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Context Therapeutics® to Present Clinical Data on ONA-XR in Breast Cancer at 2021 San Antonio Breast Cancer Symposium

Context Therapeutics LLC
·5-min read

Primary results from ONAWA (SOLTI-1802) trial of ONA-XR in early breast cancer to be presented in addition to updates from ongoing clinical trials of ONA-XR in metastatic breast cancer

PHILADELPHIA, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments to transform care for breast and gynecological cancers, today announced clinical data on onapristone extended release (ONA-XR) will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place virtually and in San Antonio, Texas, from December 7-10, 2021.

“We are pleased that ONA-XR data from multiple stages of breast cancer will be presented at SABCS including the first clinical data from the ONAWA trial, sponsored by the Spanish cancer research group SOLTI, of ONA-XR in early-stage breast cancer and updates from two ongoing clinical trials of ONA-XR in metastatic breast cancer. We look forward to connecting with the oncology community at SABCS, to discuss advancements in breast cancer and further highlight the potential of ONA-XR to make a meaningful impact in the lives of people living with breast cancer,” said Martin Lehr, CEO of Context Therapeutics.

Details on the presentations are as follows:

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Title: Primary results of ONAWA (SOLTI-1802) trial: A window of opportunity trial of onapristone in postmenopausal women with progesterone receptor-positive/HER2-negative early breast cancer (EBC)
Abstract: 511
Session: Poster Session 1, Prognostic and Predictive Factors: Predictive Biomarkers for Endocrine Therapies
Date / time: Wednesday, December 8, 2021, 8-9:30 a.m. ET / 7-8:30 a.m. CT
Presenter: Meritxell Bellet, M.D., Ph.D., SOLTI Breast Cancer Research Group, Vall d’Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Title: The SMILE study: A phase 2 trial of onapristone in combination with fulvestrant for patients with ER+ and HER2- metastatic breast cancer after progression on endocrine therapy and CDK4/6 inhibitors
Abstract: 379
Session: Ongoing Trials Poster Sessions 2, Targeted therapy - antiprogestin onapristone
Date / time: Thursday, December 9, 2021, 6-7:30 p.m. ET / 5-6:30 p.m. CT
Presenter: Sailaja Kamaraju, M.D., Medical College of Wisconsin, Milwaukee, Wis., and Kari Wisinski, M.D., University of Wisconsin - Madison

Title: Circulating tumor DNA-guided adaptive therapy escalation in ER+ MBC: A phase 1b study with letrozole, palbociclib and onapristone ER
Abstract: 1538
Session: Ongoing Trials Poster Session 2, Patient management - circulating tumor guided adaptive therapy
Date / time: Thursday, December 9, 2021, 6-7:30 p.m. ET / 5-6:30 p.m. CT
Presenter: Joshua Drago, M.D., Pedram Razavi, M.D., Ph.D., and Komal Jhaveri, M.D., Memorial Sloan Kettering Cancer Center

Details on the presentations listed above are also available on the 2021 SABCS website: https://www.sabcs.org/Program/Schedule-at-a-Glance.

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. 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 progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in PR+ breast, ovarian and endometrial cancers, as well as in two Phase 0 biomarker pharmacodynamic trials in breast cancer. 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 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, as well as two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is a novel, first-in-class small molecule under development as a complete 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 Statements
This 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 results of our clinical trials, (ii) the potential benefits of the product candidates, (iii) the likelihood data will support future development, and (iv) 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 Cestari
6 Degrees
971-797-7904
gcestari@6degreespr.com

Investor Relations Contact:
Laine Yonker
Edison Group
lyonker@edisongroup.com