Context Therapeutics® Announces Encouraging Preclinical Data from Two Programs to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2022
April 11 2022 - 7:30AM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing small molecule and
immunotherapy treatments for breast and gynecological
cancers, today announced encouraging preclinical data from two
pipeline programs, including in vivo combination and
immunomodulation data evaluating onapristone extended release
(ONA-XR), the company’s lead clinical program. The data are being
presented at the American Association for Cancer Research (AACR)
Annual Meeting 2022.
“The preclinical data for onapristone (the pharmaceutically
active component of ONA-XR) support that it is a potent, specific
progesterone receptor (PR) antagonist. The data highlights the
breadth of its potential as a highly promising combination agent
with standard of care therapies, as well as with emerging therapies
for hormone positive tumors such as immune checkpoint inhibitors
and inhibitors of the AURKA/STAT3 oncogenic axis. We look forward
to reporting preliminary data of ONA-XR from ongoing Phase 2 trials
in breast, ovarian, and endometrial cancer later this year, and to
continued evaluation of additional clinical applications,” said
Evan Dick, Ph.D., SVP of R&D at Context Therapeutics. “With
respect to our CLDN6xCD3 bispecific program, we are encouraged by
preclinical findings which highlight the program’s selectivity and
potency. We remain on track to select a candidate to support
IND-enabling studies by year-end.”
R&D Webinar:
On Wednesday, April 13, 2022, at 11 a.m. ET, Context will host a
webinar with its management team and AACR presenters, to discuss
the results from these presentations. Following the formal
presentation, the Context team, along with AACR presenters, will be
available for questions. To register for the webinar, please click
here.
Summary of Data Presented:
ONA-XR
Title: Targeting progesterone receptor (PR) with the
antiprogestin onapristone in patient-derived xenograft (PDX) models
of estrogen receptor positive (ER+), PR positive (PR+) bone
metastasis of breast cancerPresenter: Elisabetta Marangoni, Ph.D.,
Institut Curie (France)Minisymposium: MS.ENO1.01
- This study evaluated the efficacy and safety of ONA-XR in
combination with fulvestrant, palbociclib, or alpelisib in
different PDX models established from ER+ and PR+ breast cancers.
Anti-tumor activity combination of ONA-XR with fulvestrant,
palbociclib, or alpelisib was significantly increased compared to
monotherapy, while triple therapy resulted in tumor regressions in
the majority of xenografts. These findings provide in vivo support
of current clinical trial designs evaluating ONA-XR in combination
with anastrozole or fulvestrant, and in triplet with palbociclib
and letrozole.
Title: Progesterone promotes immunomodulation and tumor
development in the murine mammary glandPresenter: Lauryn Werner,
M.D., Ph.D. Candidate, University of KansasPoster: 1351/10
- This study investigated whether progesterone (P4) and PR drive
immunomodulation in the mammary gland and promote tumor formation.
Syngeneic mammary gland tumor models were utilized to evaluate the
effect of P4 on the growth of PR+ mammary gland tumors in vivo,
which revealed that P4 promoted tumor growth and decreased immune
cell infiltration of PR+ mammary gland tumors. These findings offer
a novel mechanism of P4-driven mammary gland tumor development and
provide rationale in investigating the usage of anti-progestin
therapies to promote immune-mediated elimination of mammary gland
tumors.
Title: PR/STAT3 nuclear transcriptional complexes mediate
aurora-A kinase-induced stemness plasticity in ER+ breast
cancerPresenter: Antonio D’Assoro, M.D., Ph.D., Mayo ClinicPoster:
3163/15
- This study evaluated the role of PR in mediating the
AURKA/STAT3 oncogenic signaling axis, which is associated with
cancer cell plasticity (stemness) and resistance to endocrine
therapy, including CDK4/6 inhibitors. A novel mechanism was
identified wherein AURKA-induced stemness plasticity is mediated
through the activation of phosphorylated PR transcriptional complex
that regulates the expression of KLF4 stemness reprogramming gene.
These findings provide a strong rationale for cooperative
inhibition of PR and AURKA/STAT3.
CLDN6xCD3 Bispecific Antibody
Title: Atomic-level specificity of Claudin 6 monoclonal
antibodies isolated for treating solid tumorsPresenter: Joseph
Rucker, Ph.D., Integral MolecularPoster: 318/10
- This study identified monoclonal antibodies (MAb) targeting
oncofetal protein Claudin 6 (CLDN6). Despite their potential as
cancer therapeutics, a limited number of CLDN6 monoclonal
antibodies (MAbs) are in development because MAbs with high
affinity and specificity for CLDN6 are difficult to
isolate. IM301 and IM302 binding is remarkably selective for
CLDN6 over other claudin family proteins, despite high homology in
the extracellular loops with CLDN9. The CLDN6 MAbs identified here
can be used to study CLDN6-positive cancers, including ovarian,
endometrial, lung, and testicular cancer, and have the potential to
be developed into highly selective therapeutics.
Title: Development of claudin 6 bispecific antibodies for
treatment of ovarian cancerPresenter: Joseph Rucker, Ph.D.,
Integral MolecularPoster: 2892/7
- This study evaluated a large set (> 50) of CLDN6xCD3
bispecific antibodies using multiple formats and CD3 arms that
encompass different valencies and geometries. The panel of
bispecifics was functionally tested in in vitro T cell
cytotoxicity assays cells and demonstrated potent killing of
CLDN6-expressing cells with minimal killing of cells expressing
other closely related claudin family members. The exquisite
specificity of these CLDN6xCD3 bispecifics suggests their potential
to address the need for potent therapeutic modalities for ovarian
and other CLDN6-expressing cancers.
For more information and to view the abstracts, visit the AACR
Annual Meeting website.
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. 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.
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
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statements regarding (i) the results of our clinical trials, (ii)
the potential benefits of the product candidates, (iii) the
likelihood data will support future development, (iv) the ability
of the Company, its employees and certain AACR presenters to
participate in and present at conferences and webinars, and (v) the
likelihood of obtaining regulatory approval of our product
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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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