VT3989 is a transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor to target the Hippo pathway by inhibiting the palmitoylation of TEAD protein family members.
Vivace Therapeutics president and chief executive officer Sofie Qiao said: “The granting of Orphan Drug Designation to VT3989 underscores the critical need for new, effective therapies for mesothelioma, an aggressive cancer with limited treatment options. The benefits provided by this important designation will support our continued advancement of VT3989, which has already generated compelling clinical trial data, a first for this promising therapeutic class.
“We are committed to continuing clinical development of VT3989 and discussing a move into a registrational Phase 3 study in mesothelioma with the FDA by the end of 2025.”
VT3989 has been evaluated in an ongoing Phase I clinical study involving over 200 patients with refractory metastatic solid tumours.
The trial was designed to assess safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 with refractory metastatic solid tumours, specifically in those suffering from both pleural and non-pleural malignant mesothelioma.
The clinical data gathered thus far indicate that VT3989 has demonstrated a positive safety profile in the Phase I trial, highlighting its potential as a “best-in-class” therapy option.
Mesothelioma patients who have previously failed chemotherapy and immuno-oncology treatments—currently the only approved options—have shown particularly promising responses to VT3989.