts include an
analysis based on a data cutoff of January 17, 2019, from 18
enrolled patients. Upcoming presentations at ASCO and EHA will
reflect an analysis of a larger patient population based on a data
cutoff of April 17, 2019.
MANIFEST is an open-label Phase 2 clinical trial of CPI-0610 in
patients with myelofibrosis (MF), a rare cancer of the bone marrow
that disrupts the body’s normal production of blood cells.
Constellation is evaluating CPI-0610, either as a monotherapy or in
combination with ruxolitinib, in a second-line setting in patients
with MF who are refractory to or intolerant of or have relapsed or
lost response to ruxolitinib. Patients in the two second-line arms
are being stratified based on transfusion dependent status. The
primary endpoint for the cohorts with transfusion-dependent
patients is conversion to transfusion independence for 12
consecutive weeks. The primary endpoint for the patients who were
non-transfusion dependent at baseline is spleen volume reduction.
In addition, the Company added a third arm designed to evaluate
treatment with CPI-0610 in combination with ruxolitinib as a
first-line therapy in JAK 1/2-inhibitor-naïve MF
patients.
Data Highlights From Abstracts
Below are highlights of data on second-line patients in the ASCO
and EHA abstracts, which published on May 15 and May 16,
respectively.
- Spleen volume reductions as measured by MRI occurred in all ten
evaluable patients and ranged from 6% to 44%.
- Symptom improvements were observed.
- Out of the four patients who received bone marrow assessments,
three had a one-grade improvement in bone marrow fibrosis and had
hemoglobin increases of ≥1.5 g/dL for ≥12 weeks without
transfusions. The fourth patient had a one-grade improvement in the
bone marrow reticulin score. All of these score improvements were
based on a scale of 0-3.
- Two of the four patients with bone marrow assessments were
transfusion dependent at baseline, and both of these patients
became transfusion independent.
- Hemoglobin increases of ≥1.5 g/dL occurred in both of two
evaluable patients on monotherapy and three of nine patients on the
combination with ruxolitinib.
- CPI-0610, both as monotherapy and in combination with
ruxolitinib, was generally well tolerated. The most common side
effects were Grade 1 / 2 diarrhea, nausea / vomiting, and
reversible and non-cumulative thrombocytopenia.
“Interim data from the MANIFEST trial indicate that CPI-0610 has
been generally well-tolerated, with promising therapeutic activity
for the treatment of myelofibrosis,” said Adrian Senderowicz, Chief
Medical Officer at Constellation Pharmaceuticals. “In addition to
spleen and symptom improvement in these refractory patients, we are
pleased to see an array of clinical data suggesting the potential
for disease-modifying effects, such as improved hematopoietic
function, conversion to transfusion independence, and improvement
in bone marrow fibrosis. We look forward to providing further
updates of the MANIFEST trial at both ASCO and EHA.”
ASCO Poster Presentation
TITLE: A Phase 2 Study of CPI-0610, a Bromodomain and
Extraterminal Protein Inhibitor (BETi) alone or with Ruxolitinib
(RUX), in Patients with Myelofibrosis (MF)
Poster Session: Hematologic Malignancies—Leukemia,
Myelodysplastic Syndromes, and Allotransplant
Date and Time: Monday, June 3, 2019, 8:00 AM CDT (9:00 AM
EDT)
Dr. Marina Kremyanskaya of the Mount Sinai School of Medicine,
an investigator in the MANIFEST clinical trial, will present a
poster with updated details of interim data at the American Society
for Clinical Oncology (ASCO) annual meeting. The data to be
presented in the poster were gathered from 44 patients enrolled as
of April 17, 2019. Twelve patients received 24-week assessments and
16 patients received 12-week assessments. Among the parameters
being assessed were spleen volume reduction, total symptom scores,
transfusion dependence, bone marrow fibrosis, and safety.
EHA Oral Presentation
TITLE: CPI-0610, A Bromodomain and Extraterminal Domain (BET)
Inhibitor, Reduces Proinflammatory Cytokines, Bone Marrow Fibrosis
and the Number of Transfusions in Myelofibrosis Patients
Session: New Agents in MPN
Date and Time: June 15, 12:15 PM CEST (6:15 AM EDT)
Dr. Ronald Hoffman of Mt. Sinai Health System, an investigator
in MANIFEST, will make an oral presentation on these updated
interim data at the European Hematology Association (EHA) annual
meeting on June 15 at 12:15 PM CEST.
Investor Event. Constellation will also host an
investor meeting and conference call to discuss these interim data
on June 4 at 7:00 AM CDT. This event will include participation by
Dr. Srdan Verstovsek, a medical oncologist at the University of
Texas MD Anderson Cancer Center who is an investigator in the
MANIFEST trial, and Dr. Raajit Rampal, hematologic oncologist at
Memorial Sloan Kettering Cancer Center. Details will be announced
later.
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 preliminary clinical data,
the development status of the Company’s product candidates, the
Company’s plans for future data presentations, its anticipated
achievement of milestones, including determination of proof of
concept and its financial guidance regarding the period in which it
will have capital available to fund its operations. 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 a clinical trial will be
predictive of the final results of the trial; replicate in later
clinical trials positive results found in preclinical studies and
early-stage clinical trials of CPI-1205, CPI-0610 and its other
product candidates; 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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