FDA grants Fast Track Designation to cancer and Parkinson's therapies

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to two distinct medical treatments.

BioInvent received the designation for BI-1808, a first-in-class anti-TNFR2 antibody intended for treating ovarian cancer in combination with pembrolizumab. Interim Phase 2a results indicated a 24% confirmed overall response rate and a 56% disease control rate in heavily pretreated patients. The therapy aims to enhance PD-1 inhibitor activity by targeting immunosuppressive cells in the tumor microenvironment.

Additionally, the FDA awarded fast track status to XS411, an experimental stem cell therapy developed by Xellsmart. Designed to replace lost dopamine-producing nerve cells, the therapy is being tested for early-onset Parkinson's disease. Clinical trials are currently underway in China and the U.S., with Phase 1/2 studies in Shanghai showing potential improvements in motor symptoms and quality of life.