Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a company developing novel treatments for solid tumors, with
a primary focus on female cancers, today announced that its
clinical trial collaborator, Stemline Therapeutics, Inc., a wholly
owned subsidiary of The Menarini Group (“Menarini”), received
approval from the U.S. Food and Drug Administration (FDA) for
ORSERDU (elacestrant) for the treatment of postmenopausal women or
adult men with estrogen receptor–positive (ER+), HER2-negative
(HER2-), Estrogen Receptor 1 gene (ESR1)-mutated advanced or
metastatic breast cancer with disease progression following at
least one line of endocrine therapy. ORSERDU has shown improved
efficacy over the current standard-of-care (SOC) treatment,
fulvestrant, in patients with ER+, HER2-, ESR1-mutated
advanced or metastatic breast cancer.1
"This is a watershed moment for the industry, which has spent
the last 20 years trying to develop a next-generation endocrine
therapy that is pharmacologically superior to endocrine
monotherapies, including fulvestrant. ORSERDU has the potential to
fundamentally change the treatment paradigm for patients with
ESR1-mutated breast cancer, which is found in approximately 40% of
the estimated 43,500 patients with metastatic hormone-driven breast
cancer in the United States," said Martin Lehr, CEO of Context
Therapeutics. "Our collaboration with Menarini in the ongoing Phase
1b/2 ELONA trial is evaluating the potential of Context’s oral
progesterone receptor antagonist onapristone extended release
(ONA-XR), to enhance ORSERDU’s activity in both ESR1-mutated and
wild type metastatic breast cancer. Such a combination could
potentially improve outcomes in patients without adding significant
toxicity."
According to the American Cancer Society, breast cancer is the
second most common cancer among women, occurring in 1 in 8 women
(13%) over the course of a woman’s lifetime, with ~280,000 new
cases of invasive breast cancer and 51,400 cases of non-invasive
breast cancer expected in 2023. Approximately 40% of patients with
ER+, HER2- breast cancer will have ESR1 mutations, which is
associated with poor prognosis. Endocrine monotherapy has displayed
limited efficacy in ESR1 mutations.
ORSERDU is approved under the FDA’s Priority Review and Fast
Track designation based on the results of the registrational Phase
III trial EMERALD, that demonstrated statistically significant
progression-free survival (PFS) with elacestrant vs SOC endocrine
monotherapy (fulvestrant, letrozole, anastrozole, exemestane),
meeting both primary endpoints in all patients and in those
patients whose tumors harbor ESR1 mutations.
In the group of patients whose tumors had ESR1 mutations,
elacestrant reduced the risk of progression or death by 45% (PFS
HR=0.55, 95% CI: 0.39, 0.77) vs SOC. A post-hoc analysis of the PFS
results based on the duration of prior CDK4/6i inhibitors (CDK4/6i)
usage was presented at San Antonio Breast Cancer Symposium in
December 2022. The median PFS was 8.6 months on elacestrant vs 1.9
months for SOC, in those patients whose tumors harbored ESR1
mutations and had been treated with a CDK4/6i for at least 12
months.
About ONA-XRONA-XR (onapristone extended
release) is an oral, twice-a-day, selective progesterone receptor
(PR) antagonist designed to block both ligand-dependent and
ligand-independent activity of PR. Currently, there are no approved
therapies that selectively target PR+ cancers. Preliminary
preclinical and clinical data suggest that ONA-XR has anticancer
activity by inhibiting progesterone receptor binding to chromatin,
downregulating cancer stem cell mobilization, and blocking immune
evasion. In addition to the Phase 1b/2 ELONA clinical trial
evaluating the combination of ONA-XR and ORSERDU to treat
ESR1-mutated metastatic breast cancer, ONA-XR is being studied in
Phase 2 clinical trials, including in endometrial cancer (OATH) and
breast cancer (SMILE). ONA-XR is an investigational drug that has
not been approved for marketing by any regulatory authority.
About ELONA trialIn January 2023, Context
enrolled the first patient in the ELONA trial, an open-label, Phase
1b/2 breast cancer clinical trial being conducted in partnership
with Menarini. The ELONA study is designed to explore the efficacy
of ONA-XR in combination with ORSERDU™, Menarini’s
oral selective estrogen receptor degrader approved by the U.S. Food
and Drug Administration, in patients with locally advanced or
metastatic ER+, HER2-, ESR1-mutated breast cancer who have received
prior treatment with a CDK4/6 inhibitor. Data from the Phase 1b
portion of the trial is expected in Q4 2023.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical
company committed to advancing medicines for solid tumors, with a
primary focus on female cancers. The Company’s pipeline includes
small molecule and bispecific antibody drug candidates that target
cancer signaling pathways. Context is developing CTIM-76, a
selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6
positive tumors, currently in preclinical development. Context is
also developing onapristone extended release (ONA-XR), a novel,
first-in-class potent and selective progesterone receptor
antagonist, currently in three Phase 2 clinical trials and one
Phase 1b/2 clinical trial in hormone-driven breast, ovarian,
and endometrial cancers. Context is headquartered in
Philadelphia. For more information, please
visit www.contexttherapeutics.com or follow the Company
on Twitter and LinkedIn.
