TRACON Pharma files ENVASARC protocol with FDA for sarcoma treatment
Tracon Pharmaceuticals announced the filing of the pivotal ENVASARC protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application, according to a press release.
The application cross references the open envafolimab IND maintained by Tracon’s corporate partners 3D Medicines and Alphamab Oncology.
According to the press release, the FDA agrees with Tracon’s proposal regarding the trial for envafolimab, a novel, single-domain antibody against PD-L1, in soft tissue sarcoma subtypes, undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
Enrollment in the ENVASARC trial is expected to start in the second half of 2020, with a planned 160 patients being treated with envafolimab (n = 80) or envafolimab and ipilimumab (Yervoy; Bristol-Myers Squibb) (n = 80). The primary endpoint is objective response rate with duration of response a key secondary endpoint.
Read the full press release here.