Currency in USD
Last close As at 02/02/2023
USD1.00
▲ 0.32 (47.06%)
Market capitalisation
USD16m
Research: Healthcare
Context Therapeutics has announced encouraging four-month progression-free survival (PFS) data from the Phase II SMILE trial, which is investigating the company’s first-in-class, oral progesterone receptor antagonist ONA-XR (onapristone extended release) in HR+/HER2- metastatic breast cancer (mBC). The preliminary findings, presented recently at the San Antonio Breast Cancer Symposium (SABCS), demonstrate that patients treated with ONA-XR in combination with fulvestrant had a four-month PFS of 44% (n=9) and the combination was well-tolerated. Considering the fulvestrant monotherapy following progression of CDK4/6 inhibitors has been shown to offer a median PFS of approximately two months in the same population, we view the reported results as encouraging, although it is too early to draw definitive conclusions from the preliminary data. Nevertheless, we view this as another positive development following the recent readout for endometrial cancer.
Context Therapeutics |
Initial data from the SMILE study encouraging |
Clinical update |
Pharma and biotech |
8 December 2022 |
Share price performance Business description
Analysts
Context Therapeutics is a research client of Edison Investment Research Limited |
Context Therapeutics has announced encouraging four-month progression-free survival (PFS) data from the Phase II SMILE trial, which is investigating the company’s first-in-class, oral progesterone receptor antagonist ONA-XR (onapristone extended release) in HR+/HER2- metastatic breast cancer (mBC). The preliminary findings, presented recently at the San Antonio Breast Cancer Symposium (SABCS), demonstrate that patients treated with ONA-XR in combination with fulvestrant had a four-month PFS of 44% (n=9) and the combination was well-tolerated. Considering the fulvestrant monotherapy following progression of CDK4/6 inhibitors has been shown to offer a median PFS of approximately two months in the same population, we view the reported results as encouraging, although it is too early to draw definitive conclusions from the preliminary data. Nevertheless, we view this as another positive development following the recent readout for endometrial cancer.
Year end |
Revenue |
PBT* ($m) |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(3.2) |
(9.28) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(10.6) |
(3.74) |
0.0 |
N/A |
N/A |
12/22e |
0.0 |
(18.1) |
(1.13) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(27.4) |
(1.72) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding exceptional items.
As a reminder, the SMILE trial is a Phase II, open-label, single-arm, multi-center, investigator-sponsored trial evaluating ONA-XR in combination with Faslodex (fulvestrant) in second-line or third-line ER+/HER2- mBC patients who have progressed on first-line standard of care (aromatase inhibitor + CDK4/6 inhibitor). The study is sponsored by the Wisconsin Oncology Network and will enroll up to 39 patients across four trial sites in the United States (the first patient was dosed in October 2021). The primary endpoint will be overall response rate (ORR) and secondary endpoints will include duration of tumor response, PFS, disease control rate, time to response and incidence of adverse events. Following previous encouraging preliminary Phase II data in endometrial cancer (ONA-XR + anastrozole), which demonstrated a four-month PFS of 77.7%, we see this recent data in breast cancer as a further positive support for the company’s development pipeline.
In addition to Wisconsin Oncology Network presenting the SMILE data at SABCS, Context also provided an initial report on the trial design of the ELONA Phase Ib/II clinical trial, which is evaluating ONA-XR in combination with elacestrant (Menarini’s oral selective estrogen degrader) in second- and third-line HR+/HER2- mBC patients. Data from the Phase Ib portion of the trial is expected in Q4 2023.
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Research: Consumer
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