Vivace Therapeutics, a company that develops cancer treatments, announced on July 30, 2025, that the U.S. Food and Drug Administration (FDA) has granted its experimental drug, VT3989, an “Orphan Drug Designation” (ODD) to treat mesothelioma, a rare and aggressive form of cancer.
VT3989 is a TEAD inhibitor. It works by blocking the interaction of certain proteins (YAP/TAZ and TEAD) and disrupting the Hippo signaling pathway, which helps control how cells grow and divide. By stopping these proteins from interacting, the drug aims to slow down or stop the progression of cancer.
Orphan Drug Designation is a special status granted to therapies intended to treat rare diseases affecting fewer than 200,000 people in the U.S. This designation provides incentives to encourage the development of treatments for these diseases, which affect a relatively small number of people and may not be commercially viable without such support. This designation highlights VT3989’s potential to address a critical unmet medical need in mesothelioma.
VT3989 has been evaluated in over 200 patients in an ongoing Phase 1 clinical trial. It has shown encouraging anti-tumor activity, particularly in mesothelioma patients who have failed standard therapies.
Vivace stated that it plans to take their drug to a phase III trial, VT3989 for mesothelioma by the end of 2025. If successful, this could accelerate this drug towards FDA approval, bringing a much-needed treatment option for patients.
