Vivace Therapeutics has appointed Craig Gibbs as President and CEO as the company prepares to advance its lead candidate, VT3989, into a pivotal Phase 3 registrational trial.
The clinical-stage biopharmaceutical company also named Ellen Lubman as Chief Business and Strategy Officer and appointed oncology veteran Tim Clackson to its board of directors.
The FDA has granted a Safe to Proceed designation for the pivotal Phase 3 sTEADfast clinical study of VT3989 in mesothelioma patients previously treated with combination immunotherapy and combination chemotherapy.
VT3989 is a first-in-class TEAD autopalmitoylation inhibitor designed to block a cell growth pathway that is activated in mesothelioma tumors.
The drug has shown encouraging response rates, progression-free survival and tolerability in patients with refractory mesothelioma as a standalone treatment.
Gibbs most recently served as CEO of Asher Biotherapeutics and previously spent more than 20 years at Gilead Sciences in leadership roles.
Clackson most recently led IDRx, a precision oncology company that was acquired by GSK for up to $1.15 billion.
The privately held Vivace plans to initiate the registrational Phase 3 study in second-line and third-line mesothelioma patients later this year.