Context Therapeutics Highlights Clinical Responses from the Phase 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer
February 06 2023 - 7:30AM
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 two
patients have achieved a confirmed partial response (PR) among the
first 12 patients (9 evaluable) enrolled in the Phase 2 OATH
clinical trial evaluating the potential of Context’s oral
progesterone receptor antagonist onapristone extended release
(ONA-XR) in combination with anastrozole (ANA) to treat hormone
receptor positive (HR+) metastatic endometrial cancer (EC).
“Data from the ongoing Phase 2 OATH clinical trial supports the
potential for ONA-XR plus ANA combination therapy to serve as an
effective therapeutic option in metastatic EC. We are encouraged by
these findings and look forward to continued enrollment in the
trial,” said Martin Lehr, CEO of Context Therapeutics.
Metastatic EC is an aggressive cancer of the uterus that is the
fourth leading cause of cancer-related mortality in women and
results in approximately 13,000 deaths per year in the United
States. Current treatments are limited, with platinum plus taxane
combination chemotherapy being the standard of care for first line
metastatic disease. After first-line therapy, patients are
typically treated with additional toxic infusion therapies,
including chemotherapy or Lenvima® (lenvatinib) plus Keytruda®
(pembrolizumab) combination therapy. Clinician and patient feedback
indicates a high unmet need for a novel orally administered
therapeutic that provides toxic therapy-like efficacy but with
fewer debilitating side effects. Grade 3 or higher adverse events
(AE) with standard EC therapies include diarrhea, nausea, vomiting,
and hypertension.
Preliminary data from the ongoing Phase 2 OATH clinical trial
evaluating the combination of ONA-XR with ANA in HR+ EC found that
ONA-XR plus ANA demonstrated a 4-month progression free survival
(PFS) rate of 77% and an overall response rate (ORR) of 22%. These
results suggest that ONA-XR plus ANA exhibits favorable efficacy
and tolerability relative to historical data that evaluated
physician’s choice of chemotherapy (doxorubicin or paclitaxel)
versus Lenvima plus Keytruda combination therapy in a similar
treatment setting of metastatic EC.1
Preliminary Comparison of OATH Trial versus Historical
Studies
|
ONA-XR + ANA* |
Chemotherapy |
Lenvima + Keytruda |
Trial |
OATH (ongoing) |
KEYNOTE-7751 |
KEYNOTE-775 |
Patients (n) |
12 (9 evaluable) |
416 |
411 |
Lines of Prior Chemotherapy, n (%) |
|
|
|
1 |
8 (67) |
277 (67) |
324 (79) |
≥2 |
4 (33) |
139 (33) |
87 (21) |
4-month PFS rate, n (%) |
7 (77) |
174 (42)** |
278 (67)** |
ORR, n (%) |
2 (22) |
61 (14) |
131 (32) |
Drug-related Discontinuation Rate, n (%) |
0 (0) |
31 (8) |
134 (33) |
Side Effects |
Mainly Grade 1 or Grade 2 AE |
73% experienced Grade 3 or higher AE |
89% experienced Grade 3 or higher AE |
*Data cut off as of September 30, 2022, preliminary raw data;
**Context estimates
Updated data regarding the Phase 2 OATH trial is expected to be
provided in Q2 2023.
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 PR binding to chromatin, downregulating
cancer stem cell mobilization, and blocking immune evasion. In
addition to the Phase 2 OATH clinical trial evaluating the
combination of ONA-XR and anastrozole to treat endometrial cancer,
ONA-XR is also being studied in other Phase 2 clinical trials,
including two breast cancer trials in combination with selective
estrogen receptor degraders (SERD). The Phase 1b/2 ELONA trial is
evaluating the combination of ONA-XR plus the recently approved
orally administered SERD ORSERDU™ (elacestrant) and the Phase 2
SMILE trial is evaluating the combination of ONA-XR with the
injectable SERD fulvestrant. 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 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 advancing 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.
Reference[1] Makker et al.,
2022. Lenvatinib plus Pembrolizumab for Advanced Endometrial
Cancer. The New England Journal of Medicine, 386 (2022),
pp. 437 448, 10.1056/NEJMoa2108330
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) preliminary results which may not be
indicative of any final results, which may not be replicated in
subsequent or confirmatory trials, or which may not be predictive
of results in later stage or large scale clinical trials or trials
in other potential indications, (ii) the expectation to timely
provide updated data for the Phase 2 OATH trial, (iii) the
potential benefits of ONA-XR in combination with other products,
including anastrozole and ORSERDU, (iv) the timing, enrollment and
results of our clinical trials, (v) the potential benefits,
treatment potential, and side effect profile of our product
candidates and other approved products, (vi) the likelihood data
will support future development, and (vii) the likelihood of
obtaining regulatory approval of our product candidates.
Forward-looking statements in this release involve substantial
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Media Contact:Gina Cestari6
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