Odonate Therapeutics, Inc. Approves Adopting the First Amended and Restated Bylaws of the Company
Jun 24 19
On June 20, 2019, the Board of Directors of Odonate Therapeutics, Inc. amended its bylaws by approving and adopting the First Amended and Restated Bylaws of the Company. The Amended Bylaws change the Company’s vote requirement in uncontested elections of directors from a plurality vote standard to a majority vote standard. Using the plurality vote standard, there is no minimum number of votes required for a director to be elected to the Board; whereas, using the majority vote standard, the affirmative vote of a majority of votes cast is required to elect a director. The Company believes that the majority vote standard better aligns its interests with those of its stockholders.
Odonate Therapeutics, Inc. Announces IDMC for CONTESSA
Jun 3 19
Odonate Therapeutics, Inc. announced that the IDMC for CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with HER2 negative, hormone receptor positive metastatic breast cancer, recommended that the study continue with no modifications following a planned interim efficacy futility analysis. The interim efficacy futility analysis was based on a pre-specified analysis of the first approximate 100 progression-free survival (PFS) events that occurred in the study. PFS is the primary endpoint of CONTESSA. The purpose of the interim efficacy futility analysis was to facilitate the early termination of the study if the IDMC determined that achieving a positive outcome on the primary endpoint would be futile. Odonate continues to expect to complete enrollment of CONTESSA in the second half of 2019 and to report topline results in 2020. Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of multiple studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA. CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.
Odonate Therapeutics, Inc. Presents at Jefferies 2019 Healthcare Conference, Jun-05-2019 02:00 PM
May 29 19
Odonate Therapeutics, Inc. Presents at Jefferies 2019 Healthcare Conference, Jun-05-2019 02:00 PM. Venue: Grand Hyatt, 109 E 42nd St, New York, New York, United States.