About EMERALD Phase 3 Study (NCT03778931)The
EMERALD Phase 3 trial is a randomized, open label,
active-controlled study evaluating elacestrant as second- or
third-line monotherapy in ER+, HER2- advanced/metastatic breast
cancer patients. The study enrolled 478 patients who had received
prior treatment with one or two lines of endocrine therapy,
including a CDK4/6 inhibitor. Patients in the study were randomized
to receive either elacestrant or the investigator’s choice of an
approved hormonal agent. The primary endpoints of the study were
progression-free survival (PFS) in the overall patient population
and in patients with estrogen receptor 1 gene (ESR1) mutations.
About ORSERDU (elacestrant)The U.S. Food and
Drug Administration (FDA) has approved ORSERDU for the
treatment of postmenopausal women or adult men, with ER+, HER2-,
ESR1-mutated, advanced or metastatic breast cancer with disease
progression following at least one line of endocrine therapy. The
Marketing Authorization Application (MAA) is currently under review
by the European Medicines Agency (EMA).
Elacestrant is also being investigated in several clinical
trials in metastatic breast cancer disease, alone or in combination
with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108);
ELONA (NCT05618613); ELCIN (NCT05596409). Elacestrant is also
planned to be evaluated in early breast cancer disease.
For more information, please see the full Prescribing
Information for ORSERDU here.
About The Menarini GroupThe Menarini Group is a
leading international pharmaceutical and diagnostics company, with
a turnover of over $4 billion and over 17,000 employees. Menarini
is focused on therapeutic areas with high unmet needs with products
for cardiology, oncology, pneumology, gastroenterology, infectious
diseases, diabetology, inflammation, and analgesia. With 18
production sites and 9 Research and Development centers, Menarini’s
products are available in 140 countries worldwide. For further
information, please visit www.menarini.com.
About StemlineStemline Therapeutics, a
wholly-owned subsidiary of the Menarini Group, is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of novel oncology therapeutics.
Stemline commercializes Elzonris®, a novel targeted treatment
directed to CD123 for patients with blastic plasmacytoid dendritic
cell neoplasm (BPDCN), an aggressive hematologic cancer, in the
United States and Europe, the only approved treatment for BPDCN in
the US and EU to date. Stemline also commercializes Nexpovio® in
Europe, an XPO1 inhibitor for multiple myeloma originating from a
licensing deal with Karyopharm. Stemline also has an extensive
clinical pipeline of small molecules and biologics in various
stages of development for a host of solid and hematologic
cancers.
Reference[1] FDA approves
elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced
or metastatic breast cancer. News Release. FDA. January 27, 2023.
Accessed January 27, 2023. https://bit.ly/3WHsEq8
Forward-looking StatementsThis press release
contains “forward-looking statements” that involve substantial
risks and uncertainties for purposes of the safe harbor provided by
the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, included in
this press release regarding strategy, future operations,
prospects, plans and objectives of management, including words such
as "may," "will," "expect," "anticipate," "plan," "intend," and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
forward-looking statements. These include, without limitation,
statements regarding (i) the expectation to provide Phase 1b data
for the ELONA trial in the fourth quarter of 2023, (ii) the
potential benefits of ONA-XR in combination with ORSERDU, (iii) the
timing, enrollment and results of our clinical trials, (iv) the
potential benefits, treatment potential, and side effect profile of
our product candidates and other approved products, (v) the
likelihood data will support future development, and (vi) the
likelihood of obtaining regulatory approval of our product
candidates. Forward-looking statements in this release involve
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by the
forward-looking statements, and we, therefore cannot assure you
that our plans, intentions, expectations or strategies will be
attained or achieved. Other factors that may cause actual results
to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in our filings with
the U.S. Securities and Exchange Commission, including the
section titled “Risk Factors” contained therein. Except as
otherwise required by law, we disclaim any intention or obligation
to update or revise any forward-looking statements, which speak
only as of the date they were made, whether as a result of new
information, future events or circumstances or otherwise.
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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