Vivace Therapeutics Gets FDA Safe to Proceed for Phase 3 sTEADfast Trial of VT3989 in Mesothelioma
FDA cleared Vivace's pivotal Phase 3 sTEADfast study of VT3989 in mesothelioma. New leadership appointments were announced, and VT3989 holds FDA Fast Track and Orphan Drug designations.
Vivace Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class cancer therapies that target the Hippo signaling pathway, has received FDA safe to proceed for the pivotal Phase 3 sTEADfast registrational study of its lead candidate VT3989 in mesothelioma patients previously treated with both combination immunotherapy and combination chemotherapy. The company also announced a series of leadership appointments that position it for its next phase of growth as it prepares to advance VT3989 into late-stage development and toward commercialization.
VT3989, a first-in-class TEAD autopalmitoylation inhibitor that inhibits transcription by YAP/TAZ/TEAD which is activated in mesothelioma tumor cells, has generated impressive overall response (ORR) and progression-free survival (PFS) and tolerability data in patients with refractory mesothelioma as a monotherapy. In its Phase 1/2 study, VT3989 demonstrated durable antitumor activity and a favorable safety profile in heavily pretreated patients with mesothelioma, a cancer with limited treatment options after standard chemotherapy and immunotherapy. In addition to the safe to proceed for the Phase 3 sTEADfast clinical study from the FDA, VT3989 has also been granted both Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration. Vivace is now poised to initiate the registrational Phase 3 study in 2L/3L mesothelioma later this year.
The appointments come at an inflection point for Vivace. The company appointed a new President and Chief Executive Officer, a new Chief Business and Strategy Officer, and an oncology industry veteran to its Board of Directors. The new President and Chief Executive Officer most recently served as Chief Executive Officer of Asher Biotherapeutics and previously was Chief Business Officer of Forty Seven, Inc., which was acquired by Gilead Sciences. Earlier in his career, he spent more than 20 years at Gilead Sciences in leadership roles across biology research, corporate development, and commercial planning and operations after beginning his career in industry as a post-doc at Genentech Inc. The new Chief Business and Strategy Officer previously served as Chief Business Officer of Werewolf Therapeutics and has held senior business development and strategy roles across oncology and immunology, in addition to serving on the boards of multiple life sciences companies. The new Board member is a highly regarded oncology drug developer and executive whose leadership has helped shape multiple successful precision-oncology companies. The new leadership team brings deep experience in oncology drug development, corporate strategy, and value creation across the biotech landscape.