Context Therapeutics® is a clinical-stage biopharmaceutical company dedicated to improving the lives of women living with cancer.
Profound advancements in oncology drug development have expanded the treatment options available to women with cancer, yet therapeutic resistance and relapse continue to limit the efficacy and duration of such treatments. Collectively, our founders and management team have decades of experience identifying and characterizing the mechanisms that drive cancer initiation and subsequent relapse in women with cancer and have been associated with the development of products such as Kisqali (ribociclib), Arimidex (anastrozole) and Afinitor (everolimus) to treat such cancers.
Our development team is advancing a pipeline of innovative therapies with a primary focus on treating female cancers, which include, but are not limited to, breast, ovarian and endometrial cancer. Our first program and lead product candidate, onapristone extended release (“ONA-XR”), builds upon a foundation of successful drug development by our management team and advisors in the field of female hormone-dependent cancers. ONA-XR is a selective and potentially potent antagonist of the progesterone receptor (“PR”), a receptor that is activated by the hormone progesterone and that has been linked to resistance to multiple classes of cancer therapeutics, including anti-estrogen therapies, that are prescribed to treat female hormone-dependent cancers. In 2019, we initiated our Phase 2 trial of ONA-XR in women with ovarian cancer who express high levels of progesterone receptor (“PR+”) and we expect to report preliminary data from this trial in the second half of 2021.
In 2020, we initiated a Phase 2 trial of ONA-XR in combination with Arimidex (anastrozole) in PR+ endometrial cancer and a Phase 0 trial of ONA-XR in a window of opportunity study in primary breast cancer, and we expect to report preliminary data in the first half of 2022 and final data in late 2022 for each trial, respectively. The window of opportunity study is a three week study in women with primary breast cancer and subsequent lumpectomy to evaluate the direct effects of ONA-XR on the cancer signaling pathways and the tumor microenvironment.
In 2021, a Phase 1b/2 investigator-sponsored trial was initiated in collaboration with Memorial Sloan Kettering Cancer Center to evaluate ONA-XR in combination with Ibrance (palbociclib) and Femara (leterozole) in first line metastatic breast cancer patients with biochemically recurrent disease, defined as circulating tumor DNA (ctDNA) positive. This is potentially a new clinical opportunity for the estimated 20% of first line (“1L”) patients who are at high risk of early disease progression on Ibrance and Femara therapy.
Also in 2021, a Phase 2 investigator-sponsored trial was initiated in collaboration with the Wisconsin Oncology Network to evaluate ONA-XR in combination with Faslodex (fulvestrant) in women with second line (“2L”) or third line (“3L”) metastatic breast cancer. In 2021, we also initiated a sub-study of our Phase 2 trial in 2L/3L metastatic breast cancer, which evaluates the uptake of radiolabeled progesterone (F-FFNP) via PET imaging in breast tumors, with preliminary data expected to come in the first half of 2022. Our second program, CLDN6xCD3 bsAb, is an anti-CD3 x anti-Claudin 6 antigen bispecific monoclonal antibody (bsAbs) that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6.
(Note: Context Therapeutics upsized its IPO to 5 million shares – up from 1.5 million shares – and cut the price to $5 – down from a price range of $12 to $14 – in an S-1/A filing dated Oct. 15, 2021. Terms for this IPO – 1.5 million shares at $12 to $14 – were initially set in an S-1/A filing dated July 1, 2021.)
|Address||3675 Market Street, Suite 200 Philadelphia, Pennsylvania 19104|
|Phone Number||(267) 225-7416|
|View Prospectus:||Context Therapeutics|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-4.25 mil (last 12 months)|
|Price range||$5.00 - $5.00|
|Est. $ Volume||$25.0 mil|
|Manager / Joint Managers||ThinkEquity|
|Expected To Trade:||10/20/2021|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|