Context Therapeutics® Highlights 2023 Corporate Priorities and Pipeline Milestones
04 Enero 2023 - 6:30AM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a clinical-stage biopharmaceutical company developing novel
treatments for solid tumors, with a primary focus on female
cancers, today provided 2022 year-end updates and corporate
guidance for 2023.
"I am proud of the substantial progress the Context team made in
2022. We achieved key corporate milestones including nominating
CTIM-76 as our Claudin 6 (CLDN6) bispecific antibody clinical
candidate and delivering preliminary data in clinical trials of
onapristone extended release (ONA-XR), our highly potent and
selective progesterone receptor antagonist," said Martin Lehr, CEO
of Context. "In 2023, we will continue to advance ONA-XR across the
endometrial (OATH) and breast (SMILE and ELONA) cancer clinical
trials. We expect to provide a clinical data update from the
ongoing OATH Phase 2 trial in mid-2023, as well as a Phase 2 data
update and Phase 1b data from the SMILE and ELONA breast cancer
trials, respectively, in Q4 2023. In addition, we look forward to
rapidly advancing CTIM-76 toward IND submission in Q1 2024."
Key Highlights
- CTIM-76 nominated as CLDN6 x CD3 bispecific antibody
clinical candidate
- During Q4 2022, Context presented preclinical data introducing
CTIM-76 as a differentiated, potent, and selective CLDN6-directed
immunotherapy. CLDN6 is an emerging, potentially high-value
oncology target that is expressed in a broad range of cancers and
CLDN6 expression is associated with a poor prognosis and diminished
survival in cancer patients. The Company estimates that there are
approximately 62,000 patients in the United States with
CLDN6-positive metastatic cancers, including lung, ovarian,
endometrial, gastric, and testicular cancers. Currently, there are
no FDA-approved treatments targeting CLDN6. In cell-based assays,
CTIM-76 was found to be over 1,000 times more selective for CLDN6
versus CLDN9, a structurally similar protein that unlike CLDN6 is
associated with potential off-target side effects. Further, CTIM-76
was also found to be approximately 28 times more potent than a
competing approach utilizing a bispecific T-cell engager (BiTE)
format. These data were presented during a R&D webinar hosted
by Context in December 2022. IND-enabling studies are scheduled for
2023 with an IND filing to support human clinical trials expected
in Q1 2024.
- ONA-XR ongoing Phase 2 trials show encouraging
endometrial and breast cancer data
- Endometrial cancer (OATH trial): Metastatic
endometrial cancer is an aggressive cancer of the uterus that
results in approximately 13,000 deaths per year in the United
States. Current treatments are limited, with combination platinum
and taxane chemotherapy being the standard of care. Clinician and
patient feedback indicates a high unmet need for a novel
therapeutic that provides chemotherapy-like efficacy but with fewer
side effects. Initial data from a Phase 2 investigator-led clinical
trial found that the combination of ONA-XR with anastrozole in
progesterone receptor-positive (PR+) metastatic endometrial cancer
demonstrated a 4-month progression free survival (PFS) rate of 77%,
a 12-month PFS rate of 33%, and favorable safety and tolerability
in patients who had failed at least one prior chemotherapy in the
metastatic setting. Preliminary results suggest that ONA-XR
exhibits a favorable efficacy and tolerability profile relative to
chemotherapy, the standard of care, which in a similar treatment
setting demonstrated a 3.8-month median PFS in the KEYNOTE-775
Phase 3 trial1. In the KEYNOTE-775 trial, chemotherapy demonstrated
a limited durability of effect as only 4% of patients treated with
chemotherapy were progression free at 12 months, and chemotherapy
resulted in significant toxicity with 72.9% of patients exhibiting
a Grade 3 or higher adverse event. Initial clinical results from
the endometrial trial were presented in Context’s Q3 2022 earnings
release and additional data are expected in mid-2023.
- Breast cancer (SMILE trial): Metastatic breast
cancer results in approximately 43,250 deaths per year in the
United States. Primary treatment in the metastatic setting is
antiestrogen plus CDK4/6 inhibitor combination therapy. CDK4/6
resistance is a clinical challenge due to the activation of
resistance mechanisms that limit the utility of current
standard-of-care treatments, including fulvestrant, after prior
CDK4/6 inhibitor exposure. Initial data from a Phase 2
investigator-led clinical trial found that the combination of
ONA-XR with fulvestrant in estrogen receptor-positive (ER+), HER2-
locally advanced or metastatic breast cancer demonstrated a 4-month
PFS rate of 44%, and favorable safety and tolerability in patients
who had failed prior CDK4/6 inhibitor therapy in the metastatic
setting. Preliminary results suggest that ONA-XR in combination
with fulvestrant exhibits a favorable efficacy and tolerability
profile relative to fulvestrant alone, which in a similar treatment
setting to the SMILE trial, fulvestrant demonstrated a 1.9-month
median PFS in the EMERALD Phase 3 trial2. The initial clinical
results of the SMILE trial were presented in December 2022 at the
San Antonio Breast Cancer Symposium and additional data are
expected in Q4 2023.
- ELONA Phase 1b/2 breast cancer trial open and enrolled
first patient: In January 2023, Context enrolled the first
patient in the ELONA study, an open-label, Phase 1b/2 breast cancer
clinical trial being conducted in partnership with The Menarini
Group ("Menarini”). The ELONA study is designed to explore the
efficacy of ONA-XR in combination with elacestrant, Menarini’s
selective estrogen receptor degrader, in patients with locally
advanced or metastatic breast cancer who have received prior
treatment with a CDK4/6 inhibitor. In Menarini’s recently completed
EMERALD Phase 3 trial, elacestrant demonstrated a 0.9-month PFS
improvement versus the standard-of-care fulvestrant (2.8 vs 1.9
months) in a similar treatment population and as a result may
become the standard-of-care antiestrogen treatment2. Compared to
elacestrant alone, Context believes that the combination of ONA-XR
plus elacestrant may more completely inhibit progesterone and
estrogen hormone signaling that is required for breast cancer
growth and metastasis. Such a combination would potentially improve
outcomes in patients without adding significant toxicity.
Cash Guidance
The Company had cash and cash equivalents of $39.4 million as of
September 30, 2022. The Company expects its current level of cash
and cash equivalents will enable the Company to fund its operations
into Q1 2024.
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.
References
[1] Makker V, et al.; KEYNOTE-775 Investigators. Lenvatinib plus
Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022
Feb 3;386(5):437-448.
[2] Bidard FC, et al; EMERALD Investigators. Elacestrant Versus
Standard Endocrine Therapy for Estrogen Receptor-Positive, Human
Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer:
Results From the Randomized Phase III EMERALD Trial. J Clin Oncol.
2022 Oct 1;40(28):3246-3256.
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 a clinical data
update from the OATH trial in mid-2023, as well as a Phase 2 data
update from the SMILE trial and Phase 1b data for the ELONA trial
in the fourth quarter of 2023, (ii) the expectation to have an IND
submission for CTIM-76 in the first quarter of 2024, (iii) the
selectivity, potency, and safety profile of CTIM-76, (iv) the
timing, enrollment and results of our clinical trials, (v) the
potential benefits and side effect profile of our product
candidates, (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 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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