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Veru Enters into Clinical Trial Collaboration and Supply Agreement with Eli Lilly and Company to Evaluate Enobosarm in Combination with Verzenio® in Phase 3 ENABLAR-2 Trial
-- Phase 3 ENABLAR-2 Clinical Trial for 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer Expected to Commence During First Quarter of 2022 -- MIAMI,
About this update from Veru Inc.
[{"type":"text","content":"-- Phase 3 ENABLAR-2 Clinical Trial for 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer Expected to Commence During First Quarter of 2022 -- MIAMI, Feb. 01, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company. The objective of the collaboration is to evaluate the efficacy and safety of enobosarm, Veru’s oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor (AR), a tumor suppressor, in combination with Lilly’s Verzenio® (abemaciclib), a CDK4/6 inhibitor, as a second line therapy in the treatment of AR+ER+HER2- metastatic breast cancer. “Independently conducted proof of concept preclinical studies in human breast cancer models have demonstrated that the combination of enobosarm with a CDK4/6 inhibitor had greater antitumor synergistic activity in tumor samples from patients who had breast cancer progression following treatment with palbociclib, a CDK4/6 inhibitor, and an estrogen blocking agent. The ENABLAR-2 trial will evaluate the efficacy and safety of the enobosarm and abemaciclib combination in patients that have previously received first line therapy of palbociclib and estrogen blocking agent combination in AR+ER+HER2- metastatic breast cancer,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. “We are excited about potentially being an oral 2nd line therapeutic option in combination with abemaciclib for patients who have AR+ER+HER2- metastatic breast cancer. We are looking forward to our collaboration with Lilly on the ENABLAR-2 clinical trial.” Under the terms of the non-exclusive clinical trial collaboration and supply agreement, Veru is responsible for conducting the clinical trial while Lilly will supply Verzenio for the study. Veru maintains full exclusive, global rights to enobosarm. Phase 3 ENABLAR-2 Trial DesignThe Phase 3 ENABLAR-2 clinical trial is an open-label, multicenter, randomized, active control pivotal study evaluating the efficacy and safety of enobosarm 9mg oral daily dosing in combination with Verzenio®, a CDK4/6 inhibitor, versus active...