Vivace Therapeutics, Inc., a biotechnology company focused on developing small molecule cancer therapies that target the Hippo pathway, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug VT3989. The designation applies to the treatment of patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed after immune checkpoint inhibitor therapy and platinum-based chemotherapy.

The FDA grants Fast Track Designation to drug candidates intended to treat serious or life-threatening conditions with unmet medical needs. This programme is designed to speed up the development and review process, enabling patients to access new therapies sooner. The designation allows for more frequent interactions with the FDA regarding clinical development and may offer eligibility for accelerated approval and priority review.

VT3989 is a first-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor that aims to block the palmitoylation of TEAD proteins, which play a key role in the Hippo signalling pathway. The compound is being evaluated in an ongoing open-label Phase 1 clinical study involving more than 200 patients.

To date, VT3989 has shown promising clinical efficacy and a favourable safety profile, supporting its potential as a best-in-class treatment option for mesothelioma. Vivace Therapeutics considers this designation an important step in advancing VT3989 towards potential commercialisation and addressing the need for more effective therapies in this difficult-to-treat cancer.

Source: prnewswire.com