On October 21, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ONA-XR in combination with the antiestrogen anastrozole in patients with recurrent endometrial cancer (Press release, Context Therapeutics, OCT 21, 2020, View Source [SID1234570453]). Sailaja Kamaraju, MD, of the Medical College of Wisconsin, and Kari Wisinski, MD, of the University of Wisconsin Carbone Cancer Center, are the study’s Co-Primary Investigators.
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The Phase 2 trial will include patients who have progesterone receptor positive (PR+), estrogen receptor positive (ER+), HER2 negative (HER2-) metastatic breast cancer who have progressed on prior CDK4/6 inhibitor therapy. Patients will be administered the combination of onapristone extended release (ONA-XR) in combination with the antiestrogen, fulvestrant. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of ONA-XR, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of ONA-XR in these patients, as well as biomarker analyses to explore predictive factors of response to ONA-XR, including activity in patients with ESR1 and PIK3CA mutations.
"Currently, there are limited therapeutic options to treat metastatic breast cancer. Recent preclinical findings, together with Phase 1 study results in patients with metastatic PR+ breast cancers, give us reason to believe that ONA-XR can help these women with PR+ breast cancers," said Tarek Sahmoud, MD, PhD, Chief Medical Officer of Context Therapeutics. [1],[2]. "We believe ONA-XR can make a meaningful difference for patients in the trial."
About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor 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 the subject of an ongoing Phase 2 clinical trials in progesterone receptor positive breast, ovarian, and endometrial cancers. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.