TCON - Tracon wins FDA's fast track status for connective tissue tumor candidate

Cancer-focused biotech Tracon Pharmaceuticals ( NASDAQ: TCON ) announced Wednesday that the FDA granted fast-track designation for envafolimab (KN035) as a treatment for patients with connective tissue tumors pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

TCON shares jumped ~13% in pre-market trading after the news.

Developed by China-based Alphamab Oncology and licensed by TCON, envafolimab is a subcutaneously administered PD-( L )1 inhibitor.

The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.

If certain criteria are met, such programs will also be able to win the Accelerated Approval and Priority Review, enabling them to reach patients sooner.

Specifically, the TCON has won the fast track status for envafolimab as a treatment for patients with locally advanced, unresectable, or metastatic undifferentiated UPS and MFS, whose cancers have advanced despite one or two lines of prior chemotherapy.

The drug approved in China is currently undergoing a pivotal trial in the U.S. and U.K. involving patients with UPS and MFS. The trial is set to enroll more than 160 patients, with interim safety and efficacy reviews expected in Q4.

For further details see: