Tracon’s Envafolimab Gets Fast Track Status for Two Soft Tissue Sarcoma Subtypes

Tracon Pharmaceuticals received Fast Track designation for the development of envafolimab, also known as KN035, for the treatment of patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma who have progressed on one or two prior lines of chemotherapy.

Envafolimab is a single-domain antibody that aims for PD-L1, is a protein that helps keep immune cells from attacking nonharmful cells.

The company entered a product development collaboration agreement in December 2019 with 3D Medicines and Alphamab Pharmaceuticals that gave Tracon access to envafolimab to develop and commercialize in soft tissue sarcoma in North America.

The company says it applied for Fast Track status because of activity observed in the phase 2 clinical trial ENVASARC.

The clinical trial, when completed, is expected to provide data showing envafolimab has superior efficacy and safety compared to currently approved therapy for refractory soft tissue sarcoma, according to Tracon.