Veru, Inc. (VERU) Announces Presentation of Positive Phase 2 Clinical Data of Enobosarm in AR+ER+HER2- Metastatic Breast Cancer Patients that Have Progressed on Estrogen Blocking Agents and CDK 4/6 In

May 5, 2021 8:36 AM EDT

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Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that the clinical results from the Phase 2 clinical study of enobosarm, an oral selective androgen receptor targeting agonist, in heavily pretreated women with AR+ER+HER2- advanced breast cancer including further efficacy data and an analysis of patients who have failed both estrogen blocking agents and CDK 4/6 inhibitors, will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Congress 2021 to be held May 05-08, 2021.

Highlights of presentation:The subset analysis of patients from the Phase 2 study who were heavily pretreated with estrogen blocking agents and chemotherapy with an average of 3 prior lines of therapy in the metastatic setting and had tumor progression on a CDK 4/6 inhibitor prior to receiving enobosarm.

Enobosarm treatment in evaluable patients with measurable metastatic AR+ER+ breast cancer who had progressed following treatment with an estrogen blocking agent and CDK 4/6 inhibitor (palbociclib) resulted in a clinical benefit rate at 24 weeks of 50% and a best objective tumor response of 30% including 2 complete responses and 1 partial response. The overall mean radiographic progression free survival for the 9mg dose was 10 months. The 9mg dose of enobosarm was selected for the Phase 3 ARTEST study that is anticipated to commence in June 2021.

“Despite progressing on the standard of care, patients treated with enobosarm had significant clinical responses”, said Professor Carlo Palmieri, BSc, MB BS, PhD, FRCP, Professor of Translational Oncology & Medical Oncologist, University of Liverpool and the presenter of the results at the Congress. “Targeting the androgen receptor, a tumor suppressor in breast cancer, provides us with a potential novel endocrine therapy with an excellent safety profile.”

“Currently, CDK 4/6 inhibitors are standard treatment for metastatic ER-positive breast cancer, and unfortunately, these patients will eventually develop tumor progression. Patients who have metastatic breast cancers that progress on estrogen receptor blocking agent and CDK4/6 inhibitor therapies are a group in which we need to define the most optimal drug treatment. Although a small cohort in this Phase 2 study, the ability of these refractory patients to have significant clinical responses to enobosarm, an AR targeted treatment, is clinically meaningful and promising,” said Dr. Mitchell Steiner, Chairman, President and CEO of Veru Inc. “Further, enobosarm was very well tolerated and has shown to improve the quality of life as well. We are excited about the Phase 3 registration clinical trial ARTEST evaluating patients in this clinical setting.”

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