On November 3, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the first patient has been dosed in a Window of Opportunity study (title: "ONAWA") in primary breast cancer (Press release, Context Therapeutics, NOV 3, 2020, View Source [SID1234570454]). Meritxell Bellet, MD, PhD, of Group SOLTI (Barcelona, Spain), is the study’s Primary Investigator.

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This clinical collaboration, being supported by Context and sponsored by SOLTI, is a Window of Opportunity study (WOO) in the neoadjuvant setting for breast cancer. During the study, patients participating in the ONAWA (ONApristone Window Assessment) trial will receive oral doses of the progesterone receptor antagonist, Apristor (onapristone ER). Patients will be biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their full lumpectomy or mastectomy. Data generated from this study is intended to confirm the Recommended Phase 2 Dose (RP2D) of Apristor and to provide comprehensive biomarker data to further validate that the antitumor activity of Apristor is driven through downregulation of progesterone receptor and associated signaling pathways. This data will support Context’s ongoing and planned Phase 2 studies in breast, ovarian, and endometrial cancers.

"We are thrilled to enter into this collaboration with SOLTI and facilitate this window of opportunity study. We expect that this study will provide additional biomarker data to support our planned Phase 2 studies in progesterone receptor positive (PR+) female cancers," said Martin Lehr, CEO of Context Therapeutics.

The study, conducted within SOLTI’s network, has two Principal Investigators, both members of SOLTI Governing Board: Dr. Meritxell Bellet, Senior Consultant at Breast Cancer Unit at Vall d’Hebron University Hospital and Dr. Cristina Saura, Head of Breast Cancer Unit at Vall d’Hebron University Hospital. "The majority of breast cancer patients have an hormone-dependent disease. The hormones estrogen and progesterone drive breast cancer progression in those patients, but antiestrogens are the only antihormonal therapy available to clinicians. As such, antiestrogen resistance is now a major clinical challenge," said Dr. Bellet. "We believe that a progesterone receptor antagonist has the potential to address antiestrogen resistance and/or potentiate antiestrogen activity, which we believe will lead to better outcomes for patients. This window of opportunity provides us with the first clinical opportunity to delve deep into how progesterone receptor antagonists modulate the breast cancer tumor and its microenvironment."

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.