TRACON Shares Ascend On FDA Fast Track Status To Soft Tissue Cancer Candidate

The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s TCON lead asset envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

The regulatory grant is based on data readout from ENVASARC Phase 2 pivotal trial that evaluated efficacy and safety of envafolimab.

Envafolimab is also being investigated in a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON's corporate partners, Alphamab Oncology and 3D Medicines.

Charles Theuer, President and CEO, commented: ”We applied for fast track designation based on activity observed in the ENVASARC Phase 2 pivotal trial and are pleased to receive this notification from the FDA. Soft tissue sarcoma is a disease in need of new treatments and we expect to provide data through the ENVASARC pivotal trial showing superior efficacy and safety of envafolimab compared to currently approved therapy for refractory soft tissue sarcoma.”

The company is expected to report an independent data monitoring committee interim safety and efficacy review in the fourth quarter.

The FDA designed the fast track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs.

Price action : TRACON shares are trading around 5 percent higher at $2.00 on Wednesday at the time of publication.