Context Therapeutics® Announces Positive Data from ONA-XR in Early Breast Cancer at 2021 San Antonio Breast Cancer Symposium
December 09 2021 - 6:00PM
Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology
company developing small molecule and immunotherapy treatments for
breast and gynecological cancers, today announced that data
from the window-of-opportunity clinical trial of onapristone
extended release (ONA-XR) in postmenopausal patients with
progesterone receptor positive (PR+) early breast cancer
demonstrated ONA-XR significantly increased suppression of tumor
cell proliferation. The data were presented today during the 2021
San Antonio Breast Cancer Symposium (SABCS).
The Phase 0 open-label, single-arm, multicenter ONAWA
(SOLTI-1802) trial conducted by Spanish cancer research group
SOLTI, enrolled 10 patients with ER+/PR+/HER2- negative tumors and
levels of the cell proliferation marker "Ki67" above 10% to
evaluate ONA-XR by the rate of Complete Cell Cycle Arrest (CCCR)
determined by Ki-67 (≤2.7%) when administered for three weeks prior
to surgery (Abstract #511). Secondary endpoints of the trial
included safety and correlating biological activity with
immunohistochemistry (IHC) of tumor expression (ER, PR, Ser294-PgR,
CD24, CD44, ALDH1, Ki-67), estradiol, and progesterone blood
levels, and gene expression profile (NanoString nCounter® Breast
360TM panel). While no patients achieved a CCCR, tumor Ki-67
expression decreased in six patients, remained stable in one
patient, and increased in three patients. Mean percentage decrease
of Ki67 for tumors with baseline PR expression ≥90% (N=4) and
<90% (N=6) was -25.23% and 2.54%, respectively, indicating a
trend towards enhance response for patients with high levels of PR
expression at baseline. In addition, a shift towards more
endocrine-sensitive disease was detected, implying an increased
chance of the tumor responding to anti-estrogen therapy when used
in combination with ONA-XR. Six patients reported adverse events
(AEs), of which most were grade 1 or 2 including post-procedural
pain, dry mouth, and an increase of gamma-glutamyl transferase
(GGT). One patient experienced Grade 3 reversible GGT and aspartate
aminotransferase (AST).
“The data from the ONAWA trial signal the potential of ONA-XR to
help inhibit tumor proliferation and shift tumors to a more
endocrine treatment-sensitive phenotype during treatment prior to
surgery in postmenopausal women with operable breast cancer and
improve overall prognosis for these patients,” said co-principal
investigator Meritxell Bellet, M.D., Ph.D., medical oncologist at
Vall d'Hebron University Hospital in Barcelona and an executive
board member of SOLTI. “These results support further evaluation of
ONA-XR in the treatment of early breast cancer.”
“ONA-XR is being evaluated in four investigator-sponsored
clinical trials in hormone-driven breast, ovarian and endometrial
cancers. This readout is the first for the novel PR antagonist, and
the results are encouraging early evidence of the potential of
ONA-XR to offer a new therapeutic option for hormone-dependent
cancers,” said Martin Lehr, CEO of Context Therapeutics. “We look
forward to data updates from three other ONA-XR trials in
2022.”
The design of two additional clinical trials evaluating ONA-XR
in metastatic breast cancer (MBC) were also presented in
trials-in-progress posters during SABCS: The SMILE Study, a Phase 2
trial evaluating ONA-XR in combination with fulvestrant for
patients with ER+ and HER2- metastatic breast cancer after
progression on endocrine therapy and CDK4/6 inhibitors that is
being conducted in collaboration with the Wisconsin Oncology
Network (Abstract #311); and Memorial Sloan Kettering Cancer
Center’s Phase 1b trial designed to define the safety, tolerability
and recommended Phase 2 dose of ONA-XR in combination with
letrozole and palbociclib, in addition to investigating the
circulating tumor DNA-guided response of this triplet therapy
regimen in high-risk patients (Abstract #1538).
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 Context
Therapeutics®Context Therapeutics Inc.
(Nasdaq: CNTX), is a women’s oncology company developing small
molecule and immunotherapy treatments to transform care for 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 potent and specific 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.
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Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
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