Context Therapeutics® and Wisconsin Oncology Network Announce First Patient Dosed in Phase 2 Trial of ONA-XR in Metastatic Breast Cancer
October 27 2021 - 7:30AM
Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology
company developing advanced small molecule and immunotherapy
treatments to transform care for hormone-driven breast and
gynecological cancers, and Wisconsin Oncology Network (WON), today
announced the first patient has been dosed in the Phase 2 Trial of
OnapriStone in CoMbInation with FuLvestrant for Patients with
ER-positive, and HER2-negative Metastatic Breast Cancer after
Progression on Endocrine therapy and CDK 4/6 Inhibitors (The SMILE
Study).
The single-arm trial conducted by the WON will evaluate the
effect of progesterone receptor (PR) antagonist onapristone
extended release (ONA-XR) in combination with Faslodex
(fulvestrant) for women and men with ER+, PR+, HER2-negative
metastatic breast cancer after treatment failure of CDK4/6
inhibitor and/or PIK3α inhibitors. Estrogen and progesterone drive
progression in many breast cancer patients, but resistance after
endocrine therapy is a clinical challenge given the broad use of
antiestrogens. ONA-XR is an investigational, orally-administered
full antagonist of PR, a key unchecked mechanism in women’s
cancers, and this clinical trial will evaluate the potential of
ONA-XR and fulvestrant to address this resistance and improve
patient outcomes. ONA-XR is currently being evaluated in ongoing
Phase 2 clinical trials in hormone-driven breast, ovarian and
endometrial cancers.
The trial will enroll up to 39 patients with ER+, PR+, HER2-
metastatic breast cancer who have progressed on aromatase inhibitor
and CDK4/6 inhibitor combination therapy. The primary endpoint will
be the overall response rate (ORR), which is the proportion of
patients with a complete or partial tumor response. Secondary
endpoints will include duration of tumor response, progression-free
survival (PFS), disease control rate, time to response and
incidence of adverse events.
“Context is honored to have WON Co-Principal Investigators
Sailaja Kamaraju, MD, MS, Associate Professor at the Medical
College of Wisconsin, Milwaukee and Kari Wisinski, MD, Professor,
Interim Chief of the Division of Hematology, Medical Oncology and
Palliative Care for the Department of Medicine at UW-Madison to
spearhead this important research collaboration and explore this
combination as a potential additional treatment option for patients
living with this devastating disease,” said Martin Lehr, CEO of
Context Therapeutics. “We hope this study will provide a robust
picture of how ONA-XR works in advanced ER+, PR+, HER2- breast
cancer and inform the design of a future Phase 3 trial.”
Additional information about the trial, which is recruiting
patients, can be found on clinicaltrials.gov using the identifier
NCT04738292.
About Onapristone Extended ReleaseONA-XR
(onapristone extended release) is a potent and specific antagonist
of the progesterone receptor (PR) that is orally administered.
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. ONA-XR is currently being evaluated in
three Phase 2 clinical trials and one Phase 1b/2 clinical trial in
PR+ breast, ovarian and endometrial cancers, as well as in two
Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR
is an investigational drug that has not been approved for marketing
by any regulatory authority.
About Wisconsin Oncology NetworkThe Wisconsin
Oncology Network (WON) is a regional network of 19 sites that
allows community health centers to enroll patients in select cancer
clinical trials that are open at the University of Wisconsin
Carbone Cancer Center. Non-UW sites account for nearly 40% of
accrual to WON clinical trials. To date, more than 2,200 patients
have participated in WON studies, leading to multiple publications
and scientific presentations.
About Context
Therapeutics®Context Therapeutics Inc.
(Nasdaq: CNTX), is a women’s oncology company developing advanced
small molecule and immunotherapy treatments to transform care for
hormone-driven breast and gynecological cancers. The company’s
robust clinical program for lead candidate onapristone extended
release (ONA-XR) comprises three Phase 2 clinical trials and one
Phase 1b/2 clinical trial in hormone-driven breast, ovarian and
endometrial cancer, as well as two Phase 0 biomarker
pharmacodynamic trials in breast cancer. ONA-XR is a novel,
first-in-class small molecule under development as a complete
antagonist of the progesterone receptor, a key unchecked mechanism
in hormone-driven women’s cancers. Context is headquartered in
Philadelphia, PA. For more information, visit
www.contexttherapeutics.com.
Forward-looking StatementsThis press release
contains “forward-looking statements” that involve substantial
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statements regarding (i) the design, timing, scope and results of
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development, and (v) the likelihood of obtaining regulatory
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this release involve substantial risks and uncertainties that could
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Media Contact:
Gina Cestari6 Degrees917-797-7904gcestari@6degreespr.com
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