Tracon contemplates strategic options after sarcoma drug fails Phase II trial

TRACON Pharmaceuticals has discontinued its Phase II ENVASARC trial for envafolimab, a sarcoma therapy, due to inadequate efficacy findings that cannot support a biologics licence application (BLA). An independent central review revealed a 5% objective response rate (ORR) among 82 evaluated patients, falling short of the trial's 11% ORR target.

All clinical development activities for envafolimab have been halted to conserve resources. TRACON intends to explore strategic options such as mergers, acquisitions, or licensing agreements, emphasizing its cost-effective, in-house product development platform independent of contract research organisations (CROs).

Sarcomas, rare cancers affecting bones and soft tissues, were the focus of envafolimab's investigation, particularly in advanced stages like undifferentiated pleomorphic sarcoma and myxofibrosarcoma. Envafolimab, a single-domain antibody targeting programmed death ligand 1 (PD-L1), was licensed for North America from Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in 2019.