Vivace Therapeutics Advances VT3989, First TEAD Inhibitor, Toward Pivotal Phase 3 Trial in Mesothelioma
核心洞察
Vivace Therapeutics (搜索) announced leadership appointments and FDA "Safe to Proceed" clearance as it prepares to advance VT3989 into the pivotal Phase 3 sTEADfast trial in mesothelioma (搜索).
VT3989 is a first-in-class, orally administered TEAD (搜索) autopalmitoylation inhibitor targeting the Hippo signaling pathway, with Fast Track and Orphan Drug designations from the FDA.
The Phase 3 registrational study will enroll mesothelioma (搜索) patients previously treated with both combination immunotherapy and combination chemotherapy, with initiation planned for later this year.
Vivace Therapeutics (搜索), Inc., a clinical-stage biopharmaceutical company pioneering first-in-class cancer therapies that target the Hippo signaling pathway, announced a series of leadership appointments that position the company for its next phase of growth as it prepares to advance its lead candidate, VT3989, into the pivotal Phase 3 sTEADfast registrational trial in mesothelioma (搜索) patients previously treated with both combination immunotherapy and combination chemotherapy. Craig Gibbs, Ph.D., has been appointed President and Chief Executive Officer, Ellen Lubman has joined as Chief Business and Strategy Officer, and industry veteran Tim Clackson, Ph.D., has been appointed to the company's Board of Directors.
The appointments come at an inflection point for Vivace. VT3989, a first-in-class TEAD (搜索) autopalmitoylation inhibitor that inhibits transcription by YAP/TAZ/TEAD (搜索), which is activated in mesothelioma (搜索) tumor cells, has generated impressive overall response (ORR), progression-free survival (PFS), and tolerability data in patients with refractory mesothelioma as a monotherapy. 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. With the new team capable of advancing VT3989 through late-stage development and toward commercialization, Vivace is now poised to initiate the registrational Phase 3 study in 2L/3L mesothelioma later this year.
A Differentiated Program Approaching a Pivotal Milestone
VT3989 targets the Hippo pathway, a fundamental regulator of cell growth that has long been considered difficult to drug. In its Phase 1/2 study, VT3989 demonstrated durable antitumor activity and a favorable safety profile in heavily pretreated patients with mesothelioma (搜索), a cancer with limited treatment options after standard chemotherapy and immunotherapy. Building on these results, Vivace is preparing to initiate a Phase 3 registrational trial, marking the company's transition from an emerging clinical-stage innovator to a late-stage oncology company.
"This is an exciting moment for Vivace," said Craig Gibbs, President and Chief Executive Officer of Vivace Therapeutics (搜索). "The company has translated novel biology into a differentiated clinical asset, and the data we've seen with VT3989 gives us real conviction as we prepare for the Phase 3 sTEADfast study. Despite the approval of over 35 targeted agents for other forms of lung cancer, current treatments for mesothelioma (搜索) are limited to non-tumor specific agents. We have a huge responsibility to deliver this meaningful new targeted agent to patients who have very few options today."
Leadership Built for the Next Chapter
The new leadership team brings deep experience in oncology drug development, corporate strategy, and value creation across the biotech landscape.
Craig Gibbs, PhD, MBA, President and Chief Executive Officer, is a seasoned biopharmaceutical leader with more than three decades of experience spanning research, corporate development, and commercial strategy. He 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. He holds a Ph.D. in molecular biology from the University of Glasgow and an M.B.A. from Golden Gate University.
Ellen Lubman, MBA, Chief Business and Strategy Officer, is an accomplished business and strategy executive with a track record of building partnerships, financings, and corporate strategy across the biopharmaceutical industry. She 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. At Vivace, she will lead the company's corporate strategy, business development, and partnering efforts as it advances VT3989 toward the market.
Tim Clackson, PhD, Member of the Board of Directors, is a highly regarded oncology drug developer and executive whose leadership has helped shape multiple successful precision-oncology companies. He most recently served as Chief Executive Officer of IDRx, a private, clinical-stage precision oncology company developing velzatinib, a potential best-in-class therapy for gastrointestinal stromal tumor (GIST). Under his leadership, IDRx advanced through key development, financial, and strategic inflection points, culminating in its acquisition by GSK for up to $1.15 billion. Earlier, he served as Chief Executive Officer of Theseus Pharmaceuticals, President of Xilio Therapeutics, and as President of Research and Development at ARIAD Pharmaceuticals.
Aligned Around a Clear Strategy
"Vivace sits at the intersection of exceptional science, impactful clinical response and genuine commercial opportunity," said Ellen Lubman, Chief Business and Strategy Officer. "First-in-class assets like VT3989 don't come along often, and my priority is to make sure we build the partnerships, resources, and strategy to realize its full potential for patients and shareholders. It's a privilege to help advance this molecule to benefit as many patients as possible, including patients in earlier lines of treatment and patients at risk of resistance to other anti-tumor agents."
"The biology around TEAD (搜索) is compelling, and VT3989 translates that potential into a derisked first-in-class asset with substantial clinical data," said Tim Clackson, PhD. "Vivace has a rare opportunity to bring a truly differentiated medicine to patients, and I look forward to working with Craig, Ellen, and the rest of the team as the company enters this pivotal stage."
About VT3989
VT3989 is a first-in-class, orally administered TEAD (搜索) autopalmitoylation inhibitor designed to inhibit transcription by YAP/TAZ/TEAD (搜索) on the Hippo signaling pathway, a central driver of tumor growth. VT3989 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for the treatment of mesothelioma (搜索). VT3989 has demonstrated encouraging antitumor activity and tolerability in patients with refractory mesothelioma and other solid tumors with activated YAP/TAZ/TEAD signaling, and in preclinical tumor models where activated YAP/TAZ/TEAD signaling drives resistance to other targeted anti-tumor agents